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Thalomid

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Thalomid

Thalomid

SIDE EFFECTS

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

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.

Clinical Trials Experience

Most patients taking thalidomide can be expected to experience adverse reactions.

Teratogenicity

The most serious toxicity associated with thalidomide is its documented human teratogenicity. The risk of severe birth defects, primarily phocomelia or death to the fetus, is extremely high during the critical period of pregnancy. The critical period is estimated, depending on the source of information, to range from 35 to 50 days after the last menstrual period. The risk of other potentially severe birth defects outside this critical period is unknown, but may be significant. Based on present knowledge, thalidomide must not be used at any time during pregnancy.

Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex or synthetic condom during any sexual contact with females of reproductive potential, even if he has undergone a successful vasectomy.

Venous and Arterial Thromboembolism

An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism), ischemic heart disease (including myocardial infarction), and stroke have been reported in patients with multiple myeloma treated with thalidomide [see Venous and Arterial Thromboembolism].

Peripheral Neuropathy

Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage. Peripheral neuropathy generally occurs following chronic use over a period of months. However, reports following relatively short-term use also exist. Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy. Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.

Somnolence, dizziness, and rash are the most commonly observed adverse reactions associated with the use of thalidomide. Adverse event profiles from clinical trials are summarized in the sections that follow.

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 drug reactions ( ≥ 10%). The most frequently reported adverse reactions were fatigue, hypocalcemia, edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash/desquamation, confusion, anorexia, nausea, anxiety/agitation , tremor, fever, weight loss, thrombosis/embolism, neuropathy-motor, weight gain, dizziness, and dry skin .

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 Drug Reactions Reported in ≥ 10% of Patients in the THALOMID/Dexamethasone Arm (Study 1 - Safety Population; N=204)

Organ System Class/ Preferred Term Thal + Dex *
(N=102)
All Grades n (%)
Grade 3/4
n(%)
Dex Alone*
(N=102) All Grades
n (%)
Grade 3/4
n(%)
Metabolic/Laboratory 97 (95) 33 (32) 96 (94) 30 (29)
  Hypocalcemia 73 (72) 11 (11) 60 (59) 5 (5)
Neurology 92 (90) 30 (29) 76 (74) 18(18)
  Neuropathy-sensory 55 (54) 4 (4) 28 (28) 1 (1)
  Confusion 29 (28) 9 (9) 12 (12) 3 (3)
  Anxiety/agitation 26 (26) 1 (1) 14 (14) 3 (3)
  Tremor 26 (26) 1 (1) 6 (6) 0 (0)
  Neuropathy-motor 22 (22) 8 (8) 16 (16) 5 (5)
  Dizziness/lightheadedness 20 (20) 1 (1) 14 (14) 0 (0)
  Depressed level of consciousness 16 (16) 3 (3) 3 (3) 3 (3)
Constitutional Symptoms 91 (89) 19 (19) 84 (82) 16 (16)
  Fatigue 81 (79) 17 (17) 72 (71) 13 (13)
  Fever 24 (24) 1 (1) 20 (20) 3 (3)
  Weight loss 23 (23) 1 (1) 21 (21) 2 (2)
  Weight gain 22 (22) 1 (1) 13 (18) 0 (0)
Blood/Bone Marrow 88 (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)
Gastrointestinal 83 (81) 22 (22) 70 (69) 8 (8)
  Constipation 56 (55) 8 (8) 29 (28) 1 (1)
  Anorexia 29 (28) 4 (4) 25 (24) 2 (2)
  Nausea 29 (28) 5 (5) 23 (22) 1 (1)
  Mouth dryness 12 (12) 1 (1) 6 (6) 0 (0)
Cardiovascular 70 (69) 37 (36) 60 (59) 21 (21)
  Edema 58 (56) 6 (6) 47 (46) 4 (4)
  Thrombosis/embolism 23 (22) 21 (21) 5 (5) 5 (5)
Pain 64 (63) 10 (10) 66 (65) 15(15)
  Myalgia  17 (17) 0 (0) 14 (14) 1 (1)
  Arthralgia 13(13) 0 (0) 10 (10) 2 (2)
Pulmonary 52 (51) 19 (19) 51 (50) 20 (20)
  Dyspnea 43 (42) 13 (13) 32 (31) 15 (15)
Dermatology/Skin 48 (47) 5 (5) 35 (34) 2 (2)
  Rash/desquamation 31 (30) 4 (4) 18 (18) 2 (2)
  Dry skin 21 (21) 0 (0) 11 (11) 0 (0)
Hepatic 47 (46) 7 (7) 45 (44) 4 (4)
  Bilirubin 14 (14) 2 (2) 10 (10) 2 (2)
Musculoskeletal 42 (41) 9 (9) 41 (40) 14 (14)
  Muscle weakness 41(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 drug reactions ( ≥ 10%) that were observed. Table 3 lists the most common Grade 3/4 adverse drug 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 events; 37% (86/234) from the THALOMID/dexamethasone arm and 15% (35/232) from the placebo/dexamethasone arm.

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

MedDRA System Organ Class/
Preferred Term
Thal/Dex
(N=234)*
n (%)
Placebo/Dex
(N=232)*
n (%)
Patients with at least 1 Adverse Reaction 233 (99) 230 (99)
General Disorders and Administration Site Conditions 176 (75) 149 (64)
  Edema peripheral 80 (34) 57 (25)
  Asthenia 56 (24) 47 (20)
  Fatigue 50 (21) 36 (16)
  Edema NOS 31 (13) 19 (8)
Gastrointestinal Disorders 162 (69) 149 (64)
  Constipation 116 (50) 49 (21)
  Nausea 30 (13) 27 (12)
  Dyspepsia 27 (11) 21 (9)
Nervous System Disorders 161 (69) 138 (60)
  Tremor 62 (26) 29 (12)
  Dizziness 51 (23) 32 (14)
  Paraesthesia 27 (12) 15 (6)
  Peripheral sensory neuropathy 24 (10) 12 (5)
Infections and Infestations 139 (59) 138 (60)
  Pneumonia NOS 35 (15) 28 (12)
Psychiatric Disorders 90 (38) 97 (42)
  Anxiety 27 (12) 22 (10)
  Depression 24 (10) 19 (8)
Metabolism and Nutrition Disorders 96 (41) 89 (38)
  Hyperglycemia NOS 36 (15) 32 (14)
  Vascular Disorders 92 (39) 53 (23)
  Deep vein thrombosis 30 (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.
MedDRA = Medical Dictionary for Regulatory Activities; NOS = not otherwise specified.

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

MedDRA System Organ Class/
Preferred Term
THALOMID/Dex
(N=234)*
n (%)
Placebo/Dex
(N=232)*
n (%)
Infections and Infestations 50 (21) 36 (16)
  Pneumonia NOS 17 (7) 14 (6)
  Bronchopneumonia NOS 7 (3) 3 (1)
General Disorders and Administration Site Conditions 44 (19) 26 (11)
  Asthenia 11 (5) 4 (2)
Metabolism and Nutrition Disorders 33 (14) 34 (15)
  Hypokalemia 7 (3) 3 (1)
Nervous System Disorders 47 (20) 20 (9)
  Syncope 8 (3) 1 ( < 1)
  Peripheral neuropathy NOS 8 (3) 0 (0)
  Cerebrovascular accident 6 (3) 1 ( < 1)
Cardiac Disorders 35 (15) 27 (11)
  Atrial fibrillation 11 (5) 8 (3)
  Myocardial ischemia 6 (3) 2 (1)
Vascular Disorders 42 (18) 14 (6)
  Deep vein thrombosis 27 (12) 4 (2)
Gastrointestinal Disorders 26 (11) 22 (10)
  Constipation 7 (3) 2 (1)
Investigations 21 (9) 21 (9)
  Weight increased 8 (3) 4 (2)
Blood and Lymphatic System Disorders 24 (10) 17 (7)
  Neutropenia 8 (3) 6 (3)
Respiratory, Thoracic, and Mediastinal Disorders 27 (12) 13 (6)
  Pulmonary embolism 16 (7) 4 (2)
Psychiatric Disorders 19 (8) 8 (3)
  Anxiety 5 (2) 3 (1)
  Confusional state 5 (2) 2 (1)
Ear and Labyrinth Disorders 6 (3) 0 (0)
  Vertigo 5 (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.
MedDRA = Medical Dictionary for Regulatory Activities; NOS = not otherwise specified.

Less Common Adverse Drug Reactions in Multiple Myeloma Controlled Clinical Trials

In Study 2, THALOMID in combination with dexamethasone in patients with multiple myeloma, the following adverse drug 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 Events (AEs) Reported in Celgene-sponsored Controlled Clinical Trials

Body System/
Adverse Event
All AEs Reported in Patients with ENL AEs Reported in ≥ 3 HIV-seropositive Patients
Thalidomide
50 to 300 mg/day
(N=24)
100 mg/day
(N=36)
200 mg/day
(N=32)
Placebo
(N=35)
Body as a Whole 16 (66.7%) 18 (50.0%) 19 (59.4%) 13 (37.1%)
  Abdominal pain 1 (4.2%) 1 (2.8%) 1 (3.1%) 4 (11.4%)
  Accidental injury 1 (4.2%) 2 (5.6%) 0 1 (2.9%)
  Asthenia 2 (8.3%) 2 (5.6%) 7 (21.9%) 1 (2.9%)
  Back pain 1 (4.2%) 2 (5.6%) 0 0
  Chills 1 (4.2%) 0 3 (9.4%) 4 (11.4%)
  Facial edema 1 (4.2%) 0 0 0
  Fever 0 7 (19.4%) 7 (21.9%) 6 (17.1%)
  Headache 3 (12.5%) 6 (16.7%) 6 (18.7%) 4 (11.4%)
  Infection 0 3 (8.3%) 2 (6.3%) 1 (2.9%)
  Malaise 2 (8.3%) 0 0 0
  Neck pain 1 (4.2%) 0 0 0
  Neck rigidity 1 (4.2%) 0 0 0
  Pain 2 (8.3%) 0 1 (3.1%) 2 (5.7%)
Digestive System 5 (20.8%) 16 (44.4%) 16 (50.0%) 15 (42.9%)
  Anorexia 0 1 (2.8%) 3 (9.4%) 2 (5.7%)
  Constipation 1 (4.2%) 1 (2.8%) 3 (9.4%) 0
  Diarrhea 1 (4.2%) 4 (11.1%) 6 (18.7%) 6 (17.1%)
  Dry mouth 0 3 (8.3%) 3 (9.4%) 2 (5.7%)
  Flatulence 0 3 (8.3%) 0 2 (5.7%)
  Liver function tests multiple abnormalities 0 0 3 (9.4%) 0
  Nausea 1 (4.2%) 0 4 (12.5%) 1 (2.9%)
  Oral moniliasis 1 (4.2%) 4 (11.1%) 2 (6.3%) 0
  Tooth pain 1 (4.2%) 0 0 0
Hemic and Lymphatic 0 8 (22.2%) 13 (40.6%) 10 (28.6%)
  Anemia 0 2 (5.6%) 4 (12.5%) 3 (8.6%)
  Leukopenia 0 6 (16.7%) 8 (25.0%) 3 (8.6%)
  Lymphadenopathy 0 2 (5.6%) 4 (12.5%) 3 (8.6%)
Metabolic and Endocrine Disorders 1 (4.2%) 8 (22.2%) 12 (37.5%) 8 (22.9%)
  Edema peripheral 1 (4.2%) 3 (8.3%) 1 (3.1%) 0
  Hyperlipemia 0 2 (5.6%) 3 (9.4%) 1 (2.9%)
  SGOT increased 0 1 (2.8%) 4 (12.5%) 2 (5.7%)
Nervous System 13 (54.2%) 19 (52.8%) 18 (56.3%) 12 (34.3%)
  Agitation 0 0 3 (9.4%) 0
  Dizziness 1 (4.2%) 7 (19.4%) 6 (18.7%) 0
  Insomnia 0 0 3 (9.4%) 2 (5.7%)
  Nervousness 0 1 (2.8%) 3 (9.4%) 0
  Neuropathy 0 3 (8.3%) 0 0
  Paresthesia 0 2 (5.6%) 5 (15.6%) 4 (11.4%)
  Somnolence 9 (37.5%) 13 (36.1%) 12 (37.5%) 4 (11.4%)
  Tremor 1 (4.2%) 0 0 0
  Vertigo 2 (8.3%) 0 0 0
Respiratory System 3 (12.5%) 9 (25.0%) 6 (18.7%) 9 (25.7%)
  Pharyngitis 1 (4.2%) 3 (8.3%) 2 (6.3%) 2 (5.7%)
  Rhinitis 1 (4.2%) 0 0 4 (11.4%)
  Sinusitis 1 (4.2%) 3 (8.3%) 1 (3.1%) 2 (5.7%)
Skin and Appendages 10 (41.7%) 17 (47.2%) 18 (56.3%) 19 (54.3%)
  Acne 0 4 (11.1%) 1 (3.1%) 0
  Dermatitis fungal 1 (4.2%) 2 (5.6%) 3 (9.4%) 0
  Nail disorder 1 (4.2%) 0 1 (3.1%) 0
  Pruritus 2 (8.3%) 1 (2.8%) 2 (6.3%) 2 (5.7%)
  Rash 5 (20.8%) 9 (25.0%) 8 (25.0%) 11 (31.4%)
  Rash maculopapular 1 (4.2%) 6 (16.7%) 6 (18.7%) 2 (5.7%)
  Sweating 0 0 4 (12.5%) 4 (11.4%)
Urogenital System 2 (8.3%) 6 (16.7%) 2 (6.3%) 4 (11.4%)
  Albuminuria 0 3 (8.3%) 1 (3.1%) 2 (5.7%)
  Hematuria   0 4 (11.1%) 0 1 (2.9%)
  Impotence 2 (8.3%) 1 (2.8%) 0 0

Other Adverse Events 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 events, 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 thalidomide.

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.

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

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 Events Observed in HIV-seropositive Patients

In addition to controlled clinical trials, THALOMID has been used in uncontrolled studies in 145 patients. Less frequent adverse events 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 events that have already been included in the tables and narrative above, or that are too general to be informative are not listed.

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.

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

Metabolic and Endocrine: Avitaminosis, bilirubinemia, dehydration, hypercholesteremia, 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 adverse reactions have been identified during post approval use of THALOMID. 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.

Cardiovascular System: Cardiac arrhythmias including atrial fibrillation, bradycardia, tachycardia, sick sinus syndrome, EKG abnormalities, myocardial infarction.

Digestive System: Intestinal perforation, gastrointestinal perforations, intestinal obstruction.

Metabolic and Endocrine: Electrolyte imbalance including hypercalcemia or hypocalcemia, hyperkalemia and hypokalemia, hyponatremia, hypothyroidism, increased alkaline phosphatase, tumor lysis syndrome.

Nervous System: Changes in mental status or mood including depression and suicide attempts, disturbances in consciousness including lethargy, syncope, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepticus, Parkinson's disease, stroke.

Skin and Appendages: Erythema multiforme, toxic epidermal necrolysis.

Hemic and Lymphatic: Decreased white blood cell counts including neutropenia and febrile neutropenia, changes in prothrombin time, pancytopenia.

Respiratory System: Pleural effusion.

Reproductive System and Breast Disorders: amenorrhea, sexual dysfunction.

Immune System Disorders: Hypersensitivity, angioedema/urticaria.

Ear and Labyrinthine Disorders: Hearing impairment/deafness.

Renal and Urinary Disorders: Renal failure.

Other Adverse Events in the Published Literature or Reported from Other Sources

The following additional events have been identified either in the published literature or from spontaneous reports from other sources: acute renal failure, amenorrhea, aphthous stomatitis, bile duct obstruction, carpal tunnel, chronic myelogenous leukemia, diplopia, dysesthesia, dyspnea, enuresis, erythema nodosum, erythroleukemia, foot drop, galactorrhea, gynecomastia, hangover effect, hypomagnesemia, hypothyroidism, lymphedema, lymphopenia, metrorrhagia, migraine, myxedema, nodular sclerosing Hodgkin's disease, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud's syndrome, stomach ulcer, suicide attempt, interstitial lung disease and severe infections (e.g., fatal sepsis including septic shock).

Read the Thalomid (thalidomide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Thalidomide is not a substrate for cytochrome P450 (CYP450) isoenzymes and does not inhibit or induce human CYP450 enzymes in vitro. Therefore, pharmacokinetic drug-drug interactions are not anticipated when thalidomide is coadministered with drugs that are substrates, inhibitors or inducers of cytochrome P450.

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 thalidomide 200 mg/day at steady state levels. The single dose of digoxin had no effect on the pharmacokinetic profile of thalidomide. 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 μg of ethinyl estradiol were studied. The results were similar with and without coadministration of thalidomide 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 thalidomide 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 thalidomide.

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 thalidomide with dexamethasone [see WARNINGS AND PRECAUTIONS].

Drug Abuse And Dependence

Physical and psychological dependence has not been reported in patients taking thalidomide; however, as with other tranquilizers/hypnotics, thalidomide has been reported to result in habituation to its soporific effects.

Read the Thalomid Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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