Generic Name and Formulations:
Cabazitaxel 60mg/1.5mL; soln for IV infusion after dilution; contains polysorbate 80, diluent contains ethanol.

Company:
Sanofi Aventis

Indications for JEVTANA:
In combination with prednisone, hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Adult:
Pretreat with IV antihistamine, corticosteroid, and H2 blocker 30 mins before each dose (see full labeling) and with antiemetic (IV or oral as needed). 25mg/m2 by IV infusion over 1hr every 3 weeks, with oral prednisone 10mg/day during treatment. Do not treat if neutrophil count ≤1,500 cells/mm3. Prolonged grade ≥3 neutropenia (>1 week), febrile neutropenia, grade ≥3 diarrhea: delay treatment and/or reduce dose to 20mg/m2 (see full labeling). Discontinue if reactions persist after dosing at 20mg/m2.

Children:
Not established.

Pharmacological Class:
Antimicrotubule agent.

Contraindications:
Baseline neutrophil count ≤1,500cells/mm3. Allergy to polysorbate 80.

Warnings/Precautions:
Do CBC weekly in 1st cycle and before each subsequent cycle. Increased risk of neutropenia complications; consider G-CSF prophylaxis. Discontinue if hypersensitivity reactions occur. Increased risk of GI disorders in patients with neutropenia, age, or history of pelvic radiotherapy, adhesions, ulceration, and GI bleeding. eva luate and treat if serious GI toxicity occurs; treatment delay or discontinuation may be needed. Hepatic impairment: not recommended. Severe renal impairment (CrCl <30mL/min) or ESRD. Elderly (increased susceptibility to adverse reactions); monitor closely. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:
Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) (may potentiate cabazitaxel); caution with moderate CYP3A4 inhibitors. Avoid concomitant strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) (may antagonize cabazitaxel). Avoid St. John’s Wort. Increased GI toxicity with concomitant steroids, NSAIDs, antiplatelets, anticoagulants.

Adverse Reactions:
Bone marrow suppression (esp. neutropenia, anemia, leukopenia, thrombocytopenia), febrile neutropenia, diarrhea (may be fatal), nausea, vomiting, constipation, fatigue, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, alopecia; renal failure, hypersensitivity reactions (eg, rash, hypotension, bronchospasm).

How Supplied:
Kit (single-use vial + diluent)—1