Usual Adult Dose for Acute Lymphoblastic Leukemia

2.25 mg/m2 IV over 1 hour once every 7 days

Use: Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

The manufacturer suggests using caution when selecting a dose for elderly patients due to their greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or drug therapy.

The manufacturer recommends dose modifications for vincristine liposome related peripheral neuropathy. If the patient develops grade 3 or persistent grade 2 peripheral neuropathy, then interrupt therapy; discontinue if neuropathy remains at grade 3 or 4, and reduce dose to 2 mg/m2 if the neuropathy recovers to grade 1 or 2. If the patient has persistent grade 2 peripheral neuropathy following a dose reduction, then interrupt therapy for up to 7 days; discontinue if the neuropathy increases to grade 3 or 4, and reduce dose to 1.825 mg/m2 if neuropathy recovers to grade 1. If the patient has persistent grade 2 neuropathy after the second dose reduction, then interrupt therapy for up to 7 days; discontinue if the neuropathy increases to grade 3 and reduce the dose to 1.5 mg/m2 if the neuropathy recovers to grade 1.

Precautions

US BOXED WARNINGS:

• FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES. Death has occurred with intrathecal administration.
• Vincristine sulfate LIPOSOME injection has different dosage recommendations than vincristine SULFATE injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.

• Hypersensitivity to the active component or any of the ingredients
• In patients with demyelinating conditions including Charcot-Marie-Tooth syndrome
• Intrathecal administration

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only. Fatal if given by other routes.
• Vincristine sulfate liposome has different dosage recommendations than vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.
• Patients with preexisting severe neuropathy should be treated with this drug only after careful risk-benefit assessment.

• Store this drug in the refrigerator at 2C to 8C. Do Not Freeze.

• The manufacturer product information should be consulted.

• Monitor complete blood counts prior to each dose and modify or reduce dose and administer supportive care if warranted.
• Hepatic function tests should be monitored for elevated aspartate aminotransferase and liver toxicity. A reduction or interruption of the dose may be necessary.

• Advise patients to report immediately any burning or local irritation during or after the infusion.
• This drug may cause fatigue and symptoms of peripheral neuropathy. Advise patients not to drive or operate machinery if they experience any of these symptoms.
• This drug can cause constipation. Advise patients how to avoid constipation by a diet high in bulk fiber, fruits and vegetables, and adequate fluid intake as well as use of a stool softener, such as docusate. Instruct patients to seek medical advice if they experience symptoms of constipation such bowel movement infrequency, abdominal pain, bloating, diarrhea, nausea, or vomiting.
• Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with this drug.
• Advise patients to speak with their physician about any other medication they are currently taking.