PLUVICTO®
Important note: Before prescribing, consult full prescribing information.
Presentation: One mL of solution contains 1 GBq (1,000 MBq) (27 mCi) of lutetium (177Lu) vipivotide tetraxetan at the date and time of calibration. The total amount of radioactivity per single-dose vial is 7.4 GBq (7,400 MBq) (200 mCi) ± 10% at the date and time of administration.
Indications: PLUVICTO® in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate‑specific membrane antigen (PSMA)‑positive metastatic castration‑resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane‑based chemotherapy.
Dosage and administration:
Adults: ♦The recommended Pluvicto® dose is 7.4 GBq (7,400 MBq) (200 mCi) intravenously every 6 weeks (± 1 week) for a total of 6 doses. ♦Perform hematology, kidney function, and liver function tests before and during treatment with Pluvicto.
Special populations: ♦Renal impairment: No dose adjustment for patients with mild to moderate renal impairment. ♦Hepatic impairment: No dose adjustment. ♦Geriatric patients (65 years of age or older): No dose adjustment. ♦Pediatric patients (below 18 years of age): Safety and effectiveness have not been established.
Contraindications: None.
Warnings and precautions:
♦Risk from radiation exposure: Pluvicto® contributes to patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with increased risk for cancer. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment. Encourage patients to increase oral fluids and void as often as possible. Explain necessary radioprotection precautions that patient should follow to minimize radiation exposure to others.♦Myelosuppression: Perform hematology laboratory tests. Withhold, dose reduce, or permanently discontinue and clinically manage as deemed appropriate based on severity. ♦Renal toxicity: Advise patients to remain well hydrated and urinate frequently before and after administration. Perform kidney function laboratory tests. Withhold, dose reduce, or permanently discontinue based on severity.
Pregnancy, lactation, females and males of reproductive potential:
♦Pregnancy and Lactation: Safety and efficacy have not been established in females as Pluvicto® is not indicated for use in females. All radiopharmaceuticals, including Pluvicto®, have the potential to cause fetal harm.
♦Females and males of reproductive potential: Male contraception: Advise male patients not to father a child and to use condoms for intercourse during treatment with Pluvicto® and for 14 weeks after the last dose. Infertility: Pluvicto® may cause infertility
Adverse drug reactions:
Very common (≥10%): fatigue, dry mouth, nausea, anaemia, decreased appetite, constipation, vomiting, diarrhoea, thrombocytopenia, leukopenia, lymphopenia, urinary tract infection, abdominal pain, weight decreased.
Common (≥1 to <10%): oedema peripheral, acute kidney injury, dizziness, headache, dysgeusia, pyrexia, dry eye, vertigo, pancytopenia.
Interactions: None.
Packs and prices: Country-specific.
Legal classification: Country-specific
This is a promotional international website for PLUVICTO® and is intended for healthcare professionals outside the US only. If you are a US resident, please click on the US Residents link at the top of this page. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for country specific information.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC)