Pregnancy Prevention Programme
It is important to note that due to the highly teratogenic nature of thalidomide and lenalidomide, they can only be prescribed within a strict risk management programme. This programme is called the Pregnancy Prevention Programme. It applies to all patients receiving thalidomide or lenalidomide regardless of age.
Nurses should be aware of the main points of the Programme and be able to provide information and support to patients especially those of child-bearing potential. These are summarised below:
- Hospital pharmacies must register with the programme
- Prescriptions for everyone taking thalidomide/lenalidomide are issued for a maximum of 28 days’ supply. Each time a prescription is written, patients must complete a questionnaire before treatment can begin or continue
- Patients of child-bearing potential must use an effective method of pregnancy prevention. Contraception must start four weeks prior to thalidomide/lenalidomide treatment and continue for the duration of treatment and for four weeks afterwards. This must be followed unless the patient commits to absolute and continuous abstinence which must be confirmed on a monthly basis
- Medically supervised pregnancy tests must be performed on the day the prescription is issued or in the three days prior. Further pregnancy tests must be done every four weeks during treatment and a final one conducted four weeks after thalidomide/lenalidomide treatment has finished. The result must be negative before thalidomide/lenalidomide treatment can begin or continue
- While on thalidomide/lenalidomide patients must not breast feed, donate sperm (including for a period of one week after stopping treatment) or donate blood
- Thalidomide/lenalidomide must never be shared with any other person and must be kept out of reach and sight from children
- Unused tablets should be returned to the hospital or pharmacy if no longer needed – they should never be flushed down the toilet or sink