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Prophylaxis for infusion reactions: Intravenous premedication with a corticosteroid (dexamethasone 8 mg or equivalent), an H1 receptor antagonist (diphenhydramine 25 mg or an equivalent), and an H2 receptor antagonist (ranitidine 50 mg IV or equivalent) at least 30 minutes prior to cabazitaxel administration. Refer to UpToDate topic on "Infusion reactions to systemic chemotherapy". •

Infection prophylaxis: Primary prophylaxis with G-CSF is not justified (risk of febrile neutropenia 8 percent [1] ). However, bone marrow suppression is prominent with this agent, and deaths due to neutropenia are reported. Consider primary prophylaxis for age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation, poor nutritional status, or other serious comorbidities. Refer to UpToDate topic on "Use of granulocyte colony stimulating factors in patients with chemotherapy-induced neutropenia". •

Dose adjustment for baseline liver or renal dysfunction: Cabazitaxel is not recommended for patients with bilirubin ≥ULN, or if AST and/or ALT are ≥1.5 times ULN [2] . Cabazitaxel should be used with caution in patients with a creatinine clearance <30 mL/min. Refer to UpToDate topics on "Chemotherapy hepatotoxicity and dose modification in patients with liver disease" and "Chemotherapy-related nephrotoxicity and dose modification in patients with renal insufficiency"). Monitoring parameters: • CBC with differential weekly during the first cycle and at the start of each subsequent treatment cycle. • Renal and liver function testing at least every three weeks during treatment. • Monitor neurologic function and gastrointestinal toxicities prior to each treatment cycle. Suggested dose alterations for toxicity: •

Myelotoxicity: Do not give if neutrophil count ≤1500 cells/mm 3 . For prolonged grade 3 or 4 neutropenia (greater than one week) despite appropriate medication including G-CSF for febrile neutropenia, delay treatment until improvement/resolution and neutrophil count is >1500 cells/mm 3 , then reduce dose to 20 mg/m 2 . Use G-CSF for secondary prophylaxis [2] . Discontinue cabazitaxel if these toxicities recurat the lower dose level. •

Gastrointestinal toxicity: For grade 3 or higher diarrhea or persisting diarrhea despite appropriate medication and fluid and electrolyte replacement, delay treatment until improvement or resolution, then reduce dose to 20 mg/m 2 . For persistent diarrhea despite dose reduction, discontinue cabazitaxel therapy [2] . If there is a change in body weight of at least 10 percent, cabazitaxel dose should be recalculated. This table is provided as an example of how to administer this regimen; there may be other acceptable methods. This regimen must be administered by a clinician trained in the use of chemotherapy. The clinician is expected to use his or her independent medical judgment in the context of individual circumstances to make adjustments, as necessary. IV: intravenous; G-CSF: granulocyte colony-stimulating factor; ULN: upper limit of normal; AST: aspartate aminotransferase; ALT: alanine aminotransferase; CBC: complete blood count. * Diluent solutions should not be modified without consulting a detailed reference due to potential incompatibility(ies). Δ Do not use PVC infusion containers or polyurethane infusion sets for preparation or administration. The manufacturer requires that two dilutions are performed prior to administration. Cabazitaxel can be administered in normal saline or 5 percent dextrose in water at concentrations between 0.10 mg/mL and 0.26 mg/mL. Use an in-line filter of 0.22 micrometer nominal pore size during administration [2] . References: de Bono JS, et al. Lancet 2010; 376:1147. Jevtana (cabazitaxel) injection. US FDA-approved manufacturer's package insert. US National Library of Medicine. (Available online at dailymed.nlm.nih.gov, accessed on January 13, 2012).