Indications

In combination with prednisone or prednisolone, for patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Due to high incidence of neutropenia, granulocyte-colony stimulating factor (G-CSF) should be administered within 24-72 hr since 1st cycle of Cabazitaxel administration.

Composition

Pharmacology

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.

Dosage & Administration

25 mg/m 2 administered as a 1 hr IV infusion every 3 wk in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.

Contraindications

Neutrophil counts <1,500/mm 3 ; platelets >100,000/mm 3 , haemoglobin >10 g/dL, creatinine <1.5 x ULN, hepatic impairment (bilirubin ≥1 x ULN, or AST &/or ALT ≥1.5 × ULN); concomitant vaccination with yellow fever vaccine.

Side Effects

Most commonly in all grades, anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea. Most commonly in ≥3 grade, neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea.

Pregnancy & Lactation

Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Precautions & Warnings

Hypersensitivity reaction; risk of neutropenia; risk of nausea, vomiting, diarrhea, dehydration, peripheral neuropathy; renal failure, cardiac arrhythmias; liver impairment; anemia. Pregnancy & lactation. Elderly.

Therapeutic Class

Cytotoxic Chemotherapy

Storage Conditions

Store between 15-30° C. Do not refrigerate.