Thalidomide


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Erythema nodosum leprosum (Type 2) 100-300 mg at bedtime, reduce gradually once a satisfactory reponse is achieved. Max: 400 mg/day. Multiple myeloma Initial: 200 mg once daily, increase slowly according to patient tolerance. Max: 800 mg/day.
Dosage Details
Oral
Erythema nodosum leprosum (Type 2)
Adult: 100-300 mg once daily at bedtime, reduced gradually by 50 mg every 2-4 wk once a satisfactory reponse is achieved. Not for monotherapy if moderate or severe neuritis present. Max: 400 mg/day. Patients < 50 kg: Initially, 100 mg daily.

Oral
Multiple myeloma
Adult: Initial dose of 200 mg once daily, increased by 100 mg at wkly intervals according to patient tolerance. Max: 800 mg daily.
Administration
Should be taken on an empty stomach. Take at least 1 hr after a meal, w/ a full glass of water.
Contraindications
Pregnancy and lactation.
Special Precautions
All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 wk before starting therapy, during and 4 wk after therapy is discontinued. Therapy to be stopped immediately if pregnancy occurs. Male: Use of barrier methods of contraception if partner is of child-bearing potential. Do not donate blood or sperm during therapy. Patient should not drive or operate machinery. Discontinue therapy if any skin rash develops. Do not resume therapy if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected.
Adverse Reactions
Severe and irreversible peripheral neuropathy, constipation, dizziness, orthostatic hypotension, drowsiness, somnolence, bradycardia, increase of viral load in HIV-infected patients, hypersensitivity reaction.
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis and blood dyscrasias.
Drug Interactions
Thalidomide enhances sedative activity of barbiturates, alcohol, chlorpromazine and reserpine. Avoid use of other drugs that have the potential to cause peripheral neuropathy. Increased risk of thromboembolic events with darbepoetin-alfa and doxorubicin.
Potentially Fatal: Increased risk of bone marrow supression with peg interferon alfa.
Action
Description: Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.
Pharmacokinetics:
Absorption: Slowly absorbed from GI tract. Peak plasma concentrations: 3 to 6 hr. Food may delay but does not significantly affect extent of absorption of thalidomide.
Distribution: Crosses the placenta, distributed into the semen. Elimination half-life: 5-7 hr.
Metabolism: Exact metabolic fate unknown, it appears to undergo non-enzymatic hydrolysis in plasma.
Disclaimer: This information is independently developed by MIMS based on Thalidomide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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