Marqibo

What is Marqibo?

• Marqibo (vincristine sulfate) is a vinca alkaloid used to treat acute lymphoblastic leukemia.

Vincristine

Vincristine ball-and-stick

Vincristine3D

What are the uses of this medicine?

• Marqibo® is used 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.

How does this medicine work?

• Marqibo is a sphingomyelin/cholesterol liposome encapsulated formulation of vincristine sulfate.
• Non liposomal vincristine sulfate binds to tubulin, altering the tubulin polymerization equilibrium, resulting in altered microtubule structure and function.
• Non liposomal vincristine sulfate stabilizes the spindle apparatus, preventing chromosome segregation, triggering metaphase arrest and inhibition of mitosis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• demyelinating conditions, including Charcot-Marie-Tooth syndrome.
• hypersensitivity to vincristine sulfate or any of the other components of Marqibo.
• for intrathecal administration

What drug interactions can this medicine cause?

• Avoid concomitant use of strong CYP3A inhibitors.
• Avoid concomitant use of strong CYP3A inducers.
• Avoid the concomitant use of P gp inhibitors or inducers.
• Simultaneous oral or intravenous administration of phenytoin and chemotherapy combinations that included non liposomal vincristine sulfate have been reported to reduce blood levels of phenytoin.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

• Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vincristine sulfate injection.

Recommended dosage:

• The recommended dosage of Marqibo is 2.25 mg/m2 intravenously over 1 hour once every 7 days.

Administration:

• Intravenous use only.
• Do not administer by any other route.
• Marqibo is for intravenous use only and is fatal if given by other routes.
• Death has occurred with intrathecal administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Kit for Injection: After preparation, each single-dose vial of Marqibo (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate.

This medicine is available in fallowing brand namesː

• Marqibo

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• pyrexia
• fatigue
• peripheral neuropathy
• febrile neutropenia
• diarrhea
• anemia
• decreased appetite
• insomnia

What special precautions should I follow?

• Fatal if given by other routes. Death has occurred with intrathecal use.
• Extravasation can occur with Marqibo and extravasation causes tissue injury. If suspected, discontinue infusion immediately and consider local treatment measures.
• Sensory and motor neuropathies are common and are cumulative. Monitor patients for peripheral motor and sensory, central and autonomic neuropathy. Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment. Interrupt, dose reduce, or discontinue Marqibo based on severity.
• Neutropenia, thrombocytopenia, or anemia may occur with Marqibo. Monitor blood counts prior to each dose of Marqibo. Consider Marqibo dose delay or reduction, as well as supportive care measures for grade 3 or 4 reactions.
• Tumor lysis syndrome (TLS) may occur in patients with ALL receiving Marqibo. Anticipate, monitor for, and manage.
• Marqibo can cause constipation. Institute a prophylactic bowel regimen to prevent potential constipation, bowel obstruction, and/or paralytic ileus. Use additional laxative products as needed.
• Marqibo can cause severe fatigue. Consider dose delay, reduction, or discontinuation of Marqibo as appropriate.
• Fatal hepatic toxicity and increased aspartate aminotransferase (AST) occurred. Monitor hepatic function tests. Interrupt or dose reduce as appropriate.
• Based on findings from nonclinical studies and the mechanism of action, Marqibo can cause fetal harm when administered to a pregnant woman. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Grade 3 motor neuropathy
• Grade 4 grand mal seizure
• Grade 4 increased AST and bilirubin

Can this medicine be used in pregnancy?

• Based on findings from nonclinical studies and its mechanism of action, Marqibo can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Marqibo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients:
• VINCRISTINE SULFATE

Inactive ingredients:

• MANNITOL
• SODIUM HYDROXIDE
• SULFURIC ACID
• WATER

Who manufactures and distributes this medicine?

Manufactured for: Acrotech Biopharma LLC East Windsor, NJ

What should I know about storage and disposal of this medication?

• The prepared liposome product should be administered within 12 hours of the initiation of Marqibo preparation.
• Store the Marqibo Kit in the refrigerator at 2°C to 8°C.
• Do Not Freeze.
• Marqibo is a hazardous drug.
• Follow applicable special handling and disposal procedures

• Dailymed label info on Marqibo
• FDA Marqibo

Marqibo Resources
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