PLUVICTO®
(lutetium Lu 177 vipivotide tetraxetan) is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.
PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and
•
are considered appropriate to delay taxane-based chemotherapy, or
•
have received prior taxane-based chemotherapy.
PLUVICTO is now FDA approved for patients with PSMA+ mAPMN/S prostate cancer (also known as mHSPC) at any point after diagnosis, in combination with ARPI.
PLUVICTO is the first and only PSMA-targeted therapy now approved for patients with mAPMN/S PC (mHSPC) (+ ARPI) and proven in patients with mAPMR PC (also known as mCRPC) after only 1 ARPI. This approval allows for the consideration of PLUVICTO treatment earlier in the metastatic disease setting.
This is not a guarantee of coverage. Patient out-of-pocket costs may vary. Coverage and reimbursement decisions vary.
†
Coverage determined based on patients treated with at least one ARPI. The other 20% do not have published policies and/or cases may be determined on an individual basis. Follow up with the patient’s plan to determine coverage.
‡
A review of claims data between Q1 2023 and Q2 2024 indicated that approximately 85% of patients paid $0 for the product. For remaining patients, the out-of-pocket cost for the product varies and may be as high as the total cost of the product. Additional out-of-pocket costs may be incurred related to treatment, including but not limited to administration fees.
§
Average prior authorization approval rate for patients when enrolled through Novartis Patient Support.
||
Based on a study assessing PLUVICTO reimbursement through IQVIA LAAD medical claims. Mean physician reimbursement days (median: 16 days).
IMPORTANT SAFETY INFORMATION
Risk From Radiation Exposure
•
PLUVICTO contributes to a patient’s long-term cumulative radiation exposure, which 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 practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection.
•
Ensure patients increase oral fluid intake and advise them to void as often as possible to reduce bladder radiation.
•
To minimize radiation exposure to others, advise patients to limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days, to refrain from sexual activity for 7 days, and to sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days.
Myelosuppression
•
PLUVICTO can cause severe and life-threatening myelosuppression. In clinical trials (PSMAddition, PSMAfore, VISION) grade 3 or 4 decreased hemoglobin (ranged from 4.3-15%), decreased leukocytes (4.4-7%), decreased neutrophils (3.5-4.5%), and decreased platelets (1.1-9%) occurred in patients treated with PLUVICTO. 5 myelosuppression-related deaths have occurred, including one due to bone marrow failure during long-term follow-up.
•
Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity of myelosuppression.
Renal Toxicity
•
PLUVICTO can cause severe renal toxicity. In clinical trials grade 3 or 4 acute kidney injury (ranged from 1.3-3.4%) 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 (CrCl), before and during treatment. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity of renal toxicity.
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. 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.
Infertility
•
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.
Adverse Reactions and Laboratory Abnormalities
•
In the pooled safety population for the PSMAddition, PSMAfore and VISION studies (N=1320), the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (86%), decreased hemoglobin (68%), fatigue (51%), dry mouth (46%), decreased neutrophils (35%), nausea (35%), decreased platelets (33%), decreased estimated glomerular filtration rate (28%), increased aspartate aminotransferase (25%), decreased sodium (22%), increased magnesium (22%), increased potassium (21%), decreased calcium (21%), and increased alkaline phosphatase (20%).
1. Data on file. MMIT Market Access Claims. Novartis Pharmaceuticals Corp; April 2026. 2. Data on file. PLUVICTO IQVIA LAAD data analysis. Novartis Pharmaceuticals Corp; March 2025. 3.
Data on file. PLUVICTO NPS Metrics. Novartis Pharmaceuticals Corp; Jan 2025 to Dec 2025. 4. Data on file. PLUVICTO & LUTATHERA Reimbursement Landscape. Novartis Pharmaceuticals Corp; 2025.
This content is sponsored by Novartis, and ION Oncology Practice Network has not independently reviewed or verified the information provided by Novartis.
This email was sent to karleigh.bard-marsh@cencora.com because you have an account with or are a valued partner of Cencora Specialty GPOs | ION Oncology Practice Network. If you no longer wish to receive these types of emails, please click here to unsubscribe or update your email preferences.
