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Post-approval safety studies

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY

  • Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.
  • MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant.

Worldwide pregnancy surveillance program

If, however, pregnancy occurs during this period in either female patients or the partners of male patients, please immediately inform your healthcare provider and report the case to EMD Serono

US-based regulatory post-marketing commitments are in the planning stages, focused on long-term malignancy risk, a worldwide pregnancy surveillance program, and drug-drug interactions with oral contraceptives. In the EU, two post authorization safety studies are in progress:

CLARION

Long-term, prospective, observational cohort study evaluating the safety profile of patients with highly active relapsing MS newly started on Cladribine Tablets

Primary objective

To further characterize and compare the risk, in terms of adverse events of special interest, in patients newly initiating Cladribine Tablets or fingolimod

• 8000 patients planned
• Follow-up: 10 years for each patient
• 9 MS registries1
• 15 countries

 

1. Butzkueven H et al. ECTRIMS 2019 [EP1572]

 

CLEAR

Pregnancy and infant outcomes in women exposed to Cladribine Tablets:a multi-country cohort database study

Primary objective

To determine if exposure to oral cladribine 6 months before and/or during pregnancy has an adverse effect on pregnancy and infant outcomes in women with MS, including on pregnancies fathered by men with MS who were exposed to oral cladribine

• 447 planned pregnant women with MS
• Follow-up: Up to 1 year after birth
• 7 countries