paclitaxel protein bound (Rx)

Brand and Other Names:Abraxane
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial

Pancreatic Cancer

Indicated for metastatic adenocarcinoma of the pancreas as first-line treatment in combination with gemcitabine

125 mg/m² IV infused over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle

Administer gemcitabine 1000 mg/m² IV infused over 30-40 minutes immediately after paclitaxel protein bound on Days 1, 8 and 15 of each 28-day cycle

Dosage modifications (pancreatic cancer)

  • 1st dose reduction: 100 mg/m² (paclitaxel); 800 mg/m² (gemcitabine)
  • 2nd dose reduction: 75 mg/m² (paclitaxel); 600 mg/m² (gemcitabine)
  • Discontinue if additional dose reduction required

Dosage modifications (pancreatic cancer – hematologic toxicities)

  • Cycle Day 1: ANC <1500/mm³ or platelets <100,000/mm³ - Delay doses until recovery
  • Cycle Day 8: ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 1 dose level
  • Cycle Day 8: ANC <500/mm³ or platelets <50,000/mm³ - Withhold doses
  • Cycle Day 15: ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 1 dose level from Day 8
  • Cycle Day 15: ANC <500/mm³ or platelets <50,000/mm³ - Withhold doses
  • Cycle Day 15 (if Day 8 doses withheld): ANC >1000/mm³ or platelets ≥75,000/mm³ - Reduce 1 dose level from Day 1
  • Cycle Day 15 (if Day 8 doses withheld): ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 2 dose levels from Day 1
  • Cycle Day 15 (if Day 8 doses withheld): ANC <500/mm³ or platelets <50,000 /mm³ - Withhold doses

Dosage modifications (pancreatic cancer – other toxicities)

  • Febrile neutropenia (grade 3 or 4): Withhold until fever resolves and ANC ≥1500/mm³ - Resume at next lower dose level
  • Peripheral neuropathy (Grade 3 or 4): Withhold paclitaxel until improves to ≤ Grade 1, then resume at next lower dose (no need to reduce gemcitabine)
  • Cutaneous toxicity (Grade 2 or 3): Reduce to next lower dose level; discontinue treatment if toxicity persists
  • Gastrointestinal toxicity (Grade 3 mucositis or diarrhea): Withhold until improves to ≤ Grade 1; resume at next lower dose level

Breast Cancer

Microtubule inhibitor indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless contraindicated

260 mg/m² IV infused over 30 minutes q3weeks

Dosage modfications (breast cancer)

  • Severe neutropenia (<500 cells/mm³) or severe sensory neuropathy: Decrease dose to 220 mg/m²
  • Recurrence of severe neutropenia or severe sensory neuropathy: Decrease dose to 180 mg/m²
  • Grade 3 sensory neuropathy: Hold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses

Non-Small Cell Lung Cancer

Indicated for locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

100 mg/m² IV infused over 30 minutes on Days 1, 8, and 15 of each 21-day cycle, PLUS

Carboplatin AUC 6 mg•min/mL IV on Day 1 of each 21 day cycle immediately after paclitaxel protein bound infusion

Dosage modifications (NSCLS)

  • Do not administer on Day 1 of a cycle until ANC is at least 1500 cells/mm³ and platelet count is at least 100,000 cells/mm³
  • Severe neutropenia or thrombocytopenia: Withhold treatment until counts recover to an ANC of at least 1500 cells/mm³ and platelet count of at least 100,000 cells/mm³ on Day 1 or to an ANC of at least 500 cells/mm³ and platelet count of at least 50,000 cells/mm³ on Days 8 or 15 of the cycle
  • Grade 3-4 peripheral neuropathy: Withhold dose; resume paclitaxel protein bound and carboplatin at reduced doses when peripheral neuropathy improves to Grade 1 or completely resolves

Permanent dose reductions (NSCLC)

  • Neutropenic fever (ANC <500/mm³ and fever >38°C) or next cycle delayed by >7 days for ANC <1500/mm³ or ANC <500/mm³ for >7 days or severe sensory neuropathy (grade 3 or 4):
  • -First occurrence: reduce dose to 75 mg/m² (and decrease carboplatin dose to 4.5 AUC mg•min/mL)
  • -Second occurrence: reduce dose to 50 mg/m² (and decrease carboplatin dose to 3 AUC mg•min/mL)
  • -Third occurrence: Discontinue treatment
  • Platelets <50,000/mm³:
  • -First occurrence: reduce dose to 75 mg/m² (and decrease carboplatin dose to 4.5 AUC mg•min/mL)
  • -Second occurrence: Discontinue treatment

Hepatic Impairment

Breast cancer

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.5 X ULN): No dose adjustment required
  • Moderate (AST <10 x ULN; bilirubin >1.5 to ≤ 3 x ULN): Reduce starting dose to 200 mg/m²; may increase up to 260 mg/m² if patient tolerates reduced dose for two cycles
  • Severe: (AST <10 x ULN; bilirubin >3 to ≤ 5 x ULN): Reduce starting dose to 200 mg/m²; may increase up to 260 mg/m² if patient tolerates reduced dose for two cycles
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

NSCLC

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.5 X ULN): No dose adjustment required
  • Moderate (AST <10 x ULN; bilirubin >1.5 to ≤ 3 x ULN): Reduce starting dose to 80 mg/m²; may increase up to 100 mg/m² if patient tolerates reduced dose for two cycles
  • Severe: (AST <10 x ULN; bilirubin >3 to ≤ 5 x ULN): Reduce starting dose to 80 mg/m²; may increase up to 100 mg/m² if patient tolerates reduced dose for two cycles
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

Pancreatic cancer

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.5 X ULN): No dose adjustment required
  • Moderate-to-severe (AST <10 x ULN; bilirubin >1.5-5 x ULN): Not recommended
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

Dosing Considerations

Monitor for severe neutropenia and thrombocytopenia by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer); do not administer drug to patients with baseline absolute neutrophil counts (ANC) of <1,500 cells/mm3

Use cytotoxic handling precautions

Monitor for extravasation during infusion

Premedication for hypersensitivity reaction is NOT required

Melanoma (Orphan)

Orphan designation for treatment of stage IIb to IV melanoma

Orphan sponsor

  • Abraxis BioScience, LLC; 11755 Wilshire Blvd; Los Angeles, CA 90025

Gastric Cancer (Orphan)

Orphan designation for gastric cancer

Sponsor

  • Insys Therapeutics, Inc.; 1333 South Spectrum Boulevard, Suite 100; Chandler, AZ 85286

Ovarian Cancer (Orphan)

Liposomal encapsulated paclitaxel

Sponsor

  • Insys Therapeutics, Inc; 1333 South Spectrum Boulevard, Suite 100; Chandler, AZ 85286

Breast Cancer with Brain Metastases (Orphan)

Peptide-paclitaxel conjugate

Orphan designation for treatment of patients with breast cancer with brain metastases

Sponsor

  • Angiochem, Inc; 201 President Kennedy; Montreal, Quebec H2X 3Y7; Canada

Safety and efficacy not established

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Interactions

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            Contraindicated (0)

              Serious - Use Alternative (19)

              • abametapir

                abametapir will increase the level or effect of paclitaxel protein bound 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.

              • adenovirus types 4 and 7 live, oral

                paclitaxel protein bound decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • apalutamide

                apalutamide will decrease the level or effect of paclitaxel protein bound 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.

              • deferiprone

                deferiprone, paclitaxel protein bound. 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.

              • erdafitinib

                erdafitinib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

              • idelalisib

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

              • influenza virus vaccine quadrivalent, adjuvanted

                paclitaxel protein bound decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                paclitaxel protein bound decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • ivosidenib

                ivosidenib will decrease the level or effect of paclitaxel protein bound 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.

              • lasmiditan

                lasmiditan increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • lopinavir

                lopinavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • mifepristone

                mifepristone will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • nefazodone

                nefazodone will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of paclitaxel protein bound 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.

              • quinidine

                quinidine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              • sotorasib

                sotorasib will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • tepotinib

                tepotinib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • tucatinib

                tucatinib will increase the level or effect of paclitaxel protein bound 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.

              • voxelotor

                voxelotor will increase the level or effect of paclitaxel protein bound 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 (119)

              • amiodarone

                amiodarone will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • atorvastatin

                atorvastatin will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • axitinib

                paclitaxel protein bound decreases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belatacept

                belatacept and paclitaxel protein bound both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • berotralstat

                berotralstat will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • bevacizumab

                bevacizumab will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Possible decreased paclitaxel exposure after 4 treatment cycles of bevacizumab in combination with paclitaxel and carboplatin.

              • bosutinib

                bosutinib increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cannabidiol

                cannabidiol will increase the level or effect of paclitaxel protein bound by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C8 activity. Consider reducing the dose when concomitantly using CYP2C8 substrates.

              • carbamazepine

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

                carbamazepine will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • celecoxib

                celecoxib will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • cenobamate

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

              • chloramphenicol

                chloramphenicol will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cholera vaccine

                paclitaxel protein bound 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 paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clarithromycin

                clarithromycin will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                clarithromycin will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • clotrimazole

                clotrimazole will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cobicistat

                cobicistat will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • colchicine

                colchicine will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • crizotinib

                crizotinib increases levels of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

                crizotinib increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cyclosporine

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

                cyclosporine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • dabrafenib

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

              • deferasirox

                deferasirox will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                deferasirox will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • dengue vaccine

                paclitaxel protein bound decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                paclitaxel protein bound, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dexamethasone

                dexamethasone will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • dichlorphenamide

                dichlorphenamide and paclitaxel protein bound both decrease serum potassium. Use Caution/Monitor.

              • dienogest/estradiol valerate

                paclitaxel protein bound will decrease the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Advise women to use alternative method of contraception or back-up method when moderate or weak enzyme inducer is used with combination contraceptives. Back-up contraception should be continued for 28 days after discontinuing medication to ensure contraceptive reliability.

              • diltiazem

                diltiazem will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for dose-related toxicities (eg, diarrhea, mucositis, myelosuppression, peripheral neuropathy) of paclitaxel during coadministration.

              • doxorubicin

                paclitaxel protein bound increases levels of doxorubicin by decreasing renal clearance. Modify Therapy/Monitor Closely. Monitor for doxorubicin-induced cardiovascular toxicity.

              • doxorubicin liposomal

                paclitaxel protein bound increases levels of doxorubicin liposomal by decreasing renal clearance. Modify Therapy/Monitor Closely. Monitor for doxorubicin-induced cardiovascular toxicity.

              • dronedarone

                dronedarone will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • duvelisib

                duvelisib will increase the level or effect of paclitaxel protein bound 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.

              • elagolix

                elagolix will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                elagolix decreases levels of paclitaxel protein bound 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.

              • eliglustat

                eliglustat increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of paclitaxel protein bound 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, paclitaxel protein bound. 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 paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin base

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

                erythromycin base will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin ethylsuccinate

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

                erythromycin ethylsuccinate will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin lactobionate

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

                erythromycin lactobionate will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin stearate

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

                erythromycin stearate will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ethotoin

                paclitaxel protein bound decreases levels of ethotoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                paclitaxel protein bound decreases levels of ethotoin by increasing metabolism. Use Caution/Monitor.

              • fedratinib

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

              • felodipine

                felodipine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                felodipine will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • fingolimod

                paclitaxel protein bound increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • fosphenytoin

                paclitaxel protein bound decreases levels of fosphenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                paclitaxel protein bound decreases levels of fosphenytoin by increasing metabolism. Use Caution/Monitor.

                fosphenytoin will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                fosphenytoin will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • gemfibrozil

                gemfibrozil increases levels of paclitaxel protein bound by altering metabolism. Use Caution/Monitor. Gemfibrozil inhibits CYP2C8.

                gemfibrozil will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • griseofulvin

                griseofulvin will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • hydroxyurea

                paclitaxel protein bound, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • ifosfamide

                ifosfamide will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • iloperidone

                iloperidone increases levels of paclitaxel protein bound 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.

              • indinavir

                indinavir will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • irbesartan

                irbesartan will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • isoniazid

                isoniazid will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • istradefylline

                istradefylline will increase the level or effect of paclitaxel protein bound 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.

                istradefylline will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • itraconazole

                itraconazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ivacaftor

                ivacaftor increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              • ketoconazole

                ketoconazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                ketoconazole will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • lapatinib

                lapatinib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                lapatinib will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • linagliptin

                paclitaxel protein bound will increase the level or effect of linagliptin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use of alternative treatments is strongly recommended when linagliptin is to be administered with a CYP3A4 inducer

              • lomitapide

                lomitapide increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

              • lonafarnib

                lonafarnib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • loratadine

                loratadine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • lorlatinib

                lorlatinib will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • losartan

                losartan will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • lovastatin

                lovastatin will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • mifepristone

                mifepristone will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Inhibits CYP2C8/2C9; use smallest recommended doses for substrates and monitor

              • mitotane

                mitotane decreases levels of paclitaxel protein bound 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.

              • nefazodone

                nefazodone will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nicardipine

                nicardipine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nifedipine

                nifedipine will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                nifedipine will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nilotinib

                nilotinib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ofatumumab SC

                ofatumumab SC, paclitaxel protein bound. 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.

              • olaparib

                paclitaxel protein bound and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • oxaliplatin

                oxaliplatin, paclitaxel protein bound. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with oxaliplatin may increase the risk of immunosuppression and myelosuppression. Administer taxanes derivative before oxaliplatin when given as sequential infusions to limit toxicity. .

              • pazopanib

                pazopanib increases levels of paclitaxel protein bound by decreasing metabolism. Use Caution/Monitor.

              • phenobarbital

                phenobarbital will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                phenobarbital will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • phenytoin

                paclitaxel protein bound decreases levels of phenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                paclitaxel protein bound decreases levels of phenytoin by increasing metabolism. Use Caution/Monitor.

                phenytoin will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                phenytoin will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • pioglitazone

                pioglitazone will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • ponatinib

                ponatinib increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • primidone

                primidone will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • quercetin

                quercetin will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • quinine

                quinine will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • ranolazine

                ranolazine will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ribociclib

                ribociclib will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

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

                rifampin will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                rifampin will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • rifapentine

                rifapentine will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • ritonavir

                ritonavir will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                ritonavir will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • rosiglitazone

                rosiglitazone will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • rucaparib

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

              • sacubitril/valsartan

                paclitaxel protein bound will increase 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

              • saquinavir

                saquinavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • sarecycline

                sarecycline will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • secobarbital

                secobarbital will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/efficacy may decrease when coadministered with CYP2C8 inducers

              • simvastatin

                simvastatin will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • siponimod

                siponimod and paclitaxel protein bound 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.

              • sipuleucel-T

                paclitaxel protein bound decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sirolimus

                sirolimus will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • sorafenib

                sorafenib will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • St John's Wort

                St John's Wort will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                St John's Wort will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • stiripentol

                stiripentol, paclitaxel protein bound. 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.

                stiripentol will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a CYP2C8 inhibitor. Consider dosage reduction for CYP2C8 substrates if adverse effects are experienced when coadministered.

                stiripentol will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

              • sulfisoxazole

                sulfisoxazole will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • tacrolimus

                tacrolimus will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • tazemetostat

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

              • tecovirimat

                tecovirimat will increase the level or effect of paclitaxel protein bound by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19. Monitor for adverse effects if coadministered with sensitive substrates of these enzymes.

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

              • teniposide

                teniposide will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • teriflunomide

                teriflunomide increases levels of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Comment: Teriflunomide inhibits CYP2C8; caution when coadministered with CYP2C8 substrates.

              • tipranavir

                tipranavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tolvaptan

                tolvaptan will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, paclitaxel protein bound. 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, paclitaxel protein bound. 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. .

                paclitaxel protein bound increases levels of trastuzumab deruxtecan by unknown mechanism. Modify Therapy/Monitor Closely. Coadministration increased trastuzumab levels 1.5-fold.

              • trazodone

                trazodone will decrease the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • trimethoprim

                trimethoprim will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

              • tucatinib

                tucatinib will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              • valsartan

                paclitaxel protein bound will increase 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

              • vemurafenib

                vemurafenib increases levels of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • verapamil

                verapamil will increase the level or effect of paclitaxel protein bound by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              Minor (62)

              • amobarbital

                amobarbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • aprepitant

                aprepitant will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • armodafinil

                armodafinil will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • artemether/lumefantrine

                artemether/lumefantrine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • atazanavir

                atazanavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • bosentan

                bosentan will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • budesonide

                budesonide will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • butabarbital

                butabarbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • butalbital

                butalbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cisplatin

                cisplatin increases levels of paclitaxel protein bound by decreasing renal clearance. Minor/Significance Unknown.

              • conivaptan

                conivaptan will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cortisone

                cortisone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • darifenacin

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

              • darunavir

                darunavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dasatinib

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

              • dexamethasone

                dexamethasone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • DHEA, herbal

                DHEA, herbal will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dronedarone

                dronedarone will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • efavirenz

                efavirenz will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • etravirine

                etravirine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fluconazole

                fluconazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fludrocortisone

                fludrocortisone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fosamprenavir

                fosamprenavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • grapefruit

                grapefruit will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • griseofulvin

                griseofulvin will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • hydrocortisone

                hydrocortisone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • indinavir

                indinavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lapatinib

                lapatinib will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lumefantrine

                lumefantrine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • maitake

                maitake increases effects of paclitaxel protein bound by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • marijuana

                marijuana will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • methylprednisolone

                methylprednisolone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • metronidazole

                metronidazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • miconazole vaginal

                miconazole vaginal will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • modafinil

                modafinil will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nafcillin

                nafcillin will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nelfinavir

                nelfinavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nevirapine

                nevirapine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nilotinib

                nilotinib will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nilutamide

                nilutamide will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pentobarbital

                pentobarbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • phenobarbital

                phenobarbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • phenytoin

                phenytoin will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • posaconazole

                posaconazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • prednisone

                prednisone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • primidone

                primidone will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • quinupristin/dalfopristin

                quinupristin/dalfopristin will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • rifapentine

                rifapentine will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ritonavir

                ritonavir will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • rufinamide

                rufinamide will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • saquinavir

                saquinavir increases levels of paclitaxel protein bound by decreasing metabolism. Minor/Significance Unknown.

              • secobarbital

                secobarbital will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • taurine

                paclitaxel protein bound decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

              • topiramate

                topiramate will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • verapamil

                verapamil will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vitamin A

                vitamin A, paclitaxel protein bound. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • vitamin E

                vitamin E, paclitaxel protein bound. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • voriconazole

                voriconazole will increase the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • zafirlukast

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

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              Adverse Effects

              >10%

              Alopecia (90%)

              Neutropenia (<2 x 10^9/L) (80%)

              Sensory neuropathy, any (71%)

              Abnormal EKG, all patients (60%)

              Asthenia (47%)

              Myalgia/arthralgia (44%)

              AST increased (39%)

              Alkaline phosphatase increased (36%)

              Abnormal EKG, patients normal at baseline (35%)

              Anemia (<11 g/dL) (33%)

              Nausea (30%)

              Diarrhea (27%)

              Infections (24%)

              Vomiting (18%)

              Dyspnea (12%)

              Neutropenia (grade 3-4)

              • NSCLC (47%)
              • Pancreatic cancer (38%)
              • Metastatic breast cancer (34%)

              1-10%

              Sensory neuropathy, severe (10%)

              Edema (10%)

              Neutropenia (<0.5 x 10^9/L) (9%)

              Cough (7%)

              Mucositis (7%)

              Bilirubin increased (7%)

              Hypotension, during infusion (5%)

              Hypersensitivity reactions (4%)

              Thrombocytopenia (2%)

              Febrile neutropenia (2%)

              Bleeding (2%)

              Anemia (<8 g/dL) (1%)

              Postmarketing Reports

              Hypersensitivity: Severe hypersensitivity reactions

              Cardiovascular: Congestive heart failure, left ventricular dysfunction, and atrioventricular block; most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history

              Respiratory: Interstitial pneumonia, pulmonary embolism, lung fibrosis

              Neurologic: Cranial nerve palsies, vocal cord paresis, autonomic neuropathy resulting in paralytic ileu

              Vision Disorders: Persistent optic nerve damage; reduced visual acuity due to cystoid macular edema

              Hepatic: Hepatic necrosis and hepatic encephalopathy leading to death

              Gastrointestinal: Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, neutropenic enterocolitis (typhlitis)

              Injection Site Reaction: Extravasation, severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis (may be delayed by 7-10 ten days)

              Metabolic and nutritional disorders: Tumor lysis syndrome

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              Warnings

              Black Box Warnings

              Should not be administered if baseline neutrophil counts <1,500 cells/mm³; frequent monitoring of peripheral blood cell counts for all patients recommended to avoid bone marrow suppression

              An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution; do not substitute for or with other paclitaxel formulations

              Contraindications

              Neutrophils <1500 cells/mm³

              Documented hypersensitivity to drug or excipients

              Cautions

              Severe myelosuppression (primarily neutropenia) is dose-dependent and dose-limiting toxicity of therapy; monitor CBC and withhold and/or reduce the dose as needed (see Dosage Modifications)

              Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions reported; do not rechallenge in patients who experience severe hypersensitivity

              Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption (see Dosage Modifications)

              Sepsis occurred in 5% of patients with or without neutropenia; biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis

              Pneumonitis, including fatalities, occurred in 4% of patients

              Exposure and toxicity increased with hepatic impairment; particularly from myelosuppression; closely monitor for development of profound myelosuppression; monitor AST and bilirubin and adjust dose if needed (see Dosage Modifications)

              Contains albumin derived from human blood which has a theoretical risk of viral transmission

              Fetal harm may occur when administered to a pregnant woman; women of childbearing potential should avoid becoming pregnant

              Men should not father a child while taking paclitaxel

              CYP3A4 and CYP2C8 substrate; inducers or inhibitors of these isoenzymes may alter metabolism; if coadministered, monitor closely

              Cross-hypersensitivity between drug and other taxane products reported; may include severe reactions such as anaphylaxis Patients with a previous history of hypersensitivity to other taxanes should be closely monitored during initiation of therapy

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              Pregnancy & Lactation

              Pregnancy

              Based on its mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman; there are no available human data to inform drug-associated risk

              In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m² basis; advise females of reproductive potential of potential risk to fetus

              Females of reproductive potential should have a pregnancy test prior to starting treatment

              Contraception

              • Females: Therapy can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment and for at least six months after last dose
              • Males: Based on findings in genetic toxicity and animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment and for at least three months after last dose

              Infertility

              • Based on findings in animals, therapy may impair fertility in females and males of reproductive potential

              Lactation

              There are no data on presence of drug in human milk, or effect on breastfed child or on milk production; in animal studies, paclitaxel and/or its metabolites were excreted into milk of lactating rats; because of potential for serious adverse reactions in a breastfed child from therapy, advise lactating women not to breastfeed during treatment and for two weeks after last 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

              Microtubular inhibitor (albumin-conjugated formulation); natural taxane, prevents depolymerization of cellular microtubules, which results in DNA, RNA, and protein synthesis inhibition

              Absorption

              Peak Plasma Time: Immediately after completing infusion

              Peak Plasma Concentration: 18,741 ng/mL

              Distribution

              Protein Bound: 89-98%

              Vd: 632 L/m²

              Metabolism

              Metabolized primarily to 6- alpha hydroxypaclitaxel by CYP2C8; and to 2 minor metabolites, 3’-p-hydroxypaclitaxel and 6-alpha, 3’-p-dihydroxypaclitaxel, by CYP3A4

              Elimination

              Half-life: 27 hr

              Total body clearance: 15 L/hr/m²

              Excretion: 20% feces, 4% urine (unchanged)

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              Administration

              IV Preparation

              Aseptically reconstitute vial by slowly injecting 20 mL 0.9% NaCl over 1 min by allowing fluid to fall down inside wall of tube (this will avoid foaming)

              Swirl or invert to mix (do not shake)

              Resulting reconstituted suspension should be milky and homogenous without visible particulates

              Resulting solution is 5 mg/mL

              If foaming occurs stand solution for at least 15 min until foaming subsides

              Inject the appropriate amount of reconstituted suspension into an empty, sterile IV bag (PVC containers, PVC or non-PVC type IV bag)

              The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer paclitaxel protein bound infusions

              The use of an in-line filter is not recommended

              IV Administration

              Infuse IV over 30 min

              Do not use in-line filter

              Storage

              Unopened vials: Store between 20-25ºC (68-77ºF) in the original package; neither freezing nor refrigeration adversely affects the stability of the product

              Reconstituted suspension in vial: Preferably should be used immediately, but can be refrigerated at 2-8°C (36-46°F) for up to 8 hr if needed

              Reconstituted suspension in infusion bag: Should be used immediately but may be stored at ambient temperature (approximately 25ºC) and lighting conditions for up to 4 hr; discard any unused portion

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Abraxane intravenous
              -
              100 mg vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              paclitaxel-protein bound intravenous

              PACLITAXEL PROTEIN-BOUND - INJECTION

              (pack-lih-TAX-el)

              COMMON BRAND NAME(S): Abraxane

              WARNING: This medication may often cause a serious blood disorder (decreased bone marrow function leading to a low number of white blood cells). This effect can lower your body's ability to fight an infection. Your doctor will monitor you closely and check your blood often during treatment. If your white blood cell count is too low, you should not receive this medication. Tell your doctor right away if you develop any signs of infection (e.g., fever, chills, cough, persistent sore throat, painful/difficult urination).This medication contains a form of paclitaxel that is bound to a human protein called albumin. This product acts differently in the body than other forms of paclitaxel. Therefore, this product should not be substituted for or used with any other forms of paclitaxel.

              USES: This medication is used to treat certain cancers (including breast, lung, and pancreatic cancer). Paclitaxel belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.

              HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using paclitaxel. If you have any questions, consult your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. It is given on a schedule as directed by your doctor. Dosage is based on your medical condition, body size, laboratory tests, and response to treatment.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, mouth sores, headache, muscle/joint pain, numbness/tingling/burning of the hands/feet, weakness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she 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: signs of anemia (e.g., unusual tiredness, pale skin), easy bruising/bleeding, fast/slow/irregular heartbeat, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, vision changes.This medication may rarely irritate the vein it is given into or leak out of the vein and irritate the area. These effects may cause redness, pain, swelling, discoloration, or unusual skin reactions at the injection site, either while the drug is given or rarely 7 to 10 days later. If this drug has leaked out of a vein and caused a skin reaction in the past, you may rarely have a skin reaction in that same area when the drug is given again, even when it is given into another area. Tell your doctor right away of any unusual skin/injection site symptoms.Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, coughing up blood, fainting, weakness on one side of the body, trouble speaking, confusion, sudden severe headache.This medication contains albumin that comes from human blood. There is a very small chance that you may get infections from this medication (including viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor right away if you develop any of the following: signs of infection (e.g., fever, chills, cough, persistent sore throat), signs of hepatitis (e.g., persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, increasing tiredness).A very serious allergic reaction to this drug is rare. Do not restart this medication if you have previously stopped using it due to a serious allergic reaction. Get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, flushing.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 paclitaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as docetaxel, cabazitaxel); or to products containing human albumin; 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 disorders (e.g., low white blood cell count), decreased bone marrow function, current infections, heart problems (e.g., fast/slow/irregular heartbeat), high or low blood pressure, liver disease.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).Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.Older adults may be more sensitive to the side effects of this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using paclitaxel. Paclitaxel may harm an unborn baby. Females using this medication should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. Males using this medication should ask about reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is not known if this drug 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 may decrease bone marrow function (e.g., azathioprine, trimethoprim/sulfamethoxazole).

              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: Laboratory and/or medical tests (e.g., complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

              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 September 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.

              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.