DISCLAIMER: This publication is intended for healthcare professionals. The information provided aims to update on medication safety issues and should not substitute clinical judgment. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss arising from the use of or reliance on this publication.
Overview
In Malaysia, CellCept® (mycophenolate mofetil) capsules and tablets are approved for the prophylaxis of acute organ rejection in patients receiving allogeneic renal, cardiac, and hepatic transplants, and should be used concomitantly with ciclosporin and corticosteroids. It is also indicated for the induction and maintenance treatment of lupus nephritis, to be used in combination with corticosteroids.
Background of the Safety Issue
Cases of anaphylaxis, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction have been identified in post-marketing data for CellCept®. A few cases were reported with positive rechallenge and/or positive dechallenge.
Regulatory Action
On 14 October 2025, NPRA approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to inform healthcare professionals of this safety issue. For further information, please contact your local salesperson for a copy of the DHPC. The product label for CellCept® will be updated to reflect the new important identified risk.
Advice for Health Care Professionals
- Be aware of the signs and symptoms of anaphylactic reactions and appropriate medical management.
- Advise patients to seek immediate medical attention at the first signs or symptoms of an anaphylactic reaction (such as swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, chest pain, dizziness, palpitation, rash, hives, itching, and lightheadedness) and to permanently discontinue CellCept®.
- Report all suspected adverse events related to the use of mycophenolate mofetil to the NPRA.
References
- Direct Healthcare Professional Communication (DHPC). CellCept (Mycophenolate mofetil), New Important Identified Risk - Update to Contraindications and New Warnings and Precautions: Anaphylactic reaction. Roche (Malaysia) Sdn. Bhd.; 2025 Oct 15.