Drug Action
Lenalidomide is an immunomodulating drug with anti-neoplastic, anti-angiogenic, and pro- erythropoietic properties.
Source page 1033
Loading InternPractice…
Individual generic drug information
Extracted information for Lenalidomide only.
Lenalidomide is an immunomodulating drug with anti-neoplastic, anti-angiogenic, and pro- erythropoietic properties.
Source page 1033
Newly diagnosed multiple myeloma in patients who have undergone autologous stem cell transplantation (specialist use only) Immune system and malignant disease ▶BY MOUTH ▶Adult: 10 mg once daily for 28 consecutive days of repeated 28-day cycles; increased if tolerated to 15 mg once daily, after 3 cycles, for dose adjustments due to side-effects—consult product literature Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with dexamethasone) (specialist use only) | Multiple myeloma in patients who have received at least one prior therapy (in combination with dexamethasone) (specialist use only) ▶BY MOUTH ▶Adult: 25 mg once daily for 21 consecutive days of repeated 28-day cycles, for doses of dexamethasone, and dose adjustments due to side-effects—consult product literature Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with melphalan and prednisone) (specialist use only) ▶BY MOUTH ▶Adult: 10 mg once daily for 21 consecutive days of repeated 28-day cycles for up to 9 cycles, patients who complete 9 cycles or are intolerant to combination therapy should continue treatment with lenalidomide as monotherapy, for doses of melphalan and prednisone, and dose adjustments due to side-effects— consult product literature Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with bortezomib and dexamethasone) (specialist use only) ▶BY MOUTH ▶Adult: 25 mg once daily for 14 consecutive days of repeated 21-day cycles for up to 8 cycles, followed by 25 mg once daily for 21 consecutive days of repeated 28-day cycles (in combination with dexamethasone alone), for doses of bortezomib and dexamethasone, and dose adjustments due to side-effects—consult product literature Myelodysplastic syndromes (specialist use only) ▶BY MOUTH ▶Adult: 10 mg once daily for 21 consecutive days of repeated 28-day cycles, for dose adjustments due to side-effects—consult product literature Mantle cell lymphoma (specialist use only) ▶BY MOUTH ▶Adult: 25 mg once daily for 21 consecutive days of repeated 28-day cycles, for dose adjustments due to side-effects—consult product literature Follicular lymphoma (in combination with rituximab) (specialist use only) ▶BY MOUTH ▶Adult: 20 mg once daily for 21 consecutive days of repeated 28-day cycles for up to 12 cycles, for doses of rituximab, and dose adjustments due to side-effects— consult product literature
Source page 1033
High tumour burden—risk of tumour lysis syndrome. patients with risk factors for myocardial infarction CAUTIONS, FURTHER INFORMATION ▶Thromboembolism Risk factors for thromboembolism (such as smoking, hypertension, hyperlipidaemia) should be minimised and thromboprophylaxis should be considered in patients with multiple risk factors. ▶Second primary malignancy Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as Immune system and malignant disease indicated.
Source page 1034
Patient, prescriber, and supplying pharmacy must comply with a pregnancy prevention programme. Every prescription must be accompanied by a completed Prescription Authorisation Form.
Source page 1034
NICE decisions ▶Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality (updated June 2019) NICE TA322 Lenalidomide (Revlimid ®) is recommended as an option, within its marketing authorisation, for treating transfusion-dependent anaemia caused by low or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. It is recommended only if the manufacturer provides it according to the commercial arrangement. www.nice.org.uk/guidance/ta322 ▶Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies (updated June 2019) 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 patients who have received two or more prior therapies. It is recommended only if the manufacturer provides lenalidomide according to the commercial arrangement. Patients currently receiving lenalidomide for the treatment of multiple myeloma, but who have not received two or more prior therapies, should have the option to continue therapy until they and their clinicians consider it appropriate to stop. www.nice.org.uk/guidance/ta171 ▶Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (February 2018) NICE TA505 Ixazomib, with lenalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund as an option for treating multiple myeloma in adults only if: . they have already had 2 or 3 lines of therapy, and . the conditions in the managed access agreement for ixazomib are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta505 ▶Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib (June 2019) NICE TA586 Lenalidomide (Revlimid ®) plus dexamethasone is recommended as an option for treating multiple myeloma in adults, only if: . they have had only one previous therapy, which included bortezomib, and . the manufacturer provides it according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta586 ▶Lenalidomide plus dexamethasone for previously untreated multiple myeloma (June 2019) 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, only if: . thalidomide is contra-indicated (including for pre- existing conditions that it may aggravate), or . the patient cannot tolerate thalidomide, and . the manufacturer provides lenalidomide according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta587 ▶Lenalidomide with rituximab for previously treated follicular lymphoma (April 2020) 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. It is only recommended if the manufacturer provides lenalidomide according to the commercial arrangement. www.nice.org.uk/guidance/ta627 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (May 2010) that lenalidomide, in combination with dexamethasone, is accepted for restricted use within NHS Scotland for patients with multiple myeloma who have received at least two prior therapies. The Scottish Medicines Consortium has advised (April 2014) that lenalidomide, in combination with dexamethasone, is accepted for restricted use within NHS Scotland for treatment of multiple myeloma in adults to use at first relapse in those who have received prior therapy with bortezomib and for whom thalidomide has not been tolerated or is contra-indicated. The Scottish Medicines Consortium has advised (December 2015) that lenalidomide is accepted for restricted use within NHS Scotland for patients with previously untreated multiple myeloma who are not eligible for transplant and when thalidomide-containing regimens are unsuitable.
Source pages 1034, 1035
Extracted information for Lenalidomide only.
→Appendix 1: lenalidomide
Source page 1034
▶Common or very common Anaemia. appetite decreased. arthralgia. asthenia. atrial fibrillation. chills. constipation. cough. decreased leucocytes. dehydration. diarrhoea. dizziness. dry mouth. dyspnoea. electrolyte imbalance. embolism and thrombosis. fall. fever. gastrointestinal discomfort. haemorrhage. headache. heart failure. hyperglycaemia. hypertension. hyperthyroidism. hypotension. hypothyroidism. increased risk of infection. influenza like illness. insomnia . iron overload. lethargy. mood altered. muscle complaints. muscle weakness. myocardial infarction. nausea. neoplasms. nerve disorders. neutropenia. night sweats. pain. pancytopenia. paraesthesia. peripheral oedema. renal failure. respiratory disorders. rhinorrhoea. sepsis. skin reactions. taste altered. thrombocytopenia. toothache. tumour flare. vertigo. vomiting. weight decreased ▶Uncommon Angioedema ▶Rare or very rare Severe cutaneous adverse reactions (SCARs). tumour lysis syndrome ▶Frequency not known Acquired haemophilia. gastrointestinal disorders. hepatic disorders. hypersensitivity. hypersensitivity vasculitis. pancreatitis. reactivation of infections. solid organ transplant rejection SIDE-EFFECTS, FURTHER INFORMATION If rash occurs, treatment should be discontinued and only restarted following appropriate clinical evaluation. Discontinue permanently if angioedema, exfoliative or bullous rash, or if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected.
Source page 1034
For women of child- bearing potential, pregnancy must be excluded before starting treatment with lenalidomide (perform pregnancy test on initiation or within 3 days prior to initiation). Women must practise effective contraception at least 1 month before, during, and for at least 1 month after treatment, including during dose interruptions (oral combined hormonal contraceptives and copper-releasing intra-uterine devices not recommended) and men should use condoms during treatment, during dose interruption, and for at least 1 week after stopping if their partner is pregnant or is of childbearing potential and not using effective contraception. Patients, prescribers and pharmacists must comply with pregnancy prevention measures as specified in the manufacturer’s Pregnancy Prevention Programme.
Source page 1034
Important: teratogenic risk. Lenalidomide is structurally related to thalidomide and there is a risk of teratogenesis.
Source page 1034
Discontinue breast-feeding—no information available.
Source page 1034
Dose adjustments Reduce dose in moderate to severe impairment—consult product literature.
Source page 1034
▶Monitor full blood count (including differential white cell count, platelet count, haemoglobin, and haematocrit) and liver function before treatment, then every week for the first 8 weeks, then monthly thereafter (reduce dose or interrupt treatment if neutropenia, thrombocytopenia or impaired liver function develop—consult product literature). ▶Monitor for arterial or venous thromboembolism (if thromboembolic event occurs, discontinue lenalidomide and treat with standard anticoagulation therapy; lenalidomide may be restarted with continued anticoagulation therapy once thromboembolic event resolved—consult product literature). ▶Monitor thyroid function. ▶Monitor for signs and symptoms of peripheral neuropathy. ▶Monitor visual ability regularly (risk of cataract). ▶Hepatic disorders Liver function should be monitored particularly when there is history of, or concurrent viral liver infection, or when lenalidomide is combined with drugs known to be associated with liver dysfunction (e.g. paracetamol).
Source page 1034
Extracted information for Lenalidomide only.
There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 25 ▶Revlimid (Celgene Ltd) A Lenalidomide 2.5 mg Revlimid 2.5mg capsules | 21 capsule P £3,426.00 DT = £3,426.00 Lenalidomide 5 mg Revlimid 5mg capsules | 21 capsule P £3,570.00 DT = £3,570.00 Lenalidomide 7.5 mg Revlimid 7.5mg capsules | 21 capsule P Immune system and malignant disease £3,675.00 DT = £3,675.00 Lenalidomide 10 mg Revlimid 10mg capsules | 21 capsule P £3,780.00 DT = £3,780.00 Lenalidomide 15 mg Revlimid 15mg capsules | 21 capsule P £3,969.00 DT = £3,969.00 Lenalidomide 20 mg Revlimid 20mg capsules | 21 capsule P £4,168.50 DT = £4,168.50 Lenalidomide 25 mg Revlimid 25mg capsules | 21 capsule P £4,368.00 DT = £4,368.00
Source page 1035
Extracted information for Lenalidomide only.
Thromboembolism Patients and their carers should be made aware of the symptoms of thromboembolism and advised to report sudden breathlessness, chest pain, or swelling of a limb. Neutropenia and thrombocytopenia Patients and their carers should be made aware of the symptoms of neutropenia and advised to seek medical advice if symptoms suggestive of neutropenia (such as fever, sore throat) or of thrombocytopenia (such as bleeding) develop. Conception and contraception Patient counselling is advised for lenalidomide capsules (pregnancy and contraception).
Source page 1034
Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
10 mg once daily for 28 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
25 mg once daily for 21 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
10 mg once daily for 21 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
25 mg once daily for 14 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
10 mg once daily for 21 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
25 mg once daily for 21 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033
First line only; read the complete Indications and dose section above.
20 mg once daily for 21 consecutive days of
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1033