Classifications: immunomodulator; tumor necrosis factor (tnf) modifier; Therapeutic: immunosuppressive; tnf modifier
Pregnancy Category: X
50 mg capsules
Has several antiinflammatory and immunologic actions. Antiinflammatory effects may be due to its inhibition of neutrophil
chemotaxis and decrease of monocyte phagocytosis. Immunosuppressive effect may result from suppression of excessive tumor
necrosis factor-alpha (TNF-alpha) production. Also, reduces helper T cells and increases suppressor T cells.
Has both antiinflammatory and immunosuppressive actions. Effectiveness indicated by control of cutaneous manifestations of
erythema nodosum leprosum.
Acute and maintenance treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum. Refractory Crohn's
Stimulate appetite in patients with HIV-associated cachexia, lupus, multiple myeloma.
Hypersensitivity to thalidomide; peripheral neuropathy; pregnancy (category X), lactation, children <12 y.
Liver and kidney disease; CHF or hypertension; constipation or other GI disorders; neurological disorders or history of
Route & Dosage
|Erythema Nodosum Leprosum
Adult: PO 100300 mg q.d. (max: 400 mg/d) x at least 2 wk
Child (1117 y): PO 100 mg q.d.
Refractory Crohn's Disease
Adult: PO 50100 mg q.d. (doses up to 300 mg studied)
- Give at bedtime and at least 1 h after the evening meal.
- Give this drug only to persons who understand and have signed the required consent form.
- Verify, prior to administration, that this drug was prescribed and dispensed only by persons registered by the STEPS (System
for Thalidomide Education and Prescribing Safety) program.
- Store at 15°30° C (59°86° F); protect from light.
Adverse Effects (≥1%)Body as a Whole:
Asthenia, back pain, chills, facial edema, fever,
malaise, pain. CNS:
peripheral neuropathy (possibly irreversible), dizziness,
orthostatic hypotension, headache, agitation, insomnia
, nervousness, paresthesia, tremor, vertigo, seizures. CV:
Bradycardia, peripheral edema, hyperlipidemia. GI:
Abdominal pain, anorexia, constipation
dry mouth, flatulence, abnormal liver function tests, nausea, oral moniliasis. Hematologic:
Neutropenia, anemia, leukopenia,
Pharyngitis, rhinitis, sinusitis
. Skin: Rash, acne
, nail disorder, fungal dermatitis, pruritus, sweating, toxic epiderma necrolysis. Body as a Whole:
Hypersensitivity reaction (rash, fever, tachycardia, hypotension), HIV viral load increase, infection. Urogenital:
Teratogenicity, albuminuria, hematuria, impotence.
Enhances sedation associated with barbiturates
, alcohol, chlorpromazine, reserpine.
Slowly absorbed from GI tract. Peak:
2.95.7 h. Distribution:
Crosses placenta; present in ejaculate in males. Metabolism:
Does not appear to be hepatically metabolized. Half-Life:
Assessment & Drug Effects
- Lab tests: Monitor WBC with differential prior to therapy and periodically thereafter.
- Monitor carefully for and immediately report S&S of peripheral neuropathy. Discontinue drug and notify prescriber if peripheral
neuropathy is suspected.
Patient & Family Education
- Do not share this medication with anyone else under any circumstances.
- Use effective methods of birth control (both women and men); starting 1 mo before, during, and 1 mo following discontinuation
of thalidomide therapy. Men MUST use condoms when engaging in sexual activity.
- Exercise caution while driving or engaging in potentially hazardous activities because drug may cause dizziness.
- Report pain, numbness, or tingling in the hands or feet to physician immediately.