Mylomid
Generic Name
Lenalidomide
Manufacturer
Specific manufacturer varies by region (e.g., Incepta Pharmaceuticals Ltd. for Mylomid in Bangladesh)
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
mylomid 25 mg capsule | ৳ 400.00 | ৳ 2,800.00 |
Description
Overview of the medicine
Mylomid 25 mg capsule contains Lenalidomide, an immunomodulatory agent used in the treatment of various hematologic malignancies, including multiple myeloma and myelodysplastic syndromes.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on indication and patient's renal function. For Multiple Myeloma: Typically 25 mg orally once daily on days 1-21 of a 28-day cycle, in combination with dexamethasone. For MDS: 10 mg orally once daily. For MCL: 25 mg orally once daily on days 1-21 of a 28-day cycle. Always consult prescribing information.
Elderly
No specific dose adjustment based solely on age, but renal function should be assessed, and dose adjusted accordingly.
Renal_impairment
Significant dose reduction required based on creatinine clearance. For CrCl 30-60 mL/min, initial dose may be 10 mg daily; for CrCl <30 mL/min (not requiring dialysis), 5 mg daily; for dialysis-dependent, 5 mg daily on dialysis days.
How to Take
Take orally with water, at the same time each day, with or without food. Swallow the capsule whole; do not open, break, or chew. Handle capsules with care, especially if pregnant.
Mechanism of Action
Lenalidomide possesses immunomodulatory, anti-angiogenic, and anti-neoplastic properties. It inhibits proliferation of certain hematopoietic tumor cells, enhances T cell and natural killer (NK) cell mediated immunity, inhibits pro-inflammatory cytokines, and inhibits angiogenesis.
Pharmacokinetics
Onset
Onset of therapeutic effect varies depending on the indication, typically weeks to months.
Excretion
Primarily excreted by the kidneys, with approximately 80-90% of the dose recovered in urine as unchanged drug within 24 hours.
Half life
Mean elimination half-life is approximately 3-9 hours, prolonged in patients with renal impairment.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 0.5 to 6 hours. Bioavailability is approximately 60%.
Metabolism
Minimally metabolized; primarily excreted as unchanged drug. No significant metabolism by cytochrome P450 enzymes.
Side Effects
Contraindications
- Pregnancy (due to teratogenicity)
- Hypersensitivity to lenalidomide or any component of the formulation
Drug Interactions
Digoxin
Increased digoxin exposure; monitor digoxin levels.
Warfarin
Increased risk of bleeding or thrombosis; monitor INR closely.
Oral Contraceptives
Lenalidomide's primary concern is teratogenicity, not direct interaction affecting contraceptive efficacy. Strict contraception is mandatory via REMS.
Erythropoietic Stimulating Agents (ESAs), other myelosuppressive drugs
Increased risk of myelosuppression (neutropenia, thrombocytopenia).
Storage
Store below 30°C (86°F), in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category X: Absolutely contraindicated in pregnant women due to severe teratogenic potential (e.g., phocomelia). Females of reproductive potential must use two reliable methods of contraception and undergo regular pregnancy testing. It is unknown if lenalidomide is excreted in human milk; due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended.
Side Effects
Contraindications
- Pregnancy (due to teratogenicity)
- Hypersensitivity to lenalidomide or any component of the formulation
Drug Interactions
Digoxin
Increased digoxin exposure; monitor digoxin levels.
Warfarin
Increased risk of bleeding or thrombosis; monitor INR closely.
Oral Contraceptives
Lenalidomide's primary concern is teratogenicity, not direct interaction affecting contraceptive efficacy. Strict contraception is mandatory via REMS.
Erythropoietic Stimulating Agents (ESAs), other myelosuppressive drugs
Increased risk of myelosuppression (neutropenia, thrombocytopenia).
Storage
Store below 30°C (86°F), in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category X: Absolutely contraindicated in pregnant women due to severe teratogenic potential (e.g., phocomelia). Females of reproductive potential must use two reliable methods of contraception and undergo regular pregnancy testing. It is unknown if lenalidomide is excreted in human milk; due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on manufacturer specifications.
Availability
Available in pharmacies and hospitals
Approval Status
Approved (for Lenalidomide)
Patent Status
Patent expired for generic lenalidomide, brand still protected for specific uses/formulations
Clinical Trials
Extensive clinical trials have established the efficacy and safety of lenalidomide in multiple myeloma, MDS, MCL, FL, and MZL. Ongoing studies explore its use in other cancers and specific patient populations.
Lab Monitoring
- Complete Blood Count (CBC) with differential (weekly for the first 8 weeks, then monthly)
- Renal function (creatinine clearance)
- Liver function tests (LFTs)
- Pregnancy tests (for females of reproductive potential)
Doctor Notes
- Strict adherence to the REMS program is crucial due to significant teratogenicity.
- Monitor CBC weekly for the first 8 weeks, then monthly. Adjust dose for myelosuppression.
- Assess renal function regularly and adjust dose as per guidelines.
- Prophylaxis for venous thromboembolism is recommended, especially in multiple myeloma patients on dexamethasone.
Patient Guidelines
- Adhere strictly to the REMS program requirements, including mandatory contraception for females of reproductive potential.
- Report any signs of infection, bleeding, or blood clots immediately.
- Do not donate blood, sperm, or share the medication with others.
- Store medication out of reach of children.
Missed Dose Advice
If a dose is missed by less than 12 hours, take it as soon as remembered. If more than 12 hours have passed, skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose.
Driving Precautions
Mylomid can cause dizziness, fatigue, and somnolence. Patients should be cautioned against driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Maintain good hydration to help prevent kidney issues.
- Avoid activities that could lead to injury or bleeding due to potential thrombocytopenia.
- Consult your doctor before taking any new medications, including over-the-counter drugs and herbal supplements.
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Global Brand Names
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