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Thalidomide information from DrugsUpdate  

See Available Brands of Thalidomide in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation

Thalidomide is a sedative-hypnotic and multiple myeloma medication. The drug is a potent teratogen in rabbits and primates including humans: severe birth defects may result if the drug is taken during pregnancy.

Pharmacodynamics

Pharmacokinetics

Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.

Absorption
Slowly absorbed from GI tract. Peak plasma concentrations: 3 to 6 hours. 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 hours.

Metabolism

Exact metabolic fate unknown, it appears to undergo non-enzymatic hydrolysis in plasma.

Thalidomide Indications / Thalidomide Uses

Information Not Available

Thalidomide Adverse Reactions / Thalidomide Side Effects

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.

Precautions

Warnings
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to the fetus. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. It is approved for marketing only under a special restricted distribution program approved by the FDA S.T.E.P.S. program. Only prescribers and pharmacists registered with the program are allowed to prescribe and dispense the product. Patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S. program in order to receive the product.

Treatment of multiple myeloma with thalidomide results in increased risk of venous thromboembolic events, such as deep vein thrombosis and pulmonary embolus. The risk increases with coadministration of standard chemotherapeutic agents. Patients should seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Patients may benefit from concomitant prophylactic anticoagulation or aspirin treatment.

Monitor
Monitor WBC and differential on an ongoing basis, especially in patients who may be prone to neutropenia (eg, HIV-seropositive). Perform pregnancy tests within 24 hours prior to beginning therapy and weekly during the first 4 weeks of use, then every 4 weeks in women with regular menstrual cycles or every 2 weeks in women with irregular cycles. Monitor for signs of neuropathy at monthly intervals for the first 3 months of therapy. Monitor viral load of HIV-seropositive patients after first and third mo of therapy and every 3 months thereafter.

Special Precautions

All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 weeks before starting therapy, during and 4 weeks 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.

Other 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.

Other Interactions

Information Not Available

Dosage

Oral
Erythema nodosum leprosum (Type 2)
Adult: 100-300 mg once daily at bedtime, reduced gradually by 50 mg every 2-4 weeks 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 weekly intervals according to patient tolerance. Max: 800 mg daily.

Food(before/after)

Should be taken on an empty stomach. (Take on an empty stomach at least 1 hour after a meal, with a full glass of water.)

List of Contraindications

Thalidomide and Pregnancy

Contraindicated in pregnancy

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Thalidomide and Lactation

Contraindicated in lactation

Thalidomide and Children

Safety and efficacy in children younger than 12 years of age not established.

Thalidomide and Geriatic

Information Not Available

Thalidomide and Other Contraindications

Pregnancy and lactation

Storage

Information Not Available

Lab interference

Information Not Available

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