Thalidomide
Thalidomide (Thalomid)
Thalidomide
(thah- LID-ah-myd)
Pregnancy Category: X Thalomid (Rx)

Classification: Dermatologic drug

Action/Kinetics: Immunomodulatory drug; mechanism of action not known. Drug may suppress excessive tumor necrosis factor-alpha (TNF-þ) production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. Peak plasma levels: 2.9-5.7 hr. High fat meals increase the time to peak plasma levels to about 6 hr. t 1/2: 5-7 hr. Metabolized in the plasma and excreted in the urine.

Uses: Acute treatment of moderate to severe erythema nodosum leprosum (ENL). Maintenance therapy for prevention and suppression of the cutaneous symptoms of erythema nodosum leprosum recurrence. Investigational: Treatment of recurrent and metastatic squamous cell carcinoma of the head and neck.

Contraindications: Never to be used in pregnancy or in those who could become pregnant while taking the drug (even a single 50 mg dose can cause severe birth defects). Use in males unless the client meets several conditions (see package insert). Use as monotherapy for ENL in the presence of moderate to severe neuritis. Lactation.

Special Concerns: Due to possible birth defects, thalidomide is marketed only under a special restricted distribution program called the "System for Thalidomide Education and Prescribing Safety (STEPS). Under this program only prescribers and pharmacists registered with the program are allowed to prescribe and dispense the drug. Safety and efficacy have not been determined in children less than 12 years of age.

Side Effects: Note: Only the most common side effects are listed. Human teratogenicity. GI: Constipation, diarrhea, nausea, oral moniliasis, tooth pain, abdominal pain. CNS: Drowsiness, somnolence, dizziness, tremor, vertigo, headache. Neurologic: Peripheral neuropathy. CV: Orthostatic hypotension, bradycardia. Respiratory: Pharyngitis, rhinitis, sinusitis. Hematologic: Neutropenia. Hypersensitivity: Erythematous macular rash, fever, tachycardia, hypotension. Dermatologic: Photosensitivity, rash, dermatitis, fungal nail disorder, pruritus. Musculoskeletal: Back pain, neck pain, neck rigidity. Miscellaneous: HIV viral load increase, impotence, peripheral edema, accidental injury, asthenia, chills, facial edema, malaise, pain.

Drug Interactions: Alcohol / Enhanced sedative effects Barbiturates / Enhanced sedative effects Chlorpromazine / Enhanced sedative effects Reserpine / Enhanced sedative effects

How Supplied: Capsules: 50 mg

Dosage
?Capsules Cutaneous ENL, initial therapy.
Adults, initial: 100-300 mg once daily with water, preferably at bedtime and at least 1 hr after the evening meal. Clients weighing less then 50 kg should be started at the low end of the dose range. In those with severe cutaneous ENL or who have required higher doses previously, dosing may be started at doses up to 400 mg once daily at bedtime or in divided doses with water 1 hr after meals. Continue initial dosing until signs and symptoms of active reaction have been eliminated (usually at least 2 weeks). Following this, taper clients off medication in 50 mg decrements q 2 to 4 weeks.
Maintenance therapy for prevention and suppression of ENL recurrence.
Maintain on the minimum dose (see initial therapy) necessary to control the reaction. Attempt tapering of medication q 3 to 6 months, in decrements of 50 mg q 2 to 4 weeks.