Intended for U.S. healthcare professionals only.
NOW APPROVED
The first and only FDA-approved therapy to treat recurrent respiratory papillomatosis (RRP) in adults.1,2
PAPZIMEOS (zopapogene imadenovec-drba) is a non‑replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6- and HPV 11-infected cells in adults with RRP.1
Papzimeos SUPPORT can help support your patients and care team at any site of care throughout the access process. For questions or support, call (866) 827-8180(866) 827-8180, Monday to Friday, 8 am to 8 pm ET.
HPV=human papillomavirus.
PAPZIMEOS resources
For your practice
Billing & Coding
Submit claims with billing and coding resources for PAPZIMEOS.
Dosing & Administration
Learn how to properly prepare and inject PAPZIMEOS.
Efficacy & Safety
Dive into clinical studies and data to greater understand how PAPZIMEOS may help your patients.
Navigating Access & Getting Started
Follow this guide to navigate the access and reimbursement process for PAPZIMEOS.
Papzimeos SUPPORT
Explore how Precigen can support your patients and care team. For questions or to get started, call (866) 827-8180(866) 827-8180.
Papzimeos SUPPORT Enrollment Form
Enroll your patients in Papzimeos SUPPORT for support throughout the access process.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777)1-855-PGE-NRRP (1-855-743-6777) or medinfo@precigen.com or FDA at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777)1-855-PGE-NRRP (1-855-743-6777) or medinfo@precigen.com or FDA at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
To report SUSPECTED ADVERSE REACTIONS, contact Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777) 1-855-PGE-NRRP (1-855-743-6777) or medinfo@precigen.com or FDA at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. PAPZIMEOS. Package insert. Precigen, Inc; 2025. 2. Norberg SM, Valdez J, Napier S, et al. PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial. Lancet Respir Med. 2025;13(4):318-326. doi:10.1016/S2213-2600(24)00368-0