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Saxenda liraglutide 6 mg/mL Injection, Solution — NDC 00169-2800-97 package photo

Saxenda liraglutide 6 mg/mL Injection, Solution

by Novo Nordisk Pharmaceutical Industries, LP · 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC
NDC 00169-2800-97
🏷️ FDA NDC (as labeled) 0169-2800-97 billing pads the labeler segment with a zero
This package
Contains3 mL in 1 syringe, plastic Pack sizes3 compare ↓
Also comes in: 3 mL 00169-2800-90 5 syringes 00169-2800-15
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 Liraglutide (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 · Apr 24, 2026 — Presence of particulate matter: a white thread-like structure in the cartridge (Lupin Pharmaceuticals Inc.) · FDA recall D-0541-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0169-2800-97
Product NDC 0169-2800
11-digit billing NDC 00169280097
RxCUI 1598268, 2735350
UNII 839I73S42A
Application # NDA206321
SPL Set ID 3946d389-0926-4f77-a708-0acb8153b143
Established class (EPC) GLP-1 Receptor Agonist
Mechanism of action Glucagon-like Peptide-1 (GLP-1) Agonists
Chemical class Glucagon-Like Peptide 1
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-12-31
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance LIRAGLUTIDE
GPI-14 6125205000D220
GPI class Saxenda
GCN Seq No 073258
GCN 37637
HICL code 036436
Ingredient (HICL) Liraglutide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8E
Therapeutic class — specific (HIC3) Anti-Obesity Glucagon-Like Peptide-1 Recep Agonist
AHFS code 28:20.08.92
AHFS class Anorexigenic Agents, Miscellaneous
FDB label name SAXENDA 18 MG/3 ML PEN
FDB brand name Saxenda
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP2 · RLD · RS
Why two NDCs? The FDA registers this code as 0169-2800-97 — 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 → 00169-2800-97. 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 GLP-1 Receptor Agonist class.

Pharmacologic class GLP-1 Receptor Agonist
Drug family (ATC) Insulins and analogues for injection, long-acting, Glucagon-like peptide-1 (GLP-1) analogues
How it works Glucagon-like Peptide-1 (GLP-1) Agonists
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

LabelerNovo Nordisk Pharmaceutical Industries, LP
Application holderNOVO NORDISK INC
FDA applicationNDA206321 (NDA)
Labeler code00169
First marketedDec 2014
Product typeHuman Prescription Drug
Portfolio31 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 SAXENDA 18 MG/3 ML PEN Ingredient Liraglutide
📖 What it is MedlinePlus · NLM

Liraglutide injection is used for the following: to control blood sugar levels in certain patients with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). to reduce the risk of a heart attack, stroke, or death in adults with type 2 diabetes and heart and blood vessel disease. to assist with weight loss in certain people who are obese or overweight and have weight-related medical problems. Liraglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Saxenda is a daily injectable medication that works by mimicking a hormone called GLP-1, which your body naturally makes after eating. It helps reduce your appetite, makes you feel...
  • What exactly is Saxenda and how is it different from other weight-loss options?
  • Yes, nausea is the most common side effect, and it's especially common in the first few weeks. That's actually why your prescriber starts you at a low dose and slowly increases it...
  • The nausea is really bothering me — is that normal, and will it get better?
📖 Read our full Liraglutide Injection guide →
1
Nutrient depletion considerations

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

🧪 Full Liraglutide 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.

  • 5.5 mg / 1 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • 14 mg / 1 mL UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 1.42 mg / 1 mL UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3 mL 5 syringes
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
Liraglutide 6 mg/mL 71288-0563-84 Meitheal 3 syringes $32.002 AP1 Availability likely —
Liraglutide 6 mg/mL 00143-9144-02 Hikma 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 70748-0346-02 Lupin 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 70377-0094-52 Biocon 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 72603-0745-02 NorthStar 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 69097-0920-67 Cipla 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 00480-3667-20 Teva 2 syringes $33.818 AP1 Availability likely —
Liraglutide 6 mg/mL 00480-7250-46 Teva 5 syringes $47.695 AP2 Availability likely —
liraglutide 6 mg/mL 69097-0910-55 Cipla 5 syringes $47.695 AP2 Availability likely —
Victoza 6 mg/mL 00169-4060-12 Novo 2 syringes $87.742 AP1 Availability likely —
Saxenda 6 mg/mLthis 00169-2800-97 Novo 1 syringe — AP2 FDA listed —
Saxenda 6 mg/mL 50090-4257-00 A-S 5 syringes — AP2 FDA listed —
Liraglutide 6 mg/mL 70377-0095-52 Biocon 3 syringes — AP2 FDA listed —
liraglutide 6 mg/mL 81607-0019-01 Orbicular 3 syringes — AP2 FDA listed —
Victoza 6 mg/mL 50090-2853-00 A-S 3 syringes — AP1 FDA listed —
Victoza 6 mg/mL 50090-4503-00 A-S 3 syringes — AP1 FDA listed —
Liraglutide 6 mg/mL 50090-7501-00 A-S 3 syringes — AP1 FDA listed —
Liraglutide 6 mg/mL 81607-0018-01 Orbicular 3 syringes — AP1 FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2014
First FDA approval
Dec 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 23, 2014 AP2 TE-rated RLD RS ⏳ ~10.8 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 9968659 — method of use (U-2438)
US 8114833 — drug product
US 8114833*PED — drug product
US 9968659*PED — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036
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 (4)
PatentTypeUse codeExpires
US 9968659 ↗ Method of use U-2438 Jan 9, 2037
US 8114833 ↗ Drug product — Aug 13, 2025
US 8114833*PED ↗ Drug product — Feb 13, 2026
US 9968659*PED ↗ Drug product — Jul 9, 2037
Common questions
Is there a generic version of SAXENDA 18 MG/3 ML PEN?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SAXENDA 18 MG/3 ML PEN. See the alternatives section for substitutable, lower-cost products.
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 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.
5 syringes00169-2800-15 22,538 Rx · $26,719,539
1 syringe00169-2800-90 No Medicaid data
1 syringe this page00169-2800-97 No Medicaid data
Drug total (last 4 qtrs): 22,538 Rx · 309,090 units · $26,719,539 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Liraglutide (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ 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 Liraglutide. CMS lists 3 products for this generic; we show the highest-spend one. 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
$19.11M
Claims incl. refills
44.1K
Beneficiaries
28.1K
Spend / beneficiary
$680.06
Spend / claim
$433.77
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 Liraglutide — the ingredient across all brands.

Top reported reactions

Nausea7,295
Blood Glucose Increased4,092
Vomiting3,601
Diarrhoea3,462
Pancreatitis2,354
Decreased Appetite2,159
Weight Decreased2,158

Age at onset

Neonate21
Infant4
Child8
Adolescent15
Adult8,916
Elderly3,676

Reporter sex

50,704 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization11,388
Death1,854
Life-threatening1,508
Disabling764
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,247 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 Per unit Per pack Marketing startStatus
00169-2800-15 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC $87.14 / mL $1,307.06 2015-01-19 Active
00169-2800-90 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 3 mL in 1 SYRINGE, PLASTIC — — 2015-01-19 Active
00169-2800-97 You're viewing this 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTIC — — 2015-01-19 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00169-2800-97?
NDC 00169-2800-97 is listed by the FDA — 1 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic.
What NDC number is used to bill for this package of Saxenda liraglutide 6 mg/mL Injection, Solution?
Bill NDC 00169-2800-97 — the 11-digit billing format is 00169280097. 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.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0169-2800-97, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00169-2800-97, written without dashes as 00169280097. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00169-2800-97, the first segment (00169) is the labeler code FDA assigned to Novo Nordisk Pharmaceutical Industries, LP; the middle segment (2800) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (97) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Novo Nordisk Pharmaceutical Industries, LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 syringe (00169-2800-90), 5 syringes (00169-2800-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Novo Nordisk Pharmaceutical Industries, LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether SAXENDA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • SAXENDA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Counsel patients regarding the potential risk of MTC with use of SAXENDA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with SAXENDA [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.

It is unknown whether SAXENDA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 ). • SAXENDA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 , 13.1 ).

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. • Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use • SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.

SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

( 1 ) • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals. ( 2.1 ) • The recommended dose of SAXENDA is 3 mg daily. ( 2.2 ) • Initiate at 0.6 mg per day for one week.

In weekly intervals, increase the dose until a dose of 3 mg is reached. ( 2.2 ) • If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level. Dose escalation for pediatric patients may take up to 8 weeks.

( 2.2 ) • Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily. ( 2.2 ) • Adult patients with type 2 diabetes should monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment. ( 2.2 )

2.1Important Administration Instructions • Prior to initiation of SAXENDA, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inspect SAXENDA visually prior to each injection. Only use if solution is clear, colorless, and contains no particles. • Administer SAXENDA in combination with a reduced-calorie diet and increased physical activity. • Inject SAXENDA subcutaneously once daily at any time of day, without regard to the timing of meals. • Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm.

No dosage adjustment is needed if changing the injection site and/or timing. • Rotate injection sites within the same region in order to reduce the risk of cutaneous amyloidosis [see Adverse Reactions ( 6.2) ] . • If a dose is missed, resume the once-daily regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose. • If more than 3 days have elapsed since the last SAXENDA dosage, reinitiate SAXENDA at 0.6 mg daily and follow the dosage escalation schedule in Table 1 , to reduce the risk of gastrointestinal adverse reactions associated with reinitiation of treatment.

2.2Dosage in Adults and Pediatric Patients Aged 12 Years and Older • Initiate SAXENDA with a dose of 0.6 mg daily for one week. Then follow the dosage escalation schedule in Table 1 to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.1 )]. Table 1.

Dosage Escalation Schedule Week Daily Dose 1 0.6 mg 2 1.2 mg 3 1.8 mg 4 2.4 mg 5 and onward 3 mg Adult Patients • For adults, the recommended dosage of SAXENDA is 3 mg daily, lower dosages are for titration only. • Discontinue SAXENDA if the patient cannot tolerate the 3 mg dosage. • If patients do not tolerate an increased dose during dosage escalation, consider delaying dosage escalation for approximately one additional week. • Evaluate the change in body weight 16 weeks after initiating SAXENDA and discontinue SAXENDA if the patient has not lost at least 4% of baseline body weight, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. • In adult patients with type 2 diabetes, monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment.

Pediatric Patients • For pediatric patients, the recommended maintenance dosage of SAXENDA is 3 mg daily. Pediatric patients who do not tolerate 3 mg daily may have their maintenance dose reduced to 2.4 mg daily. Discontinue SAXENDA if the patient cannot tolerate the 2.4 mg dose. • If pediatric patients do not tolerate an increased dose during dosage escalation, the dose may also be lowered to the previous level.

Dosage escalation for pediatric patients may take up to 8 weeks. • Evaluate the change in BMI after 12 weeks on the maintenance dose and discontinue SAXENDA if the patient has not had a reduction in BMI of at least 1% from baseline, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 6 mg/mL clear, colorless solution in a 3 mL prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg. Injection: 6 mg/mL solution in a 3 mL prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg. ( 3 )

⛔ Contraindications 105 words ▾

4 CONTRAINDICATIONS SAXENDA is contraindicated in: • Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )]. • Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in SAXENDA. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with SAXENDA [see Warnings and Precautions ( 5.8 )]. • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

( 4 ) • Hypersensitivity to liraglutide or any excipients in SAXENDA. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including SAXENDA. Discontinue if pancreatitis is suspected. ( 5.2 ) • Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.

( 5.3 ) • Hypoglycemia: Can occur in adults when SAXENDA is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes.

Hypoglycemia occurred in SAXENDA-treated pediatric patients. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.4 ) • Heart Rate Increase: Monitor heart rate at regular intervals.

( 5.5 ) • Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.6 ) • Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. SAXENDA is not recommended in patients with severe gastroparesis.

( 5.7 ) • Hypersensitivity Reactions: Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue SAXENDA and other suspect medications and promptly seek medical advice. ( 5.8 ) • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures.

Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 )

5.1Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see Nonclinical Toxicology ( 13.1 )] . Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether SAXENDA will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans. SAXENDA is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of SAXENDA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with SAXENDA. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC, and patients with MTC usually have calcitonin values greater than 50 ng/L.

If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including liraglutide [see Adverse Reactions ( 6 )] . After initiation of SAXENDA, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue SAXENDA and…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] • Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions ( 5.4 )] • Heart Rate Increase [see Warnings and Precautions ( 5.5 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.6 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.7 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions, reported in greater than or equal to 5% are: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-844-363-4448 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. SAXENDA was evaluated for safety in 5 double-blind, placebo controlled trials that included 3,384 overweight or obese adult patients treated with SAXENDA for a treatment period up to 56 weeks (3 trials), 52 weeks (1 trial), and 32 weeks (1 trial) and one trial of 56 weeks in 125 pediatric patients with obesity aged 12 years and older [see Clinical Studies ( 14.1 , 14.2 )].

All patients received study drug in addition to a reduced-calorie diet and increased physical activity counseling. In the adult trials, patients received SAXENDA for a mean treatment duration of 46 weeks (median, 56 weeks). Baseline characteristics included a mean age of 47 years, 71% female, 85% white, 39% with hypertension, 15% with type 2 diabetes, 34% with dyslipidemia, 29% with a BMI greater than 40 kg/m 2 , and 9% with cardiovascular disease.

In one of the 56-week trials, a subset of patients (with abnormal glucose measurements at randomization) [see Clinical Studies ( 14.1 )] were enrolled for a placebo-controlled 160-week period instead, followed by a 12-week off-treatment follow-up. For those participating in this 160-week period, patients received SAXENDA for a mean treatment duration of 110 weeks (median, 159 weeks). For all trials, dosing was initiated and increased weekly to reach the 3 mg dose.

In adult clinical trials, 9.8% of patients treated with SAXENDA and 4.3% of patients treated with placebo prematurely discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were nausea (2.9% versus 0.2% for SAXENDA and placebo, respectively), vomiting (1.7% versus less than 0.1%), and diarrhea (1.4% versus 0%). Adverse reactions reported in greater than or equal to 2% of SAXENDA-treated adult patients and more frequently than in placebo-treated patients are shown in Table 2 .

Adverse reactions reported in greater than or equal to 3% of SAXENDA-treated pediatric patients and more frequently than in placebo-treated patients are shown in Table 3 . Table 2. Adverse Reactions Occurring in ≥2% of SAXENDA-treated Adult Patients and More Frequently than Placebo Placebo N=1941 % SAXENDA N=3384 % Nausea 13.8

39.3Diarrhea 9.9

20.9Constipation 8.5

19.4Vomiting 3.9

15.7Injection Site Reaction 1 10.5

13.9Headache 12.6

13.6Hypoglycemia in T2DM 2 6.6

12.6Dyspepsia 2.7

9.6Fatigue 4.6

7.5 Dizziness 5

6.9Abdominal Pain 3.1

5.4Increased Lipase 2.2

5.3Upper Abdominal Pain 2.7…

🔄 Drug Interactions 81 words ▾

7 DRUG INTERACTIONS SAXENDA delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution. ( 7 )

7.1Oral Medications SAXENDA causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with SAXENDA.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue SAXENDA. ( 8.1 )

8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to SAXENDA during pregnancy. SAXENDA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm.

When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue SAXENDA (see Clinical Considerations ). Animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 3 mg/day.

In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryofetal risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy. Animal Data Liraglutide has been shown to be teratogenic in rats at or above 0.8-times systemic exposures in obese humans resulting from the maximum recommended human dose (MRHD) of 3 mg/day based on plasma area under the time-concentration curve (AUC) comparison.

Liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below exposure in obese humans at the MRHD based on plasma AUC comparison. Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the exposure in obese humans at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly.

Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day.

Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the exposure in obese humans at the MRHD of 3 mg/day at all doses, based on plasma AUC comparison. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), greater than or equal to 0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), greater than or equal to 0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels).

Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw,…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to SAXENDA during pregnancy. SAXENDA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm.

When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue SAXENDA (see Clinical Considerations ). Animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 3 mg/day.

In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryofetal risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy. Animal Data Liraglutide has been shown to be teratogenic in rats at or above 0.8-times systemic exposures in obese humans resulting from the maximum recommended human dose (MRHD) of 3 mg/day based on plasma area under the time-concentration curve (AUC) comparison.

Liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below exposure in obese humans at the MRHD based on plasma AUC comparison. Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the exposure in obese humans at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly.

Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day.

Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the exposure in obese humans at the MRHD of 3 mg/day at all doses, based on plasma AUC comparison. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), greater than or equal to 0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), greater than or equal to 0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels).

Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. Visce…

🧒 Pediatric Use 203 words ▾

8.4Pediatric Use The safety and effectiveness of SAXENDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management have been established in pediatric patients aged 12 years and older with body weight above 60 kg and an initial BMI corresponding to 30 kg/m 2 or greater for adults (obese) by international cut-offs. Use of SAXENDA for this indication is supported by a 56-week double-blind, placebo-controlled clinical trial in 251 pediatric patients aged 12 to 17 years, a pharmacokinetic study in pediatric patients, and studies in adults with obesity [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 , 14.2 )].

In the pediatric clinical trial, one SAXENDA-treated patient had an event of pancreatitis [see Warnings and Precautions ( 5.2 )] ; more episodes of hypoglycemia confirmed by self blood glucose monitoring occurred in SAXENDA-treated patients compared to placebo [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] ; and mean increases in resting heart rate of 3 to 7 bpm from baseline were observed with SAXENDA-treated patients [see Warnings and Precautions ( 5.5 )] . The safety and effectiveness of SAXENDA have not been established in patients less than 12 years of age.

🧓 Geriatric Use 61 words ▾

8.5Geriatric Use In the SAXENDA clinical trials, 232 (6.9%) of the SAXENDA-treated patients were 65 years of age and over, and 17 (0.5%) of the SAXENDA-treated patients were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 56 words ▾

10 OVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea, severe vomiting and severe hypoglycemia. In the event of overdosage, consider contacting the Poison Helpline (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Initiate appropriate supportive treatment according to the patient’s clinical signs and symptoms.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5 to 2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP).

Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP. GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation.

In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.

12.2Pharmacodynamics Liraglutide lowers body weight through decreased calorie intake. Liraglutide does not increase 24-hour energy expenditure. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner.

These effects can lead to a reduction of blood glucose. Gastric Emptying Liraglutide delays gastric emptying. Cardiac Electrophysiology (QTc) in healthy volunteers The effect of liraglutide on cardiac repolarization was tested in a QTc study.

Liraglutide at steady-state concentrations after daily doses up to 1.8 mg did not produce QTc prolongation. The maximum liraglutide plasma concentration (C max ) in overweight and obese subjects treated with liraglutide 3 mg is similar to the C max observed in the liraglutide QTc study in healthy volunteers.

12.3Pharmacokinetics Absorption - Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 11 hours post dosing. The average liraglutide steady state concentration (AUCτ /24 ) reached approximately 116 ng/mL in obese (BMI 30-40 kg/m 2 ) subjects following administration of SAXENDA. Liraglutide exposure increased proportionally in the dose range of 0.6 mg to 3 mg.

The intra-subject coefficient of variation for liraglutide AUC was 11% following single dose administration. Liraglutide exposures were considered similar among three subcutaneous injection sites (upper arm, abdomen, and thigh). Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.

Distribution - The mean apparent volume of distribution after subcutaneous administration of liraglutide 3 mg is 20 to 25L (for a person weighing approximately 100 kg). The mean volume of distribution after intravenous administration of liraglutide is

0.07L/kg. Liraglutide is extensively bound to plasma protein (greater than 98%). Metabolism - During the initial 24 hours following administration of a single [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.

Liraglutide is endogenously metabolized in a similar manner to large proteins without a specific organ as a major route of elimination. Elimination - Following a [3H]-liraglutide dose, intact liraglutide was not detected in urine or feces. Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or feces (6% and 5%, respectively).

The majority of urine and feces radioactivity was excreted during the f…

🧬 Mechanism of Action 201 words ▾

12.1Mechanism of Action Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5 to 2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP).

Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP. GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation.

In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.

📦 How Supplied / Storage and Handling 189 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SAXENDA injection: 6 mg/mL clear, colorless solution in a 3 mL single-patient-use prefilled pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg is available in the following package sizes: 3 x SAXENDA pen NDC 0169-2800-13 5 x SAXENDA pen NDC 0169-2800-15 Recommended Storage Prior to first use, SAXENDA should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not store in the freezer or directly adjacent to the refrigerator cooling element.

Do not freeze SAXENDA and do not use SAXENDA if it has been frozen. After initial use of the SAXENDA pen, the pen can be stored for 30 days at controlled room temperature 59°F to 86°F (15°C to 30°C) or in a refrigerator 36°F to 46°F (2°C to 8°C). Keep the pen cap on when not in use.

Protect SAXENDA from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the SAXENDA pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.

📋 Description 200 words ▾

11 DESCRIPTION SAXENDA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.

The molecular formula of liraglutide is C 172 H 265 N 43 O 51 and the molecular weight is 3751.2 Daltons. The structural formula ( Figure 1 ) is: Figure 1. Structural Formula of liraglutide SAXENDA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use.

Each 1 mL of SAXENDA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. SAXENDA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of SAXENDA equivalent to 18 mg liraglutide (free-base, anhydrous). structural-formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions Advise patients to take SAXENDA exactly as prescribed. Instruct patients to follow the dose escalation schedule and to not take more than the recommended dose.

Instruct adult patients to discontinue SAXENDA if they have not achieved 4% weight loss by 16 weeks of treatment. Instruct pediatric patients 12 years of age and older to discontinue SAXENDA if they have not achieved a BMI reduction of 1% from baseline after 12 weeks on the maintenance dose. Risk of Thyroid C-cell Tumors Inform patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that the human relevance of this finding has not been determined.

Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their health care provider [see Boxed Warning, Warnings and Precautions ( 5.1 )]. Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue SAXENDA promptly and contact their healthcare provider if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )].

Acute Gallbladder Disease Inform patients of the risk of acute gallbladder disease. Advise patients that substantial or rapid weight loss can increase the risk of gallbladder disease, but that gallbladder disease may also occur in the absence of substantial or rapid weight loss. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions ( 5.3 )].

Hypoglycemia Inform pediatric patients of the risk of hypoglycemia and educate all patients on the signs and symptoms of hypoglycemia. Inform adult patients with type 2 diabetes mellitus on an insulin secretagogue (e.g., sulfonylurea) or insulin that they may have an increased risk of hypoglycemia when using SAXENDA and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions ( 5.4 )] . Heart Rate Increase Inform patients to report symptoms of sustained periods of heart pounding or racing while at rest to their healthcare provider.

Discontinue SAXENDA in patients who experience a sustained increase in resting heart rate [see Warnings and Precautions ( 5.5 )]. Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion.

Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.6 )]. Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.7 )].

Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of SAXENDA. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking SAXENDA and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that SAXENDA may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.

Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if t…

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE SAXENDA (sax-end-ah) (liraglutide) injection, for subcutaneous use What is the most important information I should know about SAXENDA? Serious side effects may happen in people who take SAXENDA, including: • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

These may be symptoms of thyroid cancer. In studies with rats and mice, SAXENDA and medicines that work like SAXENDA caused thyroid tumors, including thyroid cancer. It is not known if SAXENDA will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use SAXENDA if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is SAXENDA? SAXENDA is an injectable prescription medicine used for adults with obesity or overweight (excess weight) who also have weight related medical problems, and children aged 12 to 17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. • SAXENDA should be used with a reduced calorie diet and increased physical activity. • SAXENDA is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. • It is not known if SAXENDA is safe and effective in children under 12 years of age. • It is not known if SAXENDA is safe and effective in children aged 12 to 17 years with type 2 diabetes.

Who should not use SAXENDA? Do not use SAXENDA if: • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). • you have had a serious allergic reaction to liraglutide or any of the ingredients in SAXENDA. See the end of this Medication Guide for a complete list of ingredients in SAXENDA.

See “ What are the possible side effects of SAXENDA? ” for symptoms of a serious allergic reaction. Before taking SAXENDA, tell your healthcare provider about all of your medical conditions, including if you: • have or have had problems with your pancreas. • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. • are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). • are breastfeeding or plan to breastfeed.

It is not known if SAXENDA passes into your breast milk. You and your healthcare provider should decide if you will use SAXENDA or breastfeed. Tell your healthcare provider about all the medicines you take including prescription, over-the-counter medicines, vitamins, and herbal supplements.

SAXENDA may affect the way some medicines work and some other medicines may affect the way SAXENDA works. Tell your healthcare provider if you take diabetes medicines, especially insulin and sulfonylurea medicines. Talk with your healthcare provider if you are not sure if you take any of these medicines.

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 SAXENDA? • Read the Instructions for Use that comes with SAXENDA. • Use SAXENDA exactly as your healthcare provider tells you to. • Your healthcare provider should show you how to use SAXENDA before you use it for the first time. • Use SAXENDA with a reduced-calorie diet and increased physical activity. • SAXENDA is injected under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm.

Do not inject into a muscle (intramuscularly) or vein (intravenously). • SAXENDA is injected 1 time each day, at any time during the day. • Start SAXENDA with 0.6 mg per d…

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