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Lenalidomide oral

Updated 2 Feb 2023 | Thalidomide and analogs


Oral formulations of lenalidomide.

Drugs List

  • lenalidomide 10mg capsules
  • lenalidomide 15mg capsules
  • lenalidomide 2.5mg capsules
  • lenalidomide 20mg capsules
  • lenalidomide 25mg capsules
  • lenalidomide 5mg capsules
  • lenalidomide 7.5mg capsules
  • REVLIMID 10mg capsules
  • REVLIMID 15mg capsules
  • REVLIMID 2.5mg capsules
  • REVLIMID 20mg capsules
  • REVLIMID 25mg capsules
  • REVLIMID 5mg capsules
  • REVLIMID 7.5mg capsules
  • Therapeutic Indications


    Follicular non-Hodgkin's lymphoma
    Mantle cell lymphoma (MCL)
    Myeloma - multiple
    Transfusion-dependent anaemia due to myelodysplastic syndrome

    Treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

    Treatment of previously untreated multiple myeloma in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone in patients not eligible for transplant.

    Treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy.

    Treatment of transfusion dependent anaemia due to low or intermediate -1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

    Treatment of adult patients with relapsed or refractory mantle cell lymphoma.

    Treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a) in combination with rituximab.


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.


    Children under 18 years
    Patients not compliant with Pregnancy Prevention Programme
    Patients not registered with Pregnancy Prevention Programme
    ANC below 0.5x10 to power of 9/L at baseline - if treating MDS
    ANC below 1x10 to power of 9/L at baseline - if treating multiple myeloma
    ANC below 1x10 to power of 9/L at baseline- if treating follicular lymphoma
    Platelet count below 25x10 to power of 9/L at baseline- if treating MDS
    Platelet count below 50 x 10 to power of 9/L at baseline - if treating FL
    Platelet count below 50x10 to power of 9/L at baseline- if treating myeloma

    Precautions and Warnings

    Females of childbearing potential
    History of herpes zoster infection
    Patients over 75 years
    Predisposition to infection
    Predisposition to thromboembolic disease
    Risk factors for cardiovascular disorder
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of hepatitis B
    Lactose intolerance
    Renal impairment - creatinine clearance below 50ml/minute
    Thyroid dysfunction

    Reduce dose in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating screen all patients for hepatitis B infection
    Consider use of anticoagulant prophylaxis if at risk of thromboembolism
    Do not initiate if history of severe rash associated with thalidomide
    Evaluate patient for cardiopulmonary disease before and during treatment
    Female: Do not exceed 4 weeks treatment on one prescription
    Maintain adequate hydration of patient prior / during treatment
    May be increased risk of skin cancer
    Premedicate with a hypouricaemic agent
    Staff & patients: Must comply with Pregnancy Prevention Programme
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor hepatic function before treatment and regularly during treatment
    Monitor renal function before treatment and regularly during treatment
    Monitor thyroid function prior to and periodically during treatment
    Elderly: Monitor renal function and consider dose modification
    Exclude pregnancy before issuing each prescription
    Monitor closely patient at risk of cardiovascular disorders
    Monitor for signs of tumour flare reaction
    Monitor full blood count regularly
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Monitor patients for development of second primary malignancies
    Monitor patients for signs of tumour lysis syndrome
    Monitor patients with high tumour burden closely during therapy
    Monitor visual status
    Advise patient to report signs of neuropathy
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Advise patients to report any signs of dyspnoea, chest pain or ankle oedema
    Consider treatment with blood growth factors if severe cytopenias develop
    Discontinue treatment if DRESS is suspected
    Discontinue treatment if Stevens-Johnson Syndrome suspected
    Discontinue treatment if toxic epidermal necrolysis is suspected
    Reactivation of hepatitis B may occur in chronic carriers
    Reactivation of herpes zoster may occur
    Consider suspending treatment if grade 2 or 3 skin reaction occurs
    Discontinue if angioedema occurs
    Discontinue if grade 4 skin reaction occurs
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue if serious allergic or anaphylactic reaction occurs
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    MDS: Discontinue if no minor erythroid response within 4 months
    MDS: Suspend therapy if platelet count falls below 25 x 10 to power of 9/L
    MM: Suspend therapy if platelet count falls below 25 x 10 to power of 9/L
    Suspend therapy if neutrophils fall below 0.5 x 10 to the power of 9 / L
    Suspend treatment if thromboembolic events occur
    Female: Contraception required during and for 1 month after treatment
    Female: Contraception required for 1 month before initiation of treatment
    Male: Contraception required for partners if patient unable to use condoms
    Male: Use of condoms advised if partner pregnant or may become pregnant
    Male: Use of condoms required during and for 1 week after treatment
    Advise patients to report skin rash
    Patients must not donate blood during or for 1 week after treatment

    Cases of hyperthyroidism and hypothyroidism have been reported, control of co-morbid conditions influencing thyroid function is recommended prior to treatment.

    Cases of viral reactivation have been reported following treatment with lenalidomide, particularly in patients previously infected with hepatitis B or herpes zoster. Cases of hepatitis B reactivation have been reported and in some cases progressed to hepatic failure requiring antiviral treatment and discontinuation of lenalidomide. Reactivation of herpes zoster led in some cases to disseminated herpes zoster, meningitis herpes zoster or ophthalmic herpes zoster and patients in these cases needed to discontinue the treatment with lenalidomide.

    Cardiovascular disorders
    Closely monitor patients with cardiovascular risk factors (e.g. prior thrombosis) action should be taken to minimise modifiable risk factors such as smoking hypertension and hyperlipidaemia.

    There is an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) with lenalidomide treatment. The use of other erythropoietic agents including hormone replacement therapy should be used with caution. A haemoglobin concentration of 12g/dl should lead to discontinuation of erythropoietic agents.

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

    Pregnancy Prevention Programme
    Lenalidomide is structurally related to thalidomide. Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. Lenalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the manufacturers Pregnancy Prevention Programme (PPP) are met. The conditions of the PPP must be fulfilled for all male and female patients. Refer to the manufacturers documentation for full details and requirements for the PPP.

    Only prescribers and pharmacies registered with the programme are allowed to prescribe and dispense the product. Prescriber, patient and dispensing pharmacist must each comply fully with the PPP.

    The PPP outlines specific criteria for determination of child bearing potential, required testing, suitable contraception, specific patient counselling, prescribing and dispensing requirements.

    The prescriber must ensure that: The patient complies with the conditions of the PPP. The patient confirms that they understand the conditions of the PPP.

    Neutropenia and thrombocytopenia
    A complete blood count, including white blood cell count with differential count, platelet count, haemoglobin and haematocrit should be performed at baseline and every week for the first 8 weeks of lenalidomide and monthly thereafter.

    In mantle cell lymphoma patients, complete blood count should be monitored every 2 weeks in cycles 3 and 4, and then at the start of each subsequent treatment cycle.

    In follicular lymphoma patients, complete blood count should be monitored weekly for the first 3 weeks of cycle 1, every 2 weeks during cycles 2 to 4 and then at the start of each subsequent treatment cycle.

    Pregnancy and Lactation


    Lenalidomide is contraindicated during pregnancy.

    The manufacturer states that lenalidomide is contraindicated during pregnancy. There have been no reports of human pregnancies exposed to lenalidomide but as it is an analogue of thalidomide which is a known human teratogen that causes life-threatening birth defects, the teratogenic effect of lenalidomide can be expected. Animal studies in have shown teratogenicity similar to thalidomide. Refer to the manufacturers documentation for requirements and responsibilities under the Pregnancy Prevention Programme in the event of pregnancy.


    Lenalidomide is contraindicated during breastfeeding.

    The manufacturer states that breastfeeding should be discontinued during therapy with lenalidomide. Animal studies have shown thalidomide, an analogue of lenalidomide, to be excreted into breast milk. It is not known if lenalidomide is excreted in human milk, however the molecular weight is low enough that excretion into milk is likely. The effects on a nursing infant from exposure to lenalidomide and its metabolites in breast milk are unknown.


    Take a missed dose if less than 12 hours has elapsed. If more than 12 hours has elapsed do not take the dose but take the next dose as normal the following day.

    Advise patients to report shortness of breath, chest pain, arm or leg swelling.

    Advise patients to report unexplained fever, sore throat, bruising or bleeding.

    Advise patients to report skin rash.

    Advise patients to report symptoms of infection immediately.

    Advise patients to report signs of neuropathy.

    Advise patients not to donate blood during or within 1 week of stopping treatment.

    Advise patients they must comply fully with the Pregnancy Prevention Program (PPP).

    Female patients of child bearing potential must use one effective method of contraception for at least 4 weeks before starting, during and for at least a further 4 weeks after stopping treatment with lenalidomide.

    Male patients must use condoms during treatment and for 1 week after treatment if their partner is pregnant or is of childbearing potential not using effective contraception.

    Advise patients that their ability to drive or operate machinery may be affected by side effects.

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Anaphylactic reaction
    Blood pressure changes
    Blurred vision
    Cerebral ischaemia
    Cerebrovascular accident
    Coagulation disorders
    Congestive cardiac failure
    Decreased appetite
    Deep vein thrombosis (DVT)
    Diabetes mellitus
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Electrolyte disturbances
    Erectile dysfunction
    Fanconi syndrome
    Febrile neutropenia
    Gastro-intestinal symptoms
    Haemolytic anaemia
    Hepatic failure
    Herpes zoster
    Hypersensitivity reactions
    Increased susceptibility to infection
    Influenza-like syndrome
    Intracranial bleeding
    Joint swelling
    Loss of balance
    Loss of libido
    Micturition disorders
    Muscle spasm
    Myocardial infarction
    Peripheral neuropathy
    Progressive multifocal leukoencephalopathy (PML)
    Pulmonary embolism
    Pulmonary hypertension
    Reduced visual acuity
    Renal failure
    Renal tubular necrosis
    Respiratory distress
    Respiratory tract infection
    Second primary malignancies
    Skin discolouration
    Stevens-Johnson syndrome
    Thyroid abnormalities
    Toxic epidermal necrolysis
    Transient ischaemic attack
    Tumour lysis syndrome
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2019

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Revlimid 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg Hard Capsules. Celgene Ltd. Revised November 2020.

    Pregnancy Prevention Program information for healthcare professionals.
    Available at:
    Last accessed: 10 July 2019

    MHRA Drug Safety Update May 2020
    Available at:
    Last accessed: 17 June 2020

    NICE Evidence Services Available at: Last accessed: 1 July 2019

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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