FULL PRESCRIBING INFORMATION

Powerfully Personal.

The first immunotherapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)

Targeted immune response: PROVENGE starts with your patient’s own immune system and activates his antigen-presenting cells (APCs) to help the immune system target and attack prostate cancer cells.1,2

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PIONEERS OF IMMUNOTHERAPY

PROVENGE is the first FDA-approved immunotherapy using the patient’s own immune system to fight advanced prostate cancer. Studies suggest that men who receive PROVENGE when their PSA level is lower live longer.3,4

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PROVENGE doctor patient

THE IMPORTANCE OF PATIENT IDENTIFICATION

Early identification of men with mCRPC who are indicated for PROVENGE is key to achieving optimal clinical benefit. Almost 25% of men assumed to have nonmetastatic CRPC were found to have metastatic disease when screened via imaging.5

According to the National Comprehensive Cancer Network® (NCCN®), sipuleucel-T (PROVENGE) may be considered for men with mCRPC if they didn't receive it as initial therapy.6

References:
References:
1.
PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
2.
Madan RA, Gulley JL, Fojo T, Dahut WL. Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression. Oncologist. 2010;15(9):969-975. doi:10.1634/theoncologist.2010-0129
3.
Higano CS, Armstrong AJ, Sartor AO, et al. Real-World Outcomes of Sipuleucel-T Treatment in PROCEED, a Prospective Registry of Men With Metastatic Castration-Resistant Prostate Cancer. Cancer. 2019 Dec 1;125(23): 4172-4180. doi: 10.1002/cncr.32445. Epub 2019 Sep 4.
4.
Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013 Jun;81(6):1297-302. doi: 10.1016/j.urology.2013.01.061. Epub 2013 Apr 9.
5.
Smith MR, Saad F, Chowdhury S, et al; SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418. doi:10.1056/NEJMoa1715546
6.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed May 21, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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