lutetium (177Lu) vipivotide tetraxetan: clinical use

Prescribing considerations

• Confirm PSMA-positive disease using appropriate PSMA imaging and that the patient meets a licensed treatment pathway.
• Treatment must be justified individually because it contributes to cumulative radiation exposure.
• Administration and disposal require authorised staff, designated facilities, aseptic technique, shielding and local radiation-safety procedures.
• Review baseline marrow reserve, kidney and liver function, previous cancer treatment and cumulative radiation exposure.
• Ensure patients can follow post-treatment radiation-protection instructions, especially where they live with children or pregnant people.

Contraindications and cautions

• Hypersensitivity to lutetium (177Lu) vipivotide tetraxetan or any excipient.
• Use particular caution with low blood-cell counts, renal impairment or substantial previous radiation exposure.
• Pharmacokinetics and safety have not been studied in severe renal impairment or end-stage renal disease.

Monitoring

• Haemoglobin, white-cell count, absolute neutrophil count and platelets before and during treatment.
• Serum creatinine and calculated creatinine clearance before and during treatment; monitor more frequently in renal impairment.
• Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, albumin and bilirubin.
• Clinical assessment for myelosuppression, renal toxicity, gastrointestinal toxicity and severe dry mouth.
• Assess new neurological symptoms or weight-bearing bone pain promptly because spinal cord compression or fracture can interrupt treatment.

Clinical pharmacology

The radioligand binds PSMA and delivers beta-minus radiation to PSMA-expressing and nearby cells. It is immediately bioavailable after intravenous administration, is primarily eliminated by the kidneys, does not undergo hepatic or renal metabolism, and has a reported terminal elimination half-life of about 42 hours. Vipivotide tetraxetan showed little clinically relevant CYP or transporter interaction potential in vitro.

Formulation and product differences

• The selected UK product is a ready-to-use, single-use solution for intravenous injection or infusion.
• It is clear and colourless to slightly yellow and supplied in a lead-shielded glass vial.
• It contains sodium and must not be mixed with other medicines except as specifically permitted in the product information.