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Thalomid (Thalidomide) - Summary

 
 



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. 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.

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.

 

THALOMID SUMMARY

THALOMID® (thalidomide), (alpha)-(N-phthalimido)glutarimide, is an immunomodulatory agent.

THALOMID® (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID® (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

THALOMID® (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

CONTRAINDICATIONS (BOXED WARNING.)

Due to its known human teratogenicity, even following a single dose, thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. (See BOXED WARNING.) When there is no alternative treatment, women of childbearing potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy. Women must commit either to abstain continuously from heterosexual sexual contact or to use two methods of reliable birth control, including at least one highly effective method (e.g., IUD, hormonal contraception, tubal ligation, or partner's vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to initiating treatment with thalidomide, during therapy with thalidomide, and continuing for 4 weeks following discontinuation of thalidomide therapy. If hormonal or IUD contraception is medically contraindicated (see also PRECAUTIONS: Drug Interactions), two other effective or highly effective methods may be used.

Women of childbearing potential being treated with thalidomide should have a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed within the 24 hours prior to beginning thalidomide therapy and then weekly during the first 4 weeks of thalidomide therapy, then at 4 week intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding. If pregnancy occurs during thalidomide treatment, thalidomide must be discontinued immediately. Under these conditions, the patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential. The risk to the fetus from the semen of male patients taking thalidomide is unknown.

THALOMID® (thalidomide) is contraindicated in patients who have demonstrated hypersensitivity to the drug and its components.

WARNINGS

(BOXED WARNING.)

Thalidomide can cause severe birth defects in humans. (See BOXED WARNING and CONTRAINDICATIONS.) Patients should be instructed to take thalidomide only as prescribed and not to share their thalidomide with anyone else. Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential. The risk to the fetus from the semen of male patients taking thalidomide is unknown.

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. Patients should be advised as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as driving a car or operating other complex or dangerous machinery.

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. Peripheral neuropathy generally occurs following chronic use over a period of months; however, reports following relatively short-term use also exist. The correlation with cumulative dose is unclear. Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all. Few reports of neuropathy have arisen in the treatment of ENL despite long-term thalidomide treatment. However, the inability clinically to differentiate thalidomide neuropathy from the neuropathy often seen in Hansen's disease makes it difficult to determine accurately the incidence of thalidomide-related neuropathy in ENL patients treated with thalidomide.

Patients should be examined at monthly intervals for the first 3 months of thalidomide therapy to enable the clinician to detect early signs of neuropathy, which include numbness, tingling or pain in the hands and feet. Patients should be evaluated periodically thereafter during treatment. Patients should be regularly counseled, questioned, and evaluated for signs or symptoms of peripheral neuropathy. Consideration should be given to electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and thereafter every 6 months in an effort to detect asymptomatic neuropathy. If symptoms of drug-induced neuropathy develop, thalidomide should be discontinued immediately to limit further damage, if clinically appropriate. Usually, treatment with thalidomide should only be reinitiated if the neuropathy returns to baseline status. Medications known to be associated with neuropathy should be used with caution in patients receiving thalidomide.

Thrombotic events have been reported in patients treated with THALOMID® (thalidomide). Patients with neoplastic and various inflammatory conditions being treated with THALOMID® (thalidomide) may have an increased incidence of pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. It is not known if concomitant therapy with other medications, including anticancer agents, are a contributing factor.

Patients should also be advised that 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 the clinical use of thalidomide. Treatment should not be initiated with an absolute neutrophil count (ANC) of <750/mm3. White blood cell count and differential should be monitored on an ongoing basis, especially in patients who may be more prone to neutropenia, such as patients who are HIV-seropositive. If ANC decreases to below 750/mm3 while on treatment, the patient's medication regimen should be re-evaluated and, if the neutropenia persists, consideration should be given to withholding thalidomide if clinically appropriate.

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).7 A similar trend was observed in a second, unpublished study conducted in patients who were HIV-seropositive.13 The clinical significance of this increase is unknown. Both studies were conducted prior to availability of highly active antiretroviral therapy. Until the clinical significance of this finding is further understood, in HIV-seropositive patients, viral load should be measured after the first and third months of treatment and every 3 months thereafter.


See all Thalomid indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Thalomid (Thalidomide)

Thalidomide plus Topotecan better for ovarian cancer
Source: The Doctors Lounge - Oncology
This trial is among the first to combine a biologic agent with a conventional chemotherapy agent for ovarian cancer.

Leprosy
Source: MedicineNet Alopecia Areata Specialty [2015.04.15]
Title: Leprosy
Category: Diseases and Conditions
Created: 6/10/2009 12:00:00 AM
Last Editorial Review: 4/15/2015 12:00:00 AM

more news >>

Published Studies Related to Thalomid (Thalidomide)

A potential new enriching trial design for selecting non-small-cell lung cancer patients with no predictive biomarker for trials based on both histology and early tumor response: further analysis of a thalidomide trial. [2013]
There are few predictive biomarkers for antiangiogenic trials in lung cancer. We examine a potential treatment strategy in which a patient group is enriched using both histology and an early assessment of response during standard chemotherapy, and where a new agent is given for the remainder of chemotherapy and as maintenance...

Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. [2011.12.01]
Background. Thalidomide has potent antimyeloma activity, but no prospective randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma... This was the first randomized controlled trial to Although thalidomide was not superior to dexamethasone in this randomized trial, demonstrate that thalidomide monotherapy may be considered is an effective salvage therapy option for relapsed/refractory multiple myeloma, particularly in patients with good prognosis and those who have received 2-3 prior therapies.

Thalidomide, dexamethasone and lovastatin with autologous stem cell transplantation as a salvage immunomodulatory therapy in patients with relapsed and refractory multiple myeloma. [2011.10]
The treatment of patients with multiple myeloma usually includes many drugs including thalidomide, lenalidomide and bortezomib.Our results suggest that the addition of lovastatin to the TD regimen may improve the response rate in patients with relapsed or refractory myeloma.

Poor tolerability of thalidomide in end-stage oesophageal cancer. [2011.09]
Oesophageal cancer cachexia is a significant clinical problem, resulting in excessive morbidity and mortality. In a pilot study, 10 patients with cachexia due to advanced cancer of the oesophagus gained weight, including lean tissue, after 14-day treatment with thalidomide... In the absence of hard supportive evidence, off-licence treatment with thalidomide should be used with great caution as an adjunct to nutritional support in patients with advanced cancer.

Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. [2011.08.04]
As part of the randomized MRC Myeloma IX trial, we compared an attenuated regimen of cyclophosphamide, thalidomide, and dexamethasone (CTDa; n = 426) with melphalan and prednisolone (MP; n = 423) in patients with newly diagnosed multiple myeloma ineligible for autologous stem-cell transplantation...

more studies >>

Clinical Trials Related to Thalomid (Thalidomide)

Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma [Completed]
This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.

Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis [Recruiting]
1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis. 2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.

Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors [Completed]
Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors

TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy [Completed]
This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.

Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer [Recruiting]
The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.

more trials >>

Reports of Suspected Thalomid (Thalidomide) Side Effects

Multiple Myeloma (57)Neuropathy Peripheral (39)Fall (30)Death (25)Fatigue (21)Cardiac Disorder (18)Renal Failure (17)Pneumonia (16)Drug Ineffective (13)Anaemia (13)more >>


Page last updated: 2015-04-15

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