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.

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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.

Mechanism of Action

About PLUVICTO

PLUVICTO is a PSMA-targeted RLT that delivers DNA-breaking radiation directly to PSMA+ bone, nodal, and visceral metastases

PLUVICTO TARGETS PSMA-POSITIVE CELLS, INCLUDING PROSTATE CANCER CELLS1

Mechanism of action step 1

PLUVICTO is comprised of 2 key components: lutetium-177, a cytotoxic radionuclide, and PSMA-617, a PSMA-targeting ligand.1

Mechanism of action step 2

PLUVICTO binds to PSMA, a transmembrane protein expressed on prostate cancer cells.1 After binding to PSMA, PLUVICTO undergoes endocytosis and is internalized into the cell.1-4

Mechanism of action step 3

Lutetium-177, the cytotoxic radionuclide of PLUVICTO, emits DNA-breaking radiation within the cell. The short path length of the radiation emitted by PLUVICTO, approximately 2 millimeters maximum,1 causes single- and double-stranded DNA breaks in targeted cells as well as surrounding cells, which can lead to cell death.1,4-6

 

 

 
 

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LEARN HOW PLUVICTO WORKS

THE FIRST AND ONLY PSMA-targeted radioligand therapy for men with PSMA+ mCRPC who have been treated with androgen receptor pathway inhibitors and a taxane-based chemotherapy.

Based on in vitro/in vivo studies. Preclinical activity does not correlate with clinical outcomes.

 

References: 1. PLUVICTO [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022. 2. Liu H, Rajasekaran AK, Moy P, et al. Constitutive and antibody-induced internalization of prostate-specific membrane antigen. Cancer Res. 1998;58:4055-4060. 3. Rajasekaran SA, Anilkumar G, Oshima E, et al. A novel cytoplasmic tail MXXXL motif mediates the internalization of prostate-specific membrane antigen. Mol Biol Cell. 2003;14(12):4835-4845. doi:10.1091/mbc.e02-11-0731. 4. Fendler WP, Stuparu AD, Evans-Axelsson S, et al. Establishing 177Lu-PSMA-617 radioligand therapy in a syngeneic model of murine prostate cancer. J Nucl Med. 2017;58(11):1786-1792. doi:10.2967/jnumed.117.193359. 5. Ruigrok EAM, van Vliet N, Dalm SU, et al. Extensive preclinical evaluation of lutetium-177-labeled PSMA-specific tracers for prostate cancer radionuclide therapy. Eur J Nucl Med Mol Imaging. 2020;48(5):1339-1350. doi:10.1007/s00259-020-05057-6. 6. Nonnekens J, van Kranenburg M, Beerens CEMT, et al. Potentiation of peptide receptor radionuclide therapy by the PARP inhibitor olaparib. Theranostics. 2016;6(11):1821-1832. doi:10.7150/thno.15311.

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.