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Trulicity Dulaglutide 4.5 mg/.5mL Injection, Solution, 4 syringes

by Eli Lilly and Company · 4 SYRINGE in 1 CARTON (0002-3182-80) / .5 mL in 1 SYRINGE (0002-3182-01)

NDC 00002-3182-80

🏷️ FDA NDC (as labeled) 0002-3182-80 billing pads the labeler segment with a zero

This package

Contains4 syringes Cost per mL$487.38 NADAC Per package$974.75 / 2 ml Pack sizes2 compare ↓

Also priced by: Medicaid pays $480.21/unit · Part D plans $482.08/unit — full pricing hub ↓

Also comes in: 2 syringes 00002-3182-61

Rx only Brand On market Non-controlled

🗂️ Data synced Aug 20, 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 Dr. Brian Staiger, PharmD

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

Past resolved recalls for this product (2)

Class II · Apr 5, 2022 · Completed — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions (Cardinal Health Inc.) · FDA recall D-0884-2022

Class II · Aug 19, 2021 · Terminated — Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. (Eli Lilly & Company) · FDA recall D-0773-2021

🆔 Identity & classification

FDA NDC (as labeled) 0002-3182-80

Product NDC 0002-3182

11-digit billing NDC 00002318280

NCPDP billing unit ML — per mL (volume)

RxCUI 1551295, 1551300, 1551304, 1551306, 2395777, 2395779, 2395783, 2395785

UNII WTT295HSY5

Application # BLA125469

SPL Set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309

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 BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-09-03

Route SUBCUTANEOUS

Dosage form INJECTION, SOLUTION

Substance DULAGLUTIDE

GCN Seq No 081454

GCN 48573

HICL code 041421

Ingredient (HICL) Dulaglutide

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C4

Therapeutic class — intermediate (HIC2) Antihyperglycemics

HIC3 code C4I

Therapeutic class — specific (HIC3) Antihypergly,Incretin Mimetic(Glp-1 Recep.agonist)

AHFS code 68:20.06.00

AHFS class Incretin Mimetics

FDB label name TRULICITY 4.5 MG/0.5 ML PEN

FDB brand name Trulicity

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 0002-3182-80 — 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 → 00002-3182-80. 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) 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

LabelerEli Lilly and Company

FDA applicationBLA125469 (BLA)

Labeler code00002

First marketedSep 2020

Product typeHuman Prescription Drug

Portfolio192 products on file

🔎 All NDCs from Eli Lilly and Company

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 TRULICITY 4.5 MG/0.5 ML PEN Ingredient Dulaglutide

📖 What it is MedlinePlus · NLM

Dulaglutide injection is used for the following: to lower blood sugar levels in people with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). to reduce the risk of a heart attack, stroke, or death in adults with type 2 diabetes who also have heart disease or who are at risk of developing heart disease. Dulaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the bl...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Trulicity helps control blood sugar in type 2 diabetes — it's used along with diet and exercise, not instead of them. If you also have heart disease or several heart risk factors,...
What exactly is Trulicity used for? My doctor mentioned it for my diabetes.
You inject Trulicity under the skin once a week — in your stomach area, thigh, or upper arm. The good news is that it doesn't matter what time of day you take it, and you can take...
How do I take it, and does it matter what time of day I inject it?

📖 Read our full Dulaglutide Injection guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Dulaglutide — tap one for details:

Siberian CockleburMajor AcaiModerate African Wild PotatoModerate Agaricus MushroomModerate AgmatineModerate AgrimonyModerate AlfalfaModerate Algal OilModerate

🌿 Every supplement checked against Dulaglutide (239 interactions) — ranked by severity →

Nutrient depletion considerations

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

COENZYME Q10 Insignificant Depletion

🧪 Full Dulaglutide 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.

0.07 mg / 0.5 mL UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
23.2 mg / 0.5 mL UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
0.125 mg / 0.5 mL UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
1.37 mg / 0.5 mL UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$487.375	$974.75 / 2 ml
Medicaid paysCMS SDUD · 12 mo	$480.21	$960.41 / 2 ml
Medicare drug plans payPart D · Q2 2026	$482.08	$964.16 / 2 ml

NADAC price history (per mL) — tap or hover for the price & month

▲ Up 20% over the last 9 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Trulicity 4.5 mg/.5mLthis 00002-3182-80	Eli	4 syringes	$487.375	—	Availability likely	—
Trulicity 4.5 mg/.5mL 50090-7589-00	A-S	4 syringes	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

2014

First FDA approval

Sep 2014

📍

2026

Currently FDA-listed

12 years listed

🔓

Biosimilar pathway open

listed protections lapsed 2026

🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Sep 2026 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.

📅 FDA approved Sep 18, 2014

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

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Trulicitydulaglutide

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Patents & exclusivity — FDA Purple Book

Exclusivity RefProduct

2014 2016 2018 2020 2022 2024 2026

Today

LOE

Biologic patent Exclusivity

🏛️Reference-product exclusivity

A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.

🧪Listed biologic patents

Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.

🔁Interchangeability

An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.

🛈 What do these terms mean?

Biologic patent: A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity: A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity: The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE): The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

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

FDA exclusivity

Code	What it grants	Expires
RefProduct	Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date	Sep 18, 2026

Common questions

Is there a biosimilar for TRULICITY 4.5 MG/0.5 ML PEN?

No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.

Why do different websites show different biosimilar dates?

Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.

Can a biosimilar launch before the last patent expires?

Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.

What does “current Purple Book estimate” mean?

It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.

What does “FDA listed” mean?

It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.

Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🗺️ 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 00002-3182-80, 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

388.4K

Units reimbursed last 4 qtrs

821K

Gross reimbursed last 4 qtrs

$394.27M

Avg / prescription

$1,015.00

Avg / unit

$480.21

Latest quarter Q4 2025

95.5KRx

Medicaid pays / mL

$480.21

gross reimbursed

NADAC / mL

$487.38

acquisition cost

Spread

−$7.1685

-1% vs cost

What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

34% FFS 66% MCO

Fee-for-service · 131,010 Rx Managed care · 257,436 Rx

State Medicaid map

Units reimbursed · per 100k residents

15.11,377

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 Ohio 1,377 /100k

2 Wisconsin 829 /100k

3 Missouri 607 /100k

4 Maine 597 /100k

5 Illinois 593 /100k

6 Michigan 508 /100k

7 Colorado 490 /100k

8 Virginia 488 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

4 syringes this page00002-3182-80 398,699 Rx · $405,333,066

2 syringes00002-3182-61 No Medicaid data

Drug total (last 4 qtrs): 398,699 Rx · 840,514 units · $405,333,066 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 Trulicity — 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 Trulicity. 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

$1.03B

Claims incl. refills

760.5K

Beneficiaries

373.5K

Spend / beneficiary

$2,749.08

Spend / claim

$1,350.23

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00002-3182-61	2 SYRINGE in 1 CARTON (0002-3182-61) / .5 mL in 1 SYRINGE	—	—	2020-09-30	Discontinued by firm
00002-3182-80 You're viewing this	4 SYRINGE in 1 CARTON (0002-3182-80) / .5 mL in 1 SYRINGE (0002-3182-01)	$487.38 / mL	$974.75	2020-09-03	Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00002-3182-80?

NDC 00002-3182-80 contains 4 syringes — 4 syringe in 1 carton / .5 ml in 1 syringe.

What is the difference between NDC 00002-3182-80 and NDC 00002-3182-61?

Both are Trulicity Dulaglutide 4.5 mg/.5mL Injection, Solution — the drug itself is identical. NDC 00002-3182-80 is the 4 syringes package, while NDC 00002-3182-61 is the 2 syringes package.

What NDC number is used to bill for this package of Trulicity Dulaglutide 4.5 mg/.5mL Injection, Solution?

Bill NDC 00002-3182-80 — the 11-digit billing format is 00002318280. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), and Nonclinical Toxicology ( 13.1 )] .

TRULICITY 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 TRULICITY and inform them of symptoms of thyroid tumors (e.g., 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 TRULICITY [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] .

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ).

🎯 Indications and Usage 135 words ▾

1 INDICATIONS AND USAGE TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated ( 1 ): As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Dosage ( 2.1 ) Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. After 4 weeks, the dosage may be increased to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase dosage in 1.5 mg increments after at least 4 weeks on the current dosage.

Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly. Pediatric Dosage ( 2.2 ) Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. If additional glycemic control is needed, increase dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage.

Recommendations Regarding Missed Dose ( 2.3 ) If a dose is missed, administer the missed dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. Important Administration Instructions ( 2.4 ) Administer once weekly at any time of day with or without food. Inject subcutaneously in the abdomen, thigh, or upper arm.

2.1Adult Dosage The recommended starting dosage of TRULICITY is 0.75 mg injected subcutaneously once weekly. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )]. After 4 weeks, the dosage may be increased to 1.5 mg once weekly for additional glycemic control.

If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage. The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.

2.2Pediatric Dosage The recommended starting dosage of TRULICITY is 0.75 mg injected subcutaneously once weekly. If additional glycemic control is needed, increase the dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )] .

2.3Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer the dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed, if necessary, as long as the last dose was administered 3 or more days before the new day of administration.

2.4Important Administration Instructions Prior to initiation, train patients and caregivers on proper injection technique [see Instructions for Use] . Administer TRULICITY once weekly, any time of day, with or without food. Inject TRULICITY subcutaneously in the abdomen, thigh, or upper arm.

Rotate injection sites with each dose. Inspect TRULICITY visually before use. It should appear clear and colorless.

Do not use TRULICITY if particulate matter or coloration is seen. When using TRULICITY with insulin, administer as separate injections and never mix. It is acceptable to inject TRULICITY and insulin in the same body region, but the injections should not be adjacent to each other.

💊 Dosage Forms and Strengths 95 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: TRULICITY is a clear and colorless solution available as: 0.75 mg/0.5 mL solution in a single-dose pen 1.5 mg/0.5 mL solution in a single-dose pen 3 mg/0.5 mL solution in a single-dose pen 4.5 mg/0.5 mL solution in a single-dose pen Injection: 0.75 mg/0.5 mL solution in a single-dose pen ( 3 ) Injection: 1.5 mg/0.5 mL solution in a single-dose pen ( 3 ) Injection: 3 mg/0.5 mL solution in a single-dose pen ( 3 ) Injection: 4.5 mg/0.5 mL solution in a single-dose pen ( 3 )

⛔ Contraindications 111 words ▾

4 CONTRAINDICATIONS TRULICITY is contraindicated in patients with: Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY [see Warnings and Precautions ( 5.4 )] .

Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ). Patients with a serious hypersensitivity reaction to dulaglutide or any of the product components ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thyroid C-cell Tumors: See Boxed Warning ( 5.1 ). Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including TRULICITY. Discontinue if pancreatitis is suspected ( 5.2 ).

Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary ( 5.3 ). Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred.

Discontinue TRULICITY and promptly seek medical advice ( 5.4 ). Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion ( 5.5 ). Severe Gastrointestinal Adverse Reactions: Use may be associated with gastrointestinal adverse reactions, sometimes severe.

TRULICITY is not recommended in patients with severe gastroparesis ( 5.6 ). Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy ( 5.7 ).

Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated ( 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 In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology ( 13.1 )] . Glucagon-like peptide-1 (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

One case of MTC was reported in a patient treated with TRULICITY in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND).

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. TRULICITY 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 TRULICITY 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 TRULICITY. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >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 TRULICITY [see Adverse Reactions ( 6 )] . Af…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious 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 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies 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. Adverse Reactions in the Clinical Trials in Adults with Type 2 Diabetes Mellitus Pool of Adult Placebo-Controlled Trials for TRULICITY 0.75 mg and 1.5 mg Doses The data in Table 1 are derived from a pool of placebo-controlled trials and include 1,670 adult patients with type 2 diabetes mellitus exposed to TRULICITY with a mean duration of exposure of 23.8 weeks [see Clinical Studies ( 14 )] .

The mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8 years, a mean HbA1c of 8.0%, and 2.5% of the population reported retinopathy.

Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m 2 ) in 96%. Table 1 shows adverse reactions, excluding hypoglycemia, occurring in ≥5% of TRULICITY treated adult patients and more commonly than placebo in a pool of placebo-controlled trials. Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials That Occurred in ≥5% of TRULICITY-Treated Adult Patients with Type 2 Diabetes Mellitus a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.

Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Adverse Reaction Placebo (N=568) % TRULICITY 0.75 mg (N=836) % TRULICITY 1.5 mg (N=834) % Nausea 5.3 12.4

21.1Diarrhea a 6.7 8.9

12.6Vomiting b 2.3 6.0

12.7Abdominal Pain c 4.9 6.5

9.4Decreased Appetite 1.6 4.9

8.6Dyspepsia 2.3 4.1

5.8Fatigue d 2.6 4.2

5.6Gastrointestinal Adverse Reactions In the pool of placebo-controlled trials, gastrointestinal (GI) adverse reactions occurred more frequently among patients who received TRULICITY compared to patients who received placebo (placebo 21%, 0.75 mg 32%, 1.5 mg 41%). A higher percentage of patients who received TRULICITY 0.75 mg (1.3%) and TRULICITY 1.5 mg (3.5%) discontinued treatment due to GI adverse reactions than patients who received placebo (0.2%). Investigators graded the severity of GI adverse reactions that occurred in those treated with 0.75 mg and 1.5 mg of TRULICITY as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe”…

🔄 Drug Interactions 208 words ▾

7 DRUG INTERACTIONS Oral Medications: Delays gastric emptying and has the potential to reduce the rate of absorption of concomitantly administered oral medications ( 7.1 ).

7.1Oral Medications TRULICITY delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. The delay in gastric emptying is dose-dependent but is attenuated with the recommended dose escalation to higher doses of TRULICITY [see Dosage and Administration ( 2.1 )] . The delay is largest after the first dose and diminishes with subsequent doses.

In clinical pharmacology studies, TRULICITY 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree [see Clinical Pharmacology ( 12.3 )] . There is limited experience with the use of concomitant medications in clinical trials with TRULICITY doses of 3 mg and 4.5 mg. Monitor drug levels of oral medications with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with TRULICITY.

7.2Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When initiating TRULICITY, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.1 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk to fetus ( 8.1 ).

8.1Pregnancy Risk Summary Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy.

TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the MRHD.

Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see Data] . The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of 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. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

Data Animal Data Pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (AUC) comparison. Reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. Irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg.

In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the MRHD, based on plasma AUC comparison. Fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. In a prenatal-postnatal study in F 0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the MRHD, based on plasma AUC comparison.

F 1 pups from F 0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. F 1 offspring from F 0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response.

These physical findings may relate to the decreased size of the offspring relative to controls as they a…

🤰 Pregnancy ~3 min read ▾

These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F 1 female offspring of the F 0 maternal rats given 1.63 mg/kg of…

🧒 Pediatric Use 118 words ▾

8.4Pediatric Use The safety and effectiveness of TRULICITY as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. Use of TRULICITY for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see Clinical Studies ( 14.6 )] . TRULICITY-treated pediatric patients reported a higher incidence of injection site-related reactions compared to TRULICITY-treated adults [see Adverse Reactions ( 6.1 )] .

The safety and effectiveness of TRULICITY have not been established in pediatric patients less than 10 years of age.

🧓 Geriatric Use 128 words ▾

8.5Geriatric Use In the adult glycemic control trials [see Clinical Studies ( 14.2 , 14.3 )] , 620 (19%) of TRULICITY-treated patients were 65 years of age or older and 65 (2%) of TRULICITY-treated patients were 75 years of age or older at baseline. In the TRULICITY 1.5 mg treatment arm of the REWIND trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors) [see Clinical Studies ( 14.5 )] , 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline.

No overall differences in safety or effectiveness for TRULICITY have been observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 65 words ▾

10 OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (e.g., nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Initiate appropriate supportive care (including frequent plasma glucose monitoring) according to the patient's clinical signs and symptoms.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release.

Dulaglutide also decreases glucagon secretion and slows gastric emptying.

12.2Pharmacodynamics TRULICITY lowers fasting glucose and reduces postprandial glucose (PPG) concentrations in patients with type 2 diabetes mellitus. The reduction in fasting and postprandial glucose can be observed after a single dose. Fasting and Postprandial Glucose In a clinical pharmacology study in patients with type 2 diabetes mellitus, treatment with once weekly TRULICITY resulted in a reduction of fasting and 2-hour PPG concentrations, and postprandial serum glucose incremental AUC, when compared to placebo (-25.6 mg/dL, -59.5 mg/dL, and -197 mg*h/dL, respectively); these effects were sustained after 6 weeks of dosing with the 1.5 mg dose.

First- and Second-Phase Insulin Secretion Both first- and second-phase insulin secretion were increased in patients with type 2 diabetes treated with TRULICITY compared with placebo. Insulin and Glucagon Secretion TRULICITY stimulates glucose-dependent insulin secretion and reduces glucagon secretion. Treatment with TRULICITY 0.75 mg and 1.5 mg once weekly increased fasting insulin from baseline at Week 26 by 35.38 and 17.50 pmol/L, respectively, and C-peptide concentration by 0.09 and 0.07 nmol/L, respectively, in a monotherapy trial.

In the same trial, fasting glucagon concentration was reduced by 1.71 and 2.05 pmol/L from baseline with TRULICITY 0.75 mg and 1.5 mg, respectively. Gastric Motility Dulaglutide causes a delay of gastric emptying. The delay in gastric emptying is dose-dependent but is attenuated with adequate dose escalation to higher doses of TRULICITY.

The delay is largest after the first dose and diminishes with subsequent doses. Cardiac Electrophysiology (QTc) The effect of dulaglutide on cardiac repolarization was tested in a thorough QTc study. Dulaglutide did not produce QTc prolongation at doses of 4 and 7 mg.

The maximum recommended dose is 4.5 mg once weekly.

12.3Pharmacokinetics The pharmacokinetics of dulaglutide is similar between healthy subjects and patients with type 2 diabetes mellitus. Following subcutaneous administration, the time to maximum plasma concentration of dulaglutide at steady state ranges from 24 to 72 hours, with a median of 48 hours. After reaching steady state, the accumulation ratio was approximately 1.56.

Steady-state plasma dulaglutide concentrations were achieved between 2 and 4 weeks following once weekly administration. Site of subcutaneous administration (abdomen, upper arm, and thigh) had no statistically significant effect on the exposure to dulaglutide. Absorption – The mean absolute bioavailability of dulaglutide following subcutaneous administration of single 0.75 mg and 1.5 mg doses was 65% and 47%, respectively.

Absolute subcutaneous bioavailability for 3 mg and 4.5 mg doses were estimated to be similar to 1.5 mg although this has not been specifically studied. Dulaglutide concentrations increased approximately proportional to dose from 0.75 mg to 4.5 mg. Distribution – Apparent population mean central volume of distribution was

3.09 L and the apparent population mean peripheral volume of distribution was

5.98L. Elimination The apparent population mean clearance of dulaglutide was 0.142 L/h. The elimination half-life of dulaglutide was approximately 5 days. Metabolism – Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways. Specific Populations The intrinsic factors of age (≥ 65 years), sex, race, ethnicity, body weight, or renal or hepatic impairment did…

🧬 Mechanism of Action 65 words ▾

Dulaglutide also decreases glucagon secretion and slows gastric emptying.

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TRULICITY (dulaglutide) injection is a clear and colorless solution supplied in single-dose pens. TRULICITY is packaged in a cardboard outer carton containing 4 single-dose TRULICITY pens and is supplied as follows: Total Strength per Total Volume NDC 0.75 mg/0.5 mL NDC 0002-1433-80 1.5 mg/0.5 mL NDC 0002-1434-80 3 mg/0.5 mL NDC 0002-2236-80 4.5 mg/0.5 mL NDC 0002-3182-80

16.2Storage and Handling Store TRULICITY in the refrigerator at 36°F to 46°F (2°C to 8°C). If needed, each single-dose pen can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days. Do not freeze TRULICITY. Do not use TRULICITY if it has been frozen. Protect TRULICITY from light. Storage of TRULICITY in the original carton is recommended until time of administration.

📦 Storage and Handling 68 words ▾

📋 Description 209 words ▾

11 DESCRIPTION Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37).

Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons.

TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection.

💬 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) . Risk of Thyroid C-cell Tumors Inform patients that TRULICITY causes benign and malignant thyroid C-cell tumors in 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, persistent hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning and 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 TRULICITY promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Inform patients that the risk of hypoglycemia may be increased when TRULICITY is used in combination with an insulin secretagogue (such as a sulfonylurea) or insulin.

Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of TRULICITY. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking TRULICITY and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.4 )] .

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 ( 5.5 )] .

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 ( 5.6 )]. Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy Inform patients to contact their physician if changes in vision are experienced during treatment with TRULICITY [see Warnings and Precautions ( 5.7 )] .

Acute Gallbladder Disease Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that TRULICITY 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 they are taking TRULICITY [see Warnings and Precautions ( 5.9 )]. Pregnancy Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations ( 8.1 )] . Missed Dose Inform patients if a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, they should administer it as soon as possible and then resume their usual once weekly dosing schedule.

If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, inform the patient to not administer the missed dose and instead resume TRULICITY with the next regularly scheduled dose [see Dosage and Administration ( 2.3 )] . Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2026, Eli…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: March 2026 TRU-0012-MG-20260312 Medication Guide TRULICITY ® (TRU-li-si-tee) (dulaglutide) injection, for subcutaneous use Read this Medication Guide before you start using TRULICITY and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about TRULICITY? TRULICITY may cause serious side effects, 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 or mice, TRULICITY and medicines that work like TRULICITY caused thyroid tumors, including thyroid cancer.

It is not known if TRULICITY will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use TRULICITY 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 TRULICITY?

TRULICITY is an injectable prescription medicine that is used: along with diet and exercise to improve blood sugar (glucose) in adults and children 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with type 2 diabetes mellitus with known heart disease or multiple cardiovascular risk factors. It is not known if TRULICITY is safe and effective to lower blood sugar (glucose) in children under 10 years of age. Do not use TRULICITY if: you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2. you have had a serious allergic reaction to dulaglutide or any of the ingredients in TRULICITY.

See the end of this Medication Guide for a complete list of ingredients in TRULICITY. See " What are the possible side effects of TRULICITY? " for symptoms of a serious allergic reaction. Before using TRULICITY, 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. have a history of diabetic retinopathy. are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). are pregnant or plan to become pregnant.

It is not known if TRULICITY will harm your unborn baby. Tell your healthcare provider if you become pregnant while using TRULICITY. are breastfeeding or plan to breastfeed. It is not known if TRULICITY passes into your breast milk.

You and your healthcare provider should decide if you should breastfeed while taking TRULICITY. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRULICITY may affect the way some medicines work, and some medicines may affect the way TRULICITY works.

Before using TRULICITY, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas. 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 TRULICITY? Read the Instructions for Use that comes with TRULICITY.

Use TRULICITY exactly as your healthcare provider tells you to. Your healthcare provider should show you how to use TRULICITY before you use it for the first time. Inject TRULICITY under the skin (subcutaneously) of your stomach…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

cholecystitis: Inflammation of the gallbladder, often caused by gallstones blocking it.

cholelithiasis: Gallstones; hardened deposits that form inside the gallbladder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diabetic ketoacidosis: A serious condition, mainly in people with diabetes, where the blood turns acidic because the body burns fat instead of sugar for energy.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

retinopathy: Damage to the retina, the light-sensing layer at the back of the eye, which can affect vision.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 00002-3116-11 · Eli 00002-3227-30 · Eli →

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.

Trulicity Dulaglutide 4.5 mg/.5mL Injection, Solution, 4 syringes

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3.09 L and the apparent population mean peripheral volume of distribution was

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