Pluvicto Special Precautions

Individual benefit/risk justification: For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
Risk from radiation exposure: Pluvicto contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer.
Radiation exposure to patients, medical personnel, and household contacts should be minimised during and after treatment with Pluvicto consistent with institutional good radiation safety practices, patient management procedures, and instructions to the patient for follow-up radiation protection at home.
Patient preparation: Patients should be encouraged to increase oral fluids and urged to void as often as possible to reduce bladder radiation, especially after high activities, e.g. for radionuclide therapy.
After the procedure: Before the patient is released, the nuclear medicine physician or healthcare professional should explain the necessary radioprotection precautions that the patient should follow to minimise radiation exposure to others.
After each administration of Pluvicto, the following general recommendations for patients can be considered along with local and institutional procedures and regulations: Limit close contact (less than 1 metre) with others in their household for 2 days or with children and pregnant women for 7 days; Refrain from sexual activity for 7 days; Sleep in a separate bedroom from others in their household for 3 days, from children for 7 days, or from pregnant women for 15 days.
Myelosuppression: In the VISION study, myelosuppression, including fatal cases, occurred more frequently in patients who received Pluvicto plus best standard of care (BSoC) compared to patients who received BSoC alone (see Adverse Reactions).
Haematology laboratory tests, including haemoglobin, white blood cell count, absolute neutrophil count and platelet count, should be performed before and during treatment with Pluvicto. Pluvicto should be withheld, dose reduced or permanently discontinued and patients should be clinically managed as deemed appropriate based on the severity of myelosuppression (see Dosage & Administration).
Renal toxicity: In the VISION study, renal toxicity occurred more frequently in patients who received Pluvicto plus BSoC compared to patients who received BSoC alone (see Adverse Reactions).
Before and after administration of Pluvicto, patients should be encouraged to increase oral fluids and urged to void as often as possible, especially after high activities, e.g. for radionuclide therapy. Kidney function laboratory tests, including serum creatinine and calculated CLcr, should be performed before and during treatment with Pluvicto. Pluvicto should be withheld, dose reduced or permanently discontinued based on the severity of renal toxicity (see Dosage & Administration).
Renal/Hepatic impairment: Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible.
Exposure (AUC) of lutetium (¹⁷⁷Lu) vipivotide tetraxetan is expected to increase with the degree of renal impairment (see Pharmacology: Pharmacokinetics under Actions). Patients with mild or moderate renal impairment may be at greater risk of toxicity. Renal function and adverse reactions should be frequently monitored in patients with mild to moderate renal impairment (see Dosage & Administration). Treatment with Pluvicto is not recommended in patients with moderate to severe renal impairment with baseline CLcr <50 mL/min or end-stage renal disease.
Fertility: Radiations of lutetium (¹⁷⁷Lu) vipivotide tetraxetan may potentially have toxic effects on male gonads and spermatogenesis. The recommended cumulative dose of 44400 MBq of Pluvicto results in a radiation absorbed dose to the testes within the range where Pluvicto may cause infertility. Genetic consultation is recommended if the patient wishes to have children after treatment. Cryopreservation of sperm can be discussed as an option for male patients before treatment (see Use in Pregnancy & Lactation).
Contraception in males: Male patients are advised not to father a child and to use a condom for intercourse during treatment with Pluvicto and for 14 weeks after the last dose (see Use in Pregnancy & Lactation).
Sodium content: This medicinal product contains up to 3.9 mmol (88.75 mg) sodium per vial, equivalent to 4.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Precautions with respect to environmental hazard: See Special precautions for disposal and other handling under Cautions for Usage.
Effects on ability to drive and use machines: Pluvicto may have a minor influence on the ability to drive and use machines.