Guidance

Immunomodulatory drugs: temporary pregnancy prevention guidance during coronavirus (COVID-19)

Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19

We have agreed for temporary modifications to be made to the pregnancy prevention programmes for these medicines to facilitate home pregnancy testing and remote consultations, where clinically appropriate, during the COVID-19 pandemic.

Pregnancy prevention with immunomodulatory drugs

Thalidomide (Thalidomide Celgene), lenalidomide (Revlimid), and pomalidomide (Imnovid) are immunomodulatory drugs that are used in some patients with multiple myeloma. Lenalidomide is also used for some other blood cancers or disorders (lymphoma and myelodysplastic syndromes).

All 3 medicines are teratogenic, which means they can cause severe birth defects, and must be used within a pregnancy prevention programme. This is a programme designed to make sure that unborn babies are not exposed to these medicines.

To enable the shielding of patients who are receiving these medicines during the COVID-19 pandemic, the manufacturer (Celgene) has issued a letter to healthcare professionals (PDF, 361KB, 3 pages) informing them of temporary modifications to the pregnancy prevention programmes to facilitate home pregnancy testing and remote consultations, where clinically appropriate.

These temporary modifications have been agreed with the MHRA until the recommended shielding measures have been lifted.

Home pregnancy testing

As part of the Pregnancy Prevention Programmes for thalidomide, lenalidomide, and pomalidomide, a medically supervised pregnancy test (minimum sensitivity of 25mlU/mL) must be performed for women of childbearing potential:

  • before starting treatment
  • at least every 4 weeks during treatment
  • at least 4 weeks after finishing treatment

Whilst shielding measures are in place, pregnancy testing by the patient at home is acceptable, at the discretion of the clinician, provided the following minimum criteria are met:

  • adequate instruction and support are provided
  • the pregnancy tests meet the minimum required sensitivity (25mIU/mL)
  • the result of each pregnancy test is verified by the prescriber

For prescriber verification, ideally the patient should send a photograph of the test result by email/video conferencing. If no email or video conferencing is available, then a telephone description of the test result, kit make, and how it was used would be a minimum requirement.

Further details on these criteria are provided in the letter to healthcare professionals.

Remote consultation

Before starting treatment with thalidomide, lenalidomide, and pomalidomide, the patient and prescriber must sign a Treatment Initiation Form (TIF). This form documents that they both agree to the conditions of the pregnancy prevention programme.

During treatment, a Prescription Authorisation Form (PAF), which is completed by the prescriber and dispensing pharmacist, must accompany each prescription of thalidomide, lenalidomide, and pomalidomide. This form documents that the patient understands the risk of teratogenicity and continues to take pregnancy prevention measures, if required. A completed PAF is required for a prescription to be dispensed.

Where the clinician determines that a remote consultation is clinically appropriate for a patient whilst shielding measures are in place, electronic editable versions of the TIFs and paper PAFs have been made available via the registered Chief Pharmacist (or their Deputy). Prescribers should contact their pharmacists to obtain access to these forms should they be required.

The electronic version of the paper PAF allows the prescriber to complete the form and send to the pharmacist electronically, who can then dispense the prescription.

If the clinician decides that a remote consultation is an appropriate environment for initiating treatment with these medicines, they must consider how they will adequately meet the requirement to educate patients and undertake the required clinical review and baseline assessment.

The Summary of Product Characteristics (SmPCs) of these medicines should be consulted to help ensure safe and effective use, including the requirement to monitor for cytopenias (a decrease in blood cells).

See the MHRA Products website for the information about these medicines, including for the SmPCs and patient information leaflets (PILs).

In addition, the patient must still receive an educational booklet and a hard copy of the TIF to read, complete and sign before they start treatment, as would be the case in a face-to-face consultation, and send the completed TIF back to the prescriber. This will help ensure that patients are fully informed about the risks of treatment (especially teratogenicity) and the required actions they should take to minimise these risks.

Report any side effects to the Yellow Card scheme

Healthcare professionals, patients, and caregivers are asked to continue to report suspected side effects using the Yellow Card scheme.

Please report to the Yellow Card scheme electronically using:

Published 21 May 2020