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.

Scanning for PSMA

Need for Novel Biomarkers in Prostate Cancer

PROGRESSING mCRPC PATIENTS URGENTLY NEED THERAPEUTIC OPTIONS THAT CAN EXTEND SURVIVAL AND IMPROVE CLINICAL OUTCOMES1-7

Why Scan for PSMA?

MORE THAN 80% OF PATIENTS WITH PROSTATE CANCER ARE PSMA+, MAKING PSMA AN IDEAL DIAGNOSTIC AND THERAPEUTIC TARGET13-17

  • PSMA is a transmembrane protein that is overexpressed on prostate cancer cells18
  • PSMA+ lesions can be visualized using PSMA positron emission tomography (PET)1,19
  • Knowing your patient is PSMA+ may enable you to offer PLUVICTO, a PSMA-targeted radioligand therapy (RLT)1,12,19

 

 

MOA, mechanism of action.

 

Scanning to Determine PSMA Status

PSMA SCANNING HELPS YOU TO SEE AND TARGET PSMA+ mCRPC1,12,19

  • PSMA PET demonstrates high sensitivity and specificity to see PSMA+ metastases1,12,19,20
  • Once a scan confirms PSMA+ mCRPC, the disease* can be treated with PLUVICTO wherever it has spread—bone, nodal, and visceral metastases1,9,12

*Please see full indication for further details.

 

Patients in Your Practice Who May Benefit From PLUVICTO

mCRPC patients with PSMA+ metastases on PSMA PET/CT scan have been shown to benefit from PLUVICTO

CONSIDER A PSMA PET/CT FOR PATIENTS IN YOUR PRACTICE WITH mCRPC7,18

Stan Patient Profile

ADT, androgen deprivation therapy; mHSPC, metastatic hormone-sensitive prostate cancer.

What is your next step for patients like Stan?

See how PLUVICTO helped patients like these in the VISION trial. View OS Data

ARPI, androgen receptor pathway inhibitor; mCRPC, metastatic castration-resistant prostate cancer.
a Product used as directed by product Prescribing Information/label.

Maurice Patient Profile

BCR, biochemical recurrence; nmCRPC, nonmetastatic castration-resistant prostate cancer; PC, prostate cancer; PSADT, prostate-specific antigen doubling time.

What is your next step for patients like Maurice?

See how PLUVICTO helped patients like these in the VISION trial. View OS Data

ARPI, androgen receptor pathway inhibitor; mCRPC, metastatic castration-resistant prostate cancer.
a Product used as directed by product Prescribing Information/label.

Jose Patient Profile

What is your next step for patients like José?

See how PLUVICTO helped patients like these in the VISION trial. View OS Data

ARPI, androgen receptor pathway inhibitor; mCRPC, metastatic castration-resistant prostate cancer.
a Product used as directed by product Prescribing Information/label.

Elliot Patient Profile

What is your next step for patients like Elliot?

See how PLUVICTO helped patients like these in the VISION trial. View OS Data

ARPI, androgen receptor pathway inhibitor; mCRPC, metastatic castration-resistant prostate cancer.
a Product used as directed by product Prescribing Information/label.

References: 1. Hofman MS, Violet J, Hicks RJ, et al. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol. 2018;19(6):825-833.​ doi:10.1016/S1470-2045(18)30198-0. 2. Abida W, Patnaik A, Campbell D, et al; TRITON2 Investigators. Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 gene alteration. J Clin Oncol. 2020;38(32):3763-3772. doi:10.1200/JCO.20.01035. 3. Yadav MP, Ballal S, Sahoo RK, et al. Radioligand therapy with 177Lu-PSMA for metastatic castration-resistant prostate cancer: a systematic review and meta-analysis. AJR Am J Roentgenol. 2019;213(2):275-285.​ doi:10.2214/AJR.18.20845. 4. Li L, Chang W, Yang G, et al. Targeting poly (ADP-ribose) polymerase and the c-Myb-TopBP1-ATR-Chk1 signaling pathway in castration-resistant prostate cancer. Sci Signal. 2015;7(326):ra47. doi:10.1126/scisignal.2005070. 5. Violet J, Sandhu S, Iravani A, et al. Long-term follow-up and outcomes of retreatment in an expanded 50-patient single-center phase II prospective trial of 177Lu-PSMA-617 theranostics in metastatic castration-resistant prostate cancer. J Nucl Med. 2020;61(6):857-865. doi:10.2967/jnumed.119.236414. 6. Barber TW, Singh A, Kulkarni HR, Niepsch K, Billah B, Baum RP. Clinical outcomes of 177Lu-PSMA radioligand therapy in earlier and later phases of metastatic castration-resistant prostate cancer grouped by previous taxane chemotherapy. J Nucl Med. 2019;60(7):955-962. doi:10.2967/jnumed.118.216820. 7. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. Published online June 23, 2021. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322. 8. de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med. 2020;382(22):2091-2102. doi:10.1056/NEJMoa1911440. 9. Baum RP, Kulkarni HR, Schuchardt C, et al. 177Lu-labeled prostate-specific membrane antigen radioligand therapy of metastatic castration-resistant prostate cancer: safety and efficacy. J Nucl Med. 2016;57(7):1006-1013. doi:10.2967/jnumed.115.168443. 10. Current K, Meyer C, Magyar CE, et al. Investigating PSMA-targeted radioligand therapy efficacy as a function of cellular PSMA levels and intratumoral PSMA heterogeneity. Clin Cancer Res. 2020;26(12):2946-2955. doi:10.1158/1078-0432.CCR-19-1485. 11. Benešová M, Schäfer M, Bauder-Wüst U, et al. Preclinical evaluation of a tailor-made DOTA-conjugated PSMA inhibitor with optimized linker moiety for imaging and endoradiotherapy of prostate cancer. J Nucl Med. 2015;56(6):914-920. doi:10.2967/jnumed.114.147413. 12. Maffey-Steffan J, Scarpa L, Svirydenka A, et al. The 68Ga/177Lu-theragnostic concept in PSMA-targeting of metastatic castration–resistant prostate cancer: impact of post-therapeutic whole-body scintigraphy in the follow-up. Eur J Nucl Med Mol Imaging. 2020;47(3):695-712. doi:10.1007/s00259-019-04583-2. 13. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623.​ doi:10.3389/fonc.2018.00623. 14. Pomykala KL, Czernin J, Grogan TR, Armstrong WR, Williams J, Calais J. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med. 2020;61(3):405-411. doi:10.2967/jnumed.119.230318. 15. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med. 2017;58(12):1956-1961. doi:10.2967/jnumed.117.192476. 16. Tsourlakis MC, Klein F, Kluth M, et al. PSMA expression is highly homogenous in primary prostate cancer. Appl Immunohistochem Mol Morphol. 2015;23(6):449-455. doi:10.1097/PAI.0000000000000110. 17. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate. 2011;71(3):281-288. doi:10.1002/pros.21241. 18. PLUVICTO [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022. 19. Vlachostergios PJ, Niaz MJ, Sun M, et al. Prostate-specific membrane antigen uptake and survival in metastatic castration-resistant prostate cancer. Front Oncol. 2021;11:630589. doi:10.3389/fonc.2021.630589. 20. Woythal N, Arsenic R, Kempkensteffen C, et al. Immunohistochemical validation of PSMA expression measured by 68Ga-PSMA PET/CT in primary prostate cancer. J Nucl Med. 2018;59(2):238-243. doi:10.2967/jnumed.117.195172. 21. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12)(suppl):1091-1103. doi:10.1056/NEJMoa2107322.

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.