Thalidomide Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Leprosy - Erythema Nodosum Leprosum

Cutaneous erythema nodosum leprosum (ENL):
Initial dose: 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; patients less than 50 kg should be started at the low end of the dose range

Severe cutaneous ENL reaction or patients previously requiring higher doses to control the reaction:
Initial dose: Up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals

Comments:
-In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with thalidomide; steroid usage can be tapered and discontinued when the neuritis has ameliorated. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
-In general, dosing should continue until active reaction subsides (usually at least 2 weeks), then tapered in 50 mg decrements every 2 to 4 weeks.
-Patients with a history of requiring prolonged maintenance to prevent recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Approved indications: For the acute treatment of cutaneous manifestations of moderate to severe ENL and as maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.

Usual Adult Dose for Multiple Myeloma

200 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal

Comments:
-Thalidomide is administered in combination with dexamethasone in 28-day treatment cycles. The dexamethasone dose is 40 mg orally on days 1 through 4, 9 through 12, and 17 through 20 every 28 days.

Approved indication: In combination with dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma.

Usual Pediatric Dose for Leprosy - Erythema Nodosum Leprosum

12 years or older:
Cutaneous erythema nodosum leprosum (ENL):
Initial dose: 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; patients less than 50 kg should be started at the low end of the dose range

Severe cutaneous ENL reaction or patients previously requiring higher doses to control the reaction:
Initial dose: Up to 400 mg/day orally once a day at bedtime or in divided doses with water, at least 1 hour after meals

Comments:
-In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with thalidomide; steroid usage can be tapered and discontinued when the neuritis has ameliorated. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
-In general, dosing should continue until active reaction subsides (usually at least 2 weeks), then tapered in 50 mg decrements every 2 to 4 weeks.
-Patients with a history of requiring prolonged maintenance to prevent recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Approved indications: For the acute treatment of cutaneous manifestations of moderate to severe ENL and as maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available

Dose Adjustments

Multiple myeloma patients who develop side effects such as constipation, oversedation, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the decrease of these side effects, the drug may be started at a lower dose or at the previous dose based on clinical judgment.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

No adjustment recommended.

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for thalidomide. It includes elements to assure safe use and an implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Administration advice:
-Capsules should be swallowed whole with water; they should not be opened or crushed.
-Capsules should be handled with care. If contact with powder contents occurs, skin should be washed immediately and thoroughly with soap and water and mucous membranes should be flushed thoroughly with water.
-If a patient misses a dose of thalidomide by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule; if the dose is missed by less than 12 hours, the patient should take the missed dose at once and then resume the usual dosing schedule.

Storage requirements:
-Capsules should be stored in blister packs until ingestion; drug must not be repackaged.

General:
-Thalidomide must only be given in compliance with the THALOMID REMS(TM) program; it may only be prescribed by certified prescribers and dispensed by certified pharmacists.
-Drug prescribing to females of reproductive potential should be contingent upon initial and continued confirmed negative results of pregnancy testing.

Monitoring:
Cardiovascular: Monitor for signs/symptoms of thromboembolism; monitor for bradycardia and syncope.
General: Pregnancy testing in females of reproductive potential (weekly during the 1st month, then every 4 weeks in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles); monitor viral load in HIV-seropositive patients (after 1st and 3rd months of therapy and every 3 months thereafter).
Hematologic: Monitor white blood cell count and differential (ongoing basis).
Nervous System: Monitor for signs of neuropathy (monthly for first 3 months and periodically thereafter); electrophysiological testing to detect asymptomatic neuropathy (at baseline and then every 6 months); monitor for clinical changes that could trigger acute seizure activity in patients with history of seizures or at risk of seizure development.
Oncologic: Monitor for tumor lysis syndrome in patients at risk.

Patient advice:
-Performance of tasks that require concentration and mechanical dexterity such as operation of machinery and driving should be avoided.

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