Cabazitaxel is indicated, in combination with Prednisone or Prednisolone, for the treatment of patients with hormone-refractory metastatic prostate cancer who have previously received a docetaxel-containing chemotherapy regimen. Because treatment with Cabazitaxel is associated with a high risk of neutropenia, prophylactic administration of granulocyte colony-stimulating factor (G-CSF) is recommended within 24–72 hours after the first treatment cycle to reduce the risk of severe neutropenia and related complications.

Cabazitaxel is a microtubule inhibitor that interferes with the normal function of microtubules within cells. It binds to tubulin, promoting the assembly of tubulin into microtubules while simultaneously preventing their disassembly. This process results in stabilization of microtubules, which disrupts essential cellular processes during both the mitotic and interphase stages of the cell cycle. As a result, cancer cells become unable to progress through the cell cycle and remain arrested at the metaphase stage, ultimately triggering programmed cell death (apoptosis).

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

Cabazitaxel may interact with certain medications that affect its metabolism. Strong CYP3A4 inhibitors may increase the plasma concentration of Cabazitaxel, potentially raising the risk of adverse reactions. Conversely, strong CYP3A4 inducers may reduce Cabazitaxel plasma levels, which could decrease its therapeutic effectiveness. In addition, vaccination with live attenuated vaccines, including the yellow fever vaccine, should be avoided during Cabazitaxel treatment due to the increased risk of infection.

Cabazitaxel should not be administered in patients with severe neutropenia (neutrophil count <1,500/mm³). It is also contraindicated in patients with significant hepatic impairment, defined as bilirubin levels equal to or greater than the upper limit of normal (ULN) or AST/ALT levels ≥1.5 × ULN. Additionally, Cabazitaxel should not be used in patients receiving yellow fever vaccination.

The most frequently reported adverse reactions with Cabazitaxel include anemia, leukopenia, neutropenia, thrombocytopenia, and diarrhea. Severe adverse reactions (Grade ≥3) most commonly include neutropenia, leukopenia, anemia, febrile neutropenia, and severe diarrhea.

Cabazitaxel is classified as Pregnancy Category D, indicating evidence of potential risk to the fetus. Although the drug may pose a risk to the unborn child, its use may be considered in life-threatening situations or serious diseases where safer treatments are not available or ineffective.

Patients receiving Cabazitaxel should be monitored carefully due to the risk of hypersensitivity reactions and severe neutropenia. Other potential risks include nausea, vomiting, diarrhea, dehydration, peripheral neuropathy, renal failure, cardiac arrhythmias, liver impairment, and anemia. Special caution should be exercised in elderly patients and in individuals with underlying medical conditions. Use during pregnancy or lactation requires careful medical supervision.

Children: The safety and effectiveness of Cabazitaxel in pediatric patients have not been established.

Elderly: No specific dose adjustment is generally required for elderly patients receiving Cabazitaxel, although close monitoring is recommended.

Hepatic Impairment: Cabazitaxel is extensively metabolized in the liver. Patients with mild hepatic impairment should receive a reduced dose of 20 mg/m² and should be monitored carefully. Limited data exist for patients with moderate hepatic impairment, and Cabazitaxel should not be used in patients with severe hepatic impairment.

Renal Impairment: Cabazitaxel is minimally eliminated through the kidneys, and dose adjustment is generally not required in patients with renal impairment who are not undergoing dialysis. However, patients with end-stage renal disease should be treated cautiously and monitored closely.

Concomitant Drug Use: Strong CYP3A inhibitors or inducers should generally be avoided during Cabazitaxel therapy. If co-administration of a strong CYP3A inhibitor is unavoidable, a 25% reduction in Cabazitaxel dose should be considered.

Cytotoxic Chemotherapy

Store at 15°C to 30°C. Do not refrigerate.