What is Thalomid (thalidomide)?

Thalomid (thalidomide) is an immunomodulatory agent used to treat and prevent the skin conditions of leprosy, a disease caused by a parasite, Mycobacterium leprae. It is also used to treat and prevent skin conditions that result from multiple myelomas.

Off-label uses for Thalomid include the treatment of:

  • tuberculosis,
  • aphthous ulcers,
  • HIV-wasting syndrome,
  • Crohn's disease, and
  • Kaposi's sarcoma.

The mechanism of action of Thalomid is not well understood. The immune system reaction to Mycobacterium leprae plays an important role in producing the skin manifestations of leprosy. Scientists believe Thalomid modifies the reaction of the immune system to Mycobacterium leprae and thereby suppresses the skin reaction. 

Common side effects of Thalomid include:

Serious side effects of Thalomid include:

Drug interactions of Thalomid include alcohol and other drugs that cause drowsiness because Thalomid increases the sedative effects.

Drugs that slow heart rate add to the heart-slowing effects of Thalomid such as:

The incidence of peripheral neuropathy increases when Thalomid is combined with other drugs (for example, amiodarone, cisplatin, phenytoin) that also cause peripheral neuropathy.

Thalomid is very harmful to a fetus and should be avoided during pregnancy. Men and women taking Thalomid should use appropriate methods of birth control. Women of childbearing age should practice two forms of birth control concurrently.

It is unknown if Thalomid passes into breast milk. Because of the possible risk to the infant, breastfeeding while using Thalomid is not recommended. 

What are the important side effects of Thalomid (thalidomide)?

WARNING

  • Thalidomide is very harmful to the fetus. Therefore, thalidomide should be avoided during pregnancy.
  • Men and women who are taking thalidomide should use appropriate methods of birth control.
  • Moreover, women of childbearing age should practice two forms of birth control concurrently.
  • Men taking thalidomide should not donate sperm, and thalidomide users should not donate blood since the recipients of the sperm and blood may receive small amounts of thalidomide.

The most common side effects are:

Other important side effects include:

Thalidomide also causes nerve damage (peripheral neuropathy), slow heart rate, hypertension, hypotension, and a decrease in white blood cells. Symptoms of nerve damage are tingling, numbness and pain in the feet or hands.

Thalomid (thalidomide) side effects list for healthcare professionals

The following clinically significant adverse reactions are described in detail in other labeling sections:

Clinical 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.

Adverse Reactions In Multiple Myeloma Controlled Clinical Trials

The safety analyses were conducted in two controlled clinical studies (Study 1 and Study 2). The safety analysis in Study 1 was conducted on 204 patients who received treatment. Table 1 lists the most common adverse reactions (≥ 10%). The most frequently reported adverse reactions were:

Twenty-three percent of patients (47/204) discontinued due to adverse reactions; 30% (31/102) from the Thalomid/dexamethasone arm and 16% (16/102) from the dexamethasone alone arm.

Table 1: Adverse Reactions Reported in ≥10% of Patients in the Thalomid/Dexamethasone Arm (Study 1 - Safety Population; N=204)

Body System
Adverse Reaction
Thal + Dex*
(N=102)
Dex Alone*
(N=102)
All Grades
n (%)
Grade 3/4
n (%)
All Grades
n (%)
Grade 3/4
n (%)
Metabolic/Laboratory97 (95)33 (32)96 (94)30 (29)
  Hypocalcemia73 (72)11 (11)60 (59)5 (5)
Neurology92 (90)30 (29)76 (74)18 (18)
  Neuropathy - sensory55 (54)4 (4)28 (28)1 (1)
  Confusion29 (28)9 (9)12 (12)3 (3)
  Anxiety/agitation26 (26)1 (1)14 (14)3 (3)
  Tremor26 (26)1 (1)6 (6)0 (0)
  Neuropathy - motor22 (22)8 (8)16 (16)5 (5)
  Dizziness/ lightheadedness20 (20)1 (1)14 (14)0 (0)
  Depressed level of consciousness16 (16)3 (3)3 (3)3 (3)
Constitutional Symptoms91 (89)19 (19)84 (82)16 (16)
  Fatigue81 (79)17 (17)72 (71)13 (13)
  Fever24 (24)1 (1)20 (20)3 (3)
  Weight loss23 (23)1 (1)21 (21)2 (2)
  Weight gain22 (22)1 (1)13 (13)0 (0)
Blood/Bone Marrow88 (86)29 (29)96 (94)19 (19)
  Leukocytes (decreased)36 (35)6 (6)30 (29)3 (3)
  Neutrophils (decreased)32 (31)10 (10)24 (24)10 (10)
Gastrointestinal83 (81)22 (22)70 (69)8 (8)
  Constipation56 (55)8 (8)29 (28)1 (1)
  Anorexia29 (28)4 (4)25 (24)2 (2)
  Nausea29 (28)5 (5)23 (22)1 (1)
  Mouth dryness12 (12)1 (1)6 (6)0 (0)
Cardiovascular70 (69)37 (36)60 (59)21 (21)
  Edema58 (56)6 (6)47 (46)4 (4)
  Thrombosis/embolism23 (22)21 (21)5 (5)5 (5)
Pain64 (63)10 (10)66 (65)15 (15)
  Myalgia17 (17)0 (0)14 (14)1 (1)
  Arthralgia13 (13)0 (0)10 (10)2 (2)
Pulmonary52 (51)19 (19)51 (50)20 (20)
  Dyspnea43 (42)13 (13)32 (31)15 (15)
Dermatology/Skin48 (47)5 (5)35 (34)2 (2)
  Rash/desquamation31 (30)4 (4)18 (18)2 (2)
  Dry skin21 (21)0 (0)11 (11)0 (0)
Hepatic47 (46)7 (7)45 (44)4 (4)
  Bilirubin14 (14)2 (2)10 (10)2 (2)
Musculoskeletal42 (41)9 (9)41 (40)14 (14)
  Muscle weakness41 (40)6 (6)38 (37)13 (13)
* Treatment-emergent adverse reactions reported in ≥10% of patients in Thalomid/dexamethasone arm and with a ≥1% difference in the Thalomid/dexamethasone arm compared to the dexamethasone alone arm.

The safety analysis in Study 2 was conducted on 466 patients who received treatment. Table 2 lists the most common adverse reactions (≥10%) that were observed. Table 3 lists the most common Grade 3/4 adverse reactions (occurring at >2%) that were observed. The adverse reactions most often reported by patients treated with Thalomid/dexamethasone were:

  • constipation,
  • peripheral edema,
  • tremor,
  • asthenia,
  • dizziness and
  • fatigue.

Adverse reactions with a frequency at least 2-fold higher in the Thalomid/dexamethasone group than in the placebo/dexamethasone group include constipation, tremor, deep vein thrombosis and peripheral sensory neuropathy.

Twenty-six percent of patients (121/466) discontinued due to adverse reactions; 37% (86/234) from the Thalomid/dexamethasone arm and 15% (35/232) from the placebo/dexamethasone arm.

Table 2: Adverse Reactions Reported in ≥10% of Patients in the Thalomid/Dexamethasone Arm (Study 2 - Safety Population; N=466)

Body System
Adverse Reaction
Thal/Dex (N=234)*
n (%)
Placebo/Dex (N=232)*
n (%)
Patients with at least 1 Adverse Reaction233 (99)230 (99)
General Disorders and Administration Site Conditions176 (75)149 (64)
  Edema peripheral80 (34)57 (25)
  Asthenia56 (24)47 (20)
  Fatigue50 (21)36 (16)
  Edema NOS31 (13)19 (8)
Gastrointestinal Disorders162 (69)149 (64)
  Constipation116 (50)49 (21)
  Nausea30 (13)27 (12)
  Dyspepsia27 (11)21 (9)
Nervous System Disorders161 (69)138 (60)
  Tremor62 (26)29 (12)
  Dizziness51 (23)32 (14)
  Paresthesia27 (12)15 (6)
  Peripheral sensory neuropathy24 (10)12 (5)
Infections and Infestations139 (59)138 (60)
  Pneumonia NOS35 (15)28 (12)
Psychiatric Disorders90 (38)97 (42)
  Anxiety27 (12)22 (10)
  Depression24 (10)19 (8)
Metabolism and Nutrition Disorders96 (41)89 (38)
  Hyperglycemia NOS36 (15)32 (14)
Vascular Disorders92 (39)53 (23)
  Deep vein thrombosis30 (13)4 (2)
*All adverse reactions reported in ≥10% of patients in Thalomid/dexamethasone arm and with a ≥1% difference in proportion of patients between the Thalomid/dexamethasone arm compared to the placebo/dexamethasone arm. NOS = not otherwise specified.

Table 3: Grade 3/4 Adverse Reactions Reported in >2% of Patients in the Thalomid/Dexamethasone Arm (Study 2 - Safety Population; N=466)

Body System
Adverse Reaction
Thalomid/Dex (N=234)*
n (%)
Placebo/Dex (N=232)*
n (%)
Infections and Infestations50 (21)36 (16)
  Pneumonia NOS17 (7)14 (6)
  Bronchopneumonia NOS7 (3)3 (1)
General Disorders and Administration Site Conditions44 (19)26 (11)
  Asthenia11 (5)4 (2)
Metabolism and Nutrition Disorders33 (14)34 (15)
  Hypokalemia7 (3)3 (1)
Nervous System Disorders47 (20)20 (9)
  Syncope8 (3)1 (<1)
  Peripheral neuropathy NOS8 (3)0 (0)
  Cerebrovascular accident6 (3)1 (<1)
Cardiac Disorders35 (15)27 (11)
  Atrial fibrillation11 (5)8 (3)
  Myocardial ischemia6 (3)2 (1)
Vascular Disorders42 (18)14 (6)
  Deep vein thrombosis27 (12)4 (2)
Gastrointestinal Disorders26 (11)22 (10)
  Constipation7 (3)2 (1)
Investigations21 (9)21 (9)
  Weight increased8 (3)4 (2)
Blood and Lymphatic System Disorders24 (10)17 (7)
  Neutropenia8 (3)6 (3)
Respiratory, Thoracic, and Mediastinal Disorders27 (12)13 (6)
  Pulmonary embolism16 (7)4 (2)
Psychiatric Disorders19 (8)8 (3)
  Anxiety5 (2)3 (1)
  Confusional state5 (2)2 (1)
Ear and Labyrinth Disorders6 (3)0 (0)
  Vertigo5 (2)0 (0)
* All Grade 3/4 adverse reactions with >2% of patients in Thalomid/dexamethasone arm and with a higher frequency in the Thalomid/dexamethasone arm compared to the placebo/dexamethasone arm.
NOS = not otherwise specified.

Less Common Adverse Reactions In Multiple Myeloma Controlled Clinical Trials

In Study 2, Thalomid in combination with dexamethasone in patients with multiple myeloma, the following adverse reactions not described above were reported*:

Gastrointestinal disorders: Vomiting NOS, dry mouth, peritonitis, diverticular perforation

Nervous system disorders: Somnolence, hypoesthesia, polyneuropathy NOS, transient ischemic attack

Respiratory, thoracic, and mediastinal disorders: Bronchitis NOS

Psychiatric disorders: Mood alteration NOS

Vascular disorders: Hypotension NOS, orthostatic hypotension

Cardiac disorders: Bradycardia NOS

Eye disorders: Blurred vision

* All adverse reactions with ≥3% of patients in Thalomid/dexamethasone arm and with a ≥1% difference in proportion of patients between the Thalomid/dexamethasone arm compared to the placebo/dexamethasone arm. All grade 3/4 and serious adverse reactions reported >2 patients in Thalomid/dexamethasone arm and with a percentage higher in the Thalomid/dexamethasone arm compared to the placebo/dexamethasone arm have been considered for possible inclusion. In any cases medical judgment has been applied for consideration of causality assessment.

Adverse Reactions In Erythema Nodosum Leprosum (ENL) Clinical Trials

Table 4 lists treatment-emergent signs and symptoms that occurred in Thalomid-treated patients in clinical trials in ENL. The most common adverse reactions (≥ 10%) reported in patients with ENL were somnolence, rash, headache. Doses ranged from 50 to 300 mg/day. All adverse reactions were mild to moderate in severity, and none resulted in discontinuation.

Table 4: Summary of Adverse Reactions (ARs) Reported in Celgene-sponsored Controlled Clinical Trials

Body System/ Adverse ReactionAll ARs Reported in Patients with ENLARs Reported in ≥3 HIV–seropositive Patients
Thalomid 50 to 300 mg/day
(N=24)
n (%)
Thalomid
100 mg/day (N=36)
n (%)
Thalomid
200 mg/day (N=32)
n (%)
Placebo
(N=35)
n(%)
Blood and Lymphatic08 (22)13 (41)10 (29)
  Anemia02 (6)4 (13)3 (9)
  Leukopenia06 (17)8 (25)3 (9)
  Lymphadenopathy02 (6)4 (13)3 (9)
Body as a Whole16 (67)18 (50)19 (59)13 (37)
  Abdominal pain1 (4)1 (3)1 (3)4 (11)
  Accidental injury1 (4)2 (6)01 (3)
  Asthenia2 (8)2 (6)7 (22)1 (3)
  Back pain1 (4)2 (6)00
  Chills1 (4)03 (9)4 (11)
  Facial edema1 (4)000
  Fever07 (19)7 (22)6 (17)
  Headache3 (13)6 (17)6 (19)4 (11)
  Infection03 (8)2 (6)1 (3)
  Malaise2 (8)000
  Neck pain1 (4)000
  Neck rigidity1 (4)000
  Pain2 (8)01 (3)2 (6)
Digestive System5 (21)16 (44)16 (50)15 (43)
  Anorexia01 (3)3 (9)2 (6)
  Constipation1 (4)1 (3)3 (9)0
  Diarrhea1 (4)4 (11)6 (19)6 (17)
  Dry mouth03 (8)3 (9)2 (6)
  Flatulence03 (8)02 (6)
  Liver function tests multiple abnormalities003 (9)0
  Nausea1 (4)04 (13)1 (3)
  Oral moniliasis1 (4)4 (11)2 (6)0
  Tooth pain1 (4)000
Metabolic and Endocrine Disorders1 (4)8 (22)12 (38)8 (23)
  Edema peripheral1 (4)3 (8)1 (3)0
  Hyperlipidemia02 (6)3 (9)1 (3)
  SGOT increased01 (3)4 (13)2 (6)
Nervous System13 (54)19 (53)18 (56)12 (34)
  Agitation003 (9)0
  Dizziness1 (4)7 (19)6 (19)0
  Insomnia003 (9)2 (6)
  Nervousness01 (3)3 (9)0
  Neuropathy03 (8)00
  Paresthesia02 (6)5 (16)4 (11)
  Somnolence9 (38)13 (36)12 (38)4 (11)
  Tremor1 (4)000
  Vertigo2 (8)000
Respiratory System3 (13)9 (25)6 (19)9 (26)
  Pharyngitis1 (4)3 (8)2 (6)2 (6)
  Rhinitis1 (4)004 (11)
  Sinusitis1 (4)3 (8)1 (3)2 (6)
Skin and Appendages10 (42)17 (47)18 (56)19 (54)
  Acne04 (11)1 (3)0
  Dermatitis fungal1 (4)2 (6)3 (9)0
  Nail disorder1 (4)01 (3)0
  Pruritus2 (8)1 (3)2 (6)2 (6)
  Rash5 (21)9 (25)8 (25)11 (31)
  Rash maculopapular1 (4)6 (17)6 (19)2 (6)
  Sweating004 (13)4 (11)
Urogenital System2 (8)6 (17)2 (6)4 (11)
  Albuminuria03 (8)1 (3)2 (6)
  Hematuria04 (11)01 (3)
  Impotence2 (8)1 (3)00

Other Adverse Reactions Observed In ENL Patients

Thalomid in doses up to 400 mg/day has been administered investigationally in the United States over a 19-year period in 1465 patients with ENL. The published literature describes the treatment of an additional 1678 patients. To provide a meaningful estimate of the proportion of the individuals having adverse reactions, similar types of events were grouped into a smaller number of standardized categories using a modified COSTART dictionary/terminology.

These categories are used in the listing below. All reported events are included except those already listed in the previous table. Due to the fact that these data were collected from uncontrolled studies, the incidence rate cannot be determined. No causal relationship between Thalomid and these events can be conclusively determined at this time. These are reports of all adverse events noted by investigators in patients to whom they had administered Thalomid.

Blood and Lymphatic: ESR decrease, eosinophilia, granulocytopenia, hypochromic anemia, leukemia, leukocytosis, leukopenia, MCV elevated, RBC abnormal, spleen palpable, thrombocytopenia.

Body as a Whole: Abdomen enlarged, fever, photosensitivity, upper extremity pain.

Cardiovascular System: Bradycardia, hypertension, hypotension, peripheral vascular disorder, tachycardia, vasodilation.

Digestive System: Anorexia, appetite increase/weight gain, dry mouth, dyspepsia, enlarged liver, eructation, flatulence, increased liver function tests, intestinal obstruction, vomiting.

Metabolic and Endocrine: ADH inappropriate, amyloidosis, bilirubinemia, BUN increased, creatinine increased, cyanosis, diabetes, edema, electrolyte abnormalities, hyperglycemia, hyperkalemia, hyperuricemia, hypocalcemia, hypoproteinemia, LDH increased, phosphorus decreased, SGPT increased.

Muscular Skeletal: Arthritis, bone tenderness, hypertonia, joint disorder, leg cramps, myalgia, myasthenia, periosteal disorder.

Nervous System: Abnormal thinking, agitation, amnesia, anxiety, causalgia, circumoral paresthesia, confusion, depression, euphoria, hyperesthesia, insomnia, nervousness, neuralgia, neuritis, neuropathy, paresthesia, peripheral neuritis, psychosis.

Respiratory System: Cough, emphysema, epistaxis, pulmonary embolus, rales, upper respiratory infection, voice alteration.

Skin and Appendages: Acne, alopecia, dry skin, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, sweating, urticaria, vesiculobullous rash.

Special Senses: Amblyopia, deafness, dry eye, eye pain, tinnitus.

Urogenital: Decreased creatinine clearance, hematuria, orchitis, proteinuria, pyuria, urinary frequency.

Other Adverse Reactions Observed In HIV-Seropositive Patients

In addition to controlled clinical trials, Thalomid has been used in uncontrolled studies in 145 patients. Less frequent adverse reactions that have been reported in these HIV-seropositive patients treated with Thalomid were grouped into a smaller number of standardized categories using modified COSTART dictionary/terminology and these categories are used in the listing below. Adverse reactions that have already been included in the tables and narrative above, or that are too general to be informative are not listed.

Blood and Lymphatic: Aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia.

Body as a Whole: Ascites, AIDS, allergic reaction, cellulitis, chest pain, chills and fever, cyst, decreased CD4 count, facial edema, flu syndrome, hernia, thyroid hormone level altered, moniliasis, photosensitivity reaction, sarcoma, sepsis, viral infection.

Cardiovascular System: Angina pectoris, arrhythmia, atrial fibrillation, bradycardia, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, heart arrest, heart failure, hypertension, hypotension, murmur, myocardial infarct, palpitation, pericarditis, peripheral vascular disorder, postural hypotension, syncope, tachycardia, thrombophlebitis, thrombosis.

Digestive System: Cholangitis, cholestatic jaundice, colitis, dyspepsia, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gum disorder, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, tooth disorder.

Metabolic and Endocrine: Avitaminosis, bilirubinemia, dehydration, hypercholesterolemia, hypoglycemia, increased alkaline phosphatase, increased lipase, increased serum creatinine, peripheral edema.

Muscular Skeletal: Myalgia, myasthenia.

Nervous System: Abnormal gait, ataxia, decreased libido, decreased reflexes, dementia, dysesthesia, dyskinesia, emotional lability, hostility, hypalgesia, hyperkinesia, incoordination, meningitis, neurologic disorder, tremor, vertigo.

Respiratory System: Apnea, bronchitis, lung disorder, lung edema, pneumonia (including Pneumocystis carinii pneumonia), rhinitis.

Skin and Appendages: Angioedema, benign skin neoplasm, eczema, herpes simplex, incomplete Stevens-Johnson syndrome, nail disorder, pruritus, psoriasis, skin discoloration, skin disorder.

Special Senses: Conjunctivitis, eye disorder, lacrimation disorder, retinitis, taste perversion.

Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of Thalomid and are not already included in Clinical Trials Experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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) and viral infections (including varicella zoster virus, cytomegalovirus, and hepatitis B virus reactivation).

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

What drugs interact with Thalomid (thalidomide)?

Opioids, Antihistamines, Antipsychotics, Anti-Anxiety Agents, Or Other CNS Depressants (Including Alcohol)

The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Thalomid may cause an additive sedative effect and should be avoided.

Drugs Which Cause Bradycardia

The use of drugs which slow cardiac conduction concomitantly with Thalomid may cause an additive bradycardic effect and should be used with caution. Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin. Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine).

In 16 healthy men, the pharmacokinetic profile of a single 0.5 mg digoxin dose was similar with and without the coadministration of Thalomid 200 mg/day at steady state levels. The single dose of digoxin had no effect on the pharmacokinetic profile of Thalomid. The safety of long-term concomitant use of Thalomid and digoxin has not been evaluated.

Drugs Which Cause Peripheral Neuropathy

The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution.

Hormonal Contraceptives

Hormonal contraceptives increase the risk of thromboembolism. It is not known whether concomitant use of hormonal contraceptives further increases the risk of thromboembolism with Thalomid.

In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 75 mcg of ethinyl estradiol were studied. The results were similar with and without coadministration of Thalomid 200 mg/day to steady-state levels.

Warfarin

In 13 healthy men, the pharmacokinetic profile and international normalized ratio (INR) of prothrombin time for warfarin, following a single oral dose of 25 mg, were similar with and without the coadministration of Thalomid 200 mg/day at steady-state levels. The single dose of warfarin had no effect on the pharmacokinetic profile of thalidomide.

Drugs That Interfere With Hormonal Contraceptives

Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John’s Wort with hormonal contraceptive agents may reduce the effectiveness of the contraception up to one month after discontinuation of these concomitant therapies. Therefore, females requiring treatment with one or more of these drugs must use two OTHER effective or highly effective methods of contraception while taking Thalomid.

Concomitant Therapies That May Increase The Risk Of Thromboembolism

Erythropoietic agents, or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies, should be used with caution in multiple myeloma patients receiving Thalomid with dexamethasone.

Drug 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.

Summary

Thalomid (thalidomide) is an immunomodulatory agent used to treat and prevent the skin conditions of leprosy, a disease caused by a parasite, Mycobacterium leprae. It is also used to treat and prevent skin conditions that result from multiple myelomas. Off-label uses for Thalomid include the treatment of tuberculosis, aphthous ulcers, HIV-wasting syndrome, Crohn's disease, and Kaposi's sarcoma. Common side effects of Thalomid include drowsiness, headache, dizziness, low blood pressure, weakness, rash, impotence, diarrhea, constipation, and increased sensitivity. Thalomid is very harmful to a fetus and should be avoided during pregnancy. Men and women taking Thalomid should use appropriate methods of birth control. Women of childbearing age should practice two forms of birth control concurrently. It is unknown if Thalomid passes into breast milk. Because of the possible risk to the infant, breastfeeding while using Thalomid is not recommended.

Treatment & Diagnosis

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Medically Reviewed on 5/20/2020
References
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Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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