Thalomid (Thalidomide) - Indications and Dosage

INDICATIONS AND USAGE

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 (See CLINICAL STUDIES section.) There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.

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.

DOSAGE AND ADMINISTRATION

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.

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.

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.

HOW SUPPLIED

(THIS PRODUCT IS ONLY SUPPLIED TO PHARMACISTS REGISTERED WITH THE S.T.E.P.S. ^® PROGRAM - See BOXED WARNINGS )

THALOMID^® (thalidomide) Capsules are supplied in the following dosages:

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

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 AND DISPENSING

PHARMACISTS NOTE:

BEFORE DISPENSING THALOMID^® (thalidomide), YOU MUST ACTIVATE THE AUTHORIZATION NUMBER ON EVERY PRESCRIPTION BY CALLING THE CELGENE CUSTOMER CARE CENTER AT 1-888-423-5436 AND OBTAINING A CONFIRMATION NUMBER. YOU MUST ALSO WRITE THE CONFIRMATION NUMBER ON THE PRESCRIPTION. YOU SHOULD ACCEPT A PRESCRIPTION ONLY IF IT HAS BEEN ISSUED WITHIN THE PREVIOUS 7 DAYS (TELEPHONE PRESCRIPTIONS ARE NOT PERMITTED); DISPENSE NO MORE THAN A 4-WEEK (28-DAY) SUPPLY. A NEW PRESCRIPTION IS REQUIRED FOR FURTHER DISPENSING. DISPENSE BLISTER PACKS INTACT (CAPSULES CANNOT BE REPACKAGED); DISPENSE SUBSEQUENT PRESCRIPTIONS ONLY IF FEWER THAN 7 DAYS OF THERAPY REMAIN ON THE PREVIOUS PRESCRIPTION; AND EDUCATE ALL STAFF PHARMACISTS ABOUT THE DISPENSING PROCEDURE FOR THALOMID^® (thalidomide).

This drug must not be repackaged.

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

Rx only and only able to be prescribed and dispensed under the terms of the S.T.E.P.S . ^® Restricted Distribution Program

Manufactured for Celgene Corporation

86 Morris Avenue

Summit, New Jersey 07901

1-(888) 423-5436