Cabazitaxel Disease Interactions

Because of their cytotoxic effects on rapidly proliferating tissues, antineoplastic agents frequently can, to varying extent, induce myelosuppression. The use of these drugs may be contraindicated in patients with known infectious diseases. All patients should be instructed to immediately report any signs or symptoms suggesting infection such as fever, sore throat, or local infection during antineoplastic therapy. Close clinical monitoring of hematopoietic function is recommended.

Cabazitaxel is extensively metabolized in the liver and is contraindicated in patients with severe hepatic impairment. Caution and close monitoring is recommended when prescribing this agent to patients with mild or moderate hepatic impairment and dosage reduction should be considered for these patients.

The use of cabazitaxel is contraindicated in patients with neutrophils count less than or equal to 1,500/mm3. The use of cabazitaxel may cause bone marrow suppression manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia. Prophylaxis therapy should be considered in patients with high-risk clinical features (age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia. Cautions should be exercised in patients using cabazitaxel with hemoglobin counts of less than 10 g/dL. It is recommended to monitor complete blood counts on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed.

Renal failure, sometimes with fatal outcomes has been documented with the use of cabazitaxel in clinical studies and most cases have occurred in association with sepsis, dehydration, or obstructive uropathy. Care and appropriate measures should be taken when prescribing this agent to these patients.

Gastrointestinal hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported in patients treated with cabazitaxel. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. It is recommended to monitor closely for early manifestations of serious gastrointestinal toxicity and to delay or discontinue treatment if necessary, in particular if patients experience Grade >=3 diarrhea.

Cabazitaxel is minimally excreted via the kidney and its use does not require dosage adjustment in patients with renal impairment not requiring hemodialysis. Patients presenting with end-stage renal disease should be monitored carefully during treatment with cabazitaxel.

Interstitial lung disease/pneumonitis and acute respiratory distress syndrome have been reported with the use of cabazitaxel. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Treatment interruption or discontinuation may be necessary if new or worsening of pulmonary symptoms develop. Close monitoring is recommended. The benefits of resuming therapy should be carefully evaluated.