PAPZIMEOS
Generic: ZOPAPOGENE IMADENOVEC
Basic Information
Manufacturer
Precigen, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
103db7f1-8540-4bea-935e-217d69e7aa01
Indications & Usage
1 INDICATIONS AND USAGE PAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis.
PAPZIMEOS™ is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.
( 1 )
PAPZIMEOS™ is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.
( 1 )
Adverse Reactions
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 v5.0.
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%).
( 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 v5.0.
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%).