Adult Dosing
Multiple Myeloma
- 200 mg PO qhs (at least 1 hr after the evening meal), administered in combination with dexamethasone in 28-day treatment cycles
- Dexamethasone 40 mg should be administered on days 1-4, 9-12, 17-20
Erythema nodosum leprosum
- Initial dosing: 100-300 mg PO qhs at least 1-hr after the evening meal; patients <50 kgs may be started on 100 mg PO qd
- Severe cutaneous erythema nodosum leprosum: 400 mg PO qhs at least 1-hr after the evening meal
- If mod-severe neuritis present, then corticosteroid therapy may be concomitantly started
- Tapering Schedule: Continue for at least 2 wks or until signs and symptoms have subsided. Taper in 50 mg decrements q2-4 wks
- Prolonged maintenance treatment: Decrease medication q3-6 months in decrements of 50 mg PO q2-4 wks
HIV associated wasting (Not FDA approved)
- 100-300 mg PO qhs at least 1-hr after the evening meal
Recurrent Aphthous Stomatitis (Not FDA approved)
- Immunocompetent/Immunocompromised: 100-600 mg/day PO
Crohn's disease, refractory (Not FDA approved)
Graft-versus-host disease (Not FDA approved)
- 800-1600 mg/day PO; not recommended for prophylaxis
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 years not established
Erythema Nodosum Leprosum
Children >12 yrs
- Initial dosing: 100-300 mg PO qhs at least 1-hr after the evening meal; patients < 50 kgs may be started on 100 mg PO qd
- Severe cutaneous erythema nodosum leprosum: 400 mg PO qhs at least 1-hr after the evening meal
- If mod-severe neuritis present, then corticosteroid therapy may be concomitantly started
- Tapering Schedule: Continue for at least 2 wks or until signs and symptoms have subsided. Taper in 50 mg decrements q2-4 wks
- Prolonged maintenance treatment: decrease medication q3-6 months in decrements of 50 mg PO q2-4 wks
[Outline]
- Note: Thalidomide causes severe fetal birth defects when used in pregnancy (U.S. Black Box Warning)
- Increased risk of DVT and PE in multiple myeloma patients, especially with concomitant dexamethasone (22.5% VTE events vs 4.9% in patients receiving placebo)
- Serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which may be fatal, have been reported
- Thalidomide may cause permanent nerve damage; not indicated as monotherapy for ENL treatment in presence of moderate to severe neuritis
- Hypersensitivity reactions, manifesting as erythematous macular rash, associated with fever, hypotension, and tachycardia, may occur
- Risk of sedation; patients must exercise caution when performing tasks which require mental alertness
- May cause neutropenia; discontinue therapy if absolute neutrophil count decreases to <750/3
- Monitor patients for signs and symptoms of peripheral neuropathy; patients should seek medical advice if symptoms such as paresthesia, abnormal coordination, or weakness develop
- Perform pregnancy test 24 hours before first dose for women of child bearing potential; then qwk x 1 mo; then qmo (depending on cycle length) until 4 weeks after drug discontinuation
- Monitor WBC with differential count; sensory nerve action potential amplitudes at baseline, then q6 mo; peripheral neurological examination qmo x 3
- Increased viral load in HIV+ patients; monitor after first and third mo of therapy; q3 mo thereafter
- Avoid blood donation during the therapy and for 1 month after discontinuation of treatment
- Therapy may cause dizziness and orthostatic hypotension, therefore sit upright for a few minutes before standing
- Evaluate the risks of adverse effects while choosing contraceptive methods in patients being treated with the therapy
Cautions: Use cautiously in
- Hypersensitivity
- Peripheral neuropathy
- Seizure disorder
- CV disease
- Women of childbearing potential
- HIV
- Orthostatic hypotension
- Tumor lysis syndrome
Pregnancy Category:X
Breastfeeding: Unsafe, because of the potential for serious adverse reactions in nursing infants, a decision should be made for the discontinuation of nursing or the discontinuation of drug (taking into account the importance of the drug to the mother)
