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.