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EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females 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 embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS™ program, approved by the Food and Drug Administration. This program was formerly known as the “System for Thalidomide Education and Prescribing Safety (S.T.E.P.S. ® program)”.
You can get the information about THALOMID and the THALOMID REMS™ program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer's toll-free number 1-888-423-5436.
The use of THALOMID® (thalidomide) in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In one controlled trial, the rate of venous thromboembolism 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. Instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Consider thromboprophylaxis based on an assessment of individual patients' underlying risk factors.
THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
Note: • = asymmetric carbon atom
Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero.
THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.
What are the possible side effects of thalidomide (Thalomid)?
Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- chest pain, sudden shortness of breath, coughing up blood;
- pain or swelling in your arm, thigh, or calf;
- fever, chills, body aches, flu symptoms, easy bruising or bleeding;
- slow heartbeats, shallow breathing, feeling like you might pass out;
- a red, blistering, peeling skin...
What are the precautions when taking thalidomide (Thalomid)?
Before taking thalidomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: numbness/tingling of arms/legs, seizures.
Caution is advised when using this drug in people with HIV because they may be more sensitive to the effects of the drug. While thalidomide is used to treat muscle wasting...
Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.
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