Jevtana

Jevtana

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Cabazitaxel
Indications/Uses
In combination w/ prednisone or prednisolone in adult patients w/ metastatic castration-resistant prostate cancer previously treated w/ docetaxel-containing regimen.
Dosage/Direction for Use
25 mg/m2 as 1-hr IV infusion every 3 wk in combination w/ PO prednisone or prednisolone 10 mg daily throughout treatment. Prolonged grade ≥3 neutropenia (>1 wk) despite appropriate treatment including G-CSF, febrile neutropenia or neutropenic infection, grade ≥3 diarrhoea or persisting diarrhoea despite appropriate treatment including fluid & electrolytes replacement, grade ≥2 peripheral neuropathy Delay treatment then reduce dose to 20 mg/m2. Mild hepatic impairment Reduce dose to 20 mg/m2. Moderate hepatic impairment Max tolerated dose: 15 mg/m2.
Contraindications
Hypersensitivity to cabazitaxel, other taxanes & polysorbate 80. Neutrophil count <1,500/mm3. Concomitant vaccination w/ yellow fever vaccine. Severe hepatic impairment (bilirubin ≥3 x upper limit of normal).
Special Precautions
Hypersensitivity reactions during 1st & 2nd infusions. Bone marrow suppression; interstitial pneumonia/pneumonitis, interstitial lung disease; cardiac arrhythmias; peripheral neuropathy; patients w/ Hb <10 g/dL. Consider primary prophylaxis w/ G-CSF in patients w/ high-risk clinical features predisposing to increased complication from prolonged neutropenia. Patients at risk of developing GI complications eg, w/ neutropenia, prior history of pelvic radiotherapy or GI disease. Monitor complete blood count on wkly basis during cycle 1 & prior to each treatment cycle thereafter; check Hb & haematocrit before treatment. Measure serum creatinine at baseline w/ each blood count & whenever there is urinary output change. Ensure adequate hydration throughout treatment. Alcoholism; epilepsy. Avoid co-administration w/ strong CYP3A inhibitors & inducers. Concomitant use of NSAIDs, antiplatelet therapy or anticoagulants. May affect ability to drive & use machines. Liver disease. End-stage renal disease (CrCl <15 mL/min/1.73 m2). Men should use effective contraception during & up to 6 mth after last dose. Not recommended during pregnancy. Not to be used during lactation. Childn & adolescent <18 yr. Elderly ≥65 yr.
Adverse Reactions
Neutropenia, anaemia, leukopenia, 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. Inhibited transport proteins of OATP1B1 substrates eg, statins, valsartan, repaglinide. Serious or fatal infections w/ live or live-attenuated vaccines.
ATC Classification
L01CD - Taxanes ; Used in the treatment of cancer.
Presentation/Packing
Form
Jevtana infusion conc (vial) 60 mg
Packing/Price
1.5 mL x 1's
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