WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
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:
Long-term, prospective, observational cohort study evaluating the safety profile of patients with highly active relapsing MS newly started on Cladribine Tablets
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]
Pregnancy and infant outcomes in women exposed to Cladribine Tablets:a multi-country cohort database study
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