Indication and Administration:

• Jevtana (cabazitaxel) is approved for use in combination with prednisone for patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

• Administer Jevtana as an intravenous infusion every 3 weeks, typically over one hour. The infusion should be followed by a corticosteroid, like prednisone, taken orally.

Dose Adjustments:

• Consider dose reduction in patients experiencing severe neutropenia or neutropenic complications despite appropriate medication, including granulocyte-colony stimulating factor (G-CSF).

• For patients with mild hepatic impairment, reduce the initial dose of Jevtana. Avoid use in patients with severe hepatic impairment.

• Delay treatment as necessary for recovery from severe adverse effects related to toxicity, particularly hematologic.

Premedication to Reduce Risk of Hypersensitivity Reactions:

• Administer pre-medications approximately 30 minutes before each dose of Jevtana to minimize hypersensitivity reactions. These typically include antihistamines (e.g., diphenhydramine), corticosteroids (e.g., dexamethasone), and H2 antagonists (e.g., ranitidine or equivalent).

Management of Neutropenia:

• Routine monitoring of complete blood counts (CBC) is advised before each treatment cycle.

• Prophylactic G-CSF may be considered in patients with a history of severe neutropenia.

Secondary Prophylaxis:

• Be vigilant for signs and symptoms of infection; educate patients to recognize these symptoms and instruct them to contact a healthcare provider immediately should they arise.

Gastrointestinal Toxicity:

• Administer antiemetics and appropriate hydration before and after infusion to prevent nausea and vomiting.

• Diarrhea can be severe; early intervention with antidiarrheal treatments and prompt fluid and electrolyte replacement is crucial.

Handling and Administration:

• Jevtana is a cytotoxic agent, and proper handling and disposal procedures must be followed. Use of a closed system transfer device and personal protective equipment are recommended to decrease drug exposure.

Renal Impairment:

• No initial dose adjustment is required in patients with mild to moderate renal impairment. The use of Jevtana in patients with severe renal impairment should be approached with caution.

Drug Interactions:

• Monitor for interactions particularly with strong CYP3A inhibitors or inducers which can significantly affect cabazitaxel blood concentrations.

• Caution with co-administration of other drugs known to prolong QT interval or potentiate risk of electrolyte imbalance.

Educating Patients:

• Inform patients about the potential side effects of Jevtana, including the importance of hydration, managing side effects proactively, and when to seek immediate medical attention.