Cabazitaxel (2 brand names, 3 dosage forms, 3 routes)
Available dosage forms: SOLUTION, INJECTABLE, UNKNOWN.
Routes of administration: INTRAVENOUS, INJECTION, UNKNOWN.
Brand Names
- CABAZITAXEL
- JEVTANA KIT
Indications and Usage
JEVTANA® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
Contraindications
JEVTANA is contraindicated in patients with: neutrophil counts of ≤1,500/mm3 [see Warnings and Precautions (5.1)] history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Warnings and Precautions (5.3)] severe hepatic impairment (total bilirubin >3 × ULN) [see Warnings and Precautions (5.8)]
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in another section of the label: Bone Marrow Suppression [see Warnings and Precautions (5.1)] Increased Toxicities in Elderly Patients [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.4)] Renal Failure [see Warnings and Precautions (5.5)] Urinary Disorders Including Cystitis [see Warnings and Precautions (5.6)] Respiratory Disorders [see Warnings and Precautions (5.7)] Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.8)]
Mechanism of Action
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 inhibition of mitotic and interphase cellular functions.
Overdosage
There is no known antidote for JEVTANA overdose. Overdose has resulted from improper preparation [see Dosage and Administration (2.5)]. Read the entire section Dosage and Administration (2) carefully before mixing or diluting. 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.