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Baqsimi glucagon 3 mg Powder, 2 tubes — NDC 00548-8352-02 package photo

Baqsimi glucagon 3 mg Powder, 2 tubes

by Amphastar Pharmaceuticals, Inc. · 2 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE
NDC 00548-8352-02
🏷️ FDA NDC (as labeled) 0548-8352-02 billing pads the labeler 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

⚠️
Other active recalls for Glucagon (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 23, 2026 — CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. (Lupin Pharmaceuticals Inc.) · FDA recall D-0723-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0548-8352-02
Product NDC 0548-8352
11-digit billing NDC 00548835202
NCPDP billing unit EA — each (per item)
RxCUI 2180666, 2180671
UNII 76LA80IG2G
Application # NDA210134
SPL Set ID f1f5df9b-872f-44e5-a18f-f0b68e7e9254
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 2019-07-24
Route NASAL
Dosage form POWDER
Substance GLUCAGON
GPI-14 27300010002920
GCN Seq No 080054
GCN 46726
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 BAQSIMI 3 MG SPRAY TWO PACK
FDB brand name Baqsimi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0548-8352-02 — a 4-4-2 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 labeler segment → 00548-8352-02. 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

LabelerAmphastar Pharmaceuticals, Inc.
Application holderAMPHASTAR PHARMACEUTICALS INC
FDA applicationNDA210134 (NDA)
Labeler code00548
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio24 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 BAQSIMI 3 MG SPRAY TWO PACK Ingredient Glucagon
📖 What it is MedlinePlus · NLM

Glucagon nasal powder is used along with emergency medical treatment to treat very low blood sugar in adults and children 4 years of age and older who have diabetes. Glucagon nasal powder is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Baqsimi is for severe low blood sugar emergencies — times when the person is unconscious, having a seizure, or so confused they can't safely eat or drink. Use it right away when yo...
  • When exactly should I use Baqsimi — and when should I call 911?
  • It's designed to be simple. Just take the device out of the tube, hold it under the person's nose, insert the tip into one nostril, and press the plunger all the way in until the g...
  • How do I actually give this? Is it hard to use?
📖 Read our full Glucagon Nasal Powder guide →
1
Nutrient depletion considerations

Glucagon may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Glucagon nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 24 mg UNII JV039JZZ3A
    Betadex is a modified sugar molecule derived from starch. It acts as a solubilizer and stabilizer in medicines, helping dissolve poorly soluble drugs and keep them stable during storage.
  • 3 mg UNII M5CF6282DD
    A synthetic surfactant (detergent-like molecule) derived from dodecanol and phosphocholine. It helps dissolve and stabilize active ingredients in liquid or semi-solid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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 eaPer package
Retail pharmacies payNADAC · weekly $293.832 $587.66 / 2 powder
Medicaid paysCMS SDUD · 12 mo $286.52 $573.04 / 2 powder
Medicare drug plans payPart D · Q2 2026 $295.43 $590.86 / 2 powder
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 Mar 2026 May 2026 $293.832 $285.211
▲ Up 3% over the last 5 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
Baqsimi 3 mg 00548-8351-01 Amphastar 1 tube $293.388 — Availability likely +0%
Baqsimi 3 mgthis 00548-8352-02 Amphastar 2 tubes $293.832 — Availability likely —
Baqsimi 3 mg 85766-0212-03 Sportpharm 1 tube — — FDA listed —
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
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2039
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 Sep 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 24, 2019 RLD RS ⏳ ~13 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 10213487 — method of use (U-2604)
US 12370241 — method of use (U-2604)
US 10765602 — drug product
Exclusivity NPP
2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
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 (3)
PatentTypeUse codeExpires
US 10213487 ↗ Method of use U-2604 Feb 16, 2036
US 12370241 ↗ Method of use U-2604 Feb 16, 2036
US 10765602 ↗ Drug product — Sep 23, 2039
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationMar 17, 2028
Common questions
Is there a generic version of BAQSIMI 3 MG SPRAY TWO PACK?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BAQSIMI 3 MG SPRAY TWO PACK. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2039 — 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 00548-8352-02, 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
96.4K
Units reimbursed last 4 qtrs
194.5K
Gross reimbursed last 4 qtrs
$55.72M
Avg / prescription
$578.16
Avg / unit
$286.52
Latest quarter Q4 2025
22KRx
Medicaid pays / ea
$286.52
gross reimbursed
vs
NADAC / ea
$293.83
acquisition cost
=
Spread
−$7.3134
-2% vs cost
What Medicaid paid per ea (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 ⓘ
39% FFS 61% MCO
Fee-for-service · 37,362 Rx Managed care · 59,009 Rx
State Medicaid map
Alaska: 677 units · 92.4 per 100k residents AK Maine: 1,395 units · 100 per 100k residents ME Washington: 2,230 units · 28.5 per 100k residents WA Idaho: 968 units · 49.3 per 100k residents ID Montana: 975 units · 86.1 per 100k residents MT North Dakota: 204 units · 26.1 per 100k residents ND Minnesota: 3,856 units · 67.2 per 100k residents MN Wisconsin: 4,068 units · 68.8 per 100k residents WI Michigan: 8,951 units · 89.2 per 100k residents MI New York: 12,190 units · 62.3 per 100k residents NY Vermont: 440 units · 68.0 per 100k residents VT New Hampshire: 813 units · 58.0 per 100k residents NH Oregon: 3,039 units · 71.8 per 100k residents OR Nevada: 659 units · 20.6 per 100k residents NV Wyoming: 237 units · 40.6 per 100k residents WY South Dakota: 415 units · 45.2 per 100k residents SD Iowa: 854 units · 26.6 per 100k residents IA Illinois: 3,025 units · 24.1 per 100k residents IL Indiana: 4,616 units · 67.3 per 100k residents IN Ohio: 14,108 units · 120 per 100k residents OH Pennsylvania: 16,017 units · 124 per 100k residents PA New Jersey: 5,552 units · 59.8 per 100k residents NJ Massachusetts: 7,016 units · 100 per 100k residents MA California: 26,416 units · 67.8 per 100k residents CA Utah: 819 units · 24.0 per 100k residents UT Colorado: 1,932 units · 32.9 per 100k residents CO Nebraska: 1,307 units · 66.1 per 100k residents NE Missouri: 3,750 units · 60.5 per 100k residents MO Kentucky: 4,566 units · 101 per 100k residents KY West Virginia: 2,022 units · 114 per 100k residents WV Virginia: 4,543 units · 52.1 per 100k residents VA Maryland: 4,027 units · 65.2 per 100k residents MD Connecticut: 4,544 units · 126 per 100k residents CT Rhode Island: 692 units · 63.2 per 100k residents RI Arizona: 645 units · 8.7 per 100k residents AZ New Mexico: 1,365 units · 64.6 per 100k residents NM Kansas: 333 units · 11.3 per 100k residents KS Arkansas: 1,382 units · 45.1 per 100k residents AR Tennessee: 2,458 units · 34.5 per 100k residents TN North Carolina: 6,437 units · 59.4 per 100k residents NC South Carolina: 1,922 units · 35.8 per 100k residents SC Delaware: 1,248 units · 121 per 100k residents DE Oklahoma: 1,974 units · 48.7 per 100k residents OK Louisiana: 4,920 units · 108 per 100k residents LA Mississippi: 1,005 units · 34.2 per 100k residents MS Alabama: 2,696 units · 52.8 per 100k residents AL Georgia: 755 units · 6.8 per 100k residents GA D.C.: 452 units · 66.6 per 100k residents DC Hawaii: 160 units · 11.1 per 100k residents HI Texas: 7,392 units · 24.2 per 100k residents TX Florida: 11,337 units · 50.1 per 100k residents FL
Units reimbursed · per 100k residents
6.8126
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 Connecticut 126 /100k
2 Pennsylvania 124 /100k
3 Delaware 121 /100k
4 Ohio 120 /100k
5 West Virginia 114 /100k
6 Louisiana 108 /100k
7 Kentucky 101 /100k
8 Massachusetts 100 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Baqsimi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Baqsimi. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.9M
Claims incl. refills
17.1K
Beneficiaries
14.6K
Spend / beneficiary
$610.50
Spend / claim
$520.88
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Baqsimi (this brand).

Top reported reactions

Dyspnoea367
Acute Kidney Injury320
Hypotension293
Hypoglycaemia272
Condition Aggravated253
Toxicity To Various Agents238
Nausea231

Age at onset

Neonate13
Infant10
Child11
Adolescent28
Adult354
Elderly266

Reporter sex

4,118 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization1,987
Death666
Disabling136
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 316 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
00548-8352-02 You're viewing this 2 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE 2024-02-07 Active

📄 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 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 53 words ▾

1 INDICATIONS AND USAGE BAQSIMI™ is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. BAQSIMI ® is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION BAQSIMI is for intranasal use only. ( 2.1 ) The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril. ( 2.2 ) Administer BAQSIMI according to the printed instructions on the shrink-wrapped tube label and the Instructions for Use.

( 2.1 ) Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line is no longer showing. The dose does not need to be inhaled. ( 2.1 ) Call for emergency assistance immediately after administering the dose.

( 2.1 ) When the patient responds to treatment, give oral carbohydrates. ( 2.1 ) Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot be reused.

Discard any unused portion. ( 2.1 ) If there has been no response after 15 minutes, an additional 3 mg dose may be administered while waiting for emergency assistance. ( 2.2 )

2.1Important Administration Instructions BAQSIMI is for intranasal use only. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires help of others to recover, instruct the patient to inform those around them about BAQSIMI and its Instructions for Use.

Administer BAQSIMI 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 BAQSIMI. Emphasize the following instructions to the patient or caregiver: Do not push the plunger or test the device prior to administration.

Administer BAQSIMI according to the printed instructions on the shrink-wrapped tube label and the Instructions for Use. Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line is no longer showing. The dose does not need to be inhaled.

Call for emergency assistance immediately after administering the dose. If there has been no response after 15 minutes, an additional dose of BAQSIMI may be administered while waiting for emergency assistance. When the patient responds to treatment, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia.

Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot be reused. Discard any unused portion.

2.2Dosage in Adults and Pediatric Patients Aged 1 Year and Older The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril. If there has been no response after 15 minutes, an additional 3 mg dose of BAQSIMI from a new device may be administered while waiting for emergency assistance.

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal Powder: 3 mg glucagon: as a white powder in an intranasal device containing one dose of glucagon Nasal powder: intranasal device containing one dose of glucagon 3 mg ( 3 )

⛔ Contraindications 97 words ▾

4 CONTRAINDICATIONS BAQSIMI is 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 BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Known hypersensitivity to glucagon or to any of the excipients ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Substantial Increase in Blood Pressure in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because BAQSIMI 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, BAQSIMI may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

( 5.2 ) Serious Hypersensitivity Reactions : Serious hypersensitivity reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. ( 5.3 ) Lack of Efficacy in Patients with Decreased Hepatic Glycogen : BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective.

Patients with these conditions should be treated with glucose. ( 5.4 )

5.1Substantial Increase in Blood Pressure in Patients with Pheochromocytoma BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate 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, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma [see Contraindications ( 4 )]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, 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 BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions.

BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications ( 4 )].

5.4Lack of Efficacy in Patients with Decreased Hepatic Glycogen Patients with insufficient hepatic stores of glycogen may not respond to BAQSIMI for the treatment of severe hypoglycemia [see Clinical Pharmacology ( 12.2 )]. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described 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 in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] . Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, itchy nose, throat and eyes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 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 BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflect the rates observed in practice. Adverse Reactions in Adult Patients Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single intranasal dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes [see Clinical Studies ( 14.1 )].

Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and Study 2. Table 1: Pooled Adverse Reactions (≥2%) in Adult Patients with Type 1 and Type 2 Diabetes in Study 1and Study 2 a Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis. Adverse Reaction BAQSIMI 3 mg (N=153) % Nausea 26 Headache 18 Vomiting 15 Upper Respiratory Tract Irritation a 12 Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in Study 1 and 2 and these adverse reactions are presented in Table 2 .

Table 2: Solicited Nasal and Non-Nasal Adverse Reactions in Adult Patients with Type 1 and Type 2 Diabetes Pooled from Study 1 and 2 a Patients were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. Adverse Reaction a BAQSIMI 3 mg (n=153) % Any increase in symptom severity a Watery eyes 59 Nasal congestion 43 Nasal itching 39 Runny nose 35 Redness of eyes 25 Itchy eyes 22 Sneezing 20 Itching of throat 12 Itching of ears 3 Adverse Reactions in Pediatric Patients Aged 1 Year and Above A single dose of BAQSIMI was compared to weight-based doses of 0.5 mg or 1 mg of IMG in pediatric patients aged 4 to less than 17 years with type 1 diabetes in Study 3 [see Clinical Studies ( 14.2 )].

Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of ≥2% in Study 3. Table 3: Adverse Reactions (≥2%) Occurring in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3 a Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing. Adverse Reaction BAQSIMI 3 mg (n=36) % Vomiting 31 Headache 25 Nausea 17 Upper Respiratory Tract Irritation a 17 Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in pediatric patients in Study 3 and these adverse reactions are presented in Table 4 .

Table 4: Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3 a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. Adverse Reaction a BAQSIMI 3 mg (n=36) % Any increase in symptom severity a Watery eyes 47 Nasal congestion 42 Nasal itching 28 Runny nose 25 Sneezing 19 Itchy eyes 17 Redness of eyes 14 Itching of throat 3…

🔄 Drug Interactions 103 words ▾

7 DRUG INTERACTIONS Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin : In patients taking indomethacin BAQSIMI may lose its ability to raise glucose or may produce hypoglycemia. ( 7.2 ) Warfarin : BAQSIMI may increase the anticoagulant effect of warfarin. ( 7.3 )

7.1Beta-blockers Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.

7.2Indomethacin In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia.

7.3Warfarin BAQSIMI may increase the anticoagulant effect of warfarin.

👥 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 BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 1 year and older. Use of BAQSIMI for this indication is supported by evidence from an adequate and well-controlled study in adults with type 1 diabetes mellitus [see Clinical Studies ( 14.1 )] , a study in 48 pediatric patients aged 4 to less than 17 years with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] , and additional pharmacokinetic and safety data from a study of seven pediatric patients aged 1 to less than 4 years with type 1 diabetes mellitus [see Adverse Reactions ( 6.1 ),Clinical Pharmacology ( 12.2 , 12.3 ), and Clinical Studies ( 14.2 )] .

The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 1 year of age.

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

🤰 Pregnancy 194 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 BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 1 year and older. Use of BAQSIMI for this indication is supported by evidence from an adequate and well-controlled study in adults with type 1 diabetes mellitus [see Clinical Studies ( 14.1 )] , a study in 48 pediatric patients aged 4 to less than 17 years with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] , and additional pharmacokinetic and safety data from a study of seven pediatric patients aged 1 to less than 4 years with type 1 diabetes mellitus [see Adverse Reactions ( 6.1 ),Clinical Pharmacology ( 12.2 , 12.3 ), and Clinical Studies ( 14.2 )] .

The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 1 year of age.

🧓 Geriatric Use 28 words ▾

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

🆘 Overdosage 96 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 levels 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 BAQSIMI, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendation.

🧬 Clinical Pharmacology ~2 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.

12.2Pharmacodynamics After administration of BAQSIMI in adult patients with diabetes, the mean maximum glucose increase from baseline was 140 mg/dL ( Figure 1 ). In pediatric patients aged 1 to less than 17 years with type 1 diabetes, the mean maximum glucose increase from baseline was 132 mg/dL (1 to less than 4 years), 138 mg/dL (4 to less than 8 years), 133 mg/dL (8 to less than 12 years), and 102 mg/dL (12 to less than 17 years) ( Figure 2 ). Sex and body weight had no clinically meaningful effects on the pharmacodynamics of BAQSIMI.

Common cold with nasal congestion tested with or without use of decongestant did not impact pharmacodynamics of BAQSIMI. Figure 1 Mean glucose concentration over time after glucagon dose in adult Type 1 Diabetes patients with insulin-induced hypoglycemia. Fi gure 2 Mean glucose concentration over time in pediatric Type 1 Diabetes patients administered BAQSIMI figure1 figure2

12.3Pharmacokinetics Absorption Glucagon absorption via the intranasal route, achieved mean peak plasma levels of 6130 pg/mL at around 15 minutes. Distribution The apparent volume of distribution was approximately 885 L. Elimination The median half-life was approximately 35 minutes.

Metabolism Glucagon is known to be degraded in the liver, kidneys, and plasma. Specific Populations Pediatrics In pediatric patients (aged 1 to less than 17 years), glucagon via the intranasal route, achieved mean peak plasma levels between 10 and 20 minutes. The median half-life was 21 to 31 minutes.

Patients with Colds Common cold with nasal congestion did not impact the pharmacokinetics of BAQSIMI. Drug Interaction Studies Common cold with use of decongestant did not impact the pharmacokinetics of BAQSIMI.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of anti-drug antibodies in other studies, including those of glucagon or of other glucagon products. In 3 clinical trials, 3/124 (2%) of BAQSIMI-treated patients had treatment-emergent ADAs as detected by an affinity capture elution (ACE) ligand-binding immunogenicity assay.

No neutralizing antibodies were detected. Because of the low occurrence of ADA, the effect of these antibodies on the pharmacokinetics, pharmacodynamics, and/or effectiveness of BAQSIMI is unknown.

🧬 Mechanism of Action 38 words ▾

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.

📦 How Supplied / Storage and Handling 94 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, white powder. BAQSIMI One Pack carton contains 1 intranasal device (NDC 0548-8351-01) BAQSIMI Two Pack carton contains 2 intranasal devices (NDC 0548-8352-02) Store at temperatures up to 86°F (30°C) in the shrink wrapped tube provided. Keep BAQSIMI in the shrink wrapped tube until ready to use.

If the tube has been opened, BAQSIMI may have been exposed to moisture and may not work as expected. Discard BAQSIMI and tube after use.

📋 Description 89 words ▾

11 DESCRIPTION BAQSIMI contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single-chain polypeptide containing 29 amino acid residues and has a molecular weight of 3483, and is identical to human glucagon. Its molecular formula is C 153 H 225 N 43 O 49 S, with the following molecular structure: BAQSIMI is a preservative-free, white powder for intranasal administration in an intranasal device containing one dose of 3 mg glucagon.

BAQSIMI contains glucagon as the active ingredient and betadex, and dodecylphosphocholine as the excipients. structure

💬 Information for Patients 110 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and family members or caregivers to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Recognition of Severe Hypoglycemia: Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia. Serious Hypersensitivity Reactions: Inform patients that serious hypersensitivity reactions can occur with BAQSIMI.

Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] . Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730, USA.

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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