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Other brands with the same active ingredient
These brands contain the same active ingredient (Lenalidomide). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
ইঙ্গিত ও ব্যবহার
ডোজ নির্দেশিকা
শুধুমাত্র নির্দেশিকা তথ্য
প্রদর্শিত ডোজগুলি সরকারি উৎসের সাধারণ নির্দেশিকা। ব্যক্তিগতকৃত ডোজের জন্য সর্বদা আপনার ডাক্তার বা ফার্মাসিস্টের পরামর্শ নিন।
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.
পার্শ্বপ্রতিক্রিয়া
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).
সতর্কতা ও নিষেধাজ্ঞা
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.
নিষেধাজ্ঞা
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.