Revlixen 25 (Lenalidomide)

Description

Revlixen
Lenalidomide 25 mg capsules

COMPOSITION :
REVLIXEN 25 capsule: Each capsule contains Lenalidomide INN 25 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
Everest
Follicular Lymphoma or Marginal Zone Lymphoma
The recommended starting dose of Lenalidomide is 20 mg orally once daily on Days 1-21 for up to 12 cycles of treatment in combination with a Rituximab.
Dosage Modifications for Patients with Renal Impairment Lenalidomide dose adjustment may be needed based on real function.
CONTRAINDICATIONS
Pregnancy
Lenalidomide can cause fetal harm when administered to a pregnant female.
Severe Hypersensitivity Reactions
Lenalidomide is contraindicated in patients who have severe hypersensitivity to Lenalidomide.
WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity
Lenalidomide may causes life-threatening human birth defects or embryo-fetal death.
Females of Reproductive Potential
Females of reproductive potential must avoid pregnancy for at least 4 weeks before and at least 4 weeks after completing therapy.
Males
Lenalidomide is present in the semen of patients receiving the drug. Patients should use contraceptive during treatment.
Hematologic Toxicity
Lenalidomide can cause significant neutropenia and thrombocytopenia.
SIDE EFFECTS
The most common adverse reactions include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/ spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor.
DRUG INTERACTIONS
Concomitant therapies that may increase the risk of thrombosis. Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used
Adult patients with MCL whose disease has relapsed or progressed with caution after making a benefit-risk assessment in patients 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
receiving Lenalidomide.
USE IN SPECIFIC POPULATIONS Pregnancy
Risk Summary
Lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy.
Lactation
Risk Summary
There is no information regarding the presence of Lenalidomide in human milk.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
Geriatric Use
Frequency of most common adverse reactions was higher in older patients.
Renal Impairment
Adjust the starting dose of Lenalidomide based on the creatinine clearance value and for patients on dialysis.
PHARMACEUTICAL INFORMATION