Home › NDC Lookup › Ingredients › Zopapogene Imadenovec › 84768-0511-01
💉image loading
(from DailyMed)

PAPZIMEOS zopapogene imadenovec 500000000000 {VP}/mL Injection, Suspension, 1 pouch

by Precigen, Inc. · 1 POUCH in 1 CARTON (84768-511-01) / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL
NDC 84768-0511-01
🏷️ FDA NDC (as labeled) 84768-511-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 84768-511-01
Product NDC 84768-511
11-digit billing NDC 84768051101
NCPDP billing unit ML — per mL (volume)
RxCUI 2723367, 2723374
UNII C525BYS7TP
Application # BLA125832
SPL Set ID 103db7f1-8540-4bea-935e-217d69e7aa01
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-15
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance ZOPAPOGENE IMADENOVEC
GPI-14 12454090001830
GCN Seq No 088155
GCN 58248
HICL code 050824
Ingredient (HICL) Zopapogene Imadenovec-Drba
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B0
Therapeutic class — intermediate (HIC2) Effect Entire Respiratory System
HIC3 code B0G
Therapeutic class — specific (HIC3) Respiratory Cell/Gene Therapy Agents
AHFS code 26:12.00.00
AHFS class Gene Therapy
FDB label name PAPZIMEOS VIAL
FDB brand name Papzimeos
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 84768-511-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84768-0511-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerPrecigen, Inc.
FDA applicationBLA125832 (BLA)
Labeler code84768
First marketedSep 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PAPZIMEOS VIAL Ingredient Zopapogene Imadenovec-Drba
📖 What it is MedlinePlus · NLM

Zopapogene imadenovec-drba injection is used with surgery to treat recurrent respiratory papillomatosis (RRP; a chronic viral infection that causes wart-like tumors to grow in air passages from the nose and mouth to the lungs). Zopapogene imadenovec-drba is in a class of medications called immune therapy. It works by helping the body's immune system fight the virus that causes RRP. It also helps to decrease the number of surgeries needed for RRP.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Papzimeos 500000000000 {VP}/mLthis 84768-0511-01 Precigen, 1 pouch — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2025
First FDA approval
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 14, 2025 ⏳ ~10.9 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Papzimeoszopapogene imadenovec-drba
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateAug 14, 2037
Common questions
Is there a biosimilar for PAPZIMEOS VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PAPZIMEOS (this brand).

Top reported reactions

Injection Site Erythema7
Pyrexia6
Injection Site Pain5
Injection Site Swelling5
Nausea5
Fatigue4
Influenza Like Illness4

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2025 2026 17 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84768-0511-01 You're viewing this 1 POUCH in 1 CARTON (84768-511-01) / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL 2025-09-15 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 84768-511-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84768-0511-01, written without dashes as 84768051101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84768-0511-01, the first segment (84768) is the labeler code FDA assigned to Precigen, Inc.; the middle segment (0511) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Precigen, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Precigen, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 36 words ▾

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 ~3 min read ▾

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 )

2.1Recommended 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.

2.2Preparation 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 bead bath with the vial in an upright position until there are no visible ice crystals in the vial. Exposure of the thawed vial to the 37°C [98.6°F] water bath or dry bead bath should be less than or equal to 5 minutes.

Immediately after thawing, wipe the vial with 70% isopropyl alcohol. Flip off the cap and wipe the rubber stopper top. Swirl gently and visually inspect the vial of PAPZIMEOS.

PAPZIMEOS should appear as a slightly opalescent to opalescent, colorless liquid, and free of visible particulates. DO NOT use if particulates or discoloration are visible in the suspension. Aseptically withdraw 1 mL of PAPZIMEOS from the thawed vial using a 3 mL syringe with an 18G to 22G needle.

DO NOT use a filter needle. Replace the 18G to 22G needle with a subcutaneous injection needle (23G to 25G). Dispose of the used needle and empty vial in a biohazard container.

DO NOT hold PAPZIMEOS at room temperature for more than 60 minutes after thawing. DO NOT store thawed PAPZIMEOS vials or filled syri…

💊 Dosage Forms and Strengths 70 words ▾

3 DOSAGE FORMS AND STRENGTHS PAPZIMEOS is supplied as a slightly opalescent to opalescent, colorless suspension for subcutaneous injection with a concentration of 5×10 11 PU/mL. Each single-dose vial delivers a minimum extractable volume of 1 mL [see How Supplied/Storage and Handling ( 16 ) ]. PAPZIMEOS is supplied in a single-dose vial that contains 5×10 11 PU in an extractable volume of 1 mL of suspension. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 128 words ▾

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 )

5.1Injection-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 and manage accordingly.

5.2Thrombotic Events Thrombotic events may occur following administration of adenoviral vector-based therapies including PAPZIMEOS due to the potential to induce prothrombotic antibody development. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.

🤒 Adverse Reactions ~1 min read ▾

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.

6.1Clinical 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%).

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation Risk Summary 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.

8.4Pediatric Use The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.

8.5Geriatric Use There were 9 patients (24%) 65 years of age and older and 1 patient (3%) 75 years of age and older in Study PRGN-2012-201. 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.

🤰 Pregnancy 85 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use There were 9 patients (24%) 65 years of age and older and 1 patient (3%) 75 years of age and older in Study PRGN-2012-201. 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.

🧬 Clinical Pharmacology 170 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics 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. reduction in or elimination of the requirement for surgical debulking during the 12 months following completion of treatment, with mean fold-change from baseline of 164.9 versus 5.1 (p<0.018).

This difference persisted at 12 weeks post-treatment, with mean fold-change of 61.5 in responders versus 11.5 in non-responders.

12.3Pharmacokinetics No biodistribution and vector shedding studies have been conducted with PAPZIMEOS.

🧬 Mechanism of Action 55 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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.

16.2Storage 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.

16.1How 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.

📦 Storage and Handling 112 words ▾

16.2Storage 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.

📋 Description 89 words ▾

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.

💬 Information for Patients 165 words ▾

17 PATIENT COUNSELING INFORMATION Discuss following with the patients. Injection Site Reactions: Inform patients injection site reactions have occurred after PAPZIMEOS injection. Signs and Symptoms may include reactions such as redness, pain, swelling, itching, or warmth at the injection site.

Advise patients to manage symptoms with cold compresses, over the counter pain relievers or antihistamines, if needed. Seek medical care if symptoms worsen or are accompanied by signs of a systemic allergic reaction (difficulty breathing, widespread rash, facial swelling) or infection [see Warnings and Precautions ( 5.1 )]. Thrombotic Events: Inform patients that thrombotic events may occur after PAPZIMEOS injection.

Signs and Symptoms may include shortness of breath, chest pain, leg swelling, persistent abdominal pain, or neurological symptoms (including severe or persistent headaches or blurred vision). Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice [see Warnings and Precautions ( 5.2 )]. Manufactured by: Precigen, Inc.

20358 Seneca Meadows Parkway Germantown, MD 20876 USA U.S. License No. 2364

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84764-0705-10 · AIKM 84769-0001-02 · Novagenix →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.