eltrombopag (Rx)

Brand and Other Names:Promacta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 12.5mg
  • 25mg
  • 50mg
  • 75mg

Chronic Immune Thrombocytopenia (ITP)

Indicated in patients with insufficient response to corticosteroids, immunoglobulins, or splenectomy

Use only in patients with ITP whose clinical condition increases bleeding risk

Initial: 50 mg PO qDay

Maintenance: Adjust dose to achieve and maintain platelet count (Plt) >50 x 10^9/L to reduce risk of bleeding; not to exceed 75 mg/day

Chronic Hepatitis C-associated Thrombocytopenia

Indicated to allow initiation and maintenance of interferon-based therapy

Initial: 25 mg PO qDay

Adjust dose in 25 mg increments q2weeks PRN to achieve target platelet count required to initiate/maintain antiviral therapy with pegylated interferon and ribavirin; not to exceed 100 mg/day

During antiviral therapy, adjust dose to avoid dose reductions of peginterferon

Severe Aplastic Anemia

First-line therapy

  • First-line treatment, in combination with standard immunosuppressive therapy, for patients with severe aplastic anemia (SAA)
  • Initial dose: 150 mg PO qDay for 6 months
  • Do not exceed initial dose; total duration is 6 months

Refractory SAA

  • Indicated for SAA in patients who fail to respond adequately to at least 1 prior immunosuppressive therapy
  • Initial dose: 50 mg PO qDay
  • Adjust dose in 50-mg increments q2Weeks PRN to achieve target Plt ≥50 x 10^9/L as necessary; not exceed 150 mg/day; may take up to 16 weeks for hematologic response

Dosage Modifications

Dosage adjustment based on platelet count

  • Chronic ITP
    • Plt <50 x 10^9/L (following ≥2 weeks of treatment): Increase daily dose by 25 mg; not to exceed 75 mg/day
    • Plt 200 to 400 x 10^9/L at any time: Decrease daily dose by 25 mg; assess effects after 2 weeks
    • Plt >400 x 10^9/L: Withhold eltrombopag; monitor twice weekly; once Plt <150 x 10^9/L, resume and reduce daily dose by 25 mg; (if taking 25 mg qDay, resume with 12.5 mg qDay)
    • Plt >400 x 10^9/L (after 2 weeks at the lowest dose): Discontinue eltrombopag
  • Dosage adjustment in adults with thrombocytopenia due to chronic hepatitis C
    • Plt <50 x 10^9/L (following ≥2 weeks of treatment): Increase daily dose by 25 mg; not to exceed 100 mg/day
    • Plt 200 to 400 x 10^9/L at any time: Decrease daily dose by 25 mg; assess effects after 2 weeks
    • Plt >400 x 10^9/L: Withhold eltrombopag; monitor twice weekly; once Plt <150 x 10^9/L, resume and reduce daily dose by 25 mg; (if taking 25 mg qDay, resume with 12.5 mg qDay)
    • Plt >400 x 10^9/L (after 2 weeks at the lowest dose): Discontinue eltrombopag
  • First-line SAA
    • Plt >200 to 400 x 10^9/L: Decrease daily dose by 25 mg q2Weeks to lowest dose that maintains Plt≥50 x 10^9/L
    • Plt >400 x 10^9/L: Discontinue eltrombopag for 1 week; once Plt is <200 x 10^9/L, resume and reduce daily dose by 25 mg
  • Refractory SAA
    • Plt <50 x 10^9/L (following ≥2 weeks of treatment): Increase daily dose by 50 mg; not to exceed 150 mg/day; if taking 25 mg qDay, increase dose to 50 mg qDay before increasing dose amount by 50 mg
    • Plt 200 to 400 x 10^9/L at any time: Decrease daily dose by 50 mg; assess after 2 weeks
    • Plt >400 x 10^9/L: Withhold dose for 1 week; when Plt is <150 x 10^9/L, resume and reduce dose by 50 mg
    • Plt >400 x 10^9/L after 2 weeks at lowest dose: Discontinue treatment
    • For patients who achieve trilineage response (eg, transfusion independence) ≥8 weeks: Reduce dose by 50%
    • Plts remain stable after 8 weeks at reduced dose: Discontinue treatment and monitor blood counts
    • If Plts <30 x 10^9/L, hemoglobin <9 g/dL, or ANC <0.5 x 10^9/L, reinitiate at previous effective dose

Discontinue treatment

  • Chronic ITP: If Plt fails to respond to a level that avoids clinically important bleeding after 4 weeks at the maximum of 75 mg/day
  • Refractory SAA: No hematologic response occurred after 16 weeks of therapy OR consider if new cytogenetic abnormalities are observed

Elevated ALT/AST (First-line SAA)

  • Increase ALT/AST >6x ULN: Discontinue treatment; once ALT/AST <5x ULN, reinitiate at same dose
  • Increase ALT/AST >6x ULN (after reinitiation): Discontinue treatment and monitor ALT/AST at least q3-4 days; once ALT/AST <5x ULN, reinitiate and reduce daily dose by 25 mg of previous dose
  • If ALT/AST returns to >6x ULN on reduced dose, the reduce daily dose by 25 mg until ALT/AST <5x ULN

Thromboembolic events (First-line SAA)

  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolus, stroke, myocardial infarction): Discontinue eltrombopag, remain on horse antithymocyte globulin (h-ATG) and cyclosporine

Asian ancestry

  • Such as Chinese, Japanese, Taiwanese, or Korean
  • Chronic ITP: Reduce to 25 mg PO qDay
  • First-line therapy for SAA: Decrease initial dose by 50%

Hepatic impairment

  • Chronic hepatitis C-associated thrombocytopenia: No dosage adjustment necessary
  • Chronic ITP
    • Mild to severe (Child-Pugh Class A to C): Reduce to 25 mg PO qDay
    • Mild to severe (Child-Pugh Class A to C) and of Asian ancestry: Reduce to 12.5 mg PO qDay
    • Wait 3 weeks before increasing dose after initiation or after any subsequent dosing increase
  • SAA
    • First-line therapy for SAA: Mild to severe (Child-Pugh Class A to C): Decrease initial dose by 50%
    • Refractory SAA: Mild to severe (Child-Pugh Class A to C): Reduce to 25 mg qDay

Dosing Considerations

During therapy, assess complete blood cell counts (CBCs) weekly until a stable Plt is achieved; obtain CBCs with differentials, monthly thereafter

Measure ALT, AST, and bilirubin prior to initiation of therapy, every other day while hospitalized for horse antithymocyte globulin (h-ATG) therapy, and then every 2 weeks during treatment

Limitations of use

  • Not indicated for treatment of myelodysplastic syndrome (MDS)
  • Safety and efficacy not established in combination with direct-acting antiviral agents used without interferon for chronic hepatitis C infection

Dosage Forms & Strengths

tablet

  • 12.5mg
  • 25mg
  • 50mg
  • 75mg

powder for oral suspension

  • 12.5mg/unit-dose
  • 25mg/unit-dose

Chronic Immune Thrombocytopenia

Indicated for treatment of thrombocytopenia in adults and pediatric patients ≥1 yr with chronic immune (idiopathic) thrombocytopenia (ITP) with insufficient response to corticosteroids, immunoglobulins, or splenectomy; use only in patients with ITP whose clinical condition increases bleeding risk

<1 year: Safety and efficacy not established

1-5 Years: Initiate at 25 mg qDay

≥6 years: Initiate at 50 mg PO qDay

Maintenance: Adjust dose to achieve and maintain platelet count (Plt) >50 x 10^9/L to reduce risk of bleeding; not to exceed 75 mg/day

Severe Aplastic Anemia

First-line therapy

  • First-line treatment, in combination with standard immunosuppressive therapy, for of adult and pediatric patients ≥2 yr with severe aplastic anemia (SAA)
  • <2 years: Safety and efficacy not established
  • 2-5 years: 2.5 mg/kg qDay for 6 months initially
  • 6-11 years: 75 mg PO qDay for 6 months initially
  • ≥12 years: 150 mg PO qDay for 6 months initially
  • Do not exceed initial dose; total duration is 6 months

Dosage Modifications

Dosage adjustment based on platelets

  • Chronic ITP
    • Plt <50 x 10^9/L (following ≥2 weeks of treatment): Increase daily dose by 25 mg; not to exceed 75 mg/day
    • Plt 200 to 400 x 10^9/L at any time: Decrease daily dose by 25 mg; assess effects after 2 weeks
    • Plt >400 x 10^9/L: Withhold eltrombopag; monitor twice weekly; once Plt <150 x 10^9/L, resume and reduce daily dose by 25 mg; (if taking 25 mg qDay, resume with 12.5 mg qDay)
    • Plt >400 x 10^9/L (after 2 weeks at the lowest dose): Discontinue eltrombopag
  • First-line SAA
    • Plt >200 to 400 x 10^9/L: Decrease daily dose by 25 mg q2Weeks to lowest dose that maintains
    • Plt≥50 x 10^9/L; decrease dose by 12.5 mg in pts <12 years
    • Plt >400 x 10^9/L: Discontinue eltrombopag for 1 week; once Plt is <200 x 10^9/L, resume and reduce daily dose by 25 mg; decrease dose by 12.5 mg in pts <12 years

Discontinue treatment

  • Chronic ITP: If Plt fails to respond to a level that avoids clinically important bleeding after 4 weeks at the maximum of 75 mg/day

Elevated ALT/AST (First-line SAA)

  • Increase ALT/AST >6x ULN: Discontinue eltrombopag; once ALT/AST <5x ULN, reinitiate at same dose
  • Increase ALT/AST >6x ULN (after reinitiation): Discontinue treatment and monitor ALT/AST at least q3-4 days; once ALT/AST <5x ULN, reinitiate and reduce daily dose by 25 mg of previous dose
  • If ALT/AST returns to >6x ULN on reduced dose, the reduce daily dose by 25 mg until ALT/AST <5x ULN
  • Patients <12 years: Reduce daily dose by at least 15% to nearest dose that can be administered

Thromboembolic events (First-line SAA)

  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolus, stroke, myocardial infarction): Discontinue eltrombopag, remain on h-ATG and cyclosporine

Asian ancestry

  • Such as Chinese, Japanese, Taiwanese, or Korean
  • Chronic ITP: Reduce to 25 mg PO qDay
  • First-line SAA: Decrease initial dose by 50%

Hepatic impairment

  • Chronic ITP
    • Mild to severe (Child-Pugh Class A to C): Reduce to 25 mg PO qDay
    • Mild to severe (Child-Pugh Class A to C) and of Asian ancestry: Reduce to 12.5 mg PO qDay
    • Wait 3 weeks before increasing dose after initiation or after any subsequent dosing increase
  • First-line therapy for SAA
    • Mild to severe (Child-Pugh Class A to C)
    • 2-5 years: 1.25 mg/kg qDay for 6 months initially
    • 6-11 years: 37.5 mg PO qDay for 6 months initially
    • ≥12 years: 75 mg PO qDay for 6 months initially

Dosing Considerations

During therapy, assess complete blood cell counts (CBCs) weekly until a stable Plt is achieved; obtain CBCs with differentials, monthly thereafter

When switching between oral suspension and tablet, assess platelets weekly for 2 weeks, and then follow standard monthly monitoring

Limitations of use

  • Not indicated for treatment of myelodysplastic syndrome (MDS)
  • Safety and efficacy not established in combination with direct-acting antiviral agents used without interferon for chronic hepatitis C infection
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Interactions

Interaction Checker

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              Serious - Use Alternative (37)

              • alpelisib

                eltrombopag will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • aluminum hydroxide

                aluminum hydroxide decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • atorvastatin

                eltrombopag increases toxicity of atorvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              • calcium acetate

                calcium acetate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • calcium carbonate

                calcium carbonate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • calcium chloride

                calcium chloride decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • calcium citrate

                calcium citrate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • calcium gluconate

                calcium gluconate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • carbonyl iron

                carbonyl iron decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • efavirenz

                efavirenz will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug.

              • eluxadoline

                eltrombopag increases levels of eluxadoline by decreasing metabolism. Avoid or Use Alternate Drug. Decrease eluxadoline dose to 75 mg PO BID if coadministered with OATP1B1 inhibitors. .

              • ferric maltol

                ferric maltol decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • ferrous fumarate

                ferrous fumarate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • ferrous gluconate

                ferrous gluconate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • ferrous sulfate

                ferrous sulfate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • fluvastatin

                eltrombopag increases toxicity of fluvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              • fluvoxamine

                fluvoxamine will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

              • iron dextran complex

                iron dextran complex decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • iron sucrose

                iron sucrose decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • magnesium chloride

                magnesium chloride decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • magnesium citrate

                magnesium citrate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • magnesium hydroxide

                magnesium hydroxide decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • magnesium oxide

                magnesium oxide decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • magnesium sulfate

                magnesium sulfate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • ozanimod

                eltrombopag increases toxicity of ozanimod by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of ozanimod (a BCRP substrate) with BCRP inhibitors increases the exposure of the minor (RP101988, RP101075) and major active metabolites (CC112273, CC1084037) of ozanimod, which may increase the risk of ozanimod adverse reactions. .

              • pitavastatin

                eltrombopag increases toxicity of pitavastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              • polysaccharide iron

                polysaccharide iron decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • pravastatin

                eltrombopag increases toxicity of pravastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              • rimegepant

                eltrombopag will increase the level or effect of rimegepant by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of rimegepant (a BCRP substrate) with inhibitors of BCRP.

              • riociguat

                eltrombopag will increase the level or effect of riociguat by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Coadministration of riociguat (P-gp substrate) with strong P-gp inhibitors may require a decreased initial dose of 0.5 mg PO TID; monitor for signs of hypotension and reduce dose if needed

              • rose hips

                rose hips decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • rosuvastatin

                eltrombopag increases toxicity of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 inhibitors may increase risk of myopathy.

              • selenium

                selenium decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • simvastatin

                eltrombopag will increase the level or effect of simvastatin by Other (see comment). Avoid or Use Alternate Drug. OATP1B1 inhibitors may increase risk of myopathy

              • sodium bicarbonate

                sodium bicarbonate decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • sodium citrate/citric acid

                sodium citrate/citric acid decreases levels of eltrombopag by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Separate by at least 4 hours.

              • talazoparib

                eltrombopag will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              Monitor Closely (91)

              • acetaminophen

                eltrombopag increases levels of acetaminophen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • acetaminophen IV

                eltrombopag increases levels of acetaminophen IV by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • acetaminophen rectal

                eltrombopag increases levels of acetaminophen rectal by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • amiodarone

                amiodarone will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • amobarbital

                amobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                amobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • artesunate

                eltrombopag will increase the level or effect of artesunate by decreasing metabolism. Use Caution/Monitor. Coadministration may increase active artesunate metabolite (DHA) by inhibiting UGT. Monitor for increased adverse effects.

              • aspirin rectal

                eltrombopag increases levels of aspirin rectal by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • aspirin/citric acid/sodium bicarbonate

                eltrombopag increases levels of aspirin/citric acid/sodium bicarbonate by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • atazanavir

                atazanavir increases levels of eltrombopag by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • atorvastatin

                eltrombopag increases levels of atorvastatin by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • belladonna and opium

                eltrombopag increases levels of belladonna and opium by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • berotralstat

                eltrombopag increases levels of berotralstat by Other (see comment). Modify Therapy/Monitor Closely. Comment: Reduced dose of berotralstat (a BCRP substrate) to 110 mg/day when coadministered with BCRP inhibitors.

              • buprenorphine buccal

                eltrombopag increases levels of buprenorphine buccal by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • butabarbital

                butabarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                butabarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • butalbital

                butalbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                butalbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                carbamazepine will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • celecoxib

                eltrombopag increases levels of celecoxib by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • choline magnesium trisalicylate

                eltrombopag increases levels of choline magnesium trisalicylate by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • cigarette smoking

                cigarette smoking will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • ciprofloxacin

                ciprofloxacin will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • deferiprone

                eltrombopag will increase the level or effect of deferiprone by decreasing metabolism. Use Caution/Monitor. Coadministration with UGT1A6 inhibitors may increase serum concentration of deferiprone.

              • diclofenac

                eltrombopag increases levels of diclofenac by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • diflunisal

                eltrombopag increases levels of diflunisal by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • duvelisib

                eltrombopag will increase the level or effect of duvelisib by Other (see comment). Use Caution/Monitor. Coadministration of duvelisib (a BCRP substrate) with a BCRP transport inhibitor may increase levels or effects of duvelisib.

              • erythromycin base

                erythromycin base will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • esomeprazole

                esomeprazole will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • ethinylestradiol

                ethinylestradiol will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • etodolac

                eltrombopag increases levels of etodolac by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • fenoprofen

                eltrombopag increases levels of fenoprofen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • flurbiprofen

                eltrombopag increases levels of flurbiprofen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • fluvastatin

                eltrombopag increases levels of fluvastatin by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • fluvoxamine

                fluvoxamine will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • glecaprevir/pibrentasvir

                eltrombopag will increase the level or effect of glecaprevir/pibrentasvir by decreasing metabolism. Use Caution/Monitor. Monitor for glecaprevir/pibrentasvir adverse effects if coadministered with drugs that are OATP1B1 and BCRP inhibitor

              • hydromorphone

                eltrombopag increases levels of hydromorphone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • ibuprofen

                eltrombopag increases levels of ibuprofen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • ibuprofen IV

                eltrombopag increases levels of ibuprofen IV by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • imatinib

                imatinib will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • indomethacin

                eltrombopag increases levels of indomethacin by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • isoniazid

                isoniazid will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • ketoprofen

                eltrombopag increases levels of ketoprofen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • ketorolac

                eltrombopag increases levels of ketorolac by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • ketorolac intranasal

                eltrombopag increases levels of ketorolac intranasal by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • leflunomide

                leflunomide will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • letermovir

                eltrombopag increases levels of letermovir by decreasing metabolism. Use Caution/Monitor. Coadminstration of letermovir, an OATP1B1/3 substrate, with OATP1B1/3 inhibitors may increase letermovir plasma concentrations.

              • levorphanol

                eltrombopag increases levels of levorphanol by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • magnesium supplement

                magnesium supplement will decrease the level or effect of eltrombopag by Other (see comment). Modify Therapy/Monitor Closely. Drug may form a chelate with polyvalent cations; may decrease absorption by the intestinal tract; applies to oral forms; may administer under fasting conditions 2 hr before administering polyvalent cation or 4 hr after

              • meclofenamate

                eltrombopag increases levels of meclofenamate by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • mefenamic acid

                eltrombopag increases levels of mefenamic acid by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • meloxicam

                eltrombopag increases levels of meloxicam by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • meperidine

                eltrombopag increases levels of meperidine by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • methadone

                eltrombopag increases levels of methadone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • methotrexate

                eltrombopag increases levels of methotrexate by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • mexiletine

                mexiletine will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • miconazole vaginal

                miconazole vaginal will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • morphine

                eltrombopag increases levels of morphine by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • nabumetone

                eltrombopag increases levels of nabumetone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • naproxen

                eltrombopag increases levels of naproxen by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • nateglinide

                nateglinide will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

                eltrombopag increases levels of nateglinide by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • omeprazole

                omeprazole will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • opium tincture

                eltrombopag increases levels of opium tincture by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • oxaprozin

                eltrombopag increases levels of oxaprozin by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • oxycodone

                eltrombopag increases levels of oxycodone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • oxymorphone

                eltrombopag increases levels of oxymorphone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • peginterferon alfa 2a

                peginterferon alfa 2a will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • pentobarbital

                pentobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                pentobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • phenobarbital

                phenobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                phenobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • piroxicam

                eltrombopag increases levels of piroxicam by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • primidone

                primidone will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                primidone will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • repaglinide

                eltrombopag increases levels of repaglinide by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • rifampin

                rifampin will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                rifampin will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

                eltrombopag increases levels of rifampin by decreasing metabolism. Use Caution/Monitor. OATP transporter protein inhibition.

              • rifapentine

                rifapentine will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • sacubitril/valsartan

                eltrombopag will decrease the level or effect of sacubitril/valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure

              • salicylates (non-asa)

                eltrombopag increases levels of salicylates (non-asa) by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • salsalate

                eltrombopag increases levels of salsalate by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • secobarbital

                secobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

                secobarbital will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • selenium

                selenium will decrease the level or effect of eltrombopag by cation binding in GI tract. Modify Therapy/Monitor Closely. Separate eltrombopag administration from polyvalent cations by at least 2 h.

              • selexipag

                eltrombopag will increase the level or effect of selexipag by Other (see comment). Use Caution/Monitor. Selexipag is a ABCG2 (BCRP) substrate. Monitor selexipag for increased pharmacologic or adverse effects when coadministered with ABCG2 (BCRP) inhibitors.

              • smoking

                smoking will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • sufentanil

                eltrombopag increases levels of sufentanil by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • sulfamethoxazole

                sulfamethoxazole will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • sulfasalazine

                eltrombopag increases levels of sulfasalazine by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • sulindac

                eltrombopag increases levels of sulindac by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • tapentadol

                eltrombopag increases levels of tapentadol by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • tobacco use

                tobacco use will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              • tolmetin

                eltrombopag increases levels of tolmetin by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

              • topotecan

                eltrombopag will increase the level or effect of topotecan by Other (see comment). Use Caution/Monitor. Avoid coadministration. Topotecan is a substrate of the efflux transporter BCRP. Eltrombopag inhibits BCRP.

              • valsartan

                eltrombopag will decrease the level or effect of valsartan by Other (see comment). Use Caution/Monitor. The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1; coadministration with OATP1B1 inhibitors may increase valsartan systemic exposure

              • zileuton

                zileuton will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

              Minor (1)

              • cimetidine

                cimetidine will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

                cimetidine will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10% (Chronic ITP)

              Upper respiratory tract infection (7-17%)

              Nasopharyngitis (12%)

              >10% (Chronic Hepatitis C)

              Anemia (40%)

              Pyrexia (30%)

              Fatigue (28%)

              Headache (21%)

              Nausea (19%)

              Diarrhea (19%)

              Decreased appetite (18%)

              Influenza-like illness (18%)

              Insomnia (16%)

              Asthenia (16%)

              Cough (15%)

              Pruritus (15%)

              Chills (14%)

              Myalgia (12%)

              >10% (SAA)

              Increased ALT (29%)

              Increased AST (17%)

              Increased blood bilirubin (17%)

              Refractory SAA

              • Nausea (33%)
              • Fatigue (28%)
              • Cough (23%)
              • Diarrhea (21%)
              • Headache (21%)
              • Pain in extremity (19%)
              • Pyrexia (14%)
              • Dizziness (14%)
              • Oropharyngeal pain (14%)
              • Abdominal pain (12%)
              • Muscle spasms (12%)
              • Transaminases increased (12%)
              • Arthralgia (12%)
              • Rhinorrhea (12%)

              1-10% (Chronic ITP)

              Headache (10%)

              Nausea (4-9%)

              Cough (9%)

              Diarrhea (9%)

              Pyrexia (9%)

              Abdominal pain (8%)

              Oropharyngeal pain (8%)

              Toothache (6%)

              Vomiting (6%)

              Urinary tract infection (5%)

              Increased ALT (5-6%)

              Increased AST (4-5%)

              Myalgia (5%)

              Cataract (5%)

              Fatigue (5%)

              Rash (3-5%)

              Increased blood bilirubin (4%)

              Oropharyngeal pain (4%)

              Pharyngitis (4%)

              Rhinorrhea (4%)

              Hyperbilirubinemia (3%)

              Back pain (3%)

              Influenza (3%)

              Paresthesia (3%)

              1-10% (Chronic Hepatitis C)

              Alopecia (10%)

              Peripheral edema (10%)

              1-10% (SAA)

              Rash (8%)

              Skin discoloration including hyperpigmentation (5%)

              Refractory SAA

              • Rash (7%)
              • Hyperbilirubinemia (7%)
              • Cataract (2%)

              Postmarketing Reports

              Skin discoloration including hyperpigmentation and skin yellowing

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              Warnings

              Black Box Warnings

              Risk for hepatic decompensation in chronic hepatitis C patients

              • Risk of hepatotoxicity
              • In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase risk of hepatic decompensation
              • May increase risk of severe and potentially life-threatening hepatotoxicity
              • Monitor hepatic function and discontinue dosing as recommended

              Contraindications

              None

              Cautions

              If patient with hepatic impairment (Child-Pugh Class A, B, C) initiates therapy for first- line treatment of severe aplastic anemia, reduce initial dose

              In aplastic anemia, use lowest dose to achieve and maintain hematologic response; discontinue if no hematologic response observed after 16 weeks of therapy, excessive platelet count responses or liver test abnormalities

              Chronic hepatitis C with cirrhosis may increase risk of hepatic decompensation and death when treated with alfa interferons; no dosage adjustment is recommended in patients with chronic hepatitis C and hepatic impairment

              Not indicated for the treatment of patients with myelodysplastic syndromes (MDS); increased risk of death and progression of MDS to acute myeloid leukemia observed in a clinical trial showing an increased relative risk of progression to AML by 166%

              Thrombotic/thromboembolic complications reported; have included both venous and arterial events and were observed at low and at normal platelet counts.

              Portal vein thrombosis reported in patients with chronic liver disease receiving therapy

              Consider potential risk of thromboembolism when administering to patients with known risk factors for thromboembolism (eg, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, chronic liver disease).

              Risk of thrombocytopenia and hemorrhage after discontinuation

              Not for normalizing platelet counts as it may increase thrombotic/thromboembolic complications; for use only when degree of thrombocytopenia and clinical conditions increase risk for bleeding in patients with chronic immune idiopathic thrombocytopenia

              May develop or worsen cataracts; screen before administering and during treatment

              Discontinue if platelet count does not respond to a level to avoid clinically important bleeding after 4 weeks at maximum recommended dose

              In hepatitis C, use only when thrombocytopenia prevents initiation and maintenance of interferon-based therapy; discontinue if antiviral therapy discontinued

              Hepatotoxicity

              • May increase risk of severe and potentially life-threatening hepatotoxicity (see Black Box Warnings); monitor liver function before and during therapy
              • Treatment of ITP, chronic hepatitis C-associated thrombocytopenia, and refractory severe aplastic anemia
                • Measure serum ALT, AST, and bilirubin prior to initiation of therapy, every 2 weeks during dose adjustment phase, and monthly following establishment of a stable dose. Drug inhibits UDP ­glucuronosyltransferase (UGT)1A1 and organic anion-transporting polypeptide (OATP)1B1, which may lead to indirect hyperbilirubinemia; if bilirubin is elevated, perform fractionation; evaluate abnormal serum liver tests with repeat testing within 3 to 5 days
                • If abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized; discontinue treatment if ALT levels increase to greater than or equal to 3 x ULN in patients with normal liver function or greater than or equal to 3 x baseline (or greater than 5 x ULN, whichever is the lower) in patients with pre-treatment elevations in transaminases and are: progressively increasing, or persistent for greater than or equal to 4 weeks, or accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation
                • If potential benefit for reinitiating treatment is considered to outweigh risk for hepatotoxicity, then consider cautiously reintroducing therapy and measure serum liver tests weekly during dose adjustment phase; hepatotoxicity may reoccur if therapy is reinitiated; if liver test abnormalities persist, worsen, or recur, then permanently discontinue therapy
              • First-line treatment of severe aplastic anemia
                • Measure ALT, AST, and bilirubin prior to initiation of therapy, every other day while hospitalized for h-ATG therapy, and then every 2 weeks during treatment; during treatment, manage increases in ALT or AST levels as recommended

              Drug interactions overview

              • Polyvalent cations
                • Eltrombopag chelates polyvalent cations (eg, iron, calcium, aluminum, magnesium, selenium, zinc) in foods, mineral supplements, and antacids
                • Administer at least 2 hr before or 4 hr after any medications or products containing polyvalent cations such as antacids, dairy products, and mineral supplements to avoid significant reduction in absorption
              • OATP1B1 or BCRP transporters
                • Use caution when coadministering with OATP1B1 substrates (eg, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or BCRP (eg, imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan)
                • Monitor closely for signs/symptoms of excessive exposure to OATP1B1 or BCRP substrates and consider reducing the dose of these drugs, if appropriate
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              Pregnancy & Lactation

              Pregnancy

              Available data from published case reports and postmarketing experience with use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes

              Animal data

              • In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses
              • Effects were observed at doses resulting in exposures that were 6 times the human clinical exposure based on AUC in patients with chronic ITP at 75 mg/day, and 3 times the AUC in patients with chronic hepatitis C at 100 mg/day

              Contraception

              • Based on animal reproduction studies, fetal harm may occur when administered to a pregnant woman
              • Use effective contraception in sexually-active females of reproductive during treatment and for at least 7 days after stopping treatment

              Lactation

              No data available regarding presence of eltrombopag or metabolites in human milk, effects on breastfed child, or on milk production

              However, drug was detected in pups of lactating rats 10 days postpartum suggesting potential for transfer during lactation; due to potential for serious adverse reactions in a breastfed child from drug, breastfeeding is not recommended during treatment

              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

              Small-molecule thrombopoietin (TPO)-receptor agonist that interacts with human TPO receptor transmembrane domain of human TPO-receptor & initiates signaling cascades that induce proliferation & differentiation of megakaryocytes from bone marrow progenitor cells

              Absorption

              Bioavailability: >52% (single 75-mg dose)

              Peak Plasma Time: 2-6 hr

              Effect of food

              • A standard high-fat breakfast (876 calories, 52 g fat, 71 g carbohydrate, 34 g protein, and 427 mg calcium) significantly decreased plasma eltrombopag AUC by ~59% and peak plasma concentration by 65% and delayed peak plasma concentrationby 1 hr
              • Calcium content of this meal may have also contributed to this decrease in exposure

              Distribution

              Protein bound: >99%

              Concentration of eltrombopag in blood cells: ~ 50-79%

              Metabolism

              Extensively metabolized predominantly through pathways including cleavage, oxidation, and conjugation with glucuronic acid, glutathione, or cysteine

              In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for the oxidative metabolism

              UGT1A1 and UGT1A3 are responsible for the glucuronidation

              Elimination

              Half-life: 26-35 hr (in patients with ITP)

              Excretion: Feces (59%); urine (31%)

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              Administration

              Oral Suspension Preparation

              Prior to use of oral suspension, ensure patients or caregivers receive training on proper dosing, preparation, and administration of oral suspension

              Prepare suspension with cool or cold water only

              Gently and slowly shake bottle back and forth for a least 20 seconds to mix thoroughly without foaming (ie, do not shake bottle hard)

              Liquid will be dark brown in color

              Transfer mixture into oral syringe

              Oral Administration

              Take on empty stomach 1 hr before or 2 hr after food

              Take foods/medication, calcium-rich foods, or supplements containing polyvalent cations (eg, calcium, iron, zinc, magnesium) 2 hr before or 4 hr after

              Do NOT administer more than 1 dose within a 24-hr period

              Oral suspension

              • Place oral syringe tip into the inside of the child’s cheek
              • Slowly push plunger down to administer entire dose

              Storage

              Powder for oral suspension or tablets: Store at room temperature between 68-77°F (20-25°C)

              Reconstituted oral suspension

              • Store for up to 30 minutes at room temperature between 68-77°F (20-25°C)
              • Discard mixture if not used within 30 minutes; do not throw down the drain
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Promacta oral
              -
              12.5 mg tablet
              Promacta oral
              -
              75 mg tablet
              Promacta oral
              -
              50 mg tablet
              Promacta oral
              -
              25 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              eltrombopag oral

              ELTROMBOPAG - ORAL

              (el-TROM-boe-pag)

              COMMON BRAND NAME(S): Promacta

              WARNING: Rarely, eltrombopag has caused severe (possibly fatal) liver problems. Get medical help right away if you develop symptoms of liver problems (such as persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin).People with a certain liver problem (chronic hepatitis C) who are taking this medication with ribavirin and interferon may sometimes experience worsening of their liver problem. Get medical help right away if you have any very serious side effects, including symptoms of liver problems, stomach/abdominal swelling, or mental/mood changes. Talk with your doctor about the risks and benefits of this medication.To help decrease the risk of liver problems, your doctor will order laboratory tests (liver function tests) before you start eltrombopag and while you are taking it. Keep all medical and lab appointments.

              USES: This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using eltrombopag and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily. Take it without a meal or with a meal low in calcium (50 milligrams or less). Ask your doctor or pharmacist for details.Take this medication at least 2 hours before or 4 hours after taking any products that contain magnesium, aluminum, or calcium-rich foods (containing more than 50 milligrams calcium). Some examples include antacids, dairy products (such as milk, yogurt), calcium-enriched juice, vitamins/minerals, quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), and sucralfate. Follow the same instructions with bismuth subsalicylate, iron, selenium, and zinc. These products may keep eltrombopag from working well.The manufacturer directs not to split, chew, or crush the tablet before taking it, and not to mix it with food or liquid. However, many similar drugs (immediate-release tablets) can be split, chewed, or crushed. Follow your doctor's directions on how to take this medication. The manufacturer also states that the powder from the tablet may stain surfaces.If you are using the suspension powder, read the manufacturer's Instructions for Use before you start using this medication. Ask your health care provider if you have any questions. Carefully follow the directions to mix and use each dose. Use the provided mixing bottle to mix each dose with cool or cold water. Gently and slowly shake the mixing bottle for at least 20 seconds to mix the water with the powder. After mixing, give this medication right away. Use the provided special measuring device (oral syringe) to prepare and give each dose. Do not use a household spoon because you may not get the correct dose. Do not re-use the oral syringe. Use a new oral syringe for each dose. If not used right away, the mixed medication may be stored at room temperature for up to 30 minutes. After 30 minutes, throw away any unused mixture, or any mixture left in the bottle. Clean the mixing supplies as directed.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage is based on your medical condition, response to treatment, age, and lab tests. Your doctor will order blood tests (platelet counts) to find the right dose for you. Keep all medical/lab appointments. Follow your doctor's directions carefully. If you are of Asian descent or if you have liver problems, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.Your risk of bleeding may increase when you stop using eltrombopag. After your last dose, your doctor should order a blood test once a week for at least 4 weeks to check your platelet count. Tell your doctor right away if you develop any bleeding/bruising.Ask your doctor if you should continue taking your other medications for ITP (such as corticosteroids, azathioprine, danazol) while you are using eltrombopag.Tell your doctor if your condition (bleeding/bruising) does not get better or if it gets worse.

              SIDE EFFECTS: See also Warning section.Nausea, diarrhea, headache, muscle pain, and tingling/numbness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: vision changes.This medication may rarely cause serious problems from blood clots in the heart, brain, legs, or lungs (such as heart attack, stroke, deep vein thrombosis, pulmonary embolism), especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you have any symptoms of a blood clot, including: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/legs, trouble speaking, weakness on one side of the body.Eltrombopag can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.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: Before using eltrombopag, 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: blood clots/clotting problems (such as Factor V Leiden), other blood disorders (such as blood cancer, myelodysplastic syndrome), certain eye problem (cataracts), liver disease.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Although this medication increases platelets and decreases the risk of bleeding, continue to avoid activities that can increase your risk of bleeding (such as contact sports, using sharp objects like razors and nail cutters).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using eltrombopag. Eltrombopag may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 7 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: See also How to Use.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.This medication may interfere with certain lab tests (creatinine and bilirubin), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

              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 count, eye exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. See also Warnings section. 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 take more than 1 dose in 24 hours. Do not double the dose to catch up.

              STORAGE: Different brands and forms of this medication have different storage needs. Check the product package for storage instructions or ask your pharmacist. 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.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2020. 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.

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              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.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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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.