Mavenclad Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mavenclad Indications
Indications
Limitations of Use
Mavenclad Dosage and Administration
Adult
Children
Mavenclad Contraindications
Contraindications
Mavenclad Boxed Warnings
Boxed Warning
Mavenclad Warnings/Precautions
Warnings/Precautions
Perform cancer screening according to guidelines prior to each course. Prior malignancy or increased risk of malignancy: evaluate benefits/risks. Risk of lymphopenia and hematologic toxicity; obtain CBC with differential (include lymphocyte counts) prior to, during, and after treatment. Exclude HIV infection prior to initiation. Screen for TB, hepatitis prior to first and second courses. Evaluate for acute infection; consider delaying start until fully controlled. Test for antibodies to varicella zoster virus; if negative, give vaccination prior to initiating cladribine; see full labeling. If lymphocyte counts <500cells/mcL: monitor for infections (eg, herpes) and treat. Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting cladribine. Obtain baseline MRI (within 3 months) prior to first course due to risk of progressive multifocal leukoencephalopathy (PML); withhold and evaluate if signs/symptoms occur. Graft-versus-host disease with blood transfusion: irradiation of cellular blood component is recommended. Obtain serum AST/ALT, total bilirubin prior to first and second course. Interrupt or discontinue treatment if hepatic dysfunction is suspected. Cardiac failure. Moderate to severe renal or hepatic impairment: not recommended. Elderly. Risk of teratogenicity. Advise females and males (w. female partners) of reproductive potential to use effective contraception during and for ≥6 months after the last dose in each treatment course. Pregnancy: exclude status before initiation; discontinue if occurs during treatment. Nursing mothers: not recommended (during and for 10 days after the last dose).
Mavenclad Pharmacokinetics
Absorption
The bioavailability of cladribine was approximately 40%. Following fasted administration of cladribine, the median time to maximum concentration (Tmax) was 0.5 h (range 0.5 to 1.5 hours).
Distribution
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Cladribine mean apparent volume of distribution ranges from 480 to 490 liters.
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The plasma protein binding of cladribine is 20% and is independent of concentration, in vitro.
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Intracellular concentrations of cladribine and/or its metabolites in human lymphocytes were approximately 30 to 40 times extracellular, in vitro.
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Cladribine has the potential to penetrate the blood brain barrier. A cerebrospinal fluid/plasma concentration ratio of approximately 0.25 was observed in cancer patients.
Elimination
Renal. Half-life: ~1 day.
Mavenclad Interactions
Interactions
Mavenclad Adverse Reactions
Adverse Reactions
Mavenclad Clinical Trials
Mavenclad Note
Not Applicable