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WARNINGS:
1. SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide) IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE “SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.®).” UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.
2. VENOUS THROMBOEMBOLIC EVENTS
THE USE OF THALOMID® (thalidomide) IN MULTIPLE MYELOMA RESULTS IN AN INCREASED RISK OF VENOUS THROMBOEMBOLIC EVENTS, SUCH AS DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLUS. THIS RISK INCREASES SIGNIFICANTLY WHEN THALIDOMIDE IS USED IN COMBINATION WITH STANDARD CHEMOTHERAPEUTIC AGENTS INCLUDING DEXAMETHASONE. IN ONE CONTROLLED TRIAL, THE RATE OF VENOUS THROMBOEMBOLIC EVENTS WAS 22.5% IN PATIENTS RECEIVING THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE COMPARED TO 4.9% IN PATIENTS RECEIVING DEXAMETHASONE ALONE (P = 0.002). PATIENTS AND PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE SIGNS AND SYMPTOMS OF THROMBOEMBOLISM. PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL CARE IF THEY DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR LEG SWELLING. PRELIMINARY DATA SUGGEST THAT PATIENTS WHO ARE APPROPRIATE CANDIDATES MAY BENEFIT FROM CONCURRENT PROPHYLACTIC ANTICOAGULATION OR ASPIRIN TREATMENT.
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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.
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.
Information for Vermont Prescribers of Prescription Drugs:
THALOMID® (thalidomide) Capsules
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