Revlimid 5mg. 10mg. 15mg. 25mg Capsule

Myelodysplastic Syndromes (MDS): Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without other cytogenetic abnormalities.

Multiple Myeloma: Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

Administration: Revlimid should be taken orally at about the same time each day. The capsules should not be opened, broken, or chewed. Revlimid capsules should be swallowed whole, preferably with water, either with or without food.

Myelodysplastic syndromes (MDS): Recommended dosage: The recommended starting dose of Revlimid is 10 mg given orally once a day on days 1-21 of repeating 28-day treatment cycles.

Multiple Myeloma: Previously Treated Multiple Myeloma: Recommended dosage: The recommended starting dose of Revlimid is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for multiple myeloma.

• Pregnancy and lactation.
• Women of childbearing potential, except when all of the conditions for pregnancy prevention have been met (see u2018Pregnancy and lactationu2019 and u2018Warnings and special precautionsu2019).
• Hypersensitivity to lenalidomide or any of the excipients.

General: Pregnancy warning Revlimid is contra-indicated during pregnancy. Revlimid is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see u2018pregnancy and lactationu2019).

For women of childbearing potential, Revlimid is contraindicated unless all of the following are met:

• She understands the expected teratogenic risk to the unborn child.
• She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment including dose interruptions, and for 4 weeks after the end of treatment.
• Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception.
• She should be capable of complying with effective contraceptive measures.
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy.
• She understands the need to commence the treatment as soon as Revlimid is dispensed following a negative pregnancy test.
• She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation.
• She acknowledges that she understands the hazards and necessary precautions associated with the use of Revlimid.

Lenalidomide is not a substrate, inhibitor or inducer of cytochrome P450 enzymes in vitro. Hence, co-administration of cytochrome P450 substrates or inhibitors with Revlimid is not likely to result in clinically relevant medicine interactions.

Co-administration of multiple doses of 10 mg of Revlimid had no effect on the single dose pharmacokinetics and pharmacodynamic of R- and S-warfarin. Coadministration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of Revlimid.

Revlimid is contraindicated in females who are pregnant or who could become pregnant. Revlimid is teratogenic to animals. The teratogenic effect of lenalidomide in humans cannot be ruled out.

Females of childbearing potential must use effective means of contraception for 28 days before therapy, during Revlimid therapy including dose interruptions, and for 28 days following discontinuation of Revlimid therapy, or continually abstain from sexual intercourse.

Breastfeeding is contra-indicated during therapy with Revlimid.

No studies on the effects on the ability to drive or use machines have been performed. Revlimid may affect the ability to drive and use machines. Fatigue, dizziness, somnolence and blurred vision have been reported with the use of Revlimid. Therefore, caution is recommended when driving or operating machines.

Overall reported Adverse Drug Reactions (ADRu2019s) in Relapsed and Refractory Multiple Myeloma and Myelodysplastic Syndromes: Adverse reactions observed in patients are listed below by system organ class/preferred term and frequency. Frequencies are defined as: very common (u2265 1/10); common (u2265 1/100 to < 1/10); uncommon (u2265 1/1 000 to < 1/100); rare (u2265 1/10 000 to < 1/1 000), very rare (< 1/10 000 including isolated reports).

There is no specific experience in the management of Revlimid overdose in patients. In studies, the dose-limiting toxicity was essentially haematological. In the event of overdose, supportive care is advised.