Safety information

Indication and clinical use:

MAVENCLAD is indicated as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. MAVENCLAD is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis. The efficacy of taking MAVENCLAD for treatment duration beyond 2 years has not been established.

MAVENCLAD is not indicated in patients below 18 years of age.

• Patients with increased risk for opportunistic infections, including those who are immunocompromised due to treatment or disease (e.g., HIV)
• Patients with latent or active infections including active chronic bacterial, fungal or viral infections (e.g., hepatitis, tuberculosis)
• Patients with a history of progressive multifocal leukoencephalopathy (PML)
• Patients with active malignancy
• Patients with moderate or severe renal impairment (creatinine clearance <60 mL/min)
• Patients who are pregnant or breastfeeding

• Potential for increased risk of malignancies
  
• Patients with prior malignancy
  
• Irradiation of cellular blood components in patients who require blood transfusion
  
• Potential for increased risk of infection, in particular herpes zoster
• Caution in elderly patients
  
• Not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6)
  
• Not recommended in patients with fructose intolerance
  
• Additive hematological adverse reactions with concomitant medications that affect the hematologic profile
  
• Decreases in lymphocyte count, neutrophil count, red blood cell count, hematocrit, hemoglobin or platelet count
  
• Latent infections may be activated, including tuberculosis or hepatitis
  
• Risk of active vaccine infection

• Check complete blood count, including lymphocyte count
  
• Evaluate for both active and inactive tuberculosis infection
  
• Evaluate for hepatitis B and C viruses (HBV and HCV)
  
• Complete immunization with live or attenuated live vaccines at least 6 weeks prior to treatment because of a risk of active vaccine infection
  
• Check varicella-zoster antibody status; if negative, vaccination is recommended
  
• In patients previously treated with immunomodulating or immunosuppressive medicinal products, initiate only if lymphocyte counts are normal
  
• Baseline MRI recommended for patients switching from an MS agent with a risk of PML
  
• Pregnancy must be excluded
  
• Counsel male and female patients on the potential for serious risk to the fetus and the need for effective contraception during treatment and for at least 6 months after the last dose

• Patients must promptly report symptoms of infection
• Determine lymphocyte counts before initiating in year 1 and year 2, and periodically between treatment courses and thereafter
• Patients must not be vaccinated with live or attenuated live vaccines during treatment or after treatment if their white blood cell counts are not within normal limits