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Thalomid (Thalidomide) - Summary

 
 



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.

 

THALOMID SUMMARY

PRESCRIBERS

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)

Lead attorney in US-based Thalidomide cases responds to recent $81 million settlement for Australian victims
Source: Litigation / Medical Malpractice News From Medical News Today [2013.12.04]
Attorneys representing plaintiffs in the US seeking compensation from the manufacturer and distributors of the birth defect-causing drug Thalidomide today lauded a $81 million settlement announced...

Thalidomide May Help Kids With Crohn's Disease
Source: MedicineNet thalidomide Specialty [2013.11.27]
Title: Thalidomide May Help Kids With Crohn's Disease
Category: Health News
Created: 11/26/2013 4:36:00 PM
Last Editorial Review: 11/27/2013 12:00:00 AM

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 Still Occurs in U.S., CDC Reports
Source: MedicineNet Rash Specialty [2014.10.31]
Title: Leprosy Still Occurs in U.S., CDC Reports
Category: Health News
Created: 10/30/2014 12:00:00 AM
Last Editorial Review: 10/31/2014 12:00:00 AM

Leprosy
Source: MedicineNet Alopecia Areata Specialty [2012.06.19]
Title: Leprosy
Category: Diseases and Conditions
Created: 6/10/2009 12:00:00 AM
Last Editorial Review: 6/19/2012 12:00:00 AM

more news >>

Published Studies Related to Thalomid (Thalidomide)

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...

Aspirin, warfarin, or enoxaparin thromboprophylaxis in patients with multiple myeloma treated with thalidomide: a phase III, open-label, randomized trial. [2011.03.10]
PURPOSE: In patients with myeloma, thalidomide significantly improves outcomes but increases the risk of thromboembolic events. In this randomized, open-label, multicenter trial, we compared aspirin (ASA) or fixed low-dose warfarin (WAR) versus low molecular weight heparin (LMWH) for preventing thromboembolism in patients with myeloma treated with thalidomide-based regimens... CONCLUSION: In patients with myeloma treated with thalidomide-based regimens, ASA and WAR showed similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths compared with LMWH, except in elderly patients where WAR showed less efficacy than LMWH.

more studies >>

Clinical Trials Related to Thalomid (Thalidomide)

Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma [Completed]
The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

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.

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma [Active, not recruiting]
Study Objectives

1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies.

2. To evaluate the safety of the combination of lenalidomide, dexamethasone, and thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.

Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS) [Terminated]
Neuroinflammation has recently emerged as a significant contributor to motor neuron damage. ALS tissue is characterized by inflammatory changes that are observed in both sporadic and familial ALS and in the ALS superoxide dismutase 1 (SOD1) transgenic mouse model. They include an accumulation of large numbers of activated microglia and astrocytes.

Proinflammatory cytokines, such as tumor necrosis factor (TNF-), are robustly upregulated in ALS. The receptor for tumor necrosis factor- (TNF-R1) is elevated at late presymptomatic as well as symptomatic phases of disease. TNF acts as a principal driver for neuroinflammation in ALS, while several co-stimulating cytokines and chemokines act to potentiate the TNF effects [4-6].

We propose an investigational therapy of ALS with oral administration of thalidomide. The rationale for this study is based on the anti-inflammatory properties of thalidomide through the modulation of inflammatory cytokines such as TNF. The primary aim of the trial is to determine whether treatment with thalidomide is safe and well tolerated in conjunction with riluzole and whether patients with ALS can tolerate daily doses of up to 400 mg. The trial is designed as feasibility study in planning for a larger phase IIb/III trial of efficacy.

Thalidomide to Patients With Previously Untreated Multiple Myeloma [Completed]
The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.

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: 2014-10-31

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