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The only microtubule inhibitor approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Preparation & Administration

Dosage Forms and Strengths

JEVTANA 60 mg/1.5 mL is supplied as a kit consisting of the following:
JEVTANA (cabazitaxel) injection 60 mg/1.5 mL JEVTANA (cabazitaxel) injection 60 mg/1.5 mL
Contains 60 mg cabazitaxel in 1.5 mL polysorbate 80
Diluent for JEVTANA (cabazitaxel) Diluent for JEVTANA
Contains approximately 5.7 mL of 13% (w/w) ethanol in water for injection

Preparation: 2-Step Dilution Process

Step 1: First Dilution
  1. Each vial of JEVTANA (cabazitaxel) injection 60 mg/1.5 mL must first be mixed with the entire contents of supplied diluent. Once reconstituted, the resultant solution contains 10 mg/mL of JEVTANA.
  2. When transferring the diluent, direct the needle onto the inside wall of JEVTANA vial and inject slowly to limit foaming. Remove the syringe and needle and gently mix the initial diluted solution by repeated inversions for at least 45 seconds to ensure full mixing of the drug and diluent. Do not shake.
  3. Let the solution stand for a few minutes to allow any foam to dissipate, and check that the solution is homogenous and contains no visible particulate matter. It is not required that all foam dissipate prior to continuing the preparation process.
  4. The resulting initial diluted JEVTANA solution (cabazitaxel 10 mg/mL) requires further dilution before administration. The second dilution should be done immediately (within 30 minutes) to obtain the final infusion as detailed in Step 2.
Step 2: Second (Final) Dilution
  1. Withdraw the recommended dose from the JEVTANA solution containing 10 mg/mL as prepared in Step 1 using a calibrated syringe and further dilute into a sterile 250-mL PVC-free container of either 0.9% sodium chloride solution or 5% dextrose solution for infusion. If a dose >65 mg of JEVTANA is required, use a larger volume of the infusion vehicle so that a concentration of 0.26 mg/mL JEVTANA is not exceeded. The concentration of the JEVTANA final infusion solution should be between 0.10 mg/mL and 0.26 mg/mL.
  2. Remove the syringe and thoroughly mix the final infusion solution by gently inverting the bag or bottle.
  3. As the final infusion solution is supersaturated, it may crystalize over time. Do not use if this occurs and discard.
  4. Fully prepared JEVTANA infusion solution (in either 0.9% sodium chloride solution or 5% dextrose solution) should be used within 8 hours at ambient temperature (including the one-hour infusion), or for a total of 24 hours (including the one-hour infusion) under the refrigerated conditions.
  5. Discard any unused portion.

Administration

  • Inspect visually for particulate matter, any crystals, and discoloration prior to administration. If the JEVTANA first diluted solution or second (final) infusion solution is not clear or appears to have precipitation, it should be discarded
  • Use an in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) during administration
  • The final JEVTANA infusion solution should be administered intravenously as a one-hour infusion at room temperature

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IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
  • Severe hypersensitivity: Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

CONTRAINDICATIONS

JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500/mm3, patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80, and patients with severe hepatic impairment (total bilirubin >3x upper limit of normal (ULN)).

WARNINGS AND PRECAUTIONS

Bone Marrow Suppression (BMS): BMS manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. 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 is recommended in patients with high-risk clinical features. 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. Caution is recommended in patients with hemoglobin <10 g/dl.

Increased Toxicities in 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.

Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to JEVTANA. Observe patients closely, especially during the first and second infusions. Discontinue JEVTANA immediately if severe hypersensitivity occurs and treat as indicated.

Gastrointestinal (GI) Adverse Reactions: Nausea, vomiting, and severe diarrhea may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials and mortality related to diarrhea has been reported. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing grade ≥3 diarrhea, dosage should be modified.

GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

Renal Failure: Cases, including those with fatal outcomes, have been reported. Identify cause and manage aggressively.

Urinary Disorders including Cystitis: Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

Respiratory Disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

Use in Patients with Hepatic Impairment: JEVTANA dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) and moderate (total bilirubin >1.5 to ≤3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administer JEVTANA 20 mg/m2 for mild hepatic impairment. Administer JEVTANA 15 mg/m2 for moderate hepatic impairment. Monitor closely.

Embryo-Fetal Toxicity: JEVTANA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of JEVTANA.

ADVERSE REACTIONS (ARs)

The most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 are neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia.

DRUG INTERACTIONS

Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk.
  • Lactation: The safety and efficacy of JEVTANA have not been established in females. There is no information available on the presence of JEVTANA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of JEVTANA.

Please see full prescribing information, including Boxed WARNING.


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MAT-US-2013902 07/20