What are the objectives of the Cladribine Tablets safety website?

EMD Serono is committed to provide clear and timely safety information on the use of Cladribine Tablets in the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. This website is intended as one of many channels through which we will be providing up-to-date safety data to healthcare professionals. Further safety data will also be communicated through publications and presentations at major MS congresses.

What are the limitations of the content in this website?

This website is not a comprehensive source of safety information on Cladribine Tablets, and currently only provides information previously published in manuscripts or presented at MS congresses. The US Prescribing Information is the primary source of information on the known and potential risks associated with Cladribine Tablets.

How does EMD Serono verify and report adverse events to regulatory authorities?

Robust global systems are in place to continuously monitor the safety of a drug from the time it is first evaluated in clinical studies through commercialization. All adverse event reports received by EMD Serono are reviewed, assessed, and due diligence is performed. The reports are then submitted to regulatory authorities as per legal and regulatory requirements.

How often is the website updated?

Currently, we update the website after major MS congresses or when significant new data is available.

How do I get more information on the safety of Cladribine Tablets?

For more information, you may also call EMD Serono Medical Information at 1-888-275-7376, visit medical.emdserono.com or contact your EMD Serono Medical representative.

How do I report adverse events occurring in patients treated with Cladribine Tablets?

You may contact the US Product Surveillance Adverse Event Reporting at 1-800-283-8088 ext. 5563, call EMD Serono Medical Information at +1 888-275-7376, visit medical.emdserono.com, contact your EMD Serono Medical representative or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch in order to report adverse events in patients treated with Cladribine Tablets.

When and how do I report exposure to Cladribine Tablets before and during pregnancy?

Cladribine Tablets are contraindicated in pregnancy.

Female patients of childbearing potential:

• Pregnancy must be excluded before the initiation of Cladribine Tablets in Year 1 and Year 2.
• Pregnancy must be prevented by use of effective contraception during Cladribine Tablets dosing and for at least 6 months after the last tablet in each treatment year.

Male patients must take precautions to prevent pregnancy of their partner during Cladribine Tablets dosing and for at least 6 months after the last tablet in each treatment year.

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