Thalidomide

DEA Class; Rx

Common Brand Names; Thalomid

• Antineoplastics, Angiogenesis Inhibitor

Indicated for acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); also indicated as maintenance therapy for prevention and suppression of cutaneous recurrence

Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence

Note: Not indicated as monotherapy for ENL in the presence of moderate-to-severe neuritis

Indicated in combination with dexamethasone for newly diagnosed multiple myeloma (MM)

Hypersensitivity

Pregnancy; highly teratogenic (even a single dose)

• Fatigue (21-79%)
• Hypocalcemia (72%)
• Edema (13-56%)
• Constipation (50-55%)
• Neuropathy-sensory (54%)
• Dyspnea (42%)
• Muscle weakness (40%)
• Leukocytes decreased (35%)
• Peripheral edema (34%)
• Neutrophils decreased (31%)
• Rash/desquamation (30%)
• Confusion (28%)
• Anorexia (28%)
• Nausea (13-28%)
• Anxiety/agitation (26%)
• Tremor (26%)
• Fever (24%)
• Asthenia (24%)
• Weight loss (23%)
• Weight gain (22%)
• Thrombosis/embolism (22%)
• Neuropathy-motor (22%)
• Dry skin (21%)
• Dizziness/lightheadedness (20-23%)
• Myalgia (17%)
• Depressed level of consciousness (16%)
• Pneumonia (15%)
• Hyperglycemia (15%)
• Bilirubin (14%)
• Arthralgia (13%)
• Deep vein thrombosis (13%)
• Dry mouth (12%)
• Paresthesia (12%)
• Anxiety (12%)
• Dyspepsia (11%)

Powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose; mortality at or shortly after birth reported in ~40% of infants; when there is no satisfactory alternant treatment, females of reproductive potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy; only available through the Thalomid REMS program (see Black Box Warnings, Contraindications, and Pregnancy)

Do not donate blood during treatment and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed thalidomide

Increased risk of venous thromboembolism reported in patients with multiple myeloma (MM) treatment; the presence of underlying malignancy, and/or use of an estrogen-containing contraceptive can each increase risk of thromboembolism; it is not known if these risks of thromboembolism are additive; however, should be taken into consideration when choosing contraceptive methods (see Black Box Warnings)

Ischemic heart disease (including myocardial infarction) and stroke observed

Drowsiness and somnolence may occur; instruct patients to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness

Peripheral neuropathy reported; examine patients at monthly intervals for the first 3 months of therapy and periodically thereafter; consider 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; usually, treatment with this drug should only be reinitiated if neuropathy returns to baseline status

Dizziness and orthostatic hypotension may occur; advise patients to sit upright for a few minutes prior to standing up from a recumbent position

Thrombocytopenia, including Grade 3 or 4 occurrences, reported in association with the clinical use of thalidomide; monitor blood counts, including platelet counts; dose reduction, delay, or discontinuation may be required; monitor for signs and symptoms of bleeding including petechiae, epistaxis, and gastrointestinal bleeding, especially if concomitant medication may increase the risk of bleeding

May increased HIV viral load when used in HIV-seropositive patients; clinical significance unknown, measure viral load after the first and third months of treatment and every 3 months thereafter

Based on the mechanism of action, human and animal data, thalidomide can cause embryo-fetal harm when administered to pregnant female

There is no information regarding presence of thalidomide in human milk; effects of thalidomide on breastfed infant, or effects of thalidomide on milk production

Thalidomide 

capsule

• 50mg
• 100mg
• 150mg
• 200mg