Pluvicto Dosage/Direction for Use

Important safety instructions: Pluvicto should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see Special precautions for disposal and other handling under Cautions for Usage) and after evaluation of the patient by a qualified physician.
Radiopharmaceuticals, including Pluvicto, should be used by or under the control of healthcare professionals who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radiopharmaceuticals.
Patient identification: Patients should be identified for treatment by PSMA imaging.
Posology: The recommended treatment regimen of Pluvicto is 7400 MBq intravenously every 6 weeks (±1 week) for up to a total of 6 doses, unless there is disease progression or unacceptable toxicity.
Medical castration with a gonadotropin-releasing hormone (GnRH) analogue should be continued during treatment in patients not surgically castrated.
Treatment monitoring: Laboratory tests should be performed before and during treatment with Pluvicto: Haematology (haemoglobin, white blood cell count, absolute neutrophil count, platelet count); Kidney function (serum creatinine, calculated creatinine clearance [CLcr]); Liver function (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, blood serum albumin, total blood bilirubin).
Dosing may need to be modified based on the test results (see Table 3).
Dose modifications for adverse reactions: Recommended dose modifications of Pluvicto for adverse reactions are provided in Table 3. (See Table 3.)
Management of severe or intolerable adverse reactions may require temporary dose interruption (extending the dosing interval by 4 weeks from 6 weeks up to 10 weeks), dose reduction or permanent discontinuation of treatment with Pluvicto. If a treatment delay due to an adverse reaction persists for >4 weeks, treatment with Pluvicto must be discontinued. The dose of Pluvicto may be reduced by 20% once; the dose should not be re-escalated. If a patient has further adverse reactions that would require an additional dose reduction, treatment with Pluvicto must be discontinued.

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Special populations: Elderly: No dose adjustment is recommended in patients aged 65 years or older.
Renal impairment: No dose adjustment is recommended for patients with mild to moderate renal impairment with baseline CLcr ≥50 mL/min by Cockcroft-Gault. 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 as the pharmacokinetic profile and safety of Pluvicto have not been studied in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is recommended for patients with hepatic impairment. Pluvicto has not been studied in patients with moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of Pluvicto in the paediatric population in the indication of treatment of PSMA-expressing prostate cancer.
Method of administration: Pluvicto is a ready-to-use solution for injection/infusion for single use only.
Administration instructions: The recommended dose of Pluvicto may be administered intravenously as an injection using a disposable syringe fitted with a syringe shield (with or without a syringe pump), as an infusion using the gravity method (with or without an infusion pump), or as an infusion using the vial (with a peristaltic infusion pump).
A reduced dose of Pluvicto should be administered using the syringe method (with or without a syringe pump) or the vial method (with a peristaltic infusion pump). Using the gravity method to administer a reduced dose of Pluvicto is not recommended since it may result in delivery of the incorrect volume of Pluvicto if the dose is not adjusted prior to administration.
Prior to administration, flush the intravenous catheter used exclusively for Pluvicto administration with ≥10 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to ensure patency and to minimise the risk of extravasation. Cases of extravasation should be managed as per institutional guidelines. Patients should be advised to remain well hydrated and to urinate frequently before and after administration of Pluvicto (see Precautions).
For instructions on the method of preparation and intravenous methods of administration, see Instructions for preparation of radiopharmaceuticals under Cautions for Usage.
For patient preparation, see Precautions.