THALOMID^® (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. The effectiveness of THALOMID^® is based on response rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.

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.

ADDITIONAL WARNINGS:

Birth Defects:

• THALOMID^® (thalidomide) can cause severe birth defects in humans.
• Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential, even if he has had a successful vasectomy.
• The risk to the fetus from semen of male patients taking thalidomide is unknown.
• Patients taking THALOMID^® (thalidomide) should not share their drug with others or donate blood. Male patients taking THALOMID^® (thalidomide) should not donate sperm.

Drowsiness and Somnolence:

• THALOMID^® (thalidomide) frequently causes drowsiness and somnolence.
• Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice.

Peripheral Neuropathy:

• THALOMID^® (thalidomide) is known to cause nerve damage that may be permanent.
• Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible.

Dizziness and Orthostatic Hypotension:

• Patients should also be advised that THALOMID^® (thalidomide) may cause dizziness and orthostatic hypotension and that, therefore, they should sit upright for a few minutes prior to standing up from a recumbent position.

Neutropenia:

• Decreased white blood cell counts, including neutropenia, have been reported in association with clinical use of THALOMID^® (thalidomide).
• Treatment should not be initiated with an absolute neutrophil count (ANC) of <750/mm3.

Increased HIV Viral Load:

• In a randomized, placebo controlled trial of thalidomide in an HIV-seropositive patient population, plasma HIV RNA levels were found to increase (median change = 0.42 log10 copies HIV RNA/mL, p =0.04 compared to placebo).
• A similar trend was observed in a second, unpublished study conducted in patients who were HIV-seropositive. The clinical significance of this increase is unknown.

PRECAUTIONS:

Hypersensitivity:

• THALOMID^® (thalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.

Bradycardia:

• Bradycardia in association with THALOMID^® (thalidomide) use has been reported.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis:

• Serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which may be fatal, have been reported.

Seizures:

• Although not reported from pre-marketing clinical trials, seizures, including grand mal convulsions, have been reported during post-approval use of THALOMID^® (thalidomide) in clinical practice.
• Patients with a history of seizures or risk factors for the development of seizures should be monitored closely.

Nursing Mothers:

• It is not known whether THALOMID^® (thalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS:

Multiple Myeloma

The most frequently reported serious adverse events in multiple myeloma patients (occurring in 20% of patients treated with THALOMID^® (thalidomide)/dexamethasone compared with dexamethasone alone) were: fatigue (79% vs 71%), hemoglobin (decreased) (78% vs 86%), hyperglycemia (73% vs 79%), hypocalcemia (72% vs 59%), constipation (55% vs 28%), sensory neuropathy (54% vs 28%), hyponatremia (43% vs 48%), muscle weakness (40% vs 37%), creatinine (35% vs 42%), leukocytes (decreased) (35% vs 29%), bone pain (30% vs 36%), neutrophils (decreased) (31% vs 24%), confusion (28% vs 12%), edema (57% vs 46%), dyspnea (42% vs 31%), thrombosis/embolism (23% vs 5%), anxiety/agitation (26% vs 14%), tremor (26% vs 6%), alkaline phosphatase (increased) (27% vs 28%), and rash/desquamation (30% vs 18%).

Other serious reported adverse events in multiple myeloma controlled clinical trials (THALOMID^® (thalidomide)/dexamethasone vs. dexamethasone alone) were: hypokalemia (23% vs 23%), insomnia (23% vs 47%), depression (22% vs 24%), neuropathy-motor (22% vs 16%), fever (24% vs 20%), weight loss (23% vs 21%), weight gain (22% vs 13%), platelets (decreased) (24% vs 33%), anorexia (28% vs 25%), nausea (28% vs 23%), pain-other (25% vs 26%), headache (20% vs 23%), dry skin (21% vs 11%), and SGOT (increased) (25% vs 24%).

Erythema Nodosum Leprosum

Common adverse events reported in THALOMID^® (thalidomide) treated patients in controlled clinical trials in ENL: somnolence (38%), rash (21%), headache (13%), asthenia (8%), malaise (8%), pain (8%), vertigo (8%), pruritus (8%), and impotence (8%).

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 and dispensed by pharmacists registered with the S.T.E.P.S.^® program.
• Patients taking THALOMID^® (thalidomide) should not share the drug.
• Male patients taking THALOMID^® (thalidomide) should not donate sperm.

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS.