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

Dosing and Dose Modifications

For patients with mCRPC previously treated with a docetaxel-containing regimen, the recommended dose of JEVTANA is 20 mg/m².

Premedication

Administer the following intravenous (IV) medications at least 30 minutes prior to each dose of JEVTANA to reduce the risk and/or severity of hypersensitivity:
- Antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine)
- Corticosteroid (dexamethasone 8 mg or equivalent steroid)
- H₂ antagonist (ranitidine 50 mg or equivalent H₂ antagonist)
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.

Prophylactic Use of G-CSF

Primary Prophylaxis with G-CSF is Recommended in Patients with High-risk Clinical Features

Older patients
Poor performance status
Previous episodes of febrile neutropenia

Extensive prior radiation ports
Poor nutritional status
Other serious comorbidities

The effectiveness of primary prophylaxis with G-CSF in patients receiving JEVTANA has not been studied.

Consider Therapeutic Use of G-CSF and Secondary Prophylaxis in All Patients at Increased Risk of Neutropenia Complications

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.

For Patients at Risk With Neutropenia

Start with the approved dose of JEVTANA: 20 mg/m ² q 3 wk + oral prednisone 10 mg daily throughout treatment. 25 mg/m ² may be considered in select patients. 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.
If neutropenia complications occur, delay treatment until neutrophil count is >1,500 cells/mm³, then reduce dosage of JEVTANA by one dose level. Use G-CSF for secondary prophylaxis.

Dose Modifications for JEVTANA

Toxicity	Dose modification
Prolonged grade ≥3 neutropenia (>1 week) despite appropriate medication including granulocyte-colony stimulating factor (G-CSF)	Delay treatment until neutrophil count is >1,500 cells/mm³, then reduce dosage of JEVTANA by one dose level. Use G-CSF for secondary prophylaxis.
Febrile neutropenia or neutropenic infection	Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm³, then reduce dosage of JEVTANA by one dose level. Use G-CSF for secondary prophylaxis.
Grade ≥3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolyte replacement	Delay treatment until improvement or resolution, then reduce dosage of JEVTANA by one dose level.
Grade 2 peripheral neuropathy	Delay treatment until improvement or resolution, then reduce dosage of JEVTANA by one dose level.
Grade ≥3 peripheral neuropathy	Discontinue JEVTANA.
Hepatic impairment	Administer JEVTANA at a dose of 20 mg/m² for patients with mild hepatic impairment and 15 mg/m² for patients with moderate hepatic impairment.

Patients at a 20 mg/m² dose who require dose reduction should decrease dosage of JEVTANA to 15 mg/m².
Patients at a 25 mg/m² dose who require dose reduction should decrease dosage of JEVTANA to 20 mg/m². One additional dose reduction to 15 mg/m² may be considered.

Watch a video discussing the change to the dosing in the JEVTANA (cabazitaxel) label.

Nicholas Vogelzang, MD

WHAT IS THE CHANGE TO THE DOSING IN THE JEVTANA LABEL?

WATCH VIDEO

Nicholas Vogelzang, MD

WHAT IS THE CHANGE TO THE DOSING IN THE JEVTANA LABEL?

WATCH VIDEO

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. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m².
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. 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, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.

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 last dose of JEVTANA.

Please see full Prescribing Information, including Boxed WARNING.

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