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

Recommended dosing option of 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

Secondary prophylaxis with G-CSF should be considered in all patients at increased risk for 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 label

Nicholas Vogelzang, MD

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

WATCH VIDEO

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. 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 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.

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