MAVENCLAD™ (cladribine tablets) │ EMD Serono
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Warnings and precautions

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 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.

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Learn about MAVENCLAD’s safety
and tolerability profile.

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Footnotes and References
  1. MAVENCLAD™ Product Monograph. EMD Serono. November 2017.
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