Lenalidomide Mylan (lenalidomide): potential for damaged capsules and precautionary handling measures.

Summary:

• Damaged capsules with the powder visible in the blister pocket have been identified in batches of Lenalidomide Mylan. This defect could potentially occur in all strengths and pack sizes.
• Visually inspect all Lenalidomide Mylan blisters upon receipt of this letter, paying special attention to the potential for damaged capsules.
• If a capsule is damaged, do not dispense the pack to patients and return it to the wholesaler and/or Viatris for a replacement.
• If the capsules are not damaged, dispense the pack to patients and ensure that the handling precautions below (see also the product information) are followed.
• Please ensure patients and caregivers are advised on the handling precautions and are requested to return any units they observe the subject defect in.

Handling precautions:

• If you are pregnant or can become pregnant, do not handle lenalidomide tablets or capsules.
• If a capsule is damaged and you see powder in a blister pocket, do not open it. Return the blister card and box, with any remaining capsules, for replacement.
• Always wear disposable gloves when handling lenalidomide tablets or capsules. Then remove the gloves carefully to prevent skin exposure, place them in a sealable plastic polyethylene bag and discard them immediately. Finally, wash your hands thoroughly with soap and water.
• If powder from a broken lenalidomide capsule makes contact with your skin, wash the skin immediately and thoroughly with soap and water.
• Follow the instructions and precautions for use in the product information.

Published on: 29 October 2025