REVLIXEN 10 mg ( Lenalidomide)

Description

COMPOSITION
REVLIXEN 10 capsule: Each capsule contains Lenalidomide INN 10 mg.
PHARMACOLOGY
Lenalidomide is an immunomodulatory, antiangiogenic, and antineo- plastic properties. Cellular activities of Lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells.
Pharmacokinetics
Absorption: Following single and multiple doses of Lenalidomide in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose.
Distribution: Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of Lenalidomide 25 mg 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 undergoes limited metabolism.
Excretion: Elimination is primarily renal.
INDICATIONS AND USAGE
Multiple Myeloma
Lenalidomide in combination with Dexamethasone is indicated for the treatment of adult patients with MM.
Lenalidomide is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation.
Myelodysplastic Syndromes
Adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Mantle Cell Lymphoma
Adult patients with MCL whose disease has relapsed or progressed after two prior therapies.
Follicular Lymphoma
In combination with a Rituximab for the treatment of adult patients with previously treated FL.
Marginal Zone Lymphoma
In combination with a Rituximab, is indicated for the treatment of adult patients with previously treated MZL.
DOSAGE AND ADMINISTRATION
Administer Lenalidomide orally at about the same time each day with or without food and swallow whole capsule. Advice patients not to break, or chew them.
Recommended Dosage of Lenalidomide are as following: Multiple Myeloma
Combination Therapy: The recommended starting dose of Lenalido- mide is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with Dexamethasone. Treatment should be continued until disease progression or unacceptable toxicity.
Maintenance Therapy Following Auto-HSCT The recommended starting dose of Lenalidomide is 10 mg once daily continuously (Days 1-28) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated.
Myelodysplastic Syndromes
The recommended dose of Lenalidomide is 10 mg daily. Continue treatment until disease progression or unacceptable toxicity.
Mantle Cell Lymphoma
The recommended dose of Lenalidomide is 25 mg/day orally on Days 1-21 for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.