Monograph Details
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Neoplasms
> Miscellaneous oncology agents
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THALOMID |
| Manufacturer |
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Celgene Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Immunomodulator. |
| Generic Name |
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Thalidomide 50mg, 100mg, 150mg, 200mg; caps. |
| Indications |
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Newly diagnosed multiple myeloma in combination with dexamethasone. Treatment, suppression and prevention of cutaneous manifestations of erythema nodosum leprosum (ENL). |
| Children |
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Not recommended. |
| Adults |
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Take at bedtime, at least 1 hour after evening meal. Multiple myeloma: 200mg once daily in combination with dexamethasone in 28-day treatment cycles. ENL: initially 100–300mg/day; <50kg: start with lower dose; continue until signs/symptoms of active reaction have subsided (usually at least 2 weeks), then taper off in 50mg decrements every 2–4 weeks. Severe ENL: may start at higher doses; max 400mg/day. Moderate to severe neuritis with severe ENL: give concomitant corticosteroids (see literature). |
| Contraindications |
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Pregnancy (Cat. X). Nursing mothers. Women who may become pregnant. |
| Precautions |
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Must register patient in STEPS program; patient must understand toxicity with fetal exposure. Counsel patient on need for contraception; female: use 2 forms of contraception 1 month before, during, and 1 month after therapy; male: use condom during and 1 month after therapy; obtain negative pregnancy test within 24 hours prior to starting treatment; repeat at least weekly for 1st month then every 4 weeks; get informed consent. Monitor for signs/symptoms of thromboembolic events, neuropathy, bradycardia, orthostatic hypotension. Discontinue if pregnancy or severe skin rash occurs. History of seizure. Avoid contact with non-intact capsule or powder content. Maximum 1 month per Rx. |
| Interactions |
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Increased sedative effect with barbituates, alcohol, chlorpromazine, reserpine. Caution with drugs associated with peripheral neuropathy. Avoid drugs (eg, rifampin, carbamazepine, St. John's wort) that decrease effectiveness of hormonal contraceptives. |
| Adverse Reactions |
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Birth defects, skin rash (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), bradycardia, peripheral neuropathy, seizures, drowsiness, dizziness, orthostatic hypotension, neutropenia, increased HIV viral load, constipation, confusion, hypocalcemia, edema, dyspnea, thrombosis/embolism. |
| Extra Text |
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Note: Available only through STEPS program. Suspected fetal exposure must be reported to the FDA at (800) FDA-1088 and Celgene at (888) 423-5436. |
| How Supplied |
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Caps—28 |
| Additional Resources |
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• Related Prescribing Note |
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