Overview
11 DESCRIPTION PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS has a concentration of 5×10 11 PU/mL. Each single-dose vial contains a minimum extractable volume of 1 mL and the following excipients: Tris base (10 mM),...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen of selected regions of human papillomavirus (HPV) proteins expressed in HPV 6- and HPV 11-infected cells. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis. 12.2 Pharmacodynamics The pharmacodynamic effect of PAPZIMEOS was evaluated in Study PRGN-2012-201 [see Clinical Studies ( 14 )] . In 28 patients evaluated at completion of treatment, the induction of HPV 6- and HPV 11-specific T cell responses in RRP patients, was higher in RRP patients demonstrating a clinical response to treatment, i.e.
Indications
- 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 )
Common Doses
- 3 mL
- 18 G
- 22 G
- 23 G
Dosage
2 DOSAGE AND ADMINISTRATION PAPZIMEOS is for subcutaneous injection only. ( 2.1 ) The recommended dose of PAPZIMEOS is 5×10 11 particle units (PU) per injection administered by subcutaneous injection four ( 4 ) times over a 12-week interval. ( 2.1 ) Prior to the initial administration of PAPZIMEOS, perform a surgical debulking of visible papilloma to establish minimal residual disease. To maintain minimal residual disease during treatment with PAPZIMEOS, remove visible papilloma, if present, prior to the third and fourth administration of PAPZIMEOS. ( 2.1 ) 2.
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.