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Other brands with the same active ingredient
These brands contain the same active ingredient (Lenalidomide). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Pharmacology
Lenalidomide is an analogue of thalidomide. It has immunomodulatory, antiangiogenic and antineoplastic properties. Its cellular effects work through its target, cereblon, which is part of a cullin ring E3 ubiquitin ligase enzyme complex. When the drug is present, substrate proteins (including Aiolos, Ikaros and CK1α) are marked for ubiquitination and then broken down, and this leads to direct cytotoxic and immunomodulatory effects. These findings come from in vitro work.
Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells, including MM, mantle cell lymphoma and del (5q) myelodysplastic syndromes, as seen in vitro. It also delays tumor growth in some nonclinical hematopoietic tumor models in vivo, including MM. Its immunomodulatory properties include a higher number and more activation of T cells and natural killer (NK) cells. This leads to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) through greater secretion of interleukin-2 and interferon-gamma, more NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. For MM cells, Lenalidomide and Dxamethasone together act synergistically, both on inhibiting cell proliferation and on inducing apoptosis.
Absorption: Lenalidomide is absorbed rapidly after oral administration. After single and multiple doses in patients with MM or MDS, maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The pharmacokinetics are linear for single and multiple doses, with AUC and Cmax rising in proportion to the dose. Multiple doses at the recommended dosage do not cause the drug to accumulate. A single 25 mg dose taken with a high-fat meal in healthy subjects reduced the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in Cmax. The trials that established efficacy and safety gave the drug without regard to food intake, so Lenalidomide can be taken with or without food. Oral absorption in patients with MCL is similar to that seen in patients with MM or MDS.
Distribution: Binding of [14 C]-Lenalidomide to plasma proteins in vitro is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and at 24 hours (35 ng/ejaculate) after Lenalidomide 25 mg is given daily.
Elimination: The mean half-life of Lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS or MCL.
Metabolism: Lenalidomide is metabolised only to a limited extent. Unchanged Lenalidomide is the main component circulating in humans. Two metabolites have been identified, 5¬ Hydroxy-Lenalidomide and N-Acetyl Lenalidomide, and each makes up less than 5% of parent levels in circulation.
Excretion: Elimination is mainly through the kidneys. After a single oral dose of [14 C]-Lenalidomide 25 mg in healthy subjects, approximately 90% of the radioactive dose was eliminated in urine and 4% in feces within ten days. About 82% of the radioactive dose was excreted as Lenalidomide in urine within 24 hours. Hydroxy-Lenalidomide and N-Acetyl-Lenalidomide accounted for 4.6% and 1.8% of the excreted dose, respectively. Renal clearance of Lenalidomide is higher than the glomerular filtration rate.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Lenalidomide combination therapy: The recommended starting dose of Lenalidomide is 25 mg taken by mouth once daily on Days 1 to 21 of repeated 28-day cycles, given together with Dexamethasone. For patients older than 75 years, the starting dose of Dexamethasone may be reduced. Treatment should continue until the disease progresses or the side effects become unacceptable. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are eligible for auto-HSCT, hematopoietic stem cell mobilization should take place within 4 cycles of a Lenalidomide-containing therapy.
Lenalidomide maintenance therapy following auto-HSCT: Following auto-HSCT, Lenalidomide maintenance therapy should be started once blood counts have recovered adequately (ANC at least 1000/mcL and/or platelet count at least 75,000/mcL). The recommended starting dose of Lenalidomide is 10 mg once daily taken continuously (Days 1 to 28 of repeated 28-day cycles) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if it is well tolerated.
Recommended dosage for myelodysplastic syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or adjusted based on clinical and laboratory findings. Treatment should continue until disease progression or unacceptable toxicity.
Recommended dosage for mantle cell lymphoma: For relapsed or refractory mantle cell lymphoma, the recommended starting dose of Lenalidomide is 25 mg per day taken by mouth on Days 1 to 21 of repeated 28-day cycles. Treatment should continue until disease progression or unacceptable toxicity. Treatment is continued, adjusted or stopped based on clinical and laboratory findings.
Recommended dosage for follicular lymphoma or marginal zone lymphoma: The recommended starting dose of Lenalidomide is 20 mg taken by mouth once daily on Days 1 to 21 of repeated 28-day cycles, for up to 12 cycles of treatment, given together with a Rituximab product.
Side Effects
Embryo-fetal toxicity, hematologic toxicity, venous and arterial thromboembolism, increased mortality in patients with CLL, second primary malignancies, hepatotoxicity, severe cutaneous reactions, tumor lysis syndrome, tumor flare reactions, impaired stem cell mobilization, thyroid disorders, early mortality in patients with MCL, and hypersensitivity. Severe hypersensitivity reactions: Ledomide is contraindicated in patients who have shown hypersensitivity to Ledomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Cautions & Contraindications
Warnings & Precautions
Ledomide REMS Program: Because of the risk to the embryo and fetus, Ledomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), known as the Ledomide REMS program. The required components of the Ledomide REMS program are as follows. Prescribers must be certified with the Ledomide REMS program by enrolling and complying with the REMS requirements. Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements, and males must comply with the contraception requirements. Pharmacies must be certified with the Ledomide REMS program, must dispense only to patients who are authorized to receive Ledomide, and must comply with the REMS requirements. Hematologic Toxicity: Ledomide can cause significant neutropenia and thrombocytopenia. Patients with neutropenia should be monitored for signs of infection. Patients should be advised to watch for bleeding or bruising, especially when using other medicines that may increase the risk of bleeding. Patients taking Ledomide should have their complete blood counts checked periodically as described below. In patients taking Ledomide in combination with Dexamethasone, or as Ledomide maintenance therapy for MM, complete blood counts (CBC) should be monitored every 7 days (weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days (4 weeks) thereafter. A dose interruption and/or dose reduction may be required. In patients taking Ledomide for MDS, complete blood counts (CBC) should be monitored weekly for the first 8 weeks and at least monthly thereafter. In patients taking Ledomide for MCL, complete blood counts (CBC) should be monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. In patients taking Ledomide for FL or MZL, complete blood counts (CBC) should be monitored weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 24, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. Venous and Arterial Thromboembolism: Venous thromboembolic events (VTE [DVT and PE]) and arterial thromboembolic events (ATE, myocardial infarction and stroke) are increased in patients treated with Ledomide. Patients with known risk factors, including prior thrombosis, may be at greater risk, and steps should be taken to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks. Patients should be instructed to report immediately any signs and symptoms suggestive of thrombotic events. ESAs and estrogens may further increase the risk of thrombosis, and their use in patients receiving Ledomide should be based on a benefit-risk decision. Increased Mortality in Patients with CLL: Ledomide is not indicated and not recommended for use in CLL outside of controlled clinical trials. Second Primary Malignancies: Patients should be monitored for the development of second primary malignancies. Both the potential benefit of Ledomide and the risk of second primary malignancies should be taken into account when considering treatment with Ledomide. Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone: Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus Dexamethasone is not recommended outside of controlled clinical trials. Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with Ledomide in combination with Dexamethasone. The mechanism of drug-induced hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Liver enzymes should be monitored periodically. Ledomide should be stopped if liver enzymes become elevated. After values return to baseline, treatment at a lower dose may be considered. Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy, with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Ledomide. Interruption or discontinuation of Ledomide should be considered for Grade 2-3 skin rash. Ledomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and it should not be resumed after discontinuation for these reactions. Tumor Lysis Syndrome: Patients at risk should be monitored closely and appropriate preventive measures taken. Tumor Flare Reaction: Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare reaction may mimic progression of disease (PD). Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with Ledomide has been reported. In patients who are candidates for auto-HSCT, referral to a transplant center should take place early in treatment to optimize the timing of stem cell collection. In patients who received more than 4 cycles of a Ledomide-containing treatment, or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of GCSF with a CXCR4 inhibitor may be considered. Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Thyroid function should be measured before the start of Ledomide treatment and during therapy.
Contraindications
Pregnancy: Lenalidomide can cause harm to an unborn baby when given to a pregnant woman. Limb abnormalities were seen in the offspring of monkeys given lenalidomide during the period of organ formation, and this effect occurred at every dose tested. Because of the findings of this monkey developmental study, and because lenalidomide is structurally similar to thalidomide, a known cause of birth defects in humans, lenalidomide must not be used in women who are pregnant. If this medicine is used during pregnancy, or if a patient becomes pregnant while taking it, she should be informed of the potential risk to the unborn baby. Severe hypersensitivity reactions: Lenalidomide must not be used in patients who have previously shown a severe allergic reaction to it.
Pregnancy & Breastfeeding
Based on the mechanism of action, Lenalidomide can harm a developing baby if taken during pregnancy, so it must not be used by women who are pregnant. It isn't known whether Lenalidomide passes into human breast milk, or what effect it might have on a breastfeeding infant or on milk supply. Since many medicines do pass into breast milk, and given the possibility of harm to a nursing infant, women are advised not to breastfeed while being treated with Lenalidomide.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
The safety and effectiveness of lenalidomide in children have not been established.
Overdose
There's no specific experience in managing a Lenalidomide overdose in patients with MM, MDS or MCL.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.
Drug Interactions
Common questions about Mylomid-25 25 mg
What is Mylomid-25 25 mg Capsule?
Mylomid-25 25 mg Capsule is a medicine that contains Lenalidomide. It is made by Drug International Ltd., Squib Road. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Mylomid-25 used for?
Mylomid-25 is used for: Anemia, Cancer.
What are the side effects of Mylomid-25?
Embryo-fetal toxicity, hematologic toxicity, venous and arterial thromboembolism, increased mortality in patients with CLL, second primary malignancies, hepatotoxicity, severe cutaneous reactions, tumor lysis syndrome, tumor flare reactions, impaired stem cell mobilization, thyroid disorders, early mortality in patients with MCL, and hypersensitivity. Severe hypersensitivity reactions: Ledomide is contraindicated in patients who have shown hypersensitivity to Ledomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Can I take Mylomid-25 during pregnancy or while breastfeeding?
Based on the mechanism of action, Lenalidomide can harm a developing baby if taken during pregnancy, so it must not be used by women who are pregnant. It isn't known whether Lenalidomide passes into human breast milk, or what effect it might have on a breastfeeding infant or on milk supply. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Mylomid-25?
There's no specific experience in managing a Lenalidomide overdose in patients with MM, MDS or MCL. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Mylomid-25?
Store below 30°C in a dry place. Protect from light.
Can I take other medicines with Mylomid-25?
Some medicines can interact with Lenalidomide, for example: Dexamethasone, Digoxin, Warfarin Sodium. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Mylomid-25?
Mylomid-25 is a prescription (Rx) medicine. Take it as your doctor advises.