RRP Foundation position statement.1,2
PAPZIMEOS dosing & administration
PAPZIMEOS is for subcutaneous injection provided as a suspension in a single-dose vial1
The recommended dose of PAPZIMEOS is 5 × 1011 particle units (PUs) per injection administered subcutaneously 4 times over a 12-week interval.1
PAPZIMEOS treatment starts with a plan
In recurrent respiratory papillomatosis (RRP), the papilloma microenvironment suppresses human papillomavirus (HPV) clearance to perpetuate a chronic infection. Decreasing the disease burden through surgical interventions prior to treatment establishes minimal residual disease (MRD) and may reduce the immunosuppression associated with the papilloma microenvironment to maximize the potential for clinical benefit.3,4
Pre treatment
- Establish MRD by performing a surgical debulking of visible papilloma1
Treatment1
Monitor patients for 30 minutes after the first dose. Injection site reactions have occurred after PAPZIMEOS injection. Signs and symptoms can include redness, pain, swelling, itching, or warmth at the injection site.
2 weeks after initial administration The second dose should occur no less than 11 days after the initial dose.
6 weeks after initial administration Assess for MRD and remove visible papilloma, if present, before administration of the third dose.
12 weeks after initial administration Assess for MRD and remove visible papilloma, if present, before administration of the fourth dose.
Post treatment
- It is recommended to follow up every 3 months or sooner during the first year following treatment if there is a clinical concern for recurrence2
If applicable, discontinue use of systemic corticosteroids or other therapies for RRP. If systemic corticosteroids are clinically necessary, it is recommended that patients avoid use for ≥14 days before each PAPZIMEOS administration. In the clinical trial, patients avoided bevacizumab or other systemic RRP treatment for 30 days prior to the first PAPZIMEOS administration. Follow any recommended, treatment-specific washout periods.5
Storage and handling for PAPZIMEOS
- PAPZIMEOS carton must be stored in an appropriate freezer at ≤ −60°C [≤ −76°F] until ready to thaw and administer.1
- PAPZIMEOS MUST BE RAPIDLY thawed before use and prepared for immediate administration.1
- Once thawed, DO NOT place the PAPZIMEOS vial in a refrigerator, freezer, or on dry ice. Protect PAPZIMEOS from light. DO NOT shake the vial.1
- DO NOT hold PAPZIMEOS at room temperature for more than 60 minutes after thawing.1
Does your site need ultra-cold storage? Contact freezerlease@precigen.com.
Please see full Prescribing Information for complete information on DOSAGE & ADMINISTRATION.
Support for your patients and practice
Papzimeos SUPPORT can help your patients and care team throughout the access process. For questions or support, call (866) 827‑8180,
Monday to Friday, 8 AM to 8 PM ET.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Indication and 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.
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.
Indication and
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.
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.
Please see full Prescribing Information.
- References:
- PAPZIMEOS. Package insert. Precigen, Inc; 2025.
- Best SR, Friedman AD, Rosen CA, et al. Recurrent Respiratory Papillomatosis Foundation position statement on the management of adults with RRP. Laryngoscope. 2026;136(suppl 4):S7–S17. doi:10.1002/lary.70379
- 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
- Ramos ML, Ueha R, Goto T, Matsumoto N, Kondo K. Pathogenesis of recurrent respiratory papillomatosis and potential novel treatment strategies. Auris Nasus Larynx. 2025;52(4):381-387. doi:10.1016/j.anl.2025.05.011
- Data on file. Precigen, Inc.