This is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen
Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.
Recommended Dose: This 20 mg/m2 administered every three weeks as a one-hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout this treatment. A dose of 25 mg/m2 can be used in select patients at the discretion of the treating healthcare provider. ? This requires two dilutions prior to administration. ? Use the entire contents of the accompanying diluent to achieve a concentration of 10 mg/mL . ? PVC equipment should not be used. ? Premedication Regimen: Administer intravenously 30 minutes before each dose of it: o Antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine) o Corticosteroid (dexamethasone 8 mg or equivalent steroid) o H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist) (2.1) Antiemetic prophylaxis (oral or intravenous) is recommended as needed.
May increase plasma conc with strong CYP3A4 inhibitors. May lead to decreased plasma conc with strong CYP3A4 inducers. Vaccination with a live attenuated vaccine should be avoided.
Neutrophil counts of ?1,500/mm3 ? History of severe hypersensitivity to it or polysorbate 80 . ? Severe hepatic impairment (Total Bilirubin >3 ? ULN) ? Pregnancy
Neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, and anorexia
Risk Summary It is contraindicated for use in pregnant women because the drug can cause fetal harm and potential loss of pregnancy.it is not indicated for use in female patients. There are no human data on the use of cabazitaxel injection in pregnant women. In animal reproduction studies, intravenous administration of cabazitaxel in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than the maximum recommended human dose Summary It is not indicated for use in female patients. There is no information available on the presence of cabazitaxel in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Cabazitaxel or cabazitaxel metabolites are excreted in maternal milk of lactating rats .
Complications of overdose include
exacerbation of adverse reactions such as bone marrow suppression and gastrointestinal
disorders. Overdose has led to fatal outcome.
In case of overdose, the patient should be kept in a specialized unit where vital signs, chemistry
and particular functions can be closely monitored. Patients should receive therapeutic G-CSF as
soon as possible after discovery of overdose. Other appropriate symptomatic measures should be
taken, as needed.
Store between 15-30° C. Do not refrigerate.
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