cabazitaxel (Rx)

Brand and Other Names:Jevtana
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

kit

  • Each kit contains
    • 60mg/1.5mL cabazitaxel injection
    • 5.7mL diluent

Prostate Cancer

Indicated in combination with prednisone for metastatic castration-resistant prostate cancer in patients previously treated with a docetaxel-containing treatment regimen

20 mg/m2 IV q3Weeks, PLUS  

Prednisone 10 mg PO qDay throughout cabazitaxel treatment

Select patients may use 25 mg/m2 IV at prescriber’s discretion

Dosage Modifications

Dosage reductions

  • If at 20 mg/m2: Reduce to 15 mg/m2
  • If at 25 mg/m2: Reduce to 20 mg/m2; once additional dose reduction to 15 mg/m2 may be considered

Neutropenia

  • Prolonged grade ≥3 neutropenia (>1 week) despite appropriate medication including G-CSF: Delay treatment until neutrophil count >1,500 cells/mm3, then reduce dose by 1 level; use G-CSF for secondary prophylaxis
  • Febrile neutropenia or neutropenic infection: Delay treatment until improvement or resolution, and until neutrophil count >1,500 cells/mm3, then reduce dose by 1 level; use G-CSF for secondary prophylaxis

Diarrhea

  • Grade ≥3 or persisting despite appropriate medication, fluid, and electrolyte replacement: Delay treatment until improvement or resolution, then reduce dose by 1 level

Peripheral neuropathy

  • Grade 2: Delay treatment until improvement or resolution, then reduce dose by 1 level
  • Grade >3: Discontinue

Strong CYP3A4 inhibitors

  • Avoid coadministration
  • If unavoidable, consider reducing dose by 25%

Renal impairment

  • All severities (not requiring hemodialysis): No dosage adjustment necessary
  • End-stage renal disease (CrCl <15 mL/min): Carefully monitor

Hepatic impairment

  • Mild (total bilirubin [TB] >1 to <1.5x ULN or AST >1.5x ULN): Administer at a dose of 20 mg/m2
  • Moderate (TB >1.5 to ≤3x ULN and any AST): Reduce dose to 15 mg/m2; based on tolerability; efficacy of this dose is unknown
  • Severe (TB >3x ULN): Contraindicated

Safety and efficacy not established

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Interactions

Interaction Checker

and cabazitaxel

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            Contraindicated (0)

              Serious - Use Alternative (27)

              • adenovirus types 4 and 7 live, oral

                cabazitaxel 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.

              • BCG intravesical live

                cabazitaxel decreases effects of BCG intravesical live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • BCG vaccine live

                cabazitaxel decreases effects of BCG vaccine live by Mechanism: pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • clarithromycin

                clarithromycin will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • conivaptan

                conivaptan will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • imatinib

                imatinib will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • influenza virus vaccine quadrivalent, adjuvanted

                cabazitaxel 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

                cabazitaxel 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.

              • isoniazid

                isoniazid will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • itraconazole

                itraconazole will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of cabazitaxel with strong CYP3A4 inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% cabazitaxel dose reduction.

              • ketoconazole

                ketoconazole will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • lopinavir

                lopinavir will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • measles mumps and rubella vaccine, live

                cabazitaxel decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • measles, mumps, rubella and varicella vaccine, live

                cabazitaxel decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • nefazodone

                nefazodone will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • nicardipine

                nicardipine will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • palifermin

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

              • posaconazole

                posaconazole will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • ropeginterferon alfa 2b

                ropeginterferon alfa 2b, cabazitaxel. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • rotavirus oral vaccine, live

                cabazitaxel decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • smallpox (vaccinia) vaccine, live

                cabazitaxel decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • typhoid vaccine live

                cabazitaxel decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • varicella virus vaccine live

                cabazitaxel decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • voriconazole

                voriconazole will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of cabazitaxel with strong CYP3A4 inhibitors should be avoided.

              • yellow fever vaccine

                cabazitaxel decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              • zoster vaccine live

                cabazitaxel decreases effects of zoster vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

              Monitor Closely (62)

              • amiodarone

                amiodarone will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • aprepitant

                aprepitant will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • atazanavir

                atazanavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • belatacept

                belatacept and cabazitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • bicalutamide

                bicalutamide will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • bosentan

                bosentan will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • bosutinib

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

              • carbamazepine

                carbamazepine will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • cholera vaccine

                cabazitaxel 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 cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • crizotinib

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

              • cyclosporine

                cyclosporine will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • dabrafenib

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

              • darunavir

                darunavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • dengue vaccine

                cabazitaxel 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

                cabazitaxel, 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.

              • diltiazem

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

              • dronedarone

                dronedarone will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • duvelisib

                duvelisib will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. will increase the level or effect of

              • efavirenz

                efavirenz will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • erythromycin base

                erythromycin base will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • etravirine

                etravirine will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • fluconazole

                fluconazole will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • fosamprenavir

                fosamprenavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • grapefruit

                grapefruit will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • indinavir

                indinavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • lapatinib

                lapatinib will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • lomitapide

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

              • meningococcal group B vaccine

                cabazitaxel decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • miconazole oral

                miconazole oral will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • nafcillin

                nafcillin will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • natalizumab

                natalizumab and cabazitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant use of natalizumab and immunosuppressive agents should be avoided.

              • nelfinavir

                nelfinavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • nevirapine

                nevirapine will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Avoid coadministration.

              • ofatumumab SC

                ofatumumab SC, cabazitaxel. 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

                cabazitaxel 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, cabazitaxel. 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.

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • pentobarbital

                pentobarbital will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • phenobarbital

                phenobarbital will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • phenytoin

                phenytoin will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • pimecrolimus

                pimecrolimus and cabazitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Avoid concomitant use of immunosuppressive agents and pimecrolimus. Potential for increased adverse effects of immunosuppressants.

              • primidone

                primidone will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • rifabutin

                rifabutin will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • rifampin

                rifampin will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • rifapentine

                rifapentine will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • ritonavir

                ritonavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • saquinavir

                saquinavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • siponimod

                siponimod and cabazitaxel 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

                cabazitaxel decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • St John's Wort

                St John's Wort will decrease the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of strong CYP3A4 inducers may decrease cabazitaxel concentrations. Avoid coadministration.

              • stiripentol

                stiripentol, cabazitaxel. 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.

              • tetracycline

                tetracycline will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • tipranavir

                tipranavir increases levels of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Avoid coadministration.

              • trastuzumab

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

              • verapamil

                verapamil will increase the level or effect of cabazitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

              • zoster vaccine recombinant

                cabazitaxel decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

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                Adverse Effects

                >10%

                Anemia (11-98%)

                Leukopenia (69-96%)

                Neutropenia (82-94%)

                Thrombocytopenia (4-48%)

                Diarrhea (6-47%)

                Fatigue (5-37%)

                Nausea (2-34%)

                Vomiting (2-22%)

                Asthenia (5-20%)

                Constipation (1-20%)

                Abdominal pain (2-17%)

                Hematuria (2-17%)

                Anorexia (1-16%)

                Back pain/arthralgia (11-16%)

                Peripheral neuropathy (1-13%)

                Pyrexia (1-12%)

                Dyspnea (1-12%)

                Cough (11%)

                Dysgeusia (11%)

                1-10%

                Dyspepsia (10%)

                Alopecia (10%)

                Peripheral edema (1-9%)

                Weight loss (9%)

                Dizziness (8%)

                Headache (8%)

                UTI (2-8%)

                Dysuria (7%)

                Febrile neutropenia (1-7%)

                Mucosal inflammation (1-6%)

                Hypotension (5%)

                Arrhythmia (1-5%)

                Postmarketing Reports

                Gastrointestinal: Gastritis, intestinal obstruction

                Interstitial pneumonia/pneumonitis

                Interstitial lung disease

                Acute respiratory distress syndrome

                Bone marrow suppression

                Renal failure

                Renal and urinary disorders: Radiation recall hemorrhagic cystitis

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                Warnings

                Black Box Warnings

                Neutropenia

                • Neutropenic deaths reported
                • Monitor for neutropenia with frequent blood cell counts
                • Contraindicated with neutrophil counts ≤1,500 cell/mm3
                • Primary prophylaxis with G-CSF recommended in high- risk patients
                • Consider G-CSF prophylaxis with dose of 25 mg/m2

                Severe hypersensitivity

                • Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension, and bronchospasm
                • Premedicate with IV antihistamine, corticosteroid, and H2 antagonist
                • Contraindicated with history of severe hypersensitivity reactions to cabazitaxel or other drugs formulated with polysorbate 80
                • Immediately discontinue therapy if hypersensitivity occurs and initiate supportive treatment as indicated

                Contraindications

                Neutrophil count ≤1,500/mm3

                Hypersensitivity to cabazitaxel or to other drugs formulated with polysorbate 80

                Severe hepatic impairment (total bilirubin >3x ULN)

                Cautions

                Extensively metabolized in liver, hepatic impairment likely to increase serum concentrations

                Bone marrow suppression manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur; neutropenic deaths reported

                Patients ≥65 years were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia

                Severe hypersensitivity reactions can occur; premedicate with IV antihistamine, corticosteroid, and H2 antagonist; discontinue infusion immediately if hypersensitivity observed and treat as indicated

                Gastrointestinal symptoms (nausea, vomiting, diarrhea), including mortality related to diarrhea, has been reported; rehydrate and treat with antiemetics and antidiarrheals as needed; incidence of gastrointestinal adverse reactions is greater in patients who have received prior radiation

                Renal failure, including cases with fatal outcomes, reported

                Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, reported; monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on therapy; interrupt or discontinue treatment in patients experiencing severe hemorrhagic cystitis; medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis

                GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome; risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelets, or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding

                Extensively metabolized in liver; contraindicated in patients with severe hepatic impairment and reduce dose in patients with mild and moderate hepatic impairment

                May cause fetal harm when administered to pregnant females

                Respiratory disorders

                • Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome, including fatal outcomes reported
                • Patients with underlying lung disease may be at higher risk for respiratory distress
                • Acute respiratory distress syndrome may occur in the setting of infection
                • Delay or discontinue therapy and treat as indicated
                • If therapy is discontinued, carefully evaluate the risks versus benefits before resumption

                Drug interaction overview

                • CYP3A substrate
                • Strong CYP3A4 inhibitors

                  • Avoid coadministration
                  • Strong CYP3A4 inhibitors that may alter drug serum levels
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                Pregnancy & Lactation

                Pregnancy

                Safety and efficacy not established in females

                No human data available on use in pregnant females

                Contraception

                • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after final dose

                Infertility

                • Fertility in males of reproductive potential may be impaired

                Animal data

                • IV administration in pregnant rats during organogenesis cause embryonic and fetal death at doses lower than maximum recommended human dose

                Lactation

                Not indicated for use in females

                No data available on presence in human milk, effects on breastfed infants, or on milk production

                Drug or drug metabolites are excreted in maternal milk of lactating rats

                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

                Microtubule inhibitor; binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly; this results in microtubule stabilization, which results in the inhibition of mitotic and interphase cellular functions

                Absorption

                Peak plasma time: 1 hr

                Peak plasma concentration: 226 ng/mL

                AUC: 991 ng•h/mL

                Distribution

                Vd: 4,864 L at steady state

                Protein bound: 89-92%; mainly bound to albumin (82%)

                Metabolism

                CYP3A substrate (main), CYP2C8 (less), P-gp substrate; extensively metabolized in liver by CYP3A4/5; 7 metabolites (3 active) detected in plasma; 20 metabolites detected in feces/urine

                Elimination

                Excretion: Feces (76%), urine (3.7%)

                Half-Life: 95 hr (terminal half-life)

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                Administration

                IV Incompatibilities

                Do not mix with any other drugs

                IV Compatibilities

                D5W

                0.9% NaCl

                IV Preparation

                Cytotoxic anticancer drug; follow applicable special handling and disposal procedure

                If diluted solutions come into contact with skin or mucous, immediately and thorough wash with soap and water

                Drug requires TWO dilutions before administration

                Visually inspect injection and supplied diluent vials; injection is a clear yellow to brownish-yellow viscous solution

                First dilution

                • Mix each vial with entire contents of supplied diluent
                • Slowly inject diluent by directing needle onto inside wall of vial to limit foaming
                • Gently mix first dilution by repeated inversion for at least 45 seconds to ensure complete mixing of drug and diluent; do not shake
                • Allow solution to stand for a few minutes to allow any foam to dissipate; not all foam needs to dissipate before continuing to second dilution
                • Check solution is not homogeneous and contains no visible particle matter; resulting concentration of first dilution is 10 mg/mL
                • Prepare second dilution immediately (within 30 min) to obtain final infusion

                Second dilution

                • Withdraw dose from first dilution and further dilute into a sterile 250 mL PVC-free container of either 0.9% NaCl or D5W for infusion; concentration of final infusion solution should be 0.1-0.26 mg/mL
                • For doses >65 mg, use a larger infusion bag (>250 mL PVC-free container) to assure 0.26 mg/mL concentration not exceeded
                • Gently invert bag to thoroughly mix final infusion
                • Final infusion solution is supersaturated and may crystallize over time; do not use if this occurs and discard

                IV Administration

                Visually inspect for particulate matter, any crystals, and discoloration before administering; discard second (final) dilution if not clear or appears to have precipitated

                Use a 0.22- or 0.2-micron inline filter during infusion

                Administer premedication regimen of IV antihistamine, corticosteroid, and H2-antagonist 30 minute before each cabazitaxel dose

                Infuse over 1 hr at room temperature

                Premedication IV regimen

                • Antihistamine (dexchlorpheniramine 5 mg, diphenhydramine 25 mg, or equivalent antihistamine)
                • Corticosteroid (dexamethasone 8 mg or equivalent steroid)
                • H2-antagonist (ranitidine 50-mg or equivalent H2-antagonist)

                Primary prophylaxis with G-CSF

                • Recommended in patients with high-risk clinical features
                • Consider in all patients receiving 25 mg/m2

                Storage

                Unopened injection and diluent

                • Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
                • Do not refrigerate

                Diluted infusion bags (second dilution)

                • Ambient room temperature: Use within 8 hr (including 1-hour infusion)
                • Refrigerated: Up to 24 hr (including 1-hour infusion)
                • Discard any unused portion
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Jevtana intravenous
                -
                10 mg/mL (first dilution) vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                cabazitaxel intravenous

                CABAZITAXEL - INJECTION

                (ka-BAZ-i-TAZ-el)

                COMMON BRAND NAME(S): Jevtana

                WARNING: Cabazitaxel may cause a serious blood disorder (a low number of white blood cells). This effect can lower your body's ability to fight an infection and thus lead to serious (rarely fatal) infections. Your doctor will monitor you closely and check your blood often during treatment. You may also receive another medication to reduce the risk of this side effect. If your white blood cell count is too low, you should not receive cabazitaxel. Tell your doctor right away if you develop any signs of infection such as sore throat that doesn't go away, fever, chills, cough, painful/difficult urination.Cabazitaxel may rarely cause serious allergic reactions. This drug must not be used in patients who have previously had an allergic reaction to it or to other medications containing polysorbate 80. Your doctor should prescribe other medications (such as antihistamines, H2 blockers, corticosteroids) to help prevent an allergic reaction. Get medical help right away if you develop any signs of an allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

                USES: Cabazitaxel is used to treat prostate cancer. It works by slowing or stopping the growth of cancer cells.

                HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using cabazitaxel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor, usually every 3 weeks. A health care professional will give you the injection slowly over 1 hour.Your doctor may prescribe other medications (such as antihistamines, H2 blockers, corticosteroids) before each injection of cabazitaxel to lessen the risk of allergic reactions and prevent side effects such as nausea/vomiting.The dosage is based on your medical condition, body size, lab tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

                SIDE EFFECTS: See also Warning section.Loss of appetite, stomach/abdominal pain, or change in sense of taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, or diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Many people using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine, pink/bloody urine), signs of a bladder infection (such as burning/pain when you urinate, urgent or frequent urination, fever), muscle cramps, weakness, dizziness, extreme thirst, unusual tiredness, fast/irregular heartbeat, easy bruising/bleeding, numbness/tingling of arms/legs, persistent constipation, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.Get medical help right away if you have any very serious side effects, including: chest pain.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 receiving cabazitaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as paclitaxel, docetaxel); or to polysorbate 80; or if you have any other allergies. This product may contain other 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: liver disease, lung disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), stomach/abdominal problems (such as ulcers, bleeding, blockage), recent/current infections, radiation treatment.Cabazitaxel can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for side effects (such as low number of white blood cells, fever, dizziness, bladder infections, dehydration) while using this drug.This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Men using this medication should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. Consult your doctor for more details.

                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 can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Other medications can affect the removal of cabazitaxel from your body, which may affect how cabazitaxel works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, nelfinavir), nefazodone, telithromycin, among others.

                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 (such as complete blood count, kidney function) must 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 hospital 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 July 2021. Copyright(c) 2021 First Databank, Inc.

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

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                Formulary

                FormularyPatient Discounts

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

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

                Adding plans allows you to:

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

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

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