Sign Out
Hypersensitivity Reactions: All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see Dosage & Administration).
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, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available. Severe reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of cabazitaxel and appropriate therapy. Patients with a hypersensitivity reaction must stop treatment with JEVTANA (see Contraindications).
Bone marrow suppression: Bone marrow suppression manifested as neutropenia, anaemia, thrombocytopenia, or pancytopenia may occur (see "Risk of neutropenia" and "Anaemia" as follows).
Risk of Neutropenia: Patients treated with cabazitaxel may receive prophylactic G-CSF, as per American Society of Clinical Oncology (ASCO) guidelines and/or current institutional guidelines, to reduce the risk or manage neutropenia complications (febrile neutropenia, prolonged neutropenia or neutropenic infection). 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. The use of G‑CSF has been shown to limit the incidence and severity of neutropenia.
Neutropenia is the most common adverse reaction of cabazitaxel (see Adverse Reactions). Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed.
The dose should be reduced in case of febrile neutropenia, or prolonged neutropenia despite appropriate treatment (see Dosage & Administration).
Patients should be re-treated only when neutrophils recover to a level ≥ 1,500/mm3 (see Contraindications).
Gastrointestinal Disorders: Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. Cabazitaxel treatment delay or discontinuation may be necessary.
Risk of Nausea, Vomiting, Diarrhoea and Dehydration: If patients experience diarrhoea following administration of cabazitaxel they may be treated with commonly used anti-diarrhoeal medicinal products. Appropriate measures should be taken to re-hydrate patients. Diarrhoea can occur more frequently in patients that have received prior abdomino-pelvic radiation. Dehydration is more common in patients aged 65 or older. Appropriate measures should be taken to rehydrate patients and to monitor and correct serum electrolyte levels, particularly potassium. Treatment delay or dose reduction may be necessary for grade ≥ 3 diarrhoea (see Dosage & Administration). If patients experience nausea or vomiting, they may be treated with commonly used anti-emetics.
Risk of Serious Gastrointestinal Reactions: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see Adverse Reactions). 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 or gastrointestinal disease, such as ulceration and GI bleeding.
Peripheral Neuropathy: Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel. Patients under treatment with cabazitaxel should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop. Physicians should assess for the presence or worsening of neuropathy before each treatment. Treatment should be delayed until improvement of symptoms. The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade > 2 peripheral neuropathy (see Dosage & Administration).
Anaemia: Anaemia has been observed in patients receiving cabazitaxel (see Adverse Reactions). Haemoglobin and haematocrit should be checked before treatment with cabazitaxel and if patients exhibit signs or symptoms of anaemia or blood loss. Caution is recommended in patients with haemoglobin <10 g/dl and appropriate measures should be taken as clinically indicated.
Risk of Renal Failure: Renal disorders, have been reported in association with sepsis, severe dehydration due to diarrhoea, vomiting and obstructive uropathy. Renal failure including cases with fatal outcome has been observed. Appropriate measures should be taken to identify the cause and intensively treat the patients if this occurs.
Adequate hydration should be ensured throughout treatment with cabazitaxel. The patient should be advised to report any significant change in daily urinary volume immediately. Serum creatinine should be measured at baseline, with each blood count and whenever the patient reports a change in urinary output. Cabazitaxel treatment should be discontinued in case of any degradation of renal failure ≥ CTCAE 4.0 Grade 3.
Respiratory disorders: Interstitial pneumonia/pneumonitis and interstitial lung disease have been reported and may be associated with fatal outcome (see Adverse Reactions). If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated. Interruption of cabazitaxel therapy is recommended until diagnosis is available. Early use of supportive care measures may help improve the condition. The benefit of resuming cabazitaxel treatment must be carefully evaluated.
Risk of Cardiac Arrhythmias: Cardiac arrhythmias have been reported, most commonly tachycardia and atrial fibrillation (see Adverse Reactions).
Elderly: Elderly people (≥ 65 years of age) may be more likely to experience certain adverse reactions including neutropenia and febrile neutropenia (see Adverse Reactions).
Patients with Liver Impairment: Treatment with JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) (see Contraindications and Pharmacology: Pharmacokinetics under Actions). Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Interactions: Co‑administration with strong CYP3A inhibitors should be avoided since they may increase the plasma concentrations of cabazitaxel (see Dosage & Administration and Interactions). If co-administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see Dosage & Administration and Interactions).
Co‑administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see Dosage & Administration and Interactions).
Excipients: The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine.
Harmful for those suffering from alcoholism.
To be taken into account in high‑risk groups such as patients with liver disease, or epilepsy.
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.
