Health Care Professional Update for COVID-19: At EMD Serono, we are taking the COVID-19 pandemic seriously and are committed to those living with MS by helping address therapeutic needs of patients. There are online resources that provide COVID-19 guidance for MS patients who are on DMTS; some examples can be found on the National MS Society and the Consortium of Multiple Sclerosis Centers websites. In addition to official public health guidance, more information about COVID-19 can be found on the Centers for Disease Control website. For any questions about EMD Serono products, please contact Medical Information at +1-888-275-7376.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered.
Avoid concomitant use of certain antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Use in Specific Populations: Studies have not been performed in pediatric or elderly patients, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
Please see the full Prescribing Information, including boxed WARNING for additional information.
MAVENCLAD® (cladribine) tablets 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.
Limitations of Use: MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered.
Avoid concomitant use of certain antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Use in Specific Populations: Studies have not been performed in pediatric or elderly patients, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
Please see the full Prescribing Information, including boxed WARNING for additional information.
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