Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Precigen Inc.
at 855-743-6777 and medinfo@precigen.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflects exposure to PAPZIMEOS in one clinical study (Study PRGN-2012-201).
A total of 38 adults with recurrent respiratory papillomatosis received a PAPZIMEOS dose of either 1×10 11 PU (n=3), or 5×10 11 PU (n=35) per injection on Days 1, 15, 43, and 85 [see Clinical Studies ( 14 )] .
The most common adverse reactions (incidence ≥5%) are summarized in Table 2 .
Table 2: Adverse Reactions occurring in ≥5% of Patients in Study PRGN-2012-201 (N=38) *Graded per NCI CTCAE v5.
There were no Grade >2 adverse reactions.
Preferred Term Grade 1-2* n (%) Injection site reaction 37 (97) Fatigue 28 (74) Chills 25 (66) Pyrexia 24 (63) Myalgia 11 (29) Nausea 10 (26) Headache 4 (11) Tachycardia 3 (8) Diarrhea 2 (5) Vomiting 2 (5) Hyperhidrosis 2 (5) Other clinically significant adverse reactions occurring in <5% of patients included vision blurred (3%), injection site bruising (3%), dizziness (3%), dyspnea (3%), and pruritus (3%).
5 WARNINGS AND PRECAUTIONS Injection-site reactions: Injection-site reactions, have been observed.
Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
( 5.1 ) 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.
( 5.2 ) 5.1 Injection-Site Reactions Injection-site reactions have occurred with PAPZIMEOS injection.
Like all medications, Papzimeos can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: