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Thalomid
Overview
What is Thalomid?
THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is CHNO and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.
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 does Thalomid look like?
What are the available doses of Thalomid?
Capsules: 50 mg, 100 mg, 150 mg and 200 mg. ()
What should I talk to my health care provider before I take Thalomid?
How should I use Thalomid?
THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM) .
THALOMID (thalidomide) must only be administered in compliance with all of the terms outlined in the THALOMID REMS program. THALOMID (thalidomide) may only be prescribed by prescribers certified with the THALOMID REMS program and may only be dispensed by pharmacists certified with the THALOMID REMS program.
Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing .
Consider dose reduction, delay, or discontinuation in patients who develop National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 or 4 adverse reactions and/or based on clinical judgment.
What interacts with Thalomid?
Sorry No Records found
What are the warnings of Thalomid?
Sorry No Records found
What are the precautions of Thalomid?
Sorry No Records found
What are the side effects of Thalomid?
Sorry No records found
What should I look out for while using Thalomid?
Pregnancy (, , , , , )
Demonstrated hypersensitivity to the drug or its components (, , )
WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
EMBRYO-FETAL TOXICITY
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.
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.
VENOUS THROMBOEMBOLISM
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.
What might happen if I take too much Thalomid?
Overdosages of up to 14.4 g have been reported in the literature. No fatalities have been reported and all overdosed patients recovered without sequelae. There is no specific antidote for a thalidomide overdose. In the event of an overdose, the patient’s vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
How should I store and handle Thalomid?
Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program. (THIS PRODUCT IS ONLY SUPPLIED TO PHARMACIES CERTIFIED IN THE THALOMID REMS PROGRAM - See
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of THALOMID is not fully understood. Cellular activities of thalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. THALOMID possesses immunomodulatory, anti-inflammatory and antiangiogenic properties. Available data from studies and clinical trials suggest that the immunologic effects of this compound can vary substantially under different conditions, but may be related to suppression of excessive tumor necrosis factor-alpha (TNF-α) production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. For example, administration of thalidomide has been reported to decrease circulating levels of TNF-α in patients with erythema nodosum leprosum (ENL); however, it has also been shown to increase plasma TNF-α levels in HIV-seropositive patients. Other anti-inflammatory and immunomodulatory properties of thalidomide may include suppression of macrophage involvement in prostaglandin synthesis, and modulation of interleukin-10 and interleukin-12 production by peripheral blood mononuclear cells. Thalidomide treatment of multiple myeloma patients is accompanied by an increase in the number of circulating natural killer cells, and an increase in plasma levels of interleukin-2 and interferon-gamma (T cell-derived cytokines associated with cytotoxic activity). Thalidomide was found to inhibit angiogenesis in a human umbilical artery explant model . The cellular processes of angiogenesis inhibited by thalidomide may include the proliferation of endothelial cells.
Non-Clinical Toxicology
Pregnancy (, , , , , )Demonstrated hypersensitivity to the drug or its components (, , )
WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM
EMBRYO-FETAL TOXICITY
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.
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.
VENOUS THROMBOEMBOLISM
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.
Thalidomide is a powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose. Mortality at or shortly after birth has been reported in about 40% of infants. When there is no satisfactory alternative treatment, females of reproductive potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy. THALOMID (thalidomide) is only available through the THALOMID REMS program .
Oral ingestion is the only type of maternal thalidomide exposure known to result in drug-associated birth defects. There are no specific data available regarding the reproductive risks of cutaneous absorption or inhalation of thalidomide; however, females of reproductive potential should avoid contact with THALOMID (thalidomide) Capsules. THALOMID Capsules should be stored in blister packs until ingestion. If there is contact with non-intact thalidomide capsules or the powder contents, the exposed area should be washed with soap and water.
If healthcare providers or other care givers are exposed to body fluids from patients receiving THALOMID (thalidomide) the exposed area should be washed with soap and water. Appropriate precautions should be utilized, such as wearing gloves to prevent the potential cutaneous exposure to THALOMID.
Females of Reproductive Potential
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with THALOMID, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of THALOMID therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing THALOMID therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles .
Males
[see ]
Blood Donation
The following adverse reactions are described in detail in other labeling sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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