Multiple Sclerosis
Mavenclad (cladribine) is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS). MAVENCLAD tablets, 10 mg, are uncoated, white, round, biconvex, and engraved with a "C" on one side and "10" on the other side. Each tablet is packaged in a child-resistant day pack containing one or two tablets in a blister card.
Dispense one box for each treatment cycle with a Medication Guide [see Dosage and Administration (2.2)].
Presentations
NDC 44087-4000-4 Box of 4 tablets: Four day packs each containing one tablet.
NDC 44087-4000-5 Box of 5 tablets: Five day packs each containing one tablet.
NDC 44087-4000-6 Box of 6 tablets: One day pack containing two tablets. Four day packs each containing one tablet.
NDC 44087-4000-7 Box of 7 tablets: Two day packs each containing two tablets. Three day packs each containing one tablet.
NDC 44087-4000-8 Box of 8 tablets: Three day packs each containing two tablets. Two day packs each containing one tablet.
NDC 44087-4000-9 Box of 9 tablets: Four day packs each containing two tablets. One day pack containing one tablet.
NDC 44087-4000-0 Box of 10 tablets: Five day packs each containing two tablets.
16.2 Storage and Handling
Store at controlled room temperature, 20�C to 25�C (68�F to 77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. Store in original package in order to protect from moisture.
MAVENCLAD is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)].1 These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD.
MAVENCLAD� (cladribine) tablets, for oral use
Initial U.S. Approval: 1993
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning.
� Malignancies
MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy. (5.1)
� Risk of Teratogenicity
MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm. (5.2)
INDICATIONS AND USAGE
MAVENCLAD is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5)]. (1)
Limitations of Use
MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5)]. (1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to starting each MAVENCLAD treatment course. (2.1)
Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course). Each treatment course 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 do not plan to use effective contraception during MAVENCLAD dosing and for 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 for 10 days after the last dose. (4, 8.2)
WARNINGS AND PRECAUTIONS
Lymphopenia: Monitor lymphocyte counts before, during and after treatment. (5.3)
Infections: Screen patients for latent infections; consider delaying treatment until infection is fully controlled. Vaccinate patients antibody-negative to varicella zoster virus prior to treatment. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections. (5.4)
Hematologic toxicity: Monitor complete blood count before, during and after treatment. (5.5)
Graft-versus-host-disease with blood transfusion: Irradiation of cellular blood components is recommended. (5.6)
Liver injury: Obtain tests prior to treatment. Discontinue if clinically significant injury is suspected. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 20%) are upper respiratory tract infection, headache, and lymphopenia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Immunosuppressive drugs: Consider overlapping effects on immune system, when used sequentially. Concomitant use not recommended. (7.1)
Hematotoxic drugs: Monitor patients for additive effects on the hematological profile. (7.3)
Antiviral and antiretroviral drugs: Avoid concomitant use. (7.4)
BCRP or ENT/CNT inhibitors: May alter bioavailability of cladribine. Avoid concomitant use. (7.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2019