Jevtana

Jevtana

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Cabazitaxel
Indications/Uses
In combination w/ prednisone or prednisolone for the treatment of adult patients w/ metastatic castration resistant prostate cancer previously treated w/ a docetaxel-containing regimen.
Dosage/Direction for Use
Adult 25 mg/m2 as a 1-hr IV infusion 3 wkly w/ oral prednisone or prednisolone 10 mg daily. Mild hepatic impairment Reduce dose to 20 mg/m2. Moderate hepatic impairment Max tolerated dose: 15 mg/m2.
Contraindications
Hypersensitivity to cabazitaxel, to other taxanes or polysorbate 80. Neutrophil count <1,500/mm3; severe hepatic impairment (total bilirubin ≥3 x ULN); concomitant vaccination w/ yellow fever vaccine.
Special Precautions
Hypersensitivity reactions during 1st & 2nd infusions. Bone marrow suppression; risk of neutropenia. Discontinue or delay treatment in case of serious GI toxicity. Appropriate measures should be taken to rehydrate patients & to monitor & correct serum electrolyte levels, particularly K. Peripheral neuropathy (sensory & motor). Hb & haematocrit should be checked before treatment & if patients exhibit signs or symptoms of anaemia or blood loss. Risk of renal failure or cardiac arrhythmias. Interstitial pneumonia/pneumonitis & interstitial lung disease. Co-administration w/ strong CYP3A inhibitors or inducers. Hepatic impairment. Patients presenting end stage renal disease. Contains 573.3 mg ethanol 96%. May influence ability to drive & use machinery. Pregnancy & lactation.
Adverse Reactions
Anaemia, leukopenia, neutropenia, thrombocytopenia; anorexia; dysgeusia; dyspnoea, cough; diarrhoea, nausea, vomiting, constipation, abdominal pain; alopecia; back pain, arthralgia; haematuria; fatigue, asthenia, pyrexia.
Drug Interactions
Increased plasma conc w/ strong CYP3A inhibitors eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. Decreased plasma conc w/ strong CYP3A inducers eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarb. Risk of interaction w/ OATP1B1 substrates eg, statins, valsartan, repaglinide. May result in serious or fatal infections w/ administration of live or live-attenuated vaccines.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD - Taxanes ; Used in the treatment of cancer.
Presentation/Packing
Form
Jevtana infusion conc 60 mg
Packing/Price
1's
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