Mavenclad Cladribine
Refer to the “Also Known As” section to reference different products that include the same medication as Mavenclad.
Drug Basics
Brand Name: Mavenclad
Generic Name: CLADRIBINE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET
Packager: EMD Serono, Inc.
Data Current As Of: 2021-03-25
Indications & Usage
MAVENCLAD is 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)].
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)
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)].
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Malignancies
Inform patients that MAVENCLAD may increase their risk of malignancies. Instruct patients to follow standard cancer screening guidelines [see Dosage and Administration (2) and Warnings and Precautions (5.1)].
Risk of Teratogenicity
Inform patients that MAVENCLAD may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant. Before initiating each treatment course, inform patients about the potential risk to the fetus, if female patients or partners of male patients get pregnant during MAVENCLAD dosing or within 6 months after the last dose in each treatment course [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].
Instruct female patients of childbearing potential to use effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course to avoid pregnancy. Advise women using systemically acting hormonal contraceptives to add a barrier method during MAVENCLAD dosing and for at least 4 weeks after the last dose in each treatment course because MAVENCLAD may reduce the effectiveness of the hormonal contraceptive [see Drug Interactions (7.7)].
Instruct male patients to take precautions to prevent pregnancy of their partner during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course.
Advise patients that female patients or partners of male patients who get pregnant immediately inform their healthcare provider.
Lactation
Inform women that they cannot breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose [see Use in Specific Populations (8.2)].
Lymphopenia and Other Hematologic Toxicity
Inform patients that MAVENCLAD may decrease lymphocyte counts and may also decrease counts of other blood cells. A blood test should be obtained before starting a treatment course, 2 and 6 months after start of treatment in each treatment course, periodically thereafter, and when clinically needed. Advise patients to keep all appointments for lymphocyte monitoring during and after MAVENCLAD treatment [see Dosage and Administration (2.5) and Warnings and Precautions (5.3, 5.5)].
Infections
Inform patients that use of MAVENCLAD may increase the risk of infections. Instruct patients to notify their healthcare provider promptly if fever or other signs of infection such as aching, painful muscles, headache, generally feeling unwell or loss of appetite occur while on therapy or after a course of treatment [see Warnings and Precautions (5.4)].
Advise patients that PML has happened with parenteral cladribine used in oncologic indications. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.4)].
Liver Injury
Inform patients that MAVENCLAD may cause liver injury. Instruct patients treated with MAVENCLAD to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained prior to each treatment course with MAVENCLAD and as clinically indicated thereafter [see Warnings and Precautions (5.7)].
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions, including skin reactions [see Warnings and Precautions (5.8)].
Cardiac Failure
Advise patients that MAVENCLAD may cause cardiac failure. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling) [see Warnings and Precautions (5.9)].
Treatment Handling and Administration
Instruct patients that MAVENCLAD is a cytotoxic drug and to use care when handling MAVENCLAD tablets, limit direct skin contact with the tablets, and wash exposed areas thoroughly. Advise patients to keep the tablets in the original package until just prior to each scheduled dose and consult their pharmacist on the proper disposal of unused tablets [see Dosage and Administration (2.4) and How Supplied/Storage and Handling (16.2)].
Distributed by:
EMD Serono, Inc.
Rockland, MA 02370
MAVENCLAD is a registered trademark of Merck KGaA, Darmstadt, Germany.
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: 3/2019 | |||||
MEDICATION GUIDE |
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What is the most important information I should know about MAVENCLAD? MAVENCLAD can cause serious side effects, including:
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What is MAVENCLAD? MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough. MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age. |
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Do not take MAVENCLAD if you:
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Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
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How should I take MAVENCLAD?
Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses. |
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What are the possible side effects of MAVENCLAD? MAVENCLAD can cause serious side effects, including:
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Your healthcare provider may delay or completely stop treatment with MAVENCLAD if you have severe side effects. The most common side effects of MAVENCLAD include: |
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These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store MAVENCLAD?
Keep MAVENCLAD and all medicines out of the reach of children. |
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General information about the safe and effective use of MAVENCLAD Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MAVENCLAD for a condition for which it was not prescribed. Do not give MAVENCLAD to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider for information about MAVENCLAD that is written for health professionals. |
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What are the ingredients in MAVENCLAD? Active ingredient: cladribine Inactive ingredients: hydroxypropyl betadex, magnesium stearate, and sorbitol. Distributed by: EMD Serono, Inc., Rockland, MA 02370 |
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