Company: Celgene UK and Ireland Ltd.
Legal category: Prescription. HT. Sport permitted.
Active ingredient: Lenalidomide 5mg, 10mg, 15mg, 25mg.
Description: Capsules marked REV followed by strength. 5mg, white; 10mg, blue-green/pale yellow; 15mg, pale blue/white; 25mg, white.
Presentation: 5mg-21, €6085.80; 10mg-21, €6423.90; 15mg- 21, €6762.00; 25mg-21, €7414.05.
Indications: Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Pharmacology: The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoetic and immunomodulatory properties.
Dosage: Adult: Swallow whole at the same time each day. Initially, 25mg once daily on days 1-21 of repeated 28-day cycles. Recommended dose of dexamethasone, 40mg once daily on days 1-4, 9-12 and 17-20 of each 28-day cycles for the first 4 cycles, then 40mg once daily on days 1-4 every 28 days, continued or modified based upon clinical and laboratory findings (see SPC). See SPC for dose adjustment or restart of treatment according to platelet and absolute neutrophil counts. Renal impairment: See SPC. Elderly: Monitor renal function. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation. Women of childbearing potential unless all the conditions of the Pregancy Prevention Programme are met. Perform pregnancy tests prior to treatment, then every 4 weeks including 4 weeks after the end of treatment. Male patients should use condoms throughout and up to one week after treatment.
Special precautions: Should be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma (Consultants or Specialist Registrars in haematooncology). Monitor renal function. Combination of lenalidomide and dexamethasone is associated with increased risk of venous thromboembolism, higher incidence of grade 4 neutropenia and of grade 3 and grade 4 thrombocytopenia. Renal impairment (caution). Hypothyroidism reported. Neurotoxic potential (increased risk of peripheral neuropathy) cannot be excluded. Patients should return unused capsules. Contains lactose. Driving/operating machines.
Drug interactions: Avoid combined oral contraception pills. Caution:Warfarin, digoxin (monitor concentrations of these drugs).
Adverse drug reactions: Atrial fibrillation, palpitations. Neutropenia, thrombocytopenia, anaemia and other blood cell count disorders. GI disorders. Cerebrovascular accident, syncope, neuropathy, dizziness, ageusia, para/hypoaesthesia, headache, tremor, memory impairment. Vision disorders. Vertigo. RTIs, dyspnoea, hiccups. Renal failure. Rash, other skin and SC disorders including sweating, alopecia, hyperpigmentation. Muscle cramp/weakness and other musculoskeletal disorders. Cushingoldlike symptoms. Hyperglycaemia, fluid/mineral balance alteration. Thrombosis, hypotension, hypertension, flushing. Fatigue, oedema, lethargy, pyrexia, rigors, mucosal inflammation. Erectile dysfunction, gynaecomastia, metrorrhagia, nipple pain. Insomnia, confusional state, hallucinations, mood alteration.
*Revlimid is structurally related to thalidomide, a known human teratogen. For this reason, and as part of a Risk Minimisation plan agreed with the Irish Medicines Board, Revlimid is only available via pharmacies that have been authorised by Celgene. The prices quoted are those reimbursable under the High-Technology Medicines scheme.
Full prescribing information and references available from Celgene UK and Ireland Ltd. Telephone: 1800 333111. Fax: 1800 333112. E-mail: firstname.lastname@example.org