thiotepa: clinical use

Prescribing considerations

• Use only under a physician experienced in transplant conditioning.
• Expect profound myelosuppression; plan blood-product, growth-factor and anti-infective support as clinically indicated.
• Assess previous chemotherapy, transplantation and irradiation because these may increase hepatic or neurological toxicity.
• Review fertility preservation and pregnancy prevention before treatment.
• Avoid simultaneous administration with cyclophosphamide within a conditioning programme.

Contraindications and cautions

• Hypersensitivity to thiotepa
• Pregnancy
• Breastfeeding
• Concurrent yellow-fever vaccine or other live viral or bacterial vaccines

Monitoring

• Frequent full blood count with differential and platelet count until recovery
• Clinical surveillance for infection and sepsis
• Liver enzymes, bilirubin and features of hepatic veno-occlusive disease
• Renal function where clinically appropriate
• Cardiac function in patients with cardiac history
• Respiratory status and neurological toxicity

Clinical pharmacology

A highly lipophilic, polyfunctional alkylating agent that distributes widely, including into cerebrospinal fluid. It undergoes extensive hepatic metabolism through CYP2B6 and CYP3A pathways to the active metabolite TEPA.

Formulation and product differences

• The selected product is a single-use powder for concentrate requiring reconstitution and further dilution before intravenous infusion.
• It contains no excipients and must be stored refrigerated without freezing.
• Thiotepa products differ in formulation characteristics, and none are currently licensed in the UK for intrathecal administration.

Solution for infusion

Route: Intravenous

Strengths: 15 mg, 100 mg