Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/694
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THALOMID (Capsule)
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THALOMID (thalidomide) MUST ONLY BE ADMINISTERED IN COMPLIANCE WITH ALL OF THE TERMS OUTLINED IN THE S.T.E.P.S. PROGRAM. THALOMID (thalidomide) MAY ONLY BE PRESCRIBED BY PRESCRIBERS REGISTERED WITH THE S.T.E.P.S. PROGRAM AND MAY ONLY BE DISPENSED BY PHARMACISTS REGISTERED WITH THE S.T.E.P.S.PROGRAM. Drug prescribing to women of childbearing potential should be contingent upon initial and continued confirmed negative results of pregnancy testing.<br/>Multiple Myeloma: THALOMID (thalidomide) is administered in combination with dexamethasone in 28-day treatment cycles. The dose of THALOMID (thalidomide) is 200 mg administered orally once daily with water, preferably at bedtime and at least 1-hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days. Patients who develop side effects such as constipation, oversedation, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these side effects, the drug may be started at a lower dose or at the previous dose based on clinical judgment.<br/>Erythema Nodosum Leprosum: For an episode of cutaneous ENL, THALOMID (thalidomide) dosing should be initiated at 100 to 300 mg/day, administered once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should be started at the low end of the dose range. In patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction, THALOMID (thalidomide) dosing may be initiated at higher doses up to 400 mg/day once daily at bedtime or in divided doses with water, at least 1 hour after meals. In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with THALOMID (thalidomide). Steroid usage can be tapered and discontinued when the neuritis has ameliorated. Dosing with THALOMID (thalidomide) should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks. Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering, should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.
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thalidomide
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THALOMID (Capsule)
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Multiple Myeloma: THALOMID (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. The effectiveness of THALOMID (thalidomide) is based on response rates There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.<br/>Erythema Nodosum Leprosum: THALOMID (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
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THALOMID
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