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SELECT WARNINGS AND PRECAUTIONS  

In clinical studies, the most clinically relevant adverse reactions were lymphopenia and dermatomal herpes zoster1

Lymphopenia1

In clinical studies, 20-25% of patients treated with MAVENCLAD™ developed transient Grade 3 or 4 lymphopenia vs. 0.5% for placebo  

<1% of patients treated with MAVENCLAD developed grade 4 lymphopenia vs. 0%
for placebo

  • It is expected that most patients with Grade 3 or 4 lymphopenia recover to either normal lymphocyte counts or Grade 1 lymphopenia within 9 months
  • To decrease the risk for severe lymphopenia, lymphocyte counts must be determined before, during and after MAVENCLAD treatment
  • If lymphocyte counts drop below 500 cells/mm³, active monitoring is recommended until values increase above 500 cells/mm³  

Infections1

In two clinical studies, slightly higher rates of infections in general (49.5% for MAVENCLAD vs. 44.1% for placebo) and serious infections (1.8% for MAVENCLAD vs. 1.1% for placebo) were observed

rate of infection

  • MAVENCLAD is contraindicated in patients at an increased risk of opportunistic infections and in patients with active infections, including active chronic bacterial, fungal or viral infections
  • MAVENCLAD increases the risk of infections, especially in patients who develop severe lymphopenia. The increased risk of infections may persist until recovery of lymphopenia
  • Latent infections may be activated; therefore, screening for latent infections is recommended prior to initiation of therapy in year 1 and year 2, and a delay in initiation of treatment is recommended until the infection is adequately treated
  • A delay in initiation of MAVENCLAD should also be considered in patients with an acute infection until the infection is fully controlled

Herpes zoster1

  • In two clinical studies, the rate of herpes zoster infection was 2.0% for MAVENCLAD patients vs. 0.2% for placebo
  • All cases of herpes zoster in patients receiving MAVENCLAD were localized (dermatomal) in nature
  • Herpes zoster infection was more likely to occur during periods of Grade 3/4 lymphopenia
  • Patients with lymphocyte counts below 500 cells/mm³ should be actively monitored for signs and symptoms suggestive of infection
  • If lymphocyte counts drop below 200 cells/mm³, anti-herpes prophylaxis should be considered during the time of Grade 4 lymphopenia  

Malignancy1

Overall in clinical studies and long-term follow-up of patients treated with MAVENCLAD, similar incidences of malignant events were observed

  • In two clinical studies, malignancies were reported in 5/662 (0.76%) patients receiving MAVENCLAD and in 0/641 (0%) patients on placebo
  • Patients with prior malignancy were excluded from participating in the clinical development program
  • MAVENCLAD is contraindicated in patients with MS with active malignancies

Learn more about MAVENCLAD

 

Demonstrated efficacy

MOA

Safety and tolerability profile

 

 

Explore MAVENCLAD’s efficacy.

Learn more

Understand MAVENCLAD’s MOA.

Learn more

Learn about MAVENCLAD’s safety
and tolerability profile.

Learn more

 
Footnotes and References

  1. MAVENCLAD™ Product Monograph. EMD Serono. November 2017.

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