Zopapogene Imadenovec
FDA Drug Information • Also known as: Papzimeos
- Brand Names
- Papzimeos
- Route
- SUBCUTANEOUS
- Dosage Form
- INJECTION, SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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), sodium chloride (75 mM), magnesium chloride hexahydrate (1 mM), polysorbate 80 (0.019 mM), and trehalose dihydrate (146 mM). PAPZIMEOS is a sterile, slightly opalescent to opalescent colorless suspension. The product contains no preservatives.
What Is Zopapogene Imadenovec Used For?
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 )
Dosage and Administration
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 ) 2.1 Recommended Dosage PAPZIMEOS is for subcutaneous injection only. The recommended dosage of PAPZIMEOS is 5×10 11 particle units (PU) per injection administered as subcutaneous injection four times over a 12-week interval. The recommended dosing schedule for PAPZIMEOS is shown in Table 1 . Table 1: Recommended Treatment Schedule for PAPZIMEOS Administration Administration Interval 1 The second administration should occur no less than 11 days after the initial administration. Initial -- Second 2 weeks after initial administration 1 Third 6 weeks after initial administration Fourth 12 weeks after initial administration 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. 2.2 Preparation and Handling PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy. Follow universal biosafety precautions for handling. PAPZIMEOS is provided as a single-dose vial of sterile frozen suspension. PAPZIMEOS MUST BE RAPIDLY thawed before use and prepared for immediate administration . 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. Recommended Supplies and Materials Freezer for storage of PAPZIMEOS at temperature ≤ -60°C [≤ -76°F] Water bath or dry bead bath set to 37°C [98.6°F] 3 mL sterile syringe Sterile needle (18G to 22G without a filter) to withdraw PAPZIMEOS from the vial Sterile needle for subcutaneous injection (23G to 25G needle, 1/2 - 5/8 inch long) 70% isopropyl alcohol pads Receipt of PAPZIMEOS PAPZIMEOS is provided as a sterile, frozen suspension that has been aseptically filled into single-dose vials fitted with a rubber stopper and aluminum flip-cap seal. Each vial is sealed inside a pouch, which is placed in the carton along with a Package Insert. The PAPZIMEOS carton is shipped frozen at ≤ -60°C [≤ -76°F] in an insulated shipping box containing dry ice. On receipt, the PAPZIMEOS carton must be stored in a freezer at ≤ -60°C [≤ -76°F]. Preparation of PAPZIMEOS for Injection Remove the carton of PAPZIMEOS from the freezer when ready for administration. Take the vial out of the pouch and immediately thaw in a 37°C [98.6°F] water bath or dry...
Side Effects (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 [email protected] 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%).
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no available data with PAPZIMEOS in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with PAPZIMEOS. In the PRGN-2012-201 study, one patient reported pregnancy at 6 months following completion of treatment with PAPZIMEOS. The patient delivered at 40 weeks without any reported birth complications or neonatal concerns. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Each carton of PAPZIMEOS (NDC 84768-511-01) contains one single-dose vial (NDC 84768-511-99) of PAPZIMEOS sterile frozen suspension. PAPZIMEOS is supplied in a single-dose vial made from cyclic olefin polymer (COP) with a rubber stopper and aluminum flip-cap seal. Each vial is sealed inside a pouch (NDC 84768-511-00). The pouch is placed in the container along with a Package Insert. Each vial is formulated to contain an extractable dose of 5×10 11 PU in a 1 mL suspension. 16.2 Storage and Handling PAPZIMEOS is shipped and stored frozen at ≤ -60°C [≤ -76°F] and should be stored in an appropriate freezer at ≤ -60°C [≤ -76°F] until ready to thaw and administer. DO NOT place the vial in a refrigerator, freezer, or on dry ice at any time once removed from the pouch. Protect the vials from light. DO NOT shake the vial. PAPZIMEOS should not be held at room temperature for more than 60 minutes after thawing. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy. Follow universal biohazard precautions for handling [see Dosage and Administration ( 2.2 )( 2.3 ) ] and for the disposal of all vials and syringes. 16.1 How Supplied Each carton of PAPZIMEOS (NDC 84768-511-01) contains one single-dose vial (NDC 84768-511-99) of PAPZIMEOS sterile frozen suspension. PAPZIMEOS is supplied in a single-dose vial made from cyclic olefin polymer (COP) with a rubber stopper and aluminum flip-cap seal. Each vial is sealed inside a pouch (NDC 84768-511-00). The pouch is placed in the container along with a Package Insert. Each vial is formulated to contain an extractable dose of 5×10 11 PU in a 1 mL suspension.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.