REVLIMID Capsules (Hard Gelatin)

REVLIMID Capsules (Hard Gelatin) is used for: Myelodysplastic disease, Multiple myeloma

Oral Myelodysplastic disease Adult: Initially, 10 mg once daily for 21 consecutive days of repeated 28-day cycle. Multiple myeloma Adult: In combination w/ dexamethasone. Lenalidomide: Initially, 25 mg once daily for 21 consecutive days of repeated 28-day cycle. Dexamethasone: 40 mg once daily on days 1-4, 9-12 and 17-20 of each 28-day cycle, for the 1st 4 cycles, then 40 mg once daily on days 1-4 of each 28-day cycle. Elderly: No dosage adjustment needed.

<18 years old: Safety and efficacy not established

Myelodysplastic disease: Moderate: 5 mg once daily. Severe (not requiring dialysis): 5 mg every other day. End-stage renal disease: 5 mg 3 times/wk after dialysis. Multiple myeloma: Moderate: 10 mg once daily may be increased to 15 mg once daily after 2 cycles if needed. Severe (not requiring dialysis): 15 mg every other day, may be increased to 10 mg once daily if needed. End-stage renal disease: 5 mg once daily after dialysis.

May be taken with or without food. Swallow whole, do not break/chew/open.

Pregnancy and lactation; sexually active women of childbearing potential not using 2 forms of contraception. Demonstrated hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Potential for human birth defects Analog of thalidomide, a known human teratogen that causes severe, life-threatening human birth defects. Avoid during pregnancy; if taken during pregnancy, likely to cause birth defects or fetal death. Pregnancy test is required prior initiation of therapy and should commence contraceptive measures following negative result. Pregnancy test must be repeated at a regular interval during therapy. History of thrombosis; smokers; patients w/ HTN, hyperlipidaemia, high tumour burden. Renal impairment. Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide with dexamethasone. Lactation: discontinue drug or do not nurse

Pregnancy Contraindicated during pregnancy (see Contraindications and Black Box Warnings) Based on the mechanism of action and findings from animal studies, lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy Thalidomide analogue; thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), bone hypoplasticity, absence of bones, external ear abnormalities (including anotia, microtia, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects Mortality at or shortly after birth has been reported in ~40% of infants Contraception Females Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception (eg, tubal ligation, IUD, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants]), or partner’s vasectomy, and 1 additional effective contraceptive method (eg, male latex or synthetic condom, diaphragm, or cervical cap) Contraception must begin 4 weeks prior to initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of therapy Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed Males Present in the semen of males; therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide and for up to 4 weeks after discontinuing, even if they have undergone a successful vasectomy Male patients taking lenalidomide must not donate sperm Lactation Unknown if distributed into human breast milk Because of the potential for adverse reactions in breastfed infants from lenalidomide, advise women not to breastfeed during treatment

May increase risk of thrombosis w/ erythropoietic agents. May increase plasma concentration of digoxin, ketoconazole, itraconazole, ciclosporin, verapamil, quinidine, clarithromycin.

Side effects of Lenalidomide : >10% Thrombocytopenia (62%), Neutropenia (59%), Diarrhea (48%), Pruritus (42%), Nausea (35%), Rash (35%), Fatigue (31%), Constipation (24%), Arthralgia (22%), Back pain (21%), Peripheral edema (21%), Pyrexia (21%), Dizziness (20%), Headache (20%), Cough (19%), Muscle cramp (18%), Dyspnea (17%), URTI (15%), Anemia (12%), Pneumonia (12%), UTI (11%) 1-10% (critical AEs) Tumor flare reaction - MCL (10%), Abdominal pain (8%), Leukopenia (8%), Myalgia (8%), Pain (7%), Bronchitis (6%), Rhinitis (6%), Febrile neutropenia (5%), Peripheral neuropathy (5%) Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioedema. Acute hepatic failure; toxic, cytolytic, cholestatic and mixed cytolytic/ cholestatic hepatitis.

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent w/ antiangiogenic and antineoplastic property. It inhibits proinflammatory cytokines secretion, increases interleukin-2 and interferon-γ secretion, and increases cytolytic T-cell and natural killer cell response. It also inhibits the growth of myeloma cells by inducing cell cycle arrest and cell death.

REVLIMID 10mg Capsules (Hard Gelatin) manufactured by CELGENE INTERNATIONAL SARL. Its generic name is Lenalidomide. REVLIMID is availble in United Arab Emirates. Farmaco UAE drug index information on REVLIMID Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.