Uses of Mylomid-10: - Multiple myeloma - Lepra reaction Myelodysplastic disease, Multiple myeloma 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)

Immunosuppressant

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.

How to use Lenalidomide: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Lenalidomide may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Swallow whole, do not break/chew/open. Adult Dose: 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. Child Dose: <18 years old: Safety and efficacy not established Renal Dose: 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 increase risk of thrombosis w/ erythropoietic agents. May increase plasma concentration of digoxin, ketoconazole, itraconazole, ciclosporin, verapamil, quinidine, clarithromycin.

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)

Common - Headache - Weakness - Nausea - Rash - Dizziness - Sleepiness - Edema (swelling) - Loss of appetite - Decreased white blood cell count - Decreased calcium level in blood - Weight gain - Muscle weakness - Fatigue - Fever - Anxiety - Blood clots - Dry skin - Weight loss - Confusion - Decreased white blood cell count (neutrophils) - Neuropathy - Constipation - Tremor >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.

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Precaution: 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

There is no specific experience in the management of Lenalidomide overdose in patients with MM, MDS, or MCL.

Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.

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.

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. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from Lenalidomide, advise women not to breastfeed during treatment with Lenalidomide.