WARNINGS
Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with an increased risk for cancer. Drink plenty of water and urinate as often as possible during the first hours after administration.
To minimize radiation exposure to others following administration of PLUVICTO, limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days. Refrain from sexual activity for 7 days, and sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days.
USES
PLUVICTO is a prescription treatment used to treat adults with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) already treated with:
hormone therapy and are considered appropriate to delay chemotherapy or
hormone therapy and chemotherapy
HOW TO USE
1.) Recommended Dosage
The recommended PLUVICTO dosage is 7.4 GBq (200 mCi) intravenously every 6 weeks for 6 doses, or until disease progression, or unacceptable toxicity.
2.) Dosage Modifications for Adverse Reactions
Recommended dosage modifications of PLUVICTO for adverse reactions are provided in Table 1. Management of adverse reactions may require temporary dose interruption, dose reduction or permanent discontinuation of treatment with PLUVICTO. If a treatment delay due to an adverse reaction persists for > 4 weeks, consider permanent discontinuation of PLUVICTO. The dose of PLUVICTO may be reduced by 20% to 5.9 GBq (160 mCi) once; do not re-escalate dose. If a patient has further adverse reactions that would require an additional dose reduction, treatment with PLUVICTO must be discontinued.
Low level of blood cell counts. Tell your doctor right away if you develop any new or worsening symptoms, including:
Tiredness or weakness
Pale skin
Shortness of breath
Bleeding or bruising more easily than normal or difficulty stopping bleeding
Frequent infections with signs such as fever, chills, sore throat, or mouth ulcers
Kidney problems. You should stay well-hydrated before and after treatment. Tell your doctor right away if you develop any new or worsening urinary symptoms.
All radiopharmaceuticals, including PLUVICTO, have the potential to cause harm to an unborn baby.
You should use effective contraception during treatment with PLUVICTO and for 14 weeks after your last dose
PLUVICTO may cause temporary or permanent infertility.
The most common side effects of PLUVICTO include:
Decreased blood cell counts
Tiredness
Dry mouth
Nausea
Appetite loss
Joint pain
Constipation
Back pain
These are not all of the possible side effects of PLUVICTO. Call your doctor for advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
None.
OVERDOSE
In the event of administration of a radiation overdosage with PLUVICTO, reduce the radiation absorbed dose to the patient by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding. Estimate the effective radiation dose that was applied and treat with additional supportive care measures as clinically indicated.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store below 30-degrees C (86-degrees F). Do not freeze. Store in the original package to protect from ionizing radiation (lead shielding).
Store PLUVICTO in accordance with local and federal laws on radioactive materials
NOTES
Medication Guide: revision date 09/2025
Prescribing Information: revision date 03/2025
For more information, please go to https://us.pluvicto.com/novartis-patient-support, or call 1-844-638-7222, or call your healthcare provider.
1.) 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.
Minimize radiation exposure to patients, medical personnel, and others during and after treatment with PLUVICTO consistent with institutional good radiation safety practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation.
Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others [see Patient Counseling Information (17)].
After each administration of PLUVICTO, advise patients to:
• Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days.
• Refrain from sexual activity for 7 days.
• Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days.
2.) Myelosuppression
PLUVICTO can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia.
In the PSMAfore study, Grade 3 or 4 decreased hemoglobin (7%), decreased leukocytes (4.4%), decreased neutrophils (3.5%), and decreased platelets (2.7%) occurred in patients treated with PLUVICTO. One death occurred due to bone marrow failure during long-term follow-up in a patient who received PLUVICTO.
In the VISION study, Grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥ 3 pancytopenia occurred in 1.1% (which includes two fatal events) of patients treated with PLUVICTO. Two deaths (0.4%) occurred due to intracranial
hemorrhage and subdural hematoma in association with thrombocytopenia, one death (0.2%) occurred due to sepsis and concurrent neutropenia, and one death (0.2%) occurred due to bone marrow failure.
Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of myelosuppression [see Dosage and Administration (2.4)].
3.) Renal Toxicity
PLUVICTO can cause severe renal toxicity.
In the PSMAfore study, Grade 3 or 4 acute kidney injury (1.3%) occurred in patients treated with PLUVICTO. In the VISION study, Grade 3 or 4 acute kidney injury (3.4%) occurred in patients treated with PLUVICTO.
Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Perform kidney function laboratory tests, including serum creatinine and calculated creatinine clearance (CLcr), before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of renal toxicity [see Dosage and Administration (2.4)].
4.) Embryo-Fetal Toxicity
The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm [see Clinical Pharmacology (12.1)]. No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from PLUVICTO, can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Use in Specific Populations (8.1, 8.3)].
5.) Infertility
PLUVICTO may cause infertility in males. The recommended cumulative dose of 44.4 GBq of PLUVICTO results in a radiation absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility [see Use in Specific Populations (8.3)].
