Lenalidomide

• Capsules 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg, 25mg

Notes

1. Pregnancy Prevention Programme is in place which must be followed for each patient. Temporary arrangements have been agreed for this programme for patients receiving lenalidomide during the COVID-19 pandemic. Please see here.
   1. See also resources for: contraception for drugs with teratogenic potential, and prescribing in pregnancy and lactation.
2. NICE TA322: Lenalidomide (Revlimid) is recommended as an option, within its marketing authorisation, that is for treating transfusion‑dependent anaemia caused by low or intermediate‑1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenic abnormality when other therapeutic options are insufficient or inadequate (September 2014).
   1. It is recommended only if the company provides it according to the commercial arrangement.
3. NICE TA171: Lenalidomide (Revlimid) in combination with dexamethasone is recommended, within its licensed indication, as an option for the treatment of multiple myeloma only in people who have received two or more prior therapies (June 2009).
   1. It is recommended only if the company provides lenalidomide according to the commercial arrangement.
4. NICE TA586: Lenalidomide (Revlimid) plus dexamethasone is recommended as an option for treating multiple myeloma in adults (June 2019), only if:
   1. they have had only 1 previous therapy, which included bortezomib, and
   2. the company provides it according to the commercial arrangement.
5. NICE TA587: Lenalidomide (Revlimid) plus dexamethasone is recommended as an option for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant (June 2019), only if:
   1. thalidomide is contraindicated (including for pre-existing conditions that it may aggravate) or
   2. the person cannot tolerate thalidomide, and
   3. the company provides lenalidomide according to the commercial arrangement.
6. NICE TA627: Lenalidomide (Revlimid) with rituximab is recommended, within its marketing authorisation, as an option for previously treated follicular lymphoma (grade 1 to 3A) in adults (April 2020).
   1. It is only recommended if the company provides lenalidomide according to the commercial arrangement.
7. NICE TA680: Lenalidomide (Revlimid) is recommended as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults (March 2021), only if:
   1. the dosage schedule is 10 mg per day on days 1 to 21 of a 28-day cycle and
   2. the company provides lenalidomide according to the commercial arrangement.
8. MHRA Drug Safety Update (February 2011): Lenalidomide: risk of thrombosis and thromboembolism: patients receiving lenalidomide for the management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
9. MHRA Drug Safety Update (November 2011): Lenalidomide (Revlimid): update on risk of second primary malignancy: Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
10. MHRA Drug Safety Update (January 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions: Routine monitoring of liver function now recommended.

Pomalidomide

• Capsules 1mg, 2mg, 3mg, 4mg

Notes

1. Pregnancy Prevention Programme is in place which must be followed for each patient. Temporary arrangements have been agreed for this programme for patients receiving lenalidomide during the COVID-19 pandemic. Please see here.
   1. See also resources for: contraception for drugs with teratogenic potential, and prescribing in pregnancy and lactation.
2. NICE TA427: Pomalidomide (Imnovid), in combination with low dose dexamethasone, is recommended as an option for treating multiple myeloma in adults at third or subsequent relapse; that is, after 3 previous treatments including both lenalidomide and bortezomib, only when the company provides pomalidomide with the discount agreed in the patient access scheme (January 2017).
3. MHRA Drug Safety Update (May 2015): Pomalidomide (Imnovid): risks of cardiac failure, interstitial lung disease and hepatotoxicity: New monitoring instructions to detect these side effects as soon as possible.
4. MHRA Drug Safety Update (May 2016): Pomalidomide (Imnovid): risk of hepatitis B reactivation: Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.

Thalidomide

• Capsules 50mg

Notes

1. Pregnancy Prevention Programme is in place which must be followed for each patient. Temporary arrangements have been agreed for this programme for patients receiving lenalidomide during the COVID-19 pandemic. Please see here.
   1. See also resources for: contraception for drugs with teratogenic potential, and prescribing in pregnancy and lactation.
2. Original pack prescribing / dispensing only as part of a risk management programme. Note that DVT prophylaxis may be necessary.
3. NICE TA228: Bortezomib (Velcade) and thalidomide (Thalidomide Celgene) for the first-line treatment of multiple myeloma (July 2011):
   1. Thalidomide (Thalidomide Celgene) in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate.
4. MHRA Drug Safety Update (July 2011): Patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism.
   1. Action should be taken to minimise all modifiable risk factors for thromboembolic events (e.g. smoking, hypertension, and hyperlipidaemia).
   2. Healthcare professionals should consider venous and arterial thrombotic risk and administer antithrombotic prophylaxis for at least the first 5 months in patients commencing thalidomide.
5. MHRA Drug Safety Update (May 2013): Thalidomide: risk of second primary malignancies: Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.
6. MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years.