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Thalomid

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Thalomid

Thalomid

INDICATIONS

Multiple Myeloma

THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).

Erythema Nodosum Leprosum

THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

DOSAGE AND ADMINISTRATION

THALOMID® (THALIDOMIDE) MUST ONLY BE ADMINISTERED IN COMPLIANCE WITH ALL OF THE TERMS OUTLINED IN THE THALOMID REMS™ PROGRAM. THALOMID® (THALIDOMIDE) MAY ONLY BE PRESCRIBED BY PRESCRIBERS CERTIFIED WITH THE THALOMID REMS™ PROGRAM AND MAY ONLY BE DISPENSED BY PHARMACISTS CERTIFIED WITH THE THALOMID REMS™ PROGRAM.

Drug prescribing to females of reproductive potential should be contingent upon initial and continued confirmed negative results of pregnancy testing.

Multiple Myeloma

THALOMID is administered in combination with dexamethasone in 28-day treatment cycles. The dose of THALOMID 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 adverse reactions such as constipation, somnolence, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these adverse reactions, the drug may be started at a lower dose or at the previous dose based on clinical judgment.

Erythema Nodosum Leprosum

For an episode of cutaneous ENL, THALOMID 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 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. Steroid usage can be tapered and discontinued when the neuritis has ameliorated.

Dosing with THALOMID 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.

HOW SUPPLIED

Dosage Forms And Strengths

THALOMID 50 mg, 100 mg, 150 mg and 200 mg capsules will be supplied through the THALOMID REMS™ program [see Storage and Handling].

THALOMID is available in the following capsule strengths:

50 mg capsules [white opaque], imprinted “Celgene/50 mg” with a “Do Not Get Pregnant” logo.

100 mg capsules [tan], imprinted “Celgene/100 mg” with a “Do Not Get Pregnant” logo.

150 mg capsules [tan and blue], imprinted “Celgene/150 mg” with a “Do Not Get Pregnant” logo

200 mg capsule [blue], imprinted “Celgene/200 mg” with a “Do not Get Pregnant” logo.

Storage And Handling

(THIS PRODUCT IS ONLY SUPPLIED TO PHARMACIES CERTIFIED IN THE THALOMID REMS™ PROGRAM - See BOXED WARNING)

How Supplied

50 mg capsules [white opaque], imprinted “Celgene/50 mg” with a “Do Not Get Pregnant” logo.

Individual blister packs of 1 capsule (NDC 59572-205-17).
Individual blister packs of 28 capsules (NDC 59572-205-14).
Boxes of 280 containing 10 prescription packs of 28 capsules each (NDC 59572-205-94).

100 mg capsules [tan], imprinted “Celgene/100 mg” with a “Do Not Get Pregnant” logo.

Individual blister packs of 28 capsules (NDC 59572-210-15).
Boxes of 140 containing 5 prescription packs of 28 capsules each (NDC 59572-210-95).

150 mg capsules [tan and blue], imprinted “Celgene/150 mg” with a “Do Not Get Pregnant” logo.

Individual blister packs of 28 capsules (NDC 59572-215-13).
Boxes of 112 containing 4 prescription packs of 28 capsules (NDC 59572-215-93).

200 mg capsules [blue], imprinted “Celgene/200 mg” with a “Do Not Get Pregnant” logo.

Individual blister packs of 28 capsules (NDC 59572-220-16).
Boxes of 84 containing 3 prescription packs of 28 capsules each (NDC 59572-220-96).

Storage

This drug must not be repackaged.

Store at 20°C- 25°C (68°F -77°F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature]. Protect from light.

Handling and Disposal

Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published1.

Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS™ Restricted Distribution Program.

Manufactured for Celgene Corporation 86 Morris Avenue Summit, NJ 07901 1-(888)-423-5436. Revised: February 2013

Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.

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