Adult: For newly diagnosed cases in patients who have undergone autologous stem cell transplantation (ASCT): As maintenance therapy following ASCT (initiated after adequate haematologic recovery [ANC ≥1,000/mm3 and platelets ≥75,000/mm3]): Initially, 10 mg once daily given continuously on Days 1-28 of repeated 28-day cycles until disease progression or intolerance. After 3 cycles, dose may be increased to 15 mg once daily if tolerated. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Dosing regimen and treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Oral Multiple myeloma
Adult: For newly diagnosed cases in patients who are not eligible for autologous stem cell transplantation (ASCT): In combination with dexamethasone: Initially, 25 mg once daily on Days 1-21 of repeated 28-day cycles. Alternatively, in combination with melphalan and prednisone: Initially, 10 mg once daily on Days 1-21 of repeated 28-day cycles for up to 9 cycles; patients who complete 9 cycles or those unable to complete the combination therapy due to intolerance are given lenalidomide monotherapy of 10 mg once daily on Days 1-21 of repeated 28-day cycles. Continue until disease progression or unacceptable toxicity occurs. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Dosing regimen and treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Oral Transfusion-dependent anaemia due to myelodysplastic syndrome with isolated del(5q)
Adult: In patients with cases due to low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenic abnormality with or without additional cytogenetic abnormalities: Initially, 10 mg once daily on Days 1-21 of repeated 28-day cycles. Continue until disease progression or unacceptable toxicity occurs. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Oral Multiple myeloma
Adult: For cases in patients who have received at least 1 prior therapy: In combination with dexamethasone: Initially, 25 mg once daily on Days 1-21 of repeated 28-day cycles. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Dosing regimen and treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Oral Mantle cell lymphoma
Adult: In patients with relapsed or refractory cases or those with disease progression after 2 prior therapies: Initially, 25 mg once daily on Days 1-21 of repeated 28-day cycles. Continue until disease progression or unacceptable toxicity occurs. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Oral Follicular lymphoma, Marginal zone lymphoma
Adult: In combination with rituximab for patients with previously treated cases: Initially, 20 mg once daily on Days 1-21 of repeated 28-day cycles for up to 12 treatment cycles. Dose reduction, dosing interruption or discontinuation may be required according to the individual haematologic status, other toxicities, or tolerability. Treatment recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Renal Impairment
Multiple myeloma; Mantle cell lymphoma:
CrCl (mL/min)
Dosage
<30 (requiring dialysis)
Initially, 5 mg once daily. On dialysis days, administer the dose after the dialysis.
<30 (not requiring dialysis)
Initially, 7.5 mg once daily or 15 mg every other day.
30-60
Initially, 10 mg once daily, may be increased to 15 mg once daily after 2 cycles if the patient does not respond to treatment but is tolerating lenalidomide.
Subsequent dose modification may be required according to individual safety or tolerability. Dosage recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Transfusion-dependent anaemia due to myelodysplastic syndrome with isolated del(5q):
CrCl (mL/min)
Dosage
<30 (requiring dialysis)
Initially, 2.5 mg once daily. On dialysis days, administer the dose after the dialysis.
<30 (not requiring dialysis)
Initially, 2.5 mg once daily.
30-60
Initially, 5 mg once daily.
Subsequent dose modification may be required according to individual safety or tolerability. Dosage recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Follicular lymphoma; Marginal zone lymphoma:
CrCl (mL/min)
Dosage
<30 (requiring dialysis)
Initially, 5 mg once daily. On dialysis days, administer the dose after the dialysis.
<30 (not requiring dialysis)
Initially, 5 mg once daily.
30-60
Initially, 10 mg once daily, may be increased to 15 mg once daily after 2 cycles if the patient has tolerated the treatment.
Subsequent dose modification may be required according to individual safety or tolerability. Dosage recommendations may vary between countries and among individual products (refer to specific local product guidelines).
Administration
cap: May be taken with or without food. Swallow whole, do not break/chew/open.
Contraindications
Hypersensitivity. Pregnancy and women of childbearing potential (unless all conditions of the local health authorities for pregnancy prevention are met); lactation.
Special Precautions
Patient with risk factors for thromboembolism (e.g. history of arterial or venous thromboembolic events, hypertension, hyperlipidaemia, smoking, infection, diabetes, inherited thrombophilia); high tumour burden prior to therapy, history of solid organ transplant before starting treatment; pre-existing viral liver disease, elevated liver enzyme at baseline. Patients undergoing stem cell mobilisation. Renal impairment. Elderly.
Adverse Reactions
Significant: Haematologic effects, including significant neutropenia and thrombocytopenia; dizziness, fatigue, peripheral neuropathy; immediate (e.g. anaphylaxis, angioedema) and delayed (e.g. myocarditis, hypersensitivity pneumonitis, rash) hypersensitivity reactions; second primary malignancies (e.g. haematologic malignancies [mainly acute myeloid leukaemia and MDS], solid tumour malignancies, non-melanoma skin cancers); thromboembolic events (e.g. DVT, pulmonary embolism, MI, stroke); heart failure, atrial fibrillation; decreased CD34+ cells collected after therapy (≥4 cycles); hypothyroidism, hyperthyroidism, abnormal LFTs, cataract (prolonged use in combination with dexamethasone). Blood and lymphatic system disorders: Febrile neutropenia, anaemia, leucopenia, lymphopenia, pancytopenia, neutropenic infection. Cardiac disorders: Palpitation, chest pain, bradycardia. Ear and labyrinth disorders: Vertigo, tinnitus, deafness. Eye disorders: Blurred vision, reduced visual acuity. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, constipation, gastroenteritis, dysgeusia, dry mouth, dyspepsia. General disorders and administration site conditions: Asthenia, pyrexia, peripheral oedema. Infections and infestations: Sepsis, bacteraemia, herpes zoster. Investigations: Decreased weight. Metabolism and nutrition disorders: Hypokalaemia, dehydration, decreased appetite, hypoglycaemia, hypocalcaemia, hyponatraemia, hyperglycaemia. Musculoskeletal and connective tissue disorders: Muscle spasm, myalgia, arthralgia, musculoskeletal pain. Nervous system disorders: Headache, paraesthesia, tremor. Psychiatric disorders: Insomnia, depression. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, rhinorrhoea, pneumonia, upper or lower respiratory tract infection, bronchitis, sinusitis, nasopharyngitis, rhinitis, influenza, epistaxis. Renal and urinary disorders: UTI, renal failure. Skin and subcutaneous tissue disorders: Dry skin, pruritus. Vascular disorders: Hypertension, hypotension, haematoma. Potentially Fatal: Severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS]), tumour flare reactions, tumour lysis syndrome; hepatic failure, pulmonary hypertension; progressive multifocal leucoencephalopathy (PML), viral reactivation, solid organ transplant rejection.
This drug may cause dizziness, vertigo and blurred vision, if affected, do not drive or operate machinery. Women of childbearing potential must commit either to abstain continuously from sexual intercourse or to use at least 1 form of effective birth control method for at least 4 weeks before, during (including during dose interruptions), and at least 4 weeks after discontinuation of therapy. Men (even if had undergone a vasectomy) with partners who are pregnant or of childbearing potential should use condoms during treatment (including during dose interruption) and for at least 7 days after stopping the treatment. Do not donate blood or sperm during therapy (including during dose interruption) and for at least 7 days following treatment cessation. Women who are pregnant or suspected to be pregnant should not handle lenalidomide blisters or capsules.
Monitoring Parameters
Perform pregnancy test in women of childbearing potential 10-14 days and 24 hours prior to treatment initiation, then weekly during the 1st 4 weeks, and then every 2-4 weeks through 4 weeks following therapy discontinuation. Monitor CBC with differential as clinically indicated (frequency may vary based on indication); serum creatinine and LFTs periodically; thyroid function tests at baseline then every 2-3 months during therapy. Perform HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to initiation of therapy; ECG (when clinically indicated). Monitor for signs and symptoms of thromboembolism, infection, secondary malignancies, tumour lysis syndrome, tumour flare reaction, hypersensitivity reactions, hepatic failure, and dermatologic toxicity.
Increased risk of thromboembolic events with erythropoietic agents and hormonal replacement therapy (e.g. estrogens). May increase the plasma concentration of digoxin. Increased risk of rhabdomyolysis with statins.
Action
Description: Mechanism of Action: Lenalidomide is a thalidomide analogue that has immunomodulatory, antiangiogenic, antineoplastic, and pro-erythropoietic properties. It selectively inhibits pro-inflammatory cytokine secretion, enhances cell-mediated immunity by stimulating the proliferation of anti-CD3 stimulated T cells, and inhibits trophic signals to angiogenic factors in cells. It induces cell cycle arrest and cell death, thereby inhibiting the growth of myeloma, lymphoma, and myelodysplastic tumour cells. Pharmacokinetics: Absorption: Rapidly absorbed. Time to peak plasma concentration: Approx 0.5-6 hours (in MDS or myeloma patients). Distribution: Distributed in semen (small amounts). Plasma protein binding: Approx 30%. Metabolism: Poorly metabolised to 5-hydroxy-lenalidomide and N-acetyl-lenalidomide. Excretion: Via urine (approx 82% as unchanged drug). Elimination half-life: 3-5 hours.
Chemical Structure
Lenalidomide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 216326, Lenalidomide. https://pubchem.ncbi.nlm.nih.gov/compound/Lenalidomide. Accessed Mar. 25, 2024.
Storage
Store between 20-25°C. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration and disposal.
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