THALIDOMIDE

THALIDOMIDE (tha-lid'o-mide) Thalomid Classifications: immunomodulator; tumor necrosis factor (tnf) modifier; Therapeutic: immunosuppressive; tnf modifier Pregnancy Category: X

Availability

50 mg capsules

Action

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.

Therapeutic Effect

Has both antiinflammatory and immunosuppressive actions. Effectiveness indicated by control of cutaneous manifestations of erythema nodosum leprosum.

Uses

Acute and maintenance treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum. Refractory Crohn's disease.

Unlabeled Uses

Stimulate appetite in patients with HIV-associated cachexia, lupus, multiple myeloma.

Contraindications

Hypersensitivity to thalidomide; peripheral neuropathy; pregnancy (category X), lactation, children <12 y.

Cautious Use

Liver and kidney disease; CHF or hypertension; constipation or other GI disorders; neurological disorders or history of neuritis.

Route & Dosage

Erythema Nodosum Leprosum Adult: PO 100–300 mg q.d. (max: 400 mg/d) x at least 2 wk Child (11–17 y): PO 100 mg q.d. Refractory Crohn's Disease Adult: PO 50–100 mg q.d. (doses up to 300 mg studied)

Administration

Oral

• 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: Drowsiness, somnolence, 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, diarrhea, dry mouth, flatulence, abnormal liver function tests, nausea, oral moniliasis. Hematologic: Neutropenia, anemia, leukopenia, lymphadenopathy. Respiratory: 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.

Interactions

Drug: Enhances sedation associated with barbiturates, alcohol, chlorpromazine, reserpine.

Pharmacokinetics

Absorption: Slowly absorbed from GI tract. Peak: 2.9–5.7 h. Distribution: Crosses placenta; present in ejaculate in males. Metabolism: Does not appear to be hepatically metabolized. Half-Life: 6–7.5 h.

Nursing Implications

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.

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Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug