Cabaxan Special Precautions

Cabazitaxel should not be used in patients with neutrophils ≤ 1,500/mm³.
Monitoring of complete blood counts is essential on a weekly basis during cycle I and before each treatment cycle thereafter so that the dose can be adjusted, if needed.
G-CSF may be administered to reduce risks of neutropenia complications associated with Cabazitaxel use. Primary prophylaxis with G-CSF 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. Therapeutic use of G-CSF and secondary prophylaxis should be considered in all patients considered to be at increased risk for neutropenia complications.
If a patient experiences febrile neutropenia or prolonged neutropenia (greater than one week) despite appropriate medication (e.g., G-CSF), the dose of cabazitaxel should be reduced. Patients can restart treatment with cabazitaxel only when neutrophil counts recover to a level > 1,500/mm³.
Hypersensitivity Reactions: Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of Cabazitaxel. Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the Cabazitaxel infusion and appropriate therapy. Patients with a history of severe hypersensitivity reactions should not be re-challenged with Cabazitaxel.
Gastrointestinal Symptoms: Nausea, vomiting and severe diarrhea at times, may occur. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Patients should be treated with rehydration, anti-diarrheal or anti-emetic medications as needed.
Treatment delay or dosage reduction may be necessary if patients experience Grade ≥ 3 diarrhea. Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with Cabazitaxel. Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy, gastrointestinal disease, such as ulceration and GI bleeding.
Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. Cabazitaxel treatment or delay or discontinuation may be necessary.
Renal Failure: Renal failure, including four cases with fatal outcome, was reported in the randomized clinical trial. Some deaths due to renal failure did not have a clear etiology. Appropriate measures should be taken to identify causes of renal failure and treat aggressively.
Hepatic Impairment: Cabazitaxel is extensively metabolized in the liver, and hepatic impairment is likely to increase Cabazitaxel concentrations.
Hepatic impairment increases the risk of severe and life-threatening complications in patients receiving other drugs belonging to the same class as Cabazitaxel. Cabazitaxel should not be given to patients with hepatic impairment (total bilirubin ≥ ULN, or AST and/or ALT ≥ 1.5 ULN).
Effects on ability to drive and use machines: Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness. Patients should be advised not to drive or use machines if they experience these adverse reactions during treatment.
Use in Children: The safety and effectiveness of Cabazitaxel in pediatric patients have not been established.
Use in the Elderly: Patients ≥ 65 years of age are more likely to experience certain adverse reactions, including neutropenia and febrile neutropenia.
Based on a population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of cabazitaxel between patients < 65 years and older.
Elderly patients (≥65 years of age) may be more likely to experience certain adverse reactions.
The incidence of neutropenia, fatigue, asthenia, pyrexia, dizziness, urinary tract infection and dehydration occurred at rates > 5% higher in patients who were 65 years of age or greater compared to younger patients.