Generic Name: vincristine sulfate
Dosage Form: injection
WARNING
•For Intravenous Use Only – Fatal if Given by Other Routes [see Warnings and Precautions (5.1)].
•Death has occurred with intrathecal administration.
•Marqibo (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.
Indications and Usage for Marqibo
Adult ALL in Second or Greater Relapse
Marqibo® is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two 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.
Marqibo Dosage and Administration
For Intravenous Use Only. Fatal if Given by Other Routes.
Marqibo (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.
Recommended Dosage
The recommended dose of Marqibo is 2.25 mg/m2 intravenously over 1 hour once every 7 days.
Marqibo is liposome-encapsulated vincristine.
Dose modifications: Peripheral Neuropathy
Marqibo is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome [see Contraindications (4)]. Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment [see Warnings and Precautions (5.3)]. For dose or schedule modifications guidelines for patients who experience peripheral neuropathy, see Table 1.
Table 1. Recommended Dose Modifications for Marqibo-related Peripheral Neuropathy Severity of Peripheral Neuropathy Signs and Symptoms* Modification of Dose and Regimen
*
Grading based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
†
Self-care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
‡
Instrumental ADL: refers to preparing meals, shopping for groceries and clothes, using telephone, managing money, etc.
If the patient develops Grade 3 (severe symptoms; limiting self-care activities of daily living [ADL]†) or persistent Grade 2 (moderate symptoms; limiting instrumental ADL‡) peripheral neuropathy: Interrupt Marqibo.
If the peripheral neuropathy remains at Grade 3 or 4, discontinue Marqibo.
If the peripheral neuropathy recovers to Grade 1 or 2, reduce the Marqibo dose to 2 mg/m2.
If the patient has persistent Grade 2 peripheral neuropathy after the first dose reduction to 2 mg/m2: Interrupt Marqibo for up to 7 days.
If the peripheral neuropathy increases to Grade 3 or 4, discontinue Marqibo.
If peripheral neuropathy recovers to Grade 1, reduce the Marqibo dose to 1.825 mg/m2.
If the patient has persistent Grade 2 peripheral neuropathy after the second dose reduction to 1.825 mg/m2: Interrupt Marqibo for up to 7 days.
If the peripheral neuropathy increases to Grade 3 or 4, discontinue Marqibo.
If the toxicity recovers to Grade 1, reduce the Marqibo dose
