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Gvoke PFS 1 mg Pre-filled Syringe glucagon injection, solution 1 mg/.2mL Injection, Solution, 1 pouch — NDC 72065-0131-11 package photo

Gvoke PFS 1 mg Pre-filled Syringe glucagon injection, solution 1 mg/.2mL Injection, Solution, 1 pouch

by Xeris Pharmaceuticals, Inc. · 1 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC
NDC 72065-0131-11
🏷️ FDA NDC (as labeled) 72065-131-11 billing pads the product segment with a zero
This package
Contains1 pouch Cost per mL$1,600.23 NADAC Per package$320.05 / 0.2 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $1,662.52/unit · Part D plans $1,618.87/unit — full pricing hub ↓
Also comes in: 1 pouch 72065-0131-99 2 pouches 72065-0131-12
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) 72065-131-11
Product NDC 72065-131
11-digit billing NDC 72065013111
NCPDP billing unit ML — per mL (volume)
RxCUI 2199299, 2199304, 2199307, 2199308, 2199315, 2199316, 2587358, 2587361
UNII 76LA80IG2G
Application # NDA212097
SPL Set ID 92385737-dbad-98c5-e053-2995a90a2805
Established class (EPC) Antihypoglycemic Agent; Gastrointestinal Motility Inhibitor
Physiologic effect Increased Gluconeogenesis; Increased Glycogenolysis; Decreased GI Smooth Muscle Tone; Decreased GI Motility; Decreased Glycolysis
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-10
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance GLUCAGON
GPI-14 2730001000E530
GCN Seq No 080196
GCN 46905
HICL code 002795
Ingredient (HICL) Glucagon
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4G
Therapeutic class — specific (HIC3) Agents To Treat Hypoglycemia (Hyperglycemics)
AHFS code 68:22.12.00
AHFS class Glycogenolytic Agents
FDB label name GVOKE PFS 1-PK 1 MG/0.2 ML SYR
FDB brand name Gvoke Pfs 1-Pack Syringe
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 72065-131-11 — 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 → 72065-0131-11. 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.

🏷️ RxNorm drug class

This medicine belongs to the Antihypoglycemic Agent class.

Pharmacologic class Antihypoglycemic Agent, Gastrointestinal Motility Inhibitor
Drug family (ATC) Glycogenolytic hormones
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerXeris Pharmaceuticals, Inc.
Application holderXERIS PHARMACEUTICALS INC
FDA applicationNDA212097 (NDA)
Labeler code72065
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio6 products on file
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 GVOKE PFS 1-PK 1 MG/0.2 ML SYR Ingredient Glucagon
📖 What it is MedlinePlus · NLM

Glucagon injection is used for emergency treatment of very low blood sugar (severe hypoglycemia). It is also used to slow down movement in the digestive system during certain X-ray lab tests. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing digestive muscles for X-ray lab testing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, this is absolutely an emergency medication. You should use Gvoke if someone with diabetes becomes severely hypoglycemic — meaning they're unconscious, having seizures, or so c...
  • When exactly should I use Gvoke — and is it really an emergency?
  • Two things: call for emergency help right away (this is required every time, no matter how quickly they recover), and watch closely for a response. If there's no improvement after...
  • What do I do after I give the injection?
📖 Read our full Glucagon Injection / Solution guide →

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 YOW8V9698H
    Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.

2 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 $1,600.230 $320.05 / 0.2 ml
Medicaid paysCMS SDUD · 12 mo $1,662.52 $332.50 / 0.2 ml
Medicare drug plans payPart D · Q2 2026 $1,618.87 $323.77 / 0.2 ml
NADAC price history (per mL) — tap or hover for the price & month
Oct 2021 Feb 2024 Feb 2026 Aug 2026 $1,604.320 $1,384.640
▲ Up 16% over the last 10 months.
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
Gvoke PFS 1 mg Pre-filled Syringe 1 mg/.2mLthis 72065-0131-11 Xeris 1 pouch $1,600.230 — Availability likely —
Gvoke Kit 1 mg/.2mL 72065-0140-11 Xeris 2 ml $1,600.990 — Availability likely +0%
Gvoke HypoPen 1 mg Auto-Injector 1 mg/.2mL 72065-0121-11 Xeris 1 pouch $1,603.460 — Availability likely +0%
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2019
First FDA approval
Sep 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 10, 2019 RLD RS ⏳ ~9.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9649364 — method of use (U-2742)
US 9649364 — method of use (U-2742)
US 9649364 — method of use (U-2742)
US 9649364 — method of use (U-2742)
US 11590205 — method of use (U-2742)
US 11590205 — method of use (U-2742)
US 11590205 — method of use (U-2742)
US 11590205 — method of use (U-2742)
US 11590205 — method of use (U-2742)
2019 2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (9)
PatentTypeUse codeExpires
US 9649364 ↗ Method of use U-2742 Apr 22, 2036
US 9649364 ↗ Method of use U-2742 Apr 22, 2036
US 9649364 ↗ Method of use U-2742 Apr 22, 2036
US 9649364 ↗ Method of use U-2742 Apr 22, 2036
US 11590205 ↗ Method of use U-2742 Apr 22, 2036
US 11590205 ↗ Method of use U-2742 Apr 22, 2036
US 11590205 ↗ Method of use U-2742 Apr 22, 2036
US 11590205 ↗ Method of use U-2742 Apr 22, 2036
US 11590205 ↗ Method of use U-2742 Apr 22, 2036
Common questions
Is there a generic version of GVOKE PFS 1-PK 1 MG/0.2 ML SYR?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for GVOKE PFS 1-PK 1 MG/0.2 ML SYR. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2036 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72065-0131-11, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.9K
Units reimbursed last 4 qtrs
509
Gross reimbursed last 4 qtrs
$846.2K
Avg / prescription
$452.28
Avg / unit
$1,661.87
Latest quarter Q4 2025
371Rx
Medicaid pays / mL
$1,661.87
gross reimbursed
vs
NADAC / mL
$1,600.23
acquisition cost
=
Spread
+$61.6371
+4% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
48% FFS 52% MCO
Fee-for-service · 896 Rx Managed care · 975 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 145 units · 0.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 49 units · 0.4 per 100k residents IL Indiana: 60 units · 0.9 per 100k residents IN Ohio: 48 units · 0.4 per 100k residents OH Pennsylvania: 81 units · 0.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 24 units · 0.3 per 100k residents MA California: 36 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 17 units · 0.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3 units · 0.0 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 25 units · 0.4 per 100k residents TN North Carolina: 13 units · 0.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 9 units · 0.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 0.9 /100k
2 New York 0.7 /100k
3 Pennsylvania 0.6 /100k
4 Ohio 0.4 /100k
5 Illinois 0.4 /100k
6 Kentucky 0.4 /100k
7 Tennessee 0.4 /100k
8 Massachusetts 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 pouch this page72065-0131-11 1,871 Rx · $846,223
2 pouches72065-0131-12 1,353 Rx · $846,688
1 pouch72065-0131-99 No Medicaid data
Drug total (last 4 qtrs): 3,224 Rx · 1,046 units · $1,692,911 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72065-0131-11 You're viewing this 1 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC $1,600.23 / mL $320.05 2019-09-10 Active
72065-0131-12 2 POUCH in 1 CARTON (72065-131-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC $1,606.19 / mL $642.48 2019-09-10 Active
72065-0131-99 1 POUCH in 1 CARTON (72065-131-99) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC — — 2019-10-28 Discontinued by firm

This pack has the lowest per-mL cost of the 2 priced pack sizes ($1,600.23 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 58% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 72065-0131-11?
NDC 72065-0131-11 contains 1 pouch — 1 pouch in 1 carton / 1 syringe, plastic in 1 pouch / .2 ml in 1 syringe, plastic.
What is the difference between NDC 72065-0131-11 and NDC 72065-0131-99?
Both are Gvoke PFS 1 mg Pre-filled Syringe glucagon injection, solution 1 mg/.2mL Injection, Solution — the drug itself is identical. NDC 72065-0131-11 is the 1 pouch package, while NDC 72065-0131-99 is the 1 pouch package.
What NDC number is used to bill for this package of Gvoke PFS 1 mg Pre-filled Syringe glucagon injection, solution 1 mg/.2mL Injection, Solution?
Bill NDC 72065-0131-11 — the 11-digit billing format is 72065013111. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 136 words ▾

1 INDICATIONS AND USAGE • GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes ( 1.1 ) • GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ( 1.2 )

1.1Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes.

1.2Diagnostic Aid in Adults GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes ( 2.1 ) • Important Administration Instructions • Administer GVOKE HypoPen, GVOKE PFS, or GVOKE Kit subcutaneously. These three presentations are referred to as GVOKE in this labeling • Administer GVOKE according to the printed instructions on the foil pouch label, carton, or the Instructions for Use. • Visually inspect GVOKE prior to administration.

The solution should appear clear and colorless to pale yellow. • Administer GVOKE subcutaneously in the lower abdomen, outer thigh, or outer upper arm. • Call for emergency assistance immediately after administering the dose. • If there has been no response after 15 minutes, may administer an additional dose from a new HypoPen, GVOKE PFS, or GVOKE Kit while waiting for emergency assistance. • When the patient has responded to GVOKE, give oral carbohydrates. • Do not attempt to reuse GVOKE. Each GVOKE device or vial contains a single dose of glucagon.

Do not reuse and discard any unused portion. • Recommended Dosage • Recommended dose for adult and pediatric patients aged 12 years of age and older is 1 mg. • Recommended dose for adult and pediatric patients aged 12 years of age and older is 1 mg. • The recommended dose for pediatric patients aged 2 to less than 12 years of age who weigh: o Less than 45 kg, is 0.5 mg o 45 kg or greater, is 1 mg Dosage and Administration of GVOKE VialDx for Intravenous Use as a Diagnostic Aid in Adults ( 2.2 ) • GVOKE VialDx is only for intravenous use under medical supervision. • The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bulb is 0.2 mg to 0.5 mg; the recommended dose to relax the colon is 0.5 mg to 0.75 mg. • See the Full Prescribing Information for administration instructions for GVOKE VialDx.

2.1Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes Important Administration Instructions To treat severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes, administer GVOKE HypoPen, GVOKE PFS, or GVOKE Kit subcutaneously. These three presentations are only for subcutaneous use and are referred to as GVOKE in this labeling. For GVOKE HypoPen or GVOKE PFS: Do not open foil pouch until ready to administer.

For GVOKE Kit: Store in original carton until ready to administer. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about GVOKE and its Instructions for Use.

Administer GVOKE subcutaneously as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for GVOKE. Visually inspect GVOKE prior to administration.

The solution should be clear, colorless to pale yellow Withdraw the correct dose (see below for dosage recommendations). Administer subcutaneously in the lower abdomen, outer thigh, or outer upper arm, according to the printed instructions on the foil pouch label, carton, or the Instructions for Use. Call for emergency assistance immediately after administering the dose.

If there has been no response after 15 minutes, an additional dose from a new GVOKE HypoPen, GVOKE PFS, or GVOKE Kit may be administered while waiting for emergency assistance. When the patient has responded to GVOKE, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. Each GVOKE HypoPen, GVOKE PFS, or GVOKE Kit product contains a single dose of glucagon.

Do not reuse and discard any unused portion. Recommended Dosage in Adult and Pediatric Patients Aged 12 Years and Older to Treat Severe Hypoglycemia To treat severe hyp…

💊 Dosage Forms and Strengths 142 words ▾

3 DOSAGE FORMS AND STRENGTHS GVOKE HypoPen, GVOKE PFS, GVOKE Kit (these three presentations are also referred to as GVOKE in this labeling) , and GVOKE VialDx are clear, colorless to pale yellow solutions. Subcutaneous Injection Injection: 0.5 mg/0.1 mL single-dose prefilled autoinjector (GVOKE HypoPen) Injection: 1 mg/0.2 mL single-dose prefilled autoinjector (GVOKE HypoPen) Injection: 1 mg/0.2 mL single-dose prefilled syringe (GVOKE PFS) Injection: 1 mg/0.2 mL single-dose vial and syringe kit (GVOKE Kit) Intravenous Injection: Injection: 1 mg/0.2 mL single-dose vial (GVOKE VialDx) Subcutaneous Injection: 0.5 mg/0.1 mL single-dose prefilled autoinjector (GVOKE HypoPen) ( 3 ) 1 mg/0.2 mL single-dose prefilled autoinjector (GVOKE HypoPen) ( 3 ) 1 mg/0.2 mL single-dose prefilled syringe (GVOKE PFS) ( 3 ) 1 mg/0.2 mL single-dose vial and syringe kit (GVOKE Kit)( 3 ) Intravenous Injection 1 mg/0.2 mL single-dose vial (GVOKE VialDx)( 3 )

⛔ Contraindications 150 words ▾

4 CONTRAINDICATIONS GVOKE and GVOKE VialDx are contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions ( 5.1 )] • Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )] • Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] .

GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see Warnings and Precautions ( 5.8 )] • Pheochromocytoma ( 4 ) • Insulinoma ( 4 ) • Prior hypersensitivity reaction to glucagon or to any of the excipients ( 4 ) • Glucagonoma when used as a diagnostic aid ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. ( 5.1 ) • Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of GVOKE or GVOKE VialDx, give glucose orally or intravenously.

( 5.2 ) • Serious Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension.( 5.3 ) • Lack of Efficacy with Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen: Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for subcutaneous use for the treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia.

( 5.4 ) • Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE and GVOKE VialDx are not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

( 5.5 ) • Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus: GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment and treat hyperglycemia if indicated. ( 5.6 ) • Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease: GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate.

Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. ( 5.7 ) • Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid: GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose levels during treatment.

( 5.8 )

5.1Substantial Increase in Blood Pressure in Patients with Pheochromocytoma GVOKE and GVOKE VialDx are contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see Contraindications ( 4 )] . If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

5.2Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE and GVOKE VialDx are contraindicated in patients with insulinoma [see Contraindications ( 4 )] . If a patient develops symptoms of hypoglycemia after a dose of GVOKE or GVOKE VialDx, give glucose orally or intravenously.

5.3Serious Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue GVOKE or GVOKE VialDx if symptoms of se…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Lack of Efficacy With Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] Necrolytic Migratory Erythema [see Warnings and Precautions ( 5.5 )] .

Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.6 )] Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence 2% or greater) reported for GVOKE were: o Adults—nausea, vomiting, injection site edema raised 1 mm or greater, and headache ( 6.1 ) o Pediatric Patients—nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria ( 6.1 ) Most common adverse reactions (incidence 5 % or greater) reported for GVOKE VialDx were nausea, dysgeusia, headache, dizziness and hot flush ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at toll-free 1-877-937-4737 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 GVOKE and GVOKE VialDx cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. GVOKE for Subcutaneous Use for the Treatment of Severe Hypoglycemia in Adult and Pediatric Patients 2 Aged Years and Older with Type 1 Diabetes Mellitus Adverse Reactions in Adult Patients The safety of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in adults with diabetes was evaluated in two randomized, blinded, 2-way crossover studies conducted in adults with type 1 diabetes mellitus.

In total, 154 patients received a subcutaneous injection of GVOKE [see Clinical Studies ( 14.1 )] . The most common adverse reactions that occurred in 2% or more of adults treated with GVOKE during these two clinical trials are listed in Table 1 . Table 1: Adverse Reactions that occurred ≥ 2% in Adult Patients with Type 1 Diabetes Mellitus Treated with GVOKE a a Adverse Reactions that occurred within 12 hours.

GVOKE 1 mg dose (N = 154) Nausea 30% Vomiting 16% Injection site edema raised 1 mm or greater 7% Headache 5% Injection site pain was reported by 1% of GVOKE-treated patients. Hypertension and tachycardia have occurred with glucagon treatment. Adverse Reactions in Pediatric Patients Aged 2 Years and Older The safety of GVOKE for the treatment of severe hypoglycemia in patients with diabetes was evaluated in one single-arm, open-label, study in 31 pediatric patients with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] .

The data in Table 2 reflect the exposure of 31 pediatric patients to 0.5 mg or 1 mg of GVOKE given subcutaneously. The most common adverse reactions that occurred in ≥2% of GVOKE-treated pediatric patients aged 2 years and older are listed in Table 2 . Table 2: Adverse Reactions That Occurred ≥ 2% in GVOKE-treated Pediatric Patients Aged 2 Years and Older with Type 1 Diabetes Mellitus a a Adverse Reactions that occurred within 12 hours.

2 to 6 years of age (0.5 mg dose) N =7 6 to 12 years of age (0.5 mg dose) N = 13 12 to 18 years of age (1 mg dose) N = 11 Total N = 31 Nausea 43% 54% 36% 45% Hypoglycemia 29% 54% 27% 39% Vomiting 14% 23% 18% 19% Headache 0% 15% 0% 7% Abdominal pain 0% 8% 0% 3%…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 4: Clinically Significant Drug Interaction with GVOKE and GVOKE VialDx Beta-Blockers Clincial Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE or GVOKE VialDx. Intervention The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Insulin Clincial Impact: Insulin acts antagonistically to glucagon.

Intervention Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin. Indomethacin Clincial Impact: In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. Intervention Monitor blood glucose levels during glucagon treatment of patients taking indomethacin.

Anticholinergic Drugs Clincial Impact: The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. Intervention Concomitant use of anticholinergic drugs with GVOKE VialDx is not recommended. Warfarin Clincial Impact: GVOKE and GVOKE Vial Dx may increase the anticoagulant effect of warfarin.

Intervention Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. Beta-blockers: GVOKE- or GVOKE VialDx-treated patients taking concomitant beta-blockers may have a transient increase in pulse and blood pressure. ( 7 ) Indomethacin: In patients taking concomitant indomethacin, GVOKE may lose its ability to raise glucose or may produce hypoglycemia.

( 7 ) Anticholinergic drugs: Concomitant use of anticholinergic drugs with GVOKE VialDx for use as a diagnostic aid is not recommended. ( 7 ) Warfarin: GVOKE and GVOKE VialDx may increase the anticoagulant effect of warfarin. ( 7 ) Insulin: Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin.

( 7 ) See 17 for PATIENT COUNSELING INFORMATION and FDA ‑ approved patient labeling for GVOKE.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, based on body surface area (mg/m 2 ) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m 2 ) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.

8.2Lactation Risk Summary There is no information available on the presence of glucagon in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.

8.4Pediatric Use The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 2 years and older. Use of GVOKE for this indication is supported by evidence from two adequate and well-controlled studies in adults with type-1 diabetes mellitus [see Clinical Studies ( 14.1 )] and from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] . The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have not been established in pediatric patients younger than 2 years of age.

Safety and effectiveness of GVOKE VialDx for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of GVOKE and GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

🤰 Pregnancy 195 words ▾

8.1Pregnancy Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, based on body surface area (mg/m 2 ) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m 2 ) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.

🧒 Pediatric Use 148 words ▾

8.4Pediatric Use The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 2 years and older. Use of GVOKE for this indication is supported by evidence from two adequate and well-controlled studies in adults with type-1 diabetes mellitus [see Clinical Studies ( 14.1 )] and from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] . The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have not been established in pediatric patients younger than 2 years of age.

Safety and effectiveness of GVOKE VialDx for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use Clinical studies of GVOKE and GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

🆘 Overdosage 95 words ▾

10 OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure, and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

In the event of an overdose of GVOKE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendation.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.

12.2Pharmacodynamics GVOKE for Subcutaneous Use for the Treatment of Severe Hypoglycemia in Patients with Type 1 Diabetes Mellitus: After subcutaneous administration of 1 mg GVOKE in adult patients with type 1 diabetes, the mean maximum glucose increase from baseline was 176 mg/dL (see Figure 1 ). Plasma Glucose (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of 1 mg of GVOKE in Adult Patients with Type 1 Diabetes Mellitus In pediatric patients with type 1 diabetes mellitus (2 to less than 18 years), the mean maximum glucose increase from baseline was 134 mg/dL (2 to less than 6 years), 145 mg/dL (6 to less than 12 years), and 123 mg/dL (12 to less than 18 years) (see Figure 2 ).

Figure 2: Plasma Glucose (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of GVOKE in Pediatric Patients with Type 1 Diabetes Mellitus GVOKE VialDx Table 5 presents the pharmacodynamic properties of another glucagon product after intravenous administration Table 5: Pharmacodynamic Properties of Another Glucagon Product After Intravenous Administration a Dose is determined based on the length of the procedure Route of Administration Dose a Time of Maximal Glucose Concentration Time of Onset of Action for GI Smooth Muscle Relaxation Duration of Smooth Muscle Relaxation Intravenous 0.25 to 0.5 mg 5 to 20 minutes 45 seconds 9 to 17 minutes Figure 1 Figure 2

12.3Pharmacokinetics Absorption Subcutaneous injection of 1 mg GVOKE in adult type 1 diabetes mellitus patients resulted in a mean glucagon C max of 2481.3 pg/mL, t max of 50 minutes and AUC 0‑240min of 3454.6 pg*min/mL.See Figure 3 . Figure 3: : Plasma Glucagon Concentration (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of 1 mg of GVOKE in Adults with Type 1 Diabetes Mellitus Distribution The apparent volume of distribution was in the range of 137-2425 L.

Elimination The half-life of GVOKE was determined to be 32 minutes. Metabolism Glucagon is extensively degraded in liver, kidney, and plasma. Excretion Urinary excretion of intact glucagon has not been measured.

Specific Populations Pediatrics Subcutaneous injection of 0.5 mg GVOKE in patients with type 1 diabetes mellitus ages 2 to under 6 years resulted in a mean glucagon C max of 2300 pg/mL, t max of 41 minutes, and AUC 0‑180min of 138900 pg/mL*min. Subcutaneous injection of 0.5 mg GVOKE in patients with type 1 diabetes ages 6 to under 12 years resulted in a mean C max of 1600 pg/mL, median t max of 34 minutes and AUC 0‑180min of 104700 pg/mL*min. Subcutaneous injection of 1 mg GVOKE in patients with type 1 diabetes ages 12 to less than 18 years resulted in a mean C max of 1900 pg/mL, t max of 51 minutes AUC 0‑180min of 134300 pg/mL*min.

Mean plasma glucagon levels were similar across the age groups following age appropriate doses of GVOKE. See Figure 4 . Figure 4: Plasma Glucagon Concentration (mean ± standard error of the mean) vs.

Time After Subcutaneous Administration of GVOKE in Pediatric Patients with Type 1 Diabetes Mellitus Figure 3 Figure 4

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

16 HOW SUPPLIED/STORAGE AND HANDLING GVOKE glucagon injection is supplied as a clear, colorless to pale yellow solution in the following configurations: Strength Package Size NDC number For Subcutaneous Use 0.5 mg per 0.1 mL 1 single-dose Gvoke HypoPen auto-injector 72065-120-11 0.5 mg per 0.1 mL 2 single-dose Gvoke HypoPen auto-injectors 72065-120-12 1 mg per 0.2 mL 1 single-dose Gvoke HypoPen auto-injector 72065-121-11 1 mg per 0.2 mL 2 single-dose Gvoke HypoPen auto-injectors (HypoPen) 72065-121-12 1 mg per 0.2 mL 1 single-dose GVOKE PFS pre-filled syringe 72065-131-11 1 mg per 0.2 mL 2 single-dose GVOKE PFS pre-filled syringes 72065-131-12 1 mg per 0.2 mL 1 single-dose GVOKE Kit vial and syringe kit 72065-140-11 For Intravaneous Use 1 mg per 0.2 mL 1 single-dose GVOKE VialDx vial 0517-2901-01 1 mg per 0.2 mL 10 single-dose GVOKE VialDx vials 0517-2901-10 Store GVOKE HypoPen, GVOKE PFS, and GVOKE Kit (these three presentations are referred to as GVOKE in this labeling), and GVOKE VialDx at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Do not refrigerate or freeze. Do not expose to extreme temperatures. Store the GVOKE HypoPen and GVOKE PFS in the original sealed foil pouch until time of use Store the GVOKE Kit vial and pouched syringe together in original carton until time of use.

Store GVOKE VialDx vials in original carton until time of use. Discard any unused portion

📋 Description ~1 min read ▾

11 DESCRIPTION Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis.

Its molecular formula is C 153 H 225 N 43 O 49 S with the following structure: GVOKE HypoPen, GVOKE PFS, and GVOKE Kit GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent.

GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent. GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent. GVOKE VialDx GVOKE VialDx (glucagon) injection is a clear, colorless to pale yellow, sterile solution for intravenous injection available in 1 mg per 0.2 mL vial.

Each 0.2 mL of GVOKE VialDx contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent prior to dilution with 0.9% Sodium Chloride [for dilution instructions, see Dosage and Administration ( 2.2) ] . The diluted solution contains 0.45 mg per mL glucagon, 5 mg per mL trehalose dihydrate, 93.2 mg per mL dimethyl sulfoxide, 2.6 mg per mL mannitol, and 0.60 mg per mL 1 N sulfuric acid. Its molecular formula is C153H225N43O49S with the following structure:

💬 Patient Medication Information ~3 min read ▾

Gvoke Patient Package Insert PATIENT INFORMATION GVOKE® (Gee-voke) (glucagon) injection, for subcutaneous use GVOKE (Gee-voke) VialDx TM (glucagon) injection, for intravenous use What is GVOKE? GVOKE is a prescription medicine used: • to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 2 years and older. It is not known if GVOKE is safe and effective in children under 2 years of age.

What is GVOKE VialDx? GVOKE VialDx is a prescription medicine used: • to stop stomach movement (gastrointestinal motility inhibitor) in adults receiving radiology exams. It is not known if GVOKE VialDx is safe and effective in children.

Do not use GVOKE or receive Gvoke VialDx if you : • have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma. • have a tumor in your pancreas called insulinoma. • have had an allergic reaction to glucagon or any of the ingredients in GVOKE, or Gvoke VialDx. See the end of this Patient Information leaflet for a complete list of ingredients in GVOKE and Gvoke VialDx. Do not receive GVOKE VialDx if you: : • have tumors in your pancreas called Glucagonomas Before using GVOKE or receiving Gvoke VialDx, tell your healthcare provider about all of your medical conditions, including if you: • have adrenal gland problems. • have a tumor in your pancreas. • have not had food or water for a long time (prolonged fasting or starvation). • have low blood sugar that does not go away (chronic hypoglycemia). • have diabetes mellitus • have heart problems • are pregnant or plan to become pregnant.

It is not known if GVOKE or GVOKE VialDx will harm your unborn baby • are breastfeeding or plan to breastfeed. It is not known if GVOKE passes into your breast milk. You and your healthcare provider should decide if you can use GVOKE while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GVOKE and Gvoke VialDx may affect the way other medicines work, and other medicines may affect how GVOKE and Gvoke VialDx works. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use GVOKE? • Read the detailed Instructions for Use that comes with GVOKE. • Use GVOKE exactly how your healthcare provider tells you to use it. • Make sure your relatives, close friends, and caregivers know where you store GVOKE and how to use it the right way before you need their help. • Act quickly. Having very low blood sugar for a period of time may be harmful. • After giving GVOKE, your caregiver should call for emergency medical help right away. • When you are able to safely swallow food or drink, your caregiver should give you a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers and cheese or a meat sandwich). • If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.

Tell your healthcare provider each time you use GVOKE. Low blood sugar may happen again after receiving an injection of GVOKE. Your diabetes medicine may need to be changed.

How will I receive Gvoke VialDx? • GVOKE VialDx will be given by a healthcare provider through a needle placed in your vein (IV infusion). What are the possible side effects of GVOKE and Gvoke VialDx? GVOKE and Gvoke VialDx may cause serious side effects, including: • high blood pressure.

GVOKE and Gvoke VialDx can cause high blood pressure in certain people with tumors in their adrenal glands. • low blood sugar. GVOKE and Gvoke VialDx can cause low blood sugar in people with certain tumors in their pancreas called insulinomas by making too much insulin in their bodies. Signs and symptoms of low blood sugar may include: o sweating o drowsiness o dizziness o sleep disturbances o irregular heartbeat o anxiety o tremor o blurred vision o hunger o slurre…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72065-0121-11 · Xeris 72065-0140-11 · Xeris →
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.