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
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.
