Jevtana Infusion

Cabazitaxel accton solvate

40mg/ml

SANOFI AVENTIS DEUTSCHLAND GmbH

Pack size	1.5ml Vial (Concentrate) + 1 Solvent Vial (4.5ml)
Dispensing mode	POM
Source	GERMANY
Agent	PHARMATRADE
Retail Price	24029.00 AED

Indications

Jevtana Infusion is used for: Metastatic prostate cancer

Adult Dose

The individual dosage is based on calculation of the Body Surface Area (BSA) and is 25 mg/m² administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout treatment. Prolonged grade > 3 neutropenia : Delay treatment until neutrophil count is > 1,500 cells/mm3, then reduce dosage to 20 mg/m2. Febrile neutropenia : Delay treatment until improvement or resolution, and until neutrophil count is > 1,500 cells/mm3, then reduce dosage to 20 mg/m2. Grade 3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement : Delay treatment until improvement or resolution, then reduce dosageto 20 mg/m2. Elderly patients: Patients > 65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely. Hepatic impairment: Mild hepatic impairment (total bilirubin > 1 to ? 1.5 x upper limit of normal (ULN) or AST >1.5 x ULN): Reduce dose to 20 mg/m² Moderate hepatic impairment (total bilirubin > 1.5 to ? 3 x ULN and AST = any): 15 mg/m² Severe hepatic impairment (total bilirubine >3 x ULN): Contraindicated

Child Dose

Safety and efficacy not established

Renal Dose

Renal Impairment: Cabazitaxel is minimally excreted through the kidney. No dose adjustment is necessary in patients with mild renal impairment [creatinine clearance (CrCl): 50-80 mL/min]. Limited data are available for patients with moderate (CrCl: 30-50 mL/min) and no data are available for patients with severe renal impairment (CrCl <30 mL/min) or end stage renal disease; therefore, these patients should be treated with caution and monitored carefully during treatment.

Administration

IV Preparation Use aseptic technique 2-step dilution process Do not mix with any other drugs Step 1 (1st dilution) Mix cabazitaxel 60 mg/1.5 mL vial with entire contents of supplied diluent Once reconstituted, resultant solution contains 10 mg/mL Vial contains slight overfill (ie, entire vial contains about 65 mg) When transferring the diluent, direct the needle onto the inside wall of vial and inject slowly to limit foaming Remove syringe and needle and gently mix the initial diluted solution by repeated inversions for at least 45 seconds to assure full mixing of the drug and diluent; DO NOT SHAKE Let solution stand for a few minutes to allow any foam to dissipate, and check that the solution is homogeneous and contains no visible particulate matter; it is not required that all foam dissipate prior to continuing the preparation process Step 2 (2nd dilution) Withdraw recommended dose from reconstituted vial containing 10 mg/mL (1st dilution) Further dilute into sterile 250 mL PVC-free container (glass, polyolefin) of either 0.9% NaCl or dextrose 5% solution for infusion Final concentration should range between 0.1-0.26 mg/mL Thoroughly mix final infusion solution by gently inverting the bag/bottle IV Administration Administer IV infusion via volumetric infusion pump Administer over 1 hr Use an in-line filter (0.22 micron pore size) during administration

Contra Indications

-Patients with neutrophil counts of > 1,500/mm3. -Patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

Precautions

Neutropenia, febrile neutropenia: Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features. Hypersensitivity: Severe hypersensitivity reactions can occur. Premedicate with corticosteroids and H2 antagonists. Discontinue infusion immediately if hypersensitivity is observed and treat as indicated. Gastrointestinal disorders: Nausea, vomiting, and diarrhea may occur. Mortality related to diarrhea has been reported. Rehydrate and treat with anti-emetics and anti-diarrheals as needed. If experiencing Grade 3 diarrhea, dosage should be modified. Deaths have occurred due to gastrointestinal hemorrhage, perforation and neutropenic enterocolitis. Delay or discontinue. Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively. It can cause fetal harm when administered to a pregnant woman. Lactation: Unknown whether distributed in breast milk, decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Pregnancy-Lactation

Pregnancy Pregnancy Category: D Contraindicated for use in pregnant women because drug can cause fetal harm and potential loss of pregnancy; not indicated for use in female patients; there are no human data on use of cabazitaxel injection in pregnant women; in animal reproduction studies, intravenous administration of drug in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than maximum recommended human dose Contraception Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after administering final dose Infertility Based on animal toxicology studies, cabazitaxel injection may impair human fertility in males of reproductive potential Lactation Not indicated for use in female patients; there is no information available on presence in human milk, effects on breastfed infant, or on milk production; drug or drug metabolites are excreted in maternal milk of lactating rats

Interactions

Increased conc w/ strong CYP3A inhibitors (eg ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) & decreased conc w/ CYP3A inducers (eg phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarb). Serious or fatal infections w/ live or live attenuated vaccines. Risk of interaction w/ OATP1B1 substrates (eg statins, valsartan, repaglinide) during 1-hr & 20 min after infusion.

Adverse Effects

Side effects of Cabazitaxel accton solvate : >10% Anemia (11-98%), Leukopenia (69-96%), Neutropenia (82-94%), Thrombocytopenia (4-48%), Diarrhea (6-47%), Fatigue (5-37%), Nausea (2-34%), Vomiting (2-22%), Asthenia (5-20%), Constipation (1-20%), Abdominal pain (2-17%), Hematuria (2-17%), Anorexia (1-16%), Back pain/arthralgia (11-16%), Peripheral neuropathy (1-13%), Pyrexia (1-12%), Dyspnea (1-12%), Cough (11%), Dysgeusia (11%) 1-10% Dyspepsia (10%), Alopecia (10%), Peripheral edema (1-9%), Weight loss (9%), Dizziness (8%), Headache (8%), UTI (2-8%), Dysuria (7%), Febrile neutropenia (1-7%), Mucosal inflammation (1-6%), Hypotension (5%), Arrhythmia (1-5%)

Mechanism of Action

Microtubule inhibitor; binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly; this results in microtubule stabilization, which results in the inhibition of mitotic and interphase cellular functions.

Note

Jevtana 40mg/ml Infusion manufactured by SANOFI AVENTIS DEUTSCHLAND GmbH. Its generic name is Cabazitaxel accton solvate. Jevtana is availble in United Arab Emirates. Farmaco UAE drug index information on Jevtana Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.