Brand Name
Thalomid
Generic Name
Thalidomide
View Brand Information FDA approval date: June 20, 2003
Form: Capsule
What is Thalomid (Thalidomide)?
THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma .
Approved To Treat
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Brand Information
Thalomid (Thalidomide)
1DOSAGE FORMS AND STRENGTHS
Capsules:
- 50 mg white, printed with "BMS/50 mg" on the body and a "Do Not Get Pregnant" logo on the cap.
- 100 mg tan, printed with "BMS/100 mg" on the body and a "Do Not Get Pregnant" logo on the cap.
- 150 mg tan body printed with "BMS/150 mg" and blue cap printed with a "Do Not Get Pregnant" logo.
- 200 mg blue, printed with "BMS/200 mg" on the body and a "Do not Get Pregnant" logo on the cap.
2ADVERSE REACTIONS
The following clinically significant adverse reactions are described in detail in other labeling sections:
- Teratogenicity
- Venous and Arterial Thromboembolism
- Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone
- Drowsiness and Somnolence
- Peripheral Neuropathy
- Dizziness and Orthostatic Hypotension
- Neutropenia
- Thrombocytopenia
- Increased HIV Viral Load
- Bradycardia
- Severe Cutaneous Reactions
- Seizures
- Tumor Lysis Syndrome
- Hypersensitivity
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most patients taking THALOMID can be expected to experience adverse reactions.
2.2Postmarketing Experience
The following additional adverse reactions have been identified during post approval use of THALOMID and are not already included in Clinical Trials Experience
Blood and Lymphatic: Decreased white blood cell counts including febrile neutropenia, changes in prothrombin time, pancytopenia, chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia, lymphedema, lymphopenia.
Body as a Whole: Hangover effect
Cardiovascular System: Sick sinus syndrome, EKG abnormalities, pulmonary hypertension.
Digestive System: Intestinal perforation, gastrointestinal perforations, bile duct obstruction, stomach ulcer, aphthous, stomatitis.
Ear and Labyrinthine Disorders: Hearing impairment.
Immune System Disorders: Hypersensitivity including anaphylaxis, solid organ transplant rejection.
Infections and infestations: Severe infections (e.g., fatal sepsis including septic shock), viral infections (including varicella zoster virus, cytomegalovirus, and hepatitis B virus reactivation) and progressive multifocal leukoencephalopathy (PML).
Metabolic and Endocrine: Electrolyte imbalance including hypercalcemia, hyponatremia and hypomagnesemia, hypothyroidism, increased alkaline phosphatase, tumor lysis syndrome, myxedema.
Nervous System: Changes in mental status or mood including suicide attempts, disturbances in consciousness including lethargy, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepticus, Parkinson's disease, stroke, carpal tunnel, Raynaud's syndrome, migraine, foot drop.
Renal and Urinary Disorders: Renal failure, acute renal failure, oliguria, enuresis.
Reproductive System and Breast Disorders: amenorrhea, sexual dysfunction, galactorrhea, gynecomastia, metrorrhagia.
Respiratory System: Pleural effusion, interstitial lung disease.
Skin and Appendages: Erythema multiforme, erythema nodosum, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), purpura, petechiae.
Special Senses: Diplopia, nystagmus
3DRUG ABUSE AND DEPENDENCE
Physical and psychological dependence has not been reported in patients taking THALOMID; however, as with other tranquilizers/hypnotics, thalidomide has been reported to result in habituation to its soporific effects.
4OVERDOSAGE
There is no specific antidote for a THALOMID 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.
5DESCRIPTION
THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C
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.
6REFERENCES
- OSHA Hazardous Drugs.
7HOW SUPPLIED/STORAGE AND HANDLING
(THIS PRODUCT IS ONLY SUPPLIED TO PHARMACIES CERTIFIED IN THE THALOMID REMS PROGRAM - See
7.1How Supplied
50 mg capsules [white opaque], imprinted "BMS/50 mg" with a "Do Not Get Pregnant" logo.
100 mg capsules [tan], imprinted "BMS/100 mg" with a "Do Not Get Pregnant" logo.
150 mg capsules [tan and blue], imprinted "BMS/150 mg" with a "Do Not Get Pregnant" logo.
200 mg capsules [blue], imprinted "BMS/200 mg" with a "Do Not Get Pregnant" logo.
7.2Storage
This drug must not be repackaged.
Store at 20°C- 25°C (68°F -77°F); excursions permitted to 15-30º C (59-86º F). [See USP Controlled Room Temperature]. Protect from light.
7.3Handling and Disposal
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.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved Patient Labeling (Medication Guide)