thalidomide: clinical use

Prescribing considerations

• Initiate and monitor only under specialist supervision with controlled prescribing and dispensing arrangements.
• Complete and document all Pregnancy Prevention Programme requirements for male and female patients.
• Assess baseline neuropathy, thrombotic and cardiovascular risk, infection history and renal or hepatic impairment.
• Establish hepatitis B status before treatment and seek appropriate expertise for positive patients.
• Counsel about sedation, driving, blood and sperm donation, safe handling and returning unused medicine.

Contraindications and cautions

• Pregnancy
• Women of childbearing potential unless every Pregnancy Prevention Programme condition is met
• Male patients unable to comply with required contraceptive measures
• Hypersensitivity to thalidomide or a formulation excipient

Monitoring

• Full blood count, including neutrophils and platelets
• Clinical and neurological examination for peripheral neuropathy
• Pregnancy testing and continuing Pregnancy Prevention Programme compliance
• Thromboembolic symptoms and modifiable cardiovascular risks
• Thyroid and liver function
• Heart rate, syncope and conduction symptoms
• Severe infection, hepatitis B reactivation and new neurological or cognitive symptoms
• Skin reactions and hypersensitivity

Clinical pharmacology

Thalidomide binds cereblon within the CRL4 E3 ubiquitin-ligase complex, altering downstream protein degradation. It also has anti-inflammatory and anti-angiogenic activity. Food delays absorption without changing overall exposure. Clearance is mainly through non-enzymatic hydrolysis, with little CYP metabolism.

Formulation and product differences

• Myrin is a sugar-coated tablet containing lactose and sucrose; the selected alternative is a hard capsule.
• Neither formulation should be crushed. Capsules must not be opened.
• The tablet formulation cannot accommodate adjustments smaller than one whole tablet; another thalidomide presentation is required where this matters.
• Check excipients and product identity carefully when switching formulations.

Capsule

Route: Oral

Strengths: 50 mg

Tablet

Route: Oral

Strengths: 100 mg