Recommended as first-line treatment per the
RRP Foundation position statement.1,2

PAPZIMEOS dosing & administration

PAPZIMEOS is for subcutaneous injection provided as a suspension in a single-dose 1-mL 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 dosing schedule chart. PAPZIMEOS dosing schedule chart.

Prior to the initial administration of PAPZIMEOS, perform a surgical debulking of visible papilloma to establish minimal residual disease (MRD).1

The second administration should occur no less than 11 days after the initial administration.1

To maintain MRD during treatment with PAPZIMEOS, remove visible papilloma, if present, prior to the third and fourth administration of PAPZIMEOS.1

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 MRD and may reduce the immunosuppression associated with the papilloma microenvironment to maximize the potential for clinical benefit.3,4

  • 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

It is recommended to follow up every 3 months or sooner during the first year following treatment if there is a clinical concern for recurrence.2

Please see full Prescribing Information for complete information on DOSAGE & ADMINISTRATION.

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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 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 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 or www.fda.gov/medwatch.

Please see full Prescribing Information.

  1. References:
  2. PAPZIMEOS. Package insert. Precigen, Inc; 2025.
  3. Best SR, Friedman AD, Rosen CA, et al. Recurrent Respiratory Papillomatosis Foundation position statement on the management of adults with RRP. Laryngoscope. Published online January 16, 2026. doi:10.1002/lary.70379
  4. 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
  5. 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