ruxolitinib (Rx)

Brand and Other Names:Jakafi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 25mg

Myelofibrosis

Kinase inhibitor indicated for treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF

Initial dose

  • Platelet count >200 x10^9/L: 20 mg PO BID
  • Platelet count 100-200 x10^9/L: 15 mg PO BID
  • Platelet count 50 to <100 x10^9/L: 5 mg PO BID

Insufficient response for patients starting treatment with a platelet count ≥100 X 10^9/L

  • If response is insufficient and platelet count and ANC are adequate, dose may be increased in 5 mg BID increments; not to exceed 25 mg PO BID
  • Do not increase dose during the first 4 weeks of therapy and no more frequently than q2Weeks
  • Consider dose increases in patients who meet all of the following conditions:
    • Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50% or a 35% reduction in spleen volume as measured by CT or MRI
    • Platelet count >125 x10^9/L at 4 weeks and never <100 x10^9/L
    • ANC levels >0.75 x10^9/L
    • Long-term maintenance at 5 mg BID has not shown responses and limit continued use at this dose to patients in whom the benefits outweigh the potential risks
    • Discontinue if there is no spleen size reduction or symptom improvement after 6 months of therapy

Insufficient response for patients starting treatment with a platelet count 50 x 10^9/L to <100 x 10^9/L

  • If response is insufficient and platelet count and ANC are adequate, doses may be increased by increments of 5 mg qDay to up to 10 mg BID
  • Do not increase dose during the first 4 weeks of therapy and no more frequently than q2Weeks
  • Consider dose increases in patients who meet all of the following conditions:
    • Platelet count has remained at least 40 x 10^9/L
    • Platelet count has not fallen by >20% in the prior 4 weeks
    • ANC >1 x 10^9/L
    • No dose reduction or interruption for an adverse event or hematological toxicity in the prior 4 weeks
  • Continuation of treatment for >6 months should be limited to patients in whom the benefits outweigh the potential risks
  • Discontinue treatment if there is no spleen size reduction or symptom improvement after 6 months of therapy

Polycythemia Vera

Indicated for polycythemia vera in patients who have had an inadequate response to or are intolerant of hydroxyurea

Initial: 10 mg PO BID

Increasing dose for insufficient response

  • If response is insufficient and platelet, hemoglobin, and neutrophil counts are adequate, doses may be increased in 5 mg BID increments to a maximum of 25 mg BID
  • Doses should not be increased during the first 4 weeks of therapy and not more frequently than q2Week
  • Consider dose increases in patients who meet all of the following criteria:
    • Inadequate efficacy as demonstrated by ≥1 of the following: continued need for phlebotomy, WBC > ULN, platelet count >ULN, palpable spleen that is reduced by <25% from baseline
    • Platelet count ≥140 x10^9/L
    • Hemoglobin ≥2 g/dL
    • ANC ≥1.5 x 10^9/L

Acute Graft versus Host Disease

Indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD)

Initial dose: 5 mg PO BID; may increase to 10 mg BID after at least 3 days if ANC and platelet counts have not decreased by ≥50% compared to baseline

Consider tapering after 6 months in patients with response who have discontinued therapeutic doses of corticosteroids

Tapering dose

  • Taper by 1 dose level ~q8Weeks (eg, 10 mg BID to 5 mg BID to 5 mg qDay)
  • Patients unable to tolerate 5 mg qDay: Interrupt treatment until clinical and/or laboratory parameters recover
  • If acute GVHD signs or symptoms recur during or after taper, consider retreatment

Chronic Graft versus Host Disease

Indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of 1 or 2 lines of systemic therapy

Initial dose: 10 mg PO BID

Consider tapering after 6 months in patients with response who have discontinued therapeutic doses of corticosteroids

Tapering dose

  • Taper by 1 dose level ~q8Weeks (eg, 10 mg BID to 5 mg BID, then from 5 mg BID to 5 mg qDay)
  • If acute GVHD signs or symptoms recur during or after taper, consider retreatment

Dosage Modifications (MF)

Dosage modification for bleeding (regardless of platelet count)

  • Interrupt treatment until bleeding resolved; consider resuming at prior dose if underlying cause of bleeding has resolved or at a reduced dose if underlying cause of bleeding persists

Treatment interruptions in patients starting treatment with a platelet count ≥100 x 10^9/L

  • Interrupt treatment for platelet count <50 x 10^9/L or ANC <0.5 x 10^9/L
  • After recovery of platelet counts >50 x 10^9/L and ANC >0.75 X 10^9/L, restart dose
  • Restart doses after interruption are as follows
    • Restart dose at least 5 mg BID below the dose at interruption; maximum doses listed below
    • Platelet count ≥125 x10^9/L: 20 mg BID
    • Platelet count 100 to <125 x10^9/L: 15 mg BID
    • Platelet count 75 to <100 x10^9/L: 10 mg BID for at least 2 weeks; if stable, may increase to 15 mg BID
    • Platelet count 50 to <75 x10^9/L: 5 mg BID for at least 2 weeks; if stable, may increase to 10 mg BID
    • Platelet count <50 x10^9/L: Continue to hold dose
    • After ANC recovers to ≥0.75 X 10^9/L, restart at the higher of 5 mg qDay or 5 mg BID below the largest dose in the week before treatment interruption
  • Dosage modifications for thrombocytopenia
    • Platelet count 100 to <125 x10^9/L: if taking 25 mg BID, decrease to 20 mg BID; if taking 20 mg BID, decrease to 15 mg BID; do not change dose if taking lower doses
    • Platelet count 75 to <100 x10^9/L: 10 mg BID; do not change dose if taking 5 mg BID
    • Platelet count 50 to <75 x10^9/L: 5 mg BID
    • Platelet count <50 x10^9/L: Hold dose
    • Long-term maintenance at a 5 mg BID dose has not shown responses and continued use at this dose should be limited to patients in whom the benefits outweigh the potential risks

Treatment interruption in patients starting treatment with a platelet count 50 to <75 x10^9/L

  • Interrupt treatment for platelet count <25 x 10^9/L or ANC less than 0.5 X 10^9/L
  • After recovery of platelet count >35 X 10^9/L and ANC >0.75 X 10^9/L, dosing may be restarted
  • Restart at the higher of 5 mg qDay or 5 mg BID below the largest dose in the week before treatment interruption
  • Dosage modifications for thrombocytopenia
    • Platelet count<25 x 10^9/L: Interrupt dose
    • Platelet count 25 x 10^9/L to <35 X 10^9/L AND the decrease in platelet count is <20% during the prior 4 weeks: Decrease dose by 5 mg qDay; for patients on 5 mg qDay, maintain current dose
    • Platelet count 25 x 10^9/L to <35 X 10^9/L AND the decrease in platelet count is ≥20%during the prior 4 weeks: Decrease dose by 5 mg BID; for patients on 5 mg BID, decrease dose to 5 mg qDay; for patients on 5 mg qDay, maintain current dose

Renal impairment

  • Moderate-to-severe (CrCl 15-59 mL/min)
    • Platelet count >150 x10^9/L: No dosage adjustment necessary
    • Platelet count 100-150 x10^9/L: Starting dose is 10 mg BID
    • Platelet count 50 to <100 x10^9/L: Starting dose is 5 mg qDay
    • Platelet count <50 x10^9/L: Avoid use
  • ESRD (CrCl <15 mL/min)
    • On dialysis and platelet count 100-200 x10^9/L: 15 mg once following dialysis session
    • On dialysis and platelet count >200 x10^9/L: 20 mg once following dialysis session
    • Not on dialysis: Avoid use

Hepatic impairment (any severity)

  • Platelet count >150 x10^9/L: No dosage adjustment necessary
  • Platelet count 100-150 x10^9/L: Starting dose is 10 mg BID
  • Platelet count 50 to <100 x10^9/L: Starting dose is 5 mg qDay
  • Platelet count <50 x10^9/L: Avoid use

Coadministration with strong CYP3A4 inhibitors or fluconazole

  • Reduce dose when coadministered with strong CYP3A4 inhibitors or fluconazole (≤200 mg/day)
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Closely monitor blood cell counts for toxicity and adjust ruxolitinib dose if necessary when coadministered with itraconazole
  • Starting dose for patients with myelofibrosis based on platelet count
    • Platelet count ≥100 x 10^9/L: 10 mg BID
    • Platelet counts 50 to <100 x 10^9/L: 5 mg BID
  • If stable on 10 mg BID, reduce by 50% (round up to the closest available tablet strength)
  • If stable on 5 mg BID, reduce 5 mg qDay
  • If stable on 5 mg qDay, avoid strong CYP3A4 inhibitor or fluconazole treatment or interrupt ruxolitinib for the duration of strong CYP3A4 inhibitor or fluconazole use

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy

Dosage Modifications (PV)

Dose reductions

  • Hgb ≥12 g/dL AND platelet count ≥100 x109/L: No change required
  • Hgb 10 to <12 g/dL AND platelet count 75 to <100 x109/L: Consider dose reduction with the goal of avoiding dose interruptions for anemia and thrombocytopenia
  • Hgb 8 to <10 g/dL OR platelet count 50 to <75 x109/L: Reduce dose by 5 mg BID; if already on 5 mg BID, then reduce dose to 5 mg qDay
  • Hgb <8 g/dL OR platelet count <50 x109/L: Interrupt dosing

Treatment interruption and restarting dosing

  • Interrupt treatment for hgb <8 g/dL, platelet counts <50 x109/L, or ANC <1 x109/L
  • After recovery to acceptable levels, dosing may be restarted
  • Use most severe category for individual parameters
    • Hgb <8 g/dL OR platelet count <50 x109/L OR ANC <1 x109/L: Continue to hold dosing
    • Hgb 8 to <10 g/dL OR platelet count 50 to <75 x109/L OR ANC 1 to <1.5 x109/L: 5 mg BID, or not to exceed 5 mg BID less than the dose which resulted in dose interruption
    • Hgb 10 to <12 g/dL OR platelet count 75 to <100 x109/L OR ANC 1.5 to <2 x10^9/L: 10 mg BID or not to exceed 5 mg BID less than the dose which resulted in dose interruption
    • Hgb ≥12 g/dL OR platelet count ≥100 x 10^9/L OR ANC ≥2 x10^9/L: 15 mg BID or not to exceed 5 mg BID less than the dose which resulted in dose interruption
    • Reinitiated doses: Continue dose for at least 2 weeks; if stable, may increase dose 5 mg BID
    • Patients receiving a dose of 5 mg BID and required dose interruption, may restart at 5 mg BID or 5 mg qDay, but not higher, once hemoglobin ≥10 g/dL, platelet count ≥75 x 10^9/L, and ANC ≥1.5 x 109/L

Renal impairment

  • Moderate-to-severe (CrCl 15-59 mL/min) with any platelet count: Starting dose is 5 mg BID
  • ESRD (CrCl <15 mL/min) on dialysis: 10 mg once after dialysis session
  • ESRD (CrCl <15 mL/min) not on dialysis: Avoid use

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, C) with any platelet count: Starting dose is 5 mg BID

Concomitant use with strong CYP3A4 inhibitors

  • Dose reductions for patients with PV on concomitant strong CYP3A4 inhibitors or fluconazole doses ≤200 mg
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Closely monitor blood cell counts for toxicity and adjust ruxolitinib dose if necessary when coadministered with itraconazole
  • Starting dose for patients with PV
    • Stable on ≥10 mg BID: Reduce dose by 50% (rounded up to the closest available tablet strength)
    • Stable on 5 mg BID: Reduce to 5 mg qDay
    • Stable on 5 mg PO qDay: Avoid coadministration with strong CYP3A4 inhibitors or fluconazole treatment or interrupt ruxolitinib treatment for the duration of strong CYP3A4 inhibitor or fluconazole use

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy

Dose Modifications (Acute GVHD)

Taper by 1 dose level (eg, 10 mg BID to 5 mg BID to 5 mg qDay)

Clinically significant thrombocytopenia after supportive measures: Reduce dose by 1 dose level; when platelets recover to previous values, restart dose to prior dose level

ANC <1 X 109/L (dose-related): Hold dose for up to 14 days; resume at 1 dose level lower upon recovery

Total bilirubin elevation, no liver GVHD

  • Total bilirubin 3 to 5x ULN: Continue at 1 dose level lower until recovery
  • Total bilirubin >5 to10x ULN: Hold dose for up to 14 days until bilirubin ≤1.5x ULN; resume at current dose upon recovery
  • Total bilirubin >10x ULN: Hold dose for up to 14 days until bilirubin ≤1.5x ULN; resume at 1 dose level lower upon recovery

Total bilirubin elevation with liver GVHD

  • Total bilirubin >3x ULN: Continue at 1 dose level lower until recovery

Renal impairment

  • Moderate or severe (CrCl 15-59 mL/min): Reduce dose to 5 mg qDay
  • ESRD (CrCl <15 mL/min) on dialysis: 5 mg once after dialysis session

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, C) with any platelet count: No dosage adjustment necessary
  • Stage 3 or 4 GvHD: Monitor blood cell counts more frequently for toxicity and consider 5 mg qDay

Concomitant use with strong CYP3A4 inhibitors

  • Dose reductions for patients with acute GvHD on concomitant strong CYP3A4 inhibitors or fluconazole doses of ≤200 mg
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Coadministered with other strong CYP3A4 inhibitors: Closely monitor blood cell counts for toxicity and adjust ruxolitinib dose if necessary

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy

Dose Modifications (Chronic GVHD)

Dose reduction schedule

  • Currently taking 10 mg BID: Reduce to 5 mg BID
  • Currently taking 5 mg BID: Reduce to 5 mg qDay
  • Currently taking 5 mg qDay: Interrupt dosing until clinical and/or laboratory parameters recover

Thrombocytopenia

  • Platelets <20 x 109/L: Reduce dose by 1 dose level
  • If resolved within 7 days, return to initial dose level
  • If not resolved within 7 days, maintain at 1 dose level lower

Decreased neutrophils

  • ANC considered related to ruxolitinib
  • ANC <0.75 x 109/L: Reduce dose by 1 level; resume at initial dose level upon recovery
  • ANC <0.5 x 109/L: Hold dose for up to 14 days; resume at 1 dose level lower upon recovery; may resume initial dose level when ANC >1 x 109/L

Total bilirubin elevation

  • Total bilirubin 3 to 5x ULN
    • Continue at 1 dose level lower until recovery; if resolved within 14 days, then increase by 1 dose level
    • If not resolved within 14 days, maintain at decreased dose level
  • Total bilirubin >5 to 10x ULN
    • Hold dose for up to 14 days until resolved; resume at current dose upon recovery
    • If not resolved within 14 days, resume at 1 dose level lower upon recovery
  • Total bilirubin >10x ULN
    • Hold dose for up to 14 days until resolved; resume at current dose upon recovery
    • Discontinue if not resolved within 14 days

Other adverse reactions

  • Grade 3: Continue at 1 dose level lower until recovery
  • Grade 4: Discontinue

Renal impairment

  • Moderate or severe (CrCl 15-59 mL/min): Reduce dose to 5 mg BID
  • ESRD (CrCl <15 mL/min) on dialysis: 10 mg once after dialysis session

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, C) without liver GVHD: No dosage adjustment necessary
  • Score 1 or 2 liver cGVHD: No dosage adjustment necessary
  • Score 3 liver cGVHD: Monitor blood cell counts more frequently for toxicity and modify dose if adverse reactions occur

Concomitant use with strong CYP3A4 inhibitors

  • Fluconazole doses ≤200 mg: Reduce to 5 mg BID
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Coadministered with other CYP3A4 inhibitors: Monitor blood cell counts more frequently for toxicity and modify dosage for adverse reactions if they occur

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy

Dosing Considerations

Perform complete blood cell count (CBC) and platelet count before initiating therapy, q2-4Weeks until doses are stabilized, and then as clinically indicated

Orphan Designations

Pancreatic cancer

Orphan sponsor

  • Incyte Corporation; 1801 Augustine Cut-Off; Wilmington, Delaware 19803

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 25mg

Acute Graft versus Host Disease

Indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adults and children (≥12 years)

<12 years: Safety and efficacy not established

≥12 years

  • Initial dose: 5 mg PO BID; may increase to 10 mg BID after at least 3 days if ANC and platelet counts have not decreased by ≥50% compared to baseline
  • Consider tapering after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids
  • Tapering dose
    • Taper by 1 dose level ~q8Weeks (eg, 10 mg BID to 5 mg BID to 5 mg qDay)
    • Patients unable to tolerate 5 mg qDay: Interrupt treatment until clinical and/or laboratory parameters recover
    • If acute GVHD signs or symptoms recur during or after taper, consider retreatment

Chronic Graft versus Host Disease

Indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of 1 or 2 lines of systemic therapy in adolescents aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years

  • Initial dose: 10 mg PO BID
  • Consider tapering after 6 months in patients with response who have discontinued therapeutic doses of corticosteroids
  • Tapering dose
    • Taper by 1 dose level ~q8Weeks (eg, 10 mg BID to 5 mg BID, then from 5 mg BID to 5 mg qDay)
    • If acute GVHD signs or symptoms recur during or after taper, consider retreatment

Dose Modifications (Acute GVHD)

Clinically significant thrombocytopenia after supportive measures: Reduce dose by 1 dose level; when platelets recover to previous values, restart dose to prior dose level

ANC <1 X 109/L (dose-related): Hold dose for up to 14 days; resume at 1 dose level lower upon recovery

Total bilirubin elevation, no liver GVHD

  • Total bilirubin 3 to 5x ULN: Continue at 1 dose level lower until recovery
  • Total bilirubin >5 to10x ULN: Hold dose for up to 14 days until bilirubin ≤1.5x ULN; resume at current dose upon recovery
  • Total bilirubin >10x ULN: Hold dose for up to 14 days until bilirubin ≤1.5x ULN; resume at 1 dose level lower upon recovery

Total bilirubin elevation with liver GVHD

  • Total bilirubin >3x ULN: Continue at 1 dose level lower until recovery

Renal impairment

  • Moderate or severe (CrCl 15-59 mL/min): Reduce dose to 5 mg qDay
  • ESRD (CrCl <15 mL/min) on dialysis: 5 mg once after dialysis session

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, C) with any platelet count: No dosage adjustment necessary
  • Stage 3 or 4 GvHD: Monitor blood cell counts more frequently for toxicity and consider 5 mg qDay

Concomitant use with strong CYP3A4 inhibitors

  • Dose reductions for patients with acute GvHD on concomitant strong CYP3A4 inhibitors or fluconazole doses of ≤200 mg
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Coadministered with other strong CYP3A4 inhibitors: Closely monitor blood cell counts for toxicity and adjust ruxolitinib dose if necessary

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy

Dose Modifications (Chronic GVHD)

Dose reduction schedule

  • Currently taking 10 mg BID: Reduce to 5 mg BID
  • Currently taking 5 mg BID: Reduce to 5 mg qDay
  • Currently taking 5 mg qDay: Interrupt dosing until clinical and/or laboratory parameters recover

Thrombocytopenia

  • Platelets <20 x 109/L: Reduce dose by 1 dose level
  • If resolved within 7 days, return to initial dose level
  • If not resolved within 7 days, maintain at 1 dose level lower

Decreased neutrophils

  • ANC considered related to ruxolitinib
  • ANC <0.75 x 109/L: Reduce dose by 1 level; resume at initial dose level upon recovery
  • ANC <0.5 x 109/L: Hold dose for up to 14 days; resume at 1 dose level lower upon recovery; may resume initial dose level when ANC >1 x 109/L

Total bilirubin elevation

  • Total bilirubin 3 to 5x ULN
    • Continue at 1 dose level lower until recovery; if resolved within 14 days, then increase by 1 dose level
    • If not resolved within 14 days, maintain at decreased dose level
  • Total bilirubin >5 to 10x ULN
    • Hold dose for up to 14 days until resolved; resume at current dose upon recovery
    • If not resolved within 14 days, resume at 1 dose level lower upon recovery
  • Total bilirubin >10x ULN
    • Hold dose for up to 14 days until resolved; resume at current dose upon recovery
    • Discontinue if not resolved within 14 days

Other adverse reactions

  • Grade 3: Continue at 1 dose level lower until recovery
  • Grade 4: Discontinue

Renal impairment

  • Moderate or severe (CrCl 15-59 mL/min): Reduce dose to 5 mg BID
  • ESRD (CrCl <15 mL/min) on dialysis: 10 mg once after dialysis session

Hepatic impairment

  • Mild, moderate, or severe (Child-Pugh A, B, C) without liver GVHD: No dosage adjustment necessary
  • Score 1 or 2 liver cGVHD: No dosage adjustment necessary
  • Score 3 liver cGVHD: Monitor blood cell counts more frequently for toxicity and modify dose if adverse reactions occur

Concomitant use with strong CYP3A4 inhibitors

  • Fluconazole doses ≤200 mg: Reduce to 5 mg BID
  • Avoid fluconazole doses >200 mg/day concomitantly with ruxolitinib
  • Coadministered with other CYP3A4 inhibitors: Monitor blood cell counts more frequently for toxicity and modify dosage for adverse reactions if they occur

Coadministration with CYP3A4 inducers

  • No dose adjustment recommended; however, closely monitor and titrate dose based on safety and efficacy
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Interactions

Interaction Checker

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              Serious - Use Alternative (33)

              • abametapir

                abametapir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • atazanavir

                atazanavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • chloramphenicol

                chloramphenicol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib dosage during coadministration with chloramphenicol in patients with myelofibrosis (MF) or polycythemia vera (PV); no dose adjustments necessary for patients with graft-versus-host disease

              • clarithromycin

                clarithromycin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • cobicistat

                cobicistat will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • conivaptan

                conivaptan will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • darunavir

                darunavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • deferiprone

                deferiprone, ruxolitinib. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • fexinidazole

                fexinidazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • fosamprenavir

                fosamprenavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • grapefruit

                grapefruit will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • idelalisib

                idelalisib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • imatinib

                imatinib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • indinavir

                indinavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • isoniazid

                isoniazid will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • itraconazole

                itraconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • ivosidenib

                ivosidenib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • ketoconazole

                ketoconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • lonafarnib

                lonafarnib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • lopinavir

                lopinavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • nefazodone

                nefazodone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • nelfinavir

                nelfinavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • nicardipine

                nicardipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • palifermin

                palifermin increases toxicity of ruxolitinib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • posaconazole

                posaconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • quinidine

                quinidine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • ritonavir

                ritonavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • saquinavir

                saquinavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • tipranavir

                tipranavir will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • tucatinib

                tucatinib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • voriconazole

                voriconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Reduce ruxolitinib starting dose to 10 mg BID with platelet count 100 X 10^9/L or more and concurrent use of strong CYP3A4 inhibitors; avoid with platelet counts <100 X 10^9/L

              • voxelotor

                voxelotor will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (54)

              • amiodarone

                amiodarone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • aprepitant

                aprepitant will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • bicalutamide

                bicalutamide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • bosentan

                bosentan will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • cholera vaccine

                ruxolitinib decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • cimetidine

                cimetidine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clotrimazole

                clotrimazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clozapine

                clozapine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • crofelemer

                crofelemer increases levels of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

              • cyclosporine

                cyclosporine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dabrafenib

                dabrafenib will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • desipramine

                desipramine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • diltiazem

                diltiazem will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • doxycycline

                doxycycline will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • dronedarone

                dronedarone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • duvelisib

                duvelisib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

              • efavirenz

                efavirenz will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • elagolix

                elagolix decreases levels of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

              • encorafenib

                encorafenib, ruxolitinib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • enzalutamide

                enzalutamide will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin base

                erythromycin base will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fedratinib

                fedratinib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fluconazole

                fluconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • haloperidol

                haloperidol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • iloperidone

                iloperidone increases levels of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • istradefylline

                istradefylline will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • lapatinib

                lapatinib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • lidocaine

                lidocaine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • metronidazole

                metronidazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mitotane

                mitotane decreases levels of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • nafcillin

                nafcillin will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ofatumumab SC

                ofatumumab SC, ruxolitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • phenobarbital

                phenobarbital will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phenytoin

                phenytoin will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • primidone

                primidone will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

                rifampin will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifapentine

                rifapentine will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rucaparib

                rucaparib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • sertraline

                sertraline will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • siponimod

                siponimod and ruxolitinib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • stiripentol

                stiripentol, ruxolitinib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • tetracycline

                tetracycline will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, ruxolitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, ruxolitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • verapamil

                verapamil will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (100)

              • acetaminophen

                acetaminophen will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • acetaminophen IV

                acetaminophen IV will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • acetaminophen rectal

                acetaminophen rectal will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • acetazolamide

                acetazolamide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • amlodipine

                amlodipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • anastrozole

                anastrozole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • armodafinil

                armodafinil will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • atorvastatin

                atorvastatin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • azelastine

                azelastine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • azithromycin

                azithromycin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • betamethasone

                betamethasone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • bortezomib

                bortezomib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • bromocriptine

                bromocriptine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • chlorzoxazone

                chlorzoxazone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ciprofloxacin

                ciprofloxacin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • clemastine

                clemastine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cocaine

                cocaine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cyclophosphamide

                cyclophosphamide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • danazol

                danazol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • darifenacin

                darifenacin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dasatinib

                dasatinib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • desvenlafaxine

                desvenlafaxine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dexmedetomidine

                dexmedetomidine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • diazepam

                diazepam will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • diclofenac

                diclofenac will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dihydroergotamine

                dihydroergotamine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dihydroergotamine intranasal

                dihydroergotamine intranasal will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • disulfiram

                disulfiram will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • docetaxel

                docetaxel will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • doxorubicin

                doxorubicin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • doxorubicin liposomal

                doxorubicin liposomal will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • drospirenone

                drospirenone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ergotamine

                ergotamine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ethinylestradiol

                ethinylestradiol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • etoposide

                etoposide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • felodipine

                felodipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fluoxetine

                fluoxetine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fluvastatin

                fluvastatin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • glyburide

                glyburide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • hydralazine

                hydralazine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ifosfamide

                ifosfamide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • irbesartan

                irbesartan will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • isradipine

                isradipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • losartan

                losartan will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lovastatin

                lovastatin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lurasidone

                lurasidone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • mefloquine

                mefloquine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • mestranol

                mestranol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • methadone

                methadone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • methimazole

                methimazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • methoxsalen

                methoxsalen will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • methylprednisolone

                methylprednisolone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • micafungin

                micafungin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • midazolam

                midazolam will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • mifepristone

                mifepristone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • mirtazapine

                mirtazapine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • mitoxantrone

                mitoxantrone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • modafinil

                modafinil will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nevirapine

                nevirapine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nifedipine

                nifedipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nisoldipine

                nisoldipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • olanzapine

                olanzapine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • omeprazole

                omeprazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • orphenadrine

                orphenadrine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • oxybutynin

                oxybutynin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • oxybutynin topical

                oxybutynin topical will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • oxybutynin transdermal

                oxybutynin transdermal will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • paroxetine

                paroxetine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pazopanib

                pazopanib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pentamidine

                pentamidine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pilocarpine

                pilocarpine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pimozide

                pimozide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pravastatin

                pravastatin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • primaquine

                primaquine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • progesterone micronized

                progesterone micronized will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • progesterone, natural

                progesterone, natural will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • propofol

                propofol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • quinine

                quinine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ranolazine

                ranolazine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ribociclib

                ribociclib will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • risperidone

                risperidone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • selegiline

                selegiline will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • sirolimus

                sirolimus will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • sulconazole

                sulconazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • tamoxifen

                tamoxifen will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • temsirolimus

                temsirolimus will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • teniposide

                teniposide will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • testosterone

                testosterone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • testosterone buccal system

                testosterone buccal system will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • testosterone topical

                testosterone topical will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ticlopidine

                ticlopidine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • tranylcypromine

                tranylcypromine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • trazodone

                trazodone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • valproic acid

                valproic acid will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vinblastine

                vinblastine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vincristine

                vincristine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vincristine liposomal

                vincristine liposomal will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vinorelbine

                vinorelbine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • zafirlukast

                zafirlukast will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ziprasidone

                ziprasidone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10% (MF and PV)

              Anemia (96.1%)

              Thrombocytopenia (69.7%)

              Increased ALT, grade 1 (25.2%)

              Bruising (23.2%)

              Neutropenia (18.7%)

              Dizziness (18.1%)

              Increased AST, grade 1 (17.1%)

              Increased cholesterol, grade 1 (16.8%)

              Headache (14.8%)

              >10% (GvHD)

              Anemia (75%)

              Thrombocytopenia (75%)

              Thrombocytopenia, Grade 3-4 (61%)

              Neutropenia (58%)

              Infections (55%)

              Edema (51%)

              Hemorrhage (49%)

              Anemia, Grade 3-4 (45%)

              Infections, Grade 3-4 (41%)

              Neutropenia (40%)

              Elevated ALT/AST (48%)

              Fatigue (37%)

              Bacterial infections (32%)

              Bacterial infections, Grade 3-4 (28%)

              Hemorrhage, Grade 3-4 (20%)

              Fatigue, Grade 3-4 (14%)

              Edema, Grade 3-4 (13%)

              Hypertriglyceridemia (11%)

              1-10% (MF and PV)

              Urinary tract infection (9%)

              Weight gain (7.1%)

              Flatulence (5.2%)

              Herpes zoster (1.9%)

              Increased ALT, grade 2 (1.9%)

              Increased ALT, grade 3 (1.3%)

              1-10% (GvHD)

              Elevated ALT/AST, Grade 3-4 (6-8%)

              Hypertriglyceridemia, Grade 3-4 (1%)

              <1%

              Increased AST, grade 2 (0.6%)

              Increased cholesterol, grade 2 (0.6%)

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              Warnings

              Contraindications

              None

              Cautions

              Nonmelanoma skin cancers reporrted including basal cell, squamous cell, and Merkel cell carcinoma

              Thrombocytopenia, anemia, & neutropenia

              • Perform CBC before initiating therapy and monitor as clinically indicated and dosing adjusted as required
              • Patients with platelet counts <200 x10^9/L at the start of therapy are more likely to develop thrombocytopenia during treatment
              • Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding dose (see Adult Dosing); if clinically indicated, platelet transfusions may be administered
              • Anemia may require blood transfusions; dose modifications may also be considered
              • Neutropenia (ANC <0.5 x10^9/L) was generally reversible and was managed by temporarily withholding dose

              Infections

              • Assess for the risk of developing serious bacterial, mycobacterial, fungal, and viral infections
              • Active serious infections should have resolved before starting therapy
              • Tuberculosis (TB) infection has been reported; before initiating, evaluate patients for TB risk factors, and those at higher risk should be tested for latent infection
              • Carefully observe patients for signs and symptoms of infection and initiate appropriate treatment promptly
              • Herpes zoster: Inform patients about early signs and symptoms of herpes zoster and advise to seek treatment as early as possible
              • Progressive multifocal leukoencephalopathy (PML): Reported with ruxolitinib treatment for myelofibrosis; if suspected, discontinue drug and evaluate
              • Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, reported in patients with chronic HBV infection; effect of ruxolitinib on viral replication unknown; treat and monitor patients with chronic HBV infection according to clinical guidelines

              Symptoms with dose interruption, dose tapering, or discontinuing

              • Following discontinuation/interruption, myelofibrosis symptoms may be exacerbated and general return to pretreatment levels after 1 week
              • Other adverse effects reported include fever, respiratory distress, hypotension, DIC, or multiorgan failure
              • If these symptoms occur after discontinuation or dose tapering, evaluate and treat any intercurrent illness and consider restarting ruxolitinib or increase the dose
              • Instruct patients not to interrupt or discontinue ruxolitinib without consulting their physician
              • When discontinuing or interrupting therapy for reasons other than thrombocytopenia or neutropenia, consider tapering the dose gradually rather than discontinuing abruptly

              Hyperlipidemia

              • Treatment has been associated with increases in lipid parameters including total cholesterol, low density lipoprotein, and triglycerides; assess lipid parameters approximately 8-12 weeks following initiation of therapy; monitor according to clinical guidelines for management of hyperlipidemia

              Drug interactions overview

              • CYP3A4 inhibitors
                • Ruxolitinib is predominantly metabolized by CYP3A4
                • Strong CYP3A4 inhibitors increase ruxolitinib Cmax and AUC 33% and 91%, respectively
                • Dose modification recommended when coadministered with strong CYP3A4 inhibitors (such as but not limited to boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole)
              • CYP3A4 inducers
                • Coadministration with strong CYP3A4 inducers may decrease ruxolitinib exposure
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              Pregnancy & Lactation

              Pregnancy

              When pregnant rats and rabbits were administered ruxolitinib during organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity

              There are no studies with use in pregnant women to inform drug-associated risks

              Lactation

              No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production

              Ruxolitinib and/or its metabolites were present in the milk of lactating rats

              Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for ruxolitinib in human studies, discontinue breastfeeding during treatment and for 2 weeks after final dose

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Kinase inhibitor; inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function

              JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression

              Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling

              Absorption

              Bioavailability: 95%

              Peak plasma time: 1-2 hr

              Distribution

              Protein bound: 97% (mostly albumin)

              Vd at steady-state: 72 L (MF); 75 L (PV)

              Metabolism

              Ruxolitinib is the predominant entity in humans representing approximately 60% of the drug-related material in circulation

              Metabolized by CYP3A4 (major)

              Metabolites: 2 major active metabolites identified representing 25% and 11% of parent AUC; these 2 metabolites have 20% and 50% of ruxolitinib’s pharmacological activity, respectively; the sum total of all active metabolites contributes 18% of the overall pharmacodynamics of ruxolitinib

              Elimination

              Half-life: 2.8- 3 hr (ruxolitinib); 5.8 hr (ruxolitinib plus metabolites); 5 hr (hepatic impairment)

              Clearance: 17.7 L/hr (women, MF); 22.1 L/hr (males, MF); 12.7 L/hr (PV); 11.9 L/hr (acute GvHD)

              Excretion: feces (22%), urine (74%); unchanged drug accounted for <1%

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              Administration

              Oral Administration

              Take with or without food

              If a dose is missed, patients do not take an additional dose, but take the next usual prescribed dose

              When discontinuing for reasons other than thrombocytopenia, consider gradual tapering the dose (eg, by 5 mg q12hr per week)

              NG tube administration

              • If unable to ingest tablets, can be administered through a nasogastric tube (8 French or greater) as follows
                • Suspend 1 tablet in ~40 mL of water with stirring for ~10 minutes
                • Administer suspension within 6 hr after the tablet has dispersed through NG using an appropriate syringe
                • Rinse NG tube with ~75 mL of water
                • Effect of tube feeding preparations on ruxolitinib exposure during administration through NG has not been evaluated

              Storage

              Tablet: Store at room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

              Suspension for NG tube: Store at room temperature 20-25°C (68-77°F) for up to 6 hr

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Jakafi oral
              -
              15 mg tablet
              Jakafi oral
              -
              10 mg tablet
              Jakafi oral
              -
              5 mg tablet
              Jakafi oral
              -
              20 mg tablet
              Jakafi oral
              -
              25 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              ruxolitinib oral

              RUXOLITINIB - ORAL

              (RUX-oh-LI-ti-nib)

              COMMON BRAND NAME(S): Jakafi

              USES: This medication is used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera). It works by blocking your body from producing substances called growth factors. Growth factors cause cells to grow and divide, and cause the blood cell and spleen problems found in these disorders. Ruxolitinib belongs to a class of drugs known as kinase inhibitors. Though not a cure for these disorders, ruxolitinib may help with some of the symptoms, including abdominal discomfort, pain under left ribs, early feelings of fullness from meals, night sweats, itching, and bone/muscle pain.Ruxolitinib is also used to treat a certain problem that may occur after certain stem cell or bone marrow transplants (graft versus host disease). It works by weakening your body's defense system (immune system).

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking ruxolitinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually twice daily. If you are unable to swallow the tablets, ask your doctor about other ways to take this medication.The dosage is based on your medical condition, laboratory test results, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Do not stop taking ruxolitinib without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as fever, trouble breathing, dizziness, and unusual bleeding/bruising. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.Tell your doctor if your symptoms do not improve or if they worsen.

              SIDE EFFECTS: Dizziness, diarrhea, headache, weight gain, or gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: unusual tiredness, easy bleeding/bruising, unusual skin changes.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, cough, painful skin rash/blisters, persistent sore throat).This medication may also increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes.Another medication similar to ruxolitinib has caused serious (possibly fatal) side effects, including heart problems, blood clots, and cancer (such as lymphoma). Before using ruxolitinib, tell your doctor or pharmacist if you have a history of heart disease, stroke, cancer, or any risk factors for heart disease (such as high blood pressure, diabetes, previous blood clots, high cholesterol, smoking or history of smoking). Discuss the risks and benefits of treatment with your doctor. Get medical help right away if you have symptoms such as shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, or weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Side Effects section.Before taking ruxolitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past/returning infections (such as tuberculosis), kidney disease, liver disease, cancer (such as skin cancer).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Ruxolitinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu, tuberculosis). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after stopping treatment. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood counts, cholesterol/triglyceride levels, skin exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.