Compliance to the safety monitoring protocols of the ‘RevAssure Programme’ of Lenalidomide (Revlimid®)

On 7 September 2009, a ‘Compliance Communication' letter was issued to healthcare professionals who purchase Revlimid® by the *Compliance Branch of HSA to inform them of the safety monitoring protocols that have been imposed on the prescribing and dispensing of lenalidomide (Revlimid®), a potentially teratogenic drug marketed by Celgene Pte Ltd. The letter also to sought the co-operation of healthcare professionals to comply to the safety monitoring protocols when prescribing lenalidomide to their patients.

Background on lenalidomide and thalidomide

Lenalidomide (Revlimid®), a prescription only medicine, is an immunomodulatory drug that is structurally related to thalidomide and is licensed for use in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one other prior therapy. Revlimid® has been approved in Singapore on 23 June 2009 but due to its potential teratogenicity, is subject to safety monitoring protocols to be complied with prior to prescription and dispensing of the drug.

Thalidomide is a known human teratogen that causes severe life-threatening birth defects. As Revlimid® is structurally related to thalidomide, a teratogenic effect cannot be ruled out when it is taken during pregnancy. An embryo-foetal development study in non-human primates indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy, similar to the birth defects observed in humans following exposure to thalidomide during pregnancy. Revlimid® is therefore contraindicated in pregnant women.

Conditions of HSA Approval and Registration of Revlimid® - the RevAssure Programme

The RevAssure is a programme implemented by Celgene, as mandated by HSA to minimize the risk of foetal exposure associated with the use of Revlimid®, in view of its potential teratogenic effect. As part of the safety protocol, healthcare professionals can only prescribe and dispense Revlimid® upon fulfilling the conditions of the RevAssure programme. Extracts of important requirements under the RevAssure** programme are as follows:

• Registering with the RevAssure programme to undertake the roles and responsibilities as described for healthcare professionals

• Obtaining patients' consent for therapy to confirm their understanding of the risks and to obtain their agreement to comply with requirements of the programme

• Conducting pregnancy tests for women of childbearing potential

• Counselling certain patient groups to use effective contraceptive methods

**Complete details of the RevAssure programme can be obtained from Celgene Pte Ltd.

Advisory to healthcare professionals

As adherence to the requirements of the RevAssure programme is essential to prevent foetal exposure to Revlimid®, the Compliance Branch of HSA seeks the co-operation of healthcare professionals to ensure the successful implementation of the RevAssure programme.

[*Note: In January 2009, HSA established the Compliance Branch to streamline the interface between HSA and health product companies which allows a seamless transition from pre-marketing approval stage of a a health product to the post-marketing regulated stage.]