Home Drug Guide Thalidomide

Drug Guide

Generic Name

Thalidomide

Brand Names Thalomid

Classification

Therapeutic: Immunomodulatory agent, Antineoplastic, Sedative

Pharmacological: Immunomodulator, Teratogen, Anti-inflammatory

FDA Approved Indications

Multiple myeloma in combination with dexamethasone
Erythema nodosum leprosum (Hansen's disease)

Mechanism of Action

Thalidomide modulates the immune system by inhibiting tumor necrosis factor-alpha (TNF-α), reducing inflammatory cytokines, and exerting anti-angiogenic effects, which contribute to its anti-cancer activity.

Dosage and Administration

Adult: Dosing varies based on indication; for multiple myeloma, typical starting dose is 200 mg daily, adjusted as needed.

Pediatric: Not approved for pediatric use.

Geriatric: Use with caution; adjust based on tolerability and response.

Renal Impairment: Adjust dose as needed; discontinue if severe renal impairment develops.

Hepatic Impairment: Use cautiously; no specific dosing adjustments established.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Widely distributed, crosses the placenta, appears in breast milk.

Metabolism: Primarily hepatic via non-enzymatic reduction.

Excretion: Renal and fecal routes.

Half Life: Approximately 6-8 hours.

Contraindications

Pregnancy (category X), due to teratogenicity (see warnings below)
Known hypersensitivity to thalidomide

Precautions

Use in women of childbearing potential only under strict REMS program; risk of thromboembolism; peripheral neuropathy; somnolence; drowsiness; sedation; risk of blood clots; peripheral neuropathy; teratogenicity; hematologic toxicity

Adverse Reactions - Common

Sleepiness, fatigue (Common)
Constipation (Common)
Peripheral neuropathy (Uncommon)
Sedation (Common)

Adverse Reactions - Serious

Thrombosis and pulmonary embolism (Uncommon)
Birth defects (teratogenicity) (Serious and preventable)
Blood dyscrasias (neutropenia, anemia, thrombocytopenia) (Serious)

Drug-Drug Interactions

Clozapine (increased risk of hematologic toxicity)
Corticosteroids (increased risk of thromboembolism)
Other drugs affecting blood clotting

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor neurological status for peripheral neuropathy, blood counts, and signs of thromboembolism.

Diagnoses:

Risk for peripheral neuropathy
Risk for bleeding or thrombosis
Risk for pregnancy-related complications

Implementation: Ensure strict adherence to pregnancy prevention program; counsel about side effects; monitor blood counts and neurological status.

Evaluation: Assess efficacy of treatment and monitor for adverse effects continuously.

Patient/Family Teaching

Must use effective contraception during therapy and for 4 weeks after discontinuation
Report signs of blood clots, neuropathy, or unusual bleeding immediately
Avoid alcohol and other CNS depressants unless approved by healthcare provider

Special Considerations

Black Box Warnings:

Embryo fetal injury and birth defects (category X) — mandatory pregnancy prevention program in place

Genetic Factors: Pharmacogenetic considerations not well established.

Lab Test Interference: May affect tests related to blood counts.

Overdose Management

Signs/Symptoms: Symptoms may include severe sedation, somnolence, peripheral neuropathy, and blood dyscrasias.

Treatment: Supportive care; monitor vital signs, blood counts, neurological status; no specific antidote.

Storage and Handling

Storage: Store at controlled room temperature (20°C to 25°C).

Stability: Stable under recommended storage conditions.