Mylomid

Lenalidomide INN

Composition: Mylomid-10: Each capsule contains Lenalidomide INN 10 mg.

Mylomid-25: Each capsule contains Lenalidomide INN 25 mg.

Indications: Multiple Myeloma: Lenalidomide in combination with Dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). Myelodysplastic Syndromes: Lenalidomide is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Mantle Cell Lymphoma: Lenalidomide is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included Bortezomib. Follicular Lymphoma: Lenalidomide in combination with a Rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

Dosage and Administration: Recommended Dosage for Multiple Myeloma: Lenalidomide Combination Therapy: The recommended starting dose of Lenalidomide is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with Dexamethasone. For patients greater than 75 years old, the starting dose of Dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity. Recommended Dosage for Myelodysplastic Syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity. Recommended Dosage for Mantle Cell Lymphoma: The recommended starting dose of Lenalidomide is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity. Recommended Dosage for Follicular Lymphoma or Marginal Zone Lymphoma: The recommended starting dose of Lenalidomide is 20 mg orally once daily on Days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment in combination with a Rituximab-product. Or, as directed by the registered physicians.

Use in Pregnancy and Lactation: Based on the mechanism of action, Lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. There is no information regarding the presence of Lenalidomide in human milk, the effects of Lenalidomide on the breastfed infant, or the effects of Lenalidomide on milk production.

Packing: Mylomid-10: Each box contains 28 capsules in alu-alu blister pack.

Mylomid-25: Each box contains 21 capsules in alu-alu blister pack.

Prescribing Description

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