HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useMAVENCLAD safely and effectively.
See full prescribing information forMAVENCLAD.
MAVENCLAD(cladribine)tablets, for oral use
Initial U.S. Approval: 1993
WARNING: MALIGNANCIES and RISK OF TERATOGENICITYSee full prescribing information for complete boxed warning.
• Malignancies
MAVENCLAD may increase the risk of malignancy. MAVENCLADis contraindicated in patients with current malignancy; eva luate thebenefits and risks on an individual basis for patients with prior orincreased risk of malignancy. (5.1)
• Risk of Teratogenicity
MAVENCLAD is contraindicated for use in pregnant women and inwomen and men of reproductive potential who do not plan to useeffective contraception because of the risk of fetal harm. (5.2)
INDICATIONS AND USAGE
MAVENCLAD is a purine antimetabolite indicated for the treatment ofrelapsing forms of multiple sclerosis (MS), to include relapsing-remittingdisease and active secondary progressive disease, in adults. Because of itssafety profile, use of MAVENCLAD is generally recommended for patientswho have had an inadequate response to, or are unable to tolerate, an alternatedrug indicated for the treatment of MS [see Warnings and Precautions (5)].
Limitations of UseMAVENCLAD is not recommended for use in patients with clinically isolatedsyndrome (CIS) because of its safety profile [see Warnings and Precautions
DOSAGE AND ADMINISTRATION
• Assessments are required prior to starting each MAVENCLAD treatmentcourse. (2.1)
• Cumulative dosage of 3.5 mg/kg administered orally and divided into2 treatment courses (1.75 mg/kg per treatment course). Each treatmentcourse is divided into 2 treatment cycles. (2.2)
• MAVENCLAD is a cytotoxic drug. (2.4)
• Separate administration from any other oral drug by at least 3 hours. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg (3)
CONTRAINDICATIONS
• Patients with current malignancy. (4)
• Pregnant women, and women and men of reproductive potential who donot plan to use effective contraception during MAVENCLAD dosing andfor 6 months after the last dose in each treatment course. (4, 8.3)
• HIV infection. (4)
• Active chronic infections (e.g., hepatitis or tuberculosis). (4)
• History of hypersensitivity to cladribine. (4, 5.8)
• Women intending to breastfeed on a MAVENCLAD treatment day and for10 days after the last dose. (4, 8.2)
WARNINGS AND PRECAUTIONS
• Lymphopenia: Monitor lymphocyte counts before, during and aftertreatment. (5.3)
• Infections: Screen patients for latent infections; consider delayingtreatment until infection is fully controlled. Vaccinate patients antibodynegativeto varicella zoster virus prior to treatment. Administer anti-herpesprophylaxis in patients with lymphocyte counts less than 200 cells permicroliter. Monitor for infections. (5.4)
• Hematologic toxicity: Measure complete blood count annually if clinicallyindicated after treatment. (5.5)
• Graft-versus-host-disease with blood transfusion: Irradiation of cellularblood components is recommended. (5.6)
• Liver injury: Obtain tests prior to treatment. Discontinue if clinicallysignificant injury is suspected. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 20%) are upper respiratory tractinfection, hea |
