• Treatment of adults with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more other therapies.

Contraindicated in:

• Hypersensitivity
• Demyelinating conditions including Charcot-Marie-Tooth syndrome
• Intrathecal administration (can be fatal)
• Concurrent use of strong inhibitors/inducers of the CYP3A4 enzyme system
• OB: Pregnancy (can cause fetal harm)
• Lactation: Should not be used in nursing mothers.

Use Cautiously in:

• Pre-existing severe neuropathy
• Female patients with child-bearing potential (contraception is necessary)
• Geri: Consider age-related decreases hepatic, renal, or cardiac function, concomitant disease or other drug therapies which may ↑ risk of adverse reactions
• Pedi: Safe and effective use in children <18 yr has not been established.

CNS: fatigue, insomnia, mental starus changes, weakness.

Resp: respiratory distress/failure.

CV: CARDIAC ARREST, hypotension.

GI: BOWEL OBSTRUCTION/PARALYTIC ILEUS, ↓appetite, diarrhea, nausea, abdominal pain, constipation, hepatotoxicity.

Hemat: bone marrow depressions.

Local: tissue damage following extravasation.

MS: muscular weakness.

Neuro: peripheral neuropathy.
Misc: TUMOR LYSIS SYNDROME, fever.

Drug-Drug:

• May ↓ blood levels and effectiveness of phenytoin.
• Blood levels and the risk of toxicity may be ↑ by concurrent use of strong CYP3A4 inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, and voriconazole and should be avoided.
• Blood levels and effectiveness may be ↓ by concurrent use of strong CYP3A inducers including carbamazepine, dexamethasone, phenytoin, rifabutin, rifampin, rifapentine, and phenobarbital, and should be avoided.
• Blood levels and effects may be altered by concurrent use of potent P-gp inhibitors or inducers should be avoided.

Drug-Natural Products:

• Blood levels and effectiveness may be ↓ by St. John's wort, concurrent use should be avoided.

• Suspension for intravenous infusion only (prepared by pharmacy): 5 mg/31 mL (0.16 mg/mL) single-dose vial (included in kit are Sphingomyelin/Cholesterol Liposome Injection (103 mg/mL) and sodium Phosphate Injection (355 mg/25 mL);

• IV (Adults and Children >18 yr): 2.25 mg/m² intravenously every 7 days. Modifications required for peripheral neuropathy, hepatotoxicity, bone marrow depression or extreme fatigue.

Marqibo

• Vincristine binds to tubulin, altering microtubule structure and function; also stabilizes spindle apparatus, triggering metaphase arrest and inhibition of mitosis.
• Liposome encapsulation delays and prolongs release of active drug.

• Death of rapidly replicating cells, particularly malignant ones. Has immunosuppressive properties.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: vinca alkaloids

Absorption: Liposome encapsulation causes delayed release into circulation.

Distribution: Unknown.

Metabolism/Excretion: Metabolized by the liver and eliminated in the feces via biliary excretion (69%), <8% eliminated in urine.

Half-life: Non-liposomal — 10.5–37.5 hr.

(median duration of remission)

• Instruct patient to read the Patient Information sheet prior to starting vincristine liposome and before each infusion in case of changes.
• Instruct patient to notify health care professional immediately if redness, swelling, burning, or pain at injection site occurs.
• May cause fatigue and mental impairment. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
• Instruct patient to report symptoms of neurotoxicity (paresthesia, pain, difficulty walking, persistent constipation). Inform patient that increased fluid intake, dietary fiber, and exercise may minimize constipation. Stool softeners or laxatives may be used. Patient should inform health care professional if severe constipation, abdominal pain, bloating, diarrhea, nausea, or vomiting occurs, as this may be a sign of neuropathy.
• Advise patient to notify health care professional if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; blood in urine, stool, or emesis; or mouth sores occur. Caution patient to avoid crowds and persons with known infections.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially St. John's Wort.
• Discuss with patient the possibility of hair loss. Explore coping strategies.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Advise patient that this medication may have teratogenic effects. Contraception should be used during and for at least 2 mo after therapy is concluded.
• Emphasize need for periodic lab tests to monitor for side effects.

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