- 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.
- 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.
- 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- A similar trend was observed in a second, unpublished study conducted in patients who were HIV-seropositive.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.
- THALOMID® (thalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.
- 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.
- 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.
- 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.
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.