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 household contacts 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.

See More
Indication

 

PLUVICTO™ (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with 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.

Dosing & Administration

Dosing

12% of patients discontinued PLUVICTO due to any treatment-related adverse events1

PLUVICTO dosing schedule2

Administered every 6 weeks for up to 6 treatments

  • PLUVICTO solution for injection contains 7.4 GBq (200 mCi) (at time of use)
  • Administered once every 6 weeks for up to 6 treatments, or until disease progression, or unacceptable toxicity
  • Slow intravenous (IV) injection (1 to 10 minutes) or infusion
     

Administration

SETUP AND ADMINISTRATION OF PLUVICTO2,3

General information

  • PLUVICTO is administered intravenously
  • Nuclear medicine health care professionals may use methods deemed appropriate and safe
  • Prior to administration with PLUVICTO, a saline flush with ≥10 mL of 0.9% sterile sodium chloride must be administered to ensure patency of the IV line and minimize the risk of extravasation
  • Manage cases of extravasation as per your institutional guidelines
  • PLUVICTO will be administered slowly by intravenous route and followed by a saline flush
  • Vital signs should be collected 15 minutes (±5 minutes) before administration, as well as 30 minutes (±5 minutes) and 60 minutes (±5 minutes) following administration

 

Find detailed information on administration, safety, and more. Download Dosing Guide

Radiation Safety

Important note regarding use of PLUVICTO2

Always use the principles of ALARA (as low as reasonably achievable)

ALARA is the guiding principle of radiation safety. It means that even a small radiation dose should be avoided if there is no benefit to receiving it. It includes 3 basic protective measures:

Any unused medicinal product or waste material should be disposed of in accordance with local and federal laws.

 

Storage and Handling

PLUVICTO IS SUPPLIED AS A SINGLE-DOSE VIAL CONTAINING 7.4 GBq (200 mCi) ± 10% OF LUTETIUM Lu 177 VIPIVOTIDE TETRAXETAN2

Shelf Life

The shelf life of PLUVICTO is 120 hours (5 days) from the date and time of calibration.

 

Special Precautions for Storage

  • Store below 30ºC (86ºF). Do not freeze
  • Store in the original package to protect from ionizing radiation (lead shielding)
  • Storage of radiopharmaceuticals should be in accordance with local and federal laws on radioactive materials
  • Do not use PLUVICTO after the expiration date and time stated on the label after “EXP”

 

Special Precautions for Handling

  • PLUVICTO is a radiopharmaceutical and should be handled with appropriate safety measures to minimize radiation exposure
  • Use waterproof gloves and effective radiation shielding when handling PLUVICTO

 

Special Precautions for Disposal

  • Dispose of any unused medicinal product or waste material in accordance with local and federal laws, as per radiation safety officer guidance
  • Lutetium-177 is prepared using 2 different sources of stable isotopes (either lutetium-176 or ytterbium-176) that require different waste management. Consult the product batch release certificate to identify the source of stable isotopes used and apply appropriate waste management

Administration Resources

Helpful tools for administering PLUVICTO and Patient Counseling

Dosing and Administration Guide

Find information on radiation safety, recommended dosing for PLUVICTO, dose modifications for adverse events, patient counseling, and more.

Download Dosing Guide

References: 1. PLUVICTO [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022. 2. Centers for Disease Control and Prevention. ALARA - as low as reasonably achievable. https://www.cdc.gov/nceh/radiation/alara.html. Accessed September 15, 2021. 3. Data on file. VISION [PSMA-617-01]. Novartis Pharmaceuticals Corp; 2021.

Indication

PLUVICTO™ (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with 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.

 

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 household contacts 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 household contacts 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 bedroom from household contacts 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 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% of patients (including 2 fatal events). Two deaths (0.4%) due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia were observed. One death due to sepsis and concurrent neutropenia was observed.

Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO and clinically treat patients based on severity of myelosuppression.

Renal Toxicity

PLUVICTO can cause severe renal toxicity. In the VISION study, grade 3 or 4 acute kidney injury (3%) and increased creatinine (0.9%) 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, all radiopharmaceuticals, including PLUVICTO, have the potential to cause fetal harm. Advise male patients 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

The most common adverse reactions (≥20%) occurring at a higher incidence in patients who received PLUVICTO plus best standard of care (BSoC) were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. Clinically relevant adverse reactions in <5% of patients included dry eye, vertigo, and pancytopenia (including bicytopenia).

Laboratory Abnormalities

The most common laboratory abnormalities that worsened from baseline in ≥30% of patients who received PLUVICTO plus BSoC were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium.

 

Please see full Prescribing Information.