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galcanezumab-gnlm 120 mg/mL Injection, Solution, 1 mL — NDC 00002-2377-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

galcanezumab-gnlm 120 mg/mL Injection, Solution, 1 mL — NDC 0002-2377-00 (Billing 00002-2377-00)

by Eli Lilly and Company · 1 mL in 1 SYRINGE

This is a package of 1 mL of galcanezumab-gnlm 120 mg/mL Injection, Solution from Eli Lilly and Company, marketed since Sep 2018 and currently FDA-listed.

NDC 00002-2377-00
🏷️ FDA NDC (as labeled) 0002-2377-00 billing pads the labeler segment with a zero
This package
Contains1 mL Pack sizes2 compare ↓
Product page 00002-2377-11 Also comes in: 1 mL 0002-2377-11
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 0002-2377-00 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0002 labeler · 2377 product · 00 package
Package marketed since
Sep 27, 2018
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0002237700 6
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-2377-00
Product NDC 0002-2377
11-digit billing NDC 00002237700
SPL Set ID 33a147be-233a-40e8-a55e-e40936e28db0
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-27
Dosage form INJECTION, SOLUTION
Substance GALCANEZUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 6770203530E520
GPI class Emgality
GCN Seq No 078997
GCN 40419
HICL code 045281
Ingredient (HICL) Galcanezumab-Gnlm
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3F
Therapeutic class — specific (HIC3) Antimigraine Preparations
AHFS code 28:32.12.00
AHFS class Calcitonin Gene-Related Peptide Antag.
FDB label name EMGALITY 120 MG/ML SYRINGE
FDB brand name Emgality Syringe
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078997
  • GCN: 40419
  • GPI-14 (Medi-Span): 6770203530E520
  • HICL (First Databank): 045281
  • AHFS class code: 28:32.12.00
Why two NDCs? The FDA registers this code as 0002-2377-00 — 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 → 00002-2377-00. 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.

Clinical

Label name EMGALITY 120 MG/ML SYRINGE Ingredient Galcanezumab-Gnlm
📗 Our plain-language guide HelloPharmacist
  • No — Emgality works differently than a typical headache or migraine medication. It's a preventive treatment, meaning you take it on a regular monthly schedule to reduce how often m...
  • Is Emgality a painkiller I take when a migraine starts?
  • Your healthcare provider or pharmacist will walk you through the steps before you try it on your own. The key things to know: take Emgality out of the fridge and let it sit for 30...
  • How do I give myself this injection at home?
📖 Read our full Galcanezumab-gnlm Injection guide →

Supplement & herbal interactions

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

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: 1 mL
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00002-2377-11 0002-2377-11 Main listing 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE $734.42 / mL $734.42 2019-01-18 — Active
00002-2377-00 You're viewing this 1 mL in 1 SYRINGE — — — — 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 this package?
This package contains 1 mL — 1 ml in 1 syringe.
How does this package differ from NDC 00002-2377-11?
Both are galcanezumab-gnlm 120 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 1 mL one, while NDC 00002-2377-11 is the 1 syringe package.
What NDC number is used to bill for this package of galcanezumab-gnlm 120 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emgality 120 mg/mL 00002-1436-11 Eli 1 syringe $734.283 — Availability likely —
galcanezumab-gnlm 120 mg/mLthis 00002-2377-00 Eli 1 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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.

  • 0.5 mg / 1 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 1.5 mg / 1 mL UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • 0.5 mg / 1 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.
  • 8.8 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 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.

Manufacturer & labeler

LabelerEli Lilly and Company
Labeler code00002
First marketedSep 2018
Product typeDrug For Further Processing
Portfolio192 products on file

More NDCs from Eli Lilly and Company labeler code 00002

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.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 )

1.1Migraine EMGALITY is indicated for the preventive treatment of migraine in adults.

1.2Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous use only. ( 2.1 , 2.2 , 2.3 ) Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. ( 2.1 ) Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period.

( 2.2 ) Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. ( 2.3 )

2.1Recommended Dosing for Migraine The recommended dosage of EMGALITY is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously. If a dose of EMGALITY is missed, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose.

2.2Recommended Dosing for Episodic Cluster Headache The recommended dosage of EMGALITY is 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. If a dose of EMGALITY is missed during a cluster period, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose until the end of the cluster period.

2.3Important Administration Instructions EMGALITY is for subcutaneous use only. EMGALITY is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer EMGALITY using the single-dose prefilled pen or single-dose prefilled syringe, including aseptic technique [see How Supplied/Storage and Handling ( 16.2 ) and Instructions for Use] : Protect EMGALITY from direct sunlight.

Prior to subcutaneous administration, allow EMGALITY to sit at room temperature for 30 minutes. Do not warm by using a heat source such as hot water or a microwave. Do not shake the product.

Inspect EMGALITY visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths ( 3 ) and How Supplied/Storage and Handling ( 16.1 )] . Do not use EMGALITY if it is cloudy or there are visible particles. Administer EMGALITY in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously.

Do not inject into areas where the skin is tender, bruised, red, or hard. Both the prefilled pen and prefilled syringe are single-dose and deliver the entire contents.

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows: Injection: 120 mg/mL in a single-dose prefilled pen Injection: 120 mg/mL in a single-dose prefilled syringe Injection: 100 mg/mL in a single-dose prefilled syringe Injection: 120 mg/mL solution in a single-dose prefilled pen ( 3 ) Injection: 120 mg/mL solution in a single-dose prefilled syringe ( 3 ) Injection: 100 mg/mL solution in a single-dose prefilled syringe ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients [see Warnings and Precautions ( 5.1 )] . EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged. ( 5.1 ) Constipation with Serious Complications: Serious complications of constipation may occur.

( 5.2 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.3 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. ( 5.4 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with EMGALITY in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy [see Contraindications ( 4 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )] .

Hypersensitivity reactions can occur days after administration and may be prolonged.

5.2Constipation with Serious Complications Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including EMGALITY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment.

The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications. Monitor patients treated with EMGALITY for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

5.3Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including EMGALITY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization.

Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. EMGALITY was discontinued in many of the reported cases. Monitor patients treated with EMGALITY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of EMGALITY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

5.4Raynaud's Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including EMGALITY. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. EMGALITY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Constipation with Serious Complications [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Raynaud's Phenomenon [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.

( 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 trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. Migraine The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of EMGALITY, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to EMGALITY once monthly for at least 6 months, and 526 patients were exposed for 12 months.

In placebo-controlled clinical studies (Studies 1, 2, and 3), 705 patients received at least one dose of EMGALITY 120 mg once monthly, and 1451 patients received placebo, during 3 months or 6 months of double-blind treatment [see Clinical Studies ( 14.1 )] . Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean age was 41 years at study entry. The most common adverse reaction was injection site reactions.

In Studies 1, 2, and 3, 1.8% of patients discontinued double-blind treatment because of adverse events. Table 1 summarizes the adverse reactions that occurred within up to 6 months of treatment in the migraine studies. Table 1: Adverse Reactions Occurring in Adults with Migraine with an Incidence of at least 2% for EMGALITY and at least 2% Greater than Placebo (up to 6 Months of Treatment) in Studies 1, 2, and 3 a Injection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus.

Adverse Reaction EMGALITY 120 mg Monthly (N=705) % Placebo Monthly (N=1451) % Injection site reactions a 18 13 Episodic Cluster Headache EMGALITY was studied for up to 2 months in a placebo-controlled trial in patients with episodic cluster headache (Study 4) [see Clinical Studies ( 14.2 )] . A total of 106 patients were studied (49 on EMGALITY and 57 on placebo). Of the EMGALITY-treated patients, approximately 84% were male, 88% were white, and the mean age was 47 years at study entry.

Two EMGALITY-treated patients discontinued double-blind treatment because of adverse events. Overall, the safety profile observed in patients with episodic cluster headache treated with EMGALITY 300 mg monthly is consistent with the safety profile in migraine patients.

6.2Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies to galcanezumab-gnlm in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. The immunogenicity of EMGALITY has been evaluated using an in vitro immunoassay for the detection of binding anti-galcanezumab-gnlm antibodies. For patients whose sera tested positive in the screening immunoassay,… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.

Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Animal Data) . 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. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data When galcanezumab-gnlm was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg; 0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on embryofetal development were observed. The highest dose tested (250 mg/kg) was associated with a plasma exposure (C ave, ss ) 38 or 18 times that in humans at the recommended human dose (RHD) for migraine (120 mg) or episodic cluster headache (300 mg), respectively.

Administration of galcanezumab-gnlm (0, 30, or 100 mg/kg) by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The higher dose tested was associated with a plasma C ave, ss 64 or 29 times that in humans at 120 mg or 300 mg, respectively. Administration of galcanezumab-gnlm (0, 30, or 250 mg/kg) by subcutaneous injection to rats throughout pregnancy and lactation produced no adverse effects on pre- and postnatal development.

The higher dose tested was associated with a plasma C ave, ss 34 or 16 times that in humans at 120 mg or 300 mg, respectively.

8.2Lactation Risk Summary There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EMGALITY and any potential adverse effects on the breastfed infant from EMGALITY or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

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

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.

Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Animal Data) . 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. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data When galcanezumab-gnlm was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg; 0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on embryofetal development were observed. The highest dose tested (250 mg/kg) was associated with a plasma exposure (C ave, ss ) 38 or 18 times that in humans at the recommended human dose (RHD) for migraine (120 mg) or episodic cluster headache (300 mg), respectively.

Administration of galcanezumab-gnlm (0, 30, or 100 mg/kg) by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The higher dose tested was associated with a plasma C ave, ss 64 or 29 times that in humans at 120 mg or 300 mg, respectively. Administration of galcanezumab-gnlm (0, 30, or 250 mg/kg) by subcutaneous injection to rats throughout pregnancy and lactation produced no adverse effects on pre- and postnatal development.

The higher dose tested was associated with a plasma C ave, ss 34 or 16 times that in humans at 120 mg or 300 mg, respectively.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 27 words ▾

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

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

12.2Pharmacodynamics There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm.

12.3Pharmacokinetics Galcanezumab-gnlm exhibits linear pharmacokinetics and exposure increases proportionally with doses between 1 and 600 mg. A loading dose of 240 mg achieved the serum galcanezumab-gnlm steady-state concentration after the first dose. A dose of 300 mg monthly would achieve steady-state concentration after the fourth dose.

The time to maximum concentration is 5 days, and the elimination half-life is 27 days. There was no difference in pharmacokinetic parameters between healthy volunteers, patients with episodic or chronic migraine, and patients with episodic cluster headache. Absorption Following a subcutaneous dose of galcanezumab-gnlm, the time to maximum concentration was about 5 days.

Injection site location did not significantly influence the absorption of galcanezumab-gnlm. Distribution The apparent volume of distribution (V/F) of galcanezumab-gnlm was

7.3L (34% Inter Individual Variability [IIV]). Metabolism and Elimination Galcanezumab-gnlm is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The apparent clearance (CL/F) of galcanezumab-gnlm was 0.008 L/h and the elimination half-life of galcanezumab was approximately 27 days.

Specific Populations Age, Sex, Weight, Race, Ethnicity The pharmacokinetics of galcanezumab-gnlm were not affected by age, sex, race, subtypes of migraine spectrum (episodic or chronic migraine), or headache diagnosis (migraine vs. episodic cluster headache) based on a population pharmacokinetics analysis. Body weight has no clinically relevant effect on the pharmacokinetics of galcanezumab-gnlm. Patients with Renal or Hepatic Impairment Renal and hepatic impairment are not expected to affect the pharmacokinetics of galcanezumab-gnlm.

Population pharmacokinetic analysis of integrated data from the galcanezumab-gnlm clinical studies revealed that creatinine clearance did not affect the pharmacokinetics of galcanezumab-gnlm in patients with mild or moderate renal impairment. Patients with severe renal impairment (creatinine clearance <30 mL/min) have not been studied. Based on a population PK analysis, bilirubin concentration did not significantly influence the CL/F of galcanezumab-gnlm.

No dedicated clinical studies were conducted to evaluate the effect of hepatic impairment or renal impairment on the pharmacokinetics of galcanezumab-gnlm. Drug Interaction Studies P450 Enzymes Galcanezumab-gnlm is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

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

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous administration. EMGALITY is not made with natural rubber latex. EMGALITY is supplied as follows: Pack Size NDC Prefilled pen 120 mg/mL single-dose Carton of 1 0002-1436-11 120 mg/mL single-dose Carton of 2 0002-1436-27 Prefilled syringe 100 mg/mL single-dose Carton of 3 0002-3115-09 120 mg/mL single-dose Carton of 1 0002-2377-11 120 mg/mL single-dose Carton of 2 0002-2377-27

16.2Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect EMGALITY from light until use. Do not freeze. Do not shake.

EMGALITY may be stored out of refrigeration in the original carton at temperatures up to 30°C (86°F) for up to 7 days. Once stored out of refrigeration, do not place back in the refrigerator. If these conditions are exceeded, EMGALITY must be discarded.

Discard the EMGALITY single-dose prefilled pen or syringe after use in a puncture-resistant container.

16.1How Supplied EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous administration. EMGALITY is not made with natural rubber latex. EMGALITY is supplied as follows: Pack Size NDC Prefilled pen 120 mg/mL single-dose Carton of 1 0002-1436-11 120 mg/mL single-dose Carton of 2 0002-1436-27 Prefilled syringe 100 mg/mL single-dose Carton of 3 0002-3115-09 120 mg/mL single-dose Carton of 1 0002-2377-11 120 mg/mL single-dose Carton of 2 0002-2377-27

📦 Storage and Handling 87 words ▾

16.2Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect EMGALITY from light until use. Do not freeze. Do not shake.

EMGALITY may be stored out of refrigeration in the original carton at temperatures up to 30°C (86°F) for up to 7 days. Once stored out of refrigeration, do not place back in the refrigerator. If these conditions are exceeded, EMGALITY must be discarded.

Discard the EMGALITY single-dose prefilled pen or syringe after use in a puncture-resistant container.

📋 Description 149 words ▾

11 DESCRIPTION Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 147 kDa.

EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1 mL single-dose prefilled pen to deliver 120 mg of galcanezumab-gnlm or a 1 mL single-dose prefilled syringe to deliver 100 mg or 120 mg of galcanezumab-gnlm. Each mL of solution contains 100 mg or 120 mg of galcanezumab-gnlm; L-histidine (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80 (0.5 mg); Sodium Chloride (8.8 mg); Water for Injection, USP.

The pH range is 5.3 - 6.3.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Instructions on Self-Administration: Provide guidance to patients and/or caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the prefilled pen or prefilled syringe correctly [see Instructions for Use] . Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use EMGALITY.

Hypersensitivity Reactions: Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with EMGALITY. Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Constipation with Serious Complications: Inform patients that constipation with serious complications can occur with EMGALITY.

Advise patients to contact their healthcare providers if they experience severe constipation [see Warnings and Precautions ( 5.2 )] . Hypertension: Inform patients that hypertension can develop or pre-existing hypertension can worsen with EMGALITY, and that they should contact their healthcare provider if they experience elevation in their blood pressure [see Warnings and Precautions ( 5.3 )] . Raynaud's Phenomenon: Inform patients that Raynaud's phenomenon can develop or worsen with EMGALITY.

Advise patients to discontinue EMGALITY and contact their healthcare provider if they experience signs or symptoms of Raynaud's phenomenon [see Warnings and Precautions ( 5.4 )] . Pregnancy Exposure Registry : Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy [see Use in Specific Populations ( 8.1 )] . For more information go to www.emgality.com or call 1-800-LillyRx (1-800-545-5979).

Literature revised: 06/2026 Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2018, 2026, Eli Lilly and Company. All rights reserved. Pat.: www.lilly.com/patents EMG-00010-USPI-20260605

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Galcanezumab-gnlm exhibits linear pharmacokinetics and exposure increases proportionally with doses between 1 and 600 mg. A loading dose of 240 mg achieved the serum galcanezumab-gnlm steady-state concentration after the first dose. A dose of 300 mg monthly would achieve steady-state concentration after the fourth dose.

The time to maximum concentration is 5 days, and the elimination half-life is 27 days. There was no difference in pharmacokinetic parameters between healthy volunteers, patients with episodic or chronic migraine, and patients with episodic cluster headache. Absorption Following a subcutaneous dose of galcanezumab-gnlm, the time to maximum concentration was about 5 days.

Injection site location did not significantly influence the absorption of galcanezumab-gnlm. Distribution The apparent volume of distribution (V/F) of galcanezumab-gnlm was

7.3L (34% Inter Individual Variability [IIV]). Metabolism and Elimination Galcanezumab-gnlm is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The apparent clearance (CL/F) of galcanezumab-gnlm was 0.008 L/h and the elimination half-life of galcanezumab was approximately 27 days.

Specific Populations Age, Sex, Weight, Race, Ethnicity The pharmacokinetics of galcanezumab-gnlm were not affected by age, sex, race, subtypes of migraine spectrum (episodic or chronic migraine), or headache diagnosis (migraine vs. episodic cluster headache) based on a population pharmacokinetics analysis. Body weight has no clinically relevant effect on the pharmacokinetics of galcanezumab-gnlm. Patients with Renal or Hepatic Impairment Renal and hepatic impairment are not expected to affect the pharmacokinetics of galcanezumab-gnlm.

Population pharmacokinetic analysis of integrated data from the galcanezumab-gnlm clinical studies revealed that creatinine clearance did not affect the pharmacokinetics of galcanezumab-gnlm in patients with mild or moderate renal impairment. Patients with severe renal impairment (creatinine clearance <30 mL/min) have not been studied. Based on a population PK analysis, bilirubin concentration did not significantly influence the CL/F of galcanezumab-gnlm.

No dedicated clinical studies were conducted to evaluate the effect of hepatic impairment or renal impairment on the pharmacokinetics of galcanezumab-gnlm. Drug Interaction Studies P450 Enzymes Galcanezumab-gnlm is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Migraine The efficacy of EMGALITY was evaluated as a preventive treatment of episodic or chronic migraine in three multicenter, randomized, double-blind, placebo-controlled studies: two 6-month studies in patients with episodic migraine (Studies 1 and 2) and one 3-month study in patients with chronic migraine (Study 3). Episodic Migraine Study 1 (NCT02614183) and Study 2 (NCT02614196) included adults with a history of episodic migraine (4 to 14 migraine days per month). All patients were randomized in a 1:1:2 ratio to receive once-monthly subcutaneous injections of EMGALITY 120 mg, EMGALITY 240 mg, or placebo.

All patients in the 120 mg EMGALITY group received an initial 240 mg loading dose. Patients were allowed to use acute headache treatments, including migraine-specific medications (i.e., triptans, ergotamine derivatives), NSAIDs, and acetaminophen during the study. The studies excluded patients on any other migraine preventive treatment, patients with medication overuse headache, patients with ECG abnormalities compatible with an acute cardiovascular event and patients with a history of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening.

The primary efficacy endpoint for Studies 1 and 2 was the mean change from baseline in the number of monthly migraine headache days over the 6-month treatment period. Key secondary endpoints included response rates (the mean percentages of patients reaching at least 50%, 75%, and 100% reduction from baseline in the number of monthly migraine headache days over the 6-month treatment period), the mean change from baseline in the number of monthly migraine headache days with use of any acute headache medication during the 6-month treatment period, and the impact of migraine on daily activities, as assessed by the mean change from baseline in the average Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score during the last 3 months of treatment (Months 4 to 6).

Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities. In Study 1, a total of 858 patients (718 females, 140 males) ranging in age from 18 to 65 years, were randomized. A total of 703 patients completed the 6-month double-blind phase.

In Study 2, a total of 915 patients (781 female, 134 male) ranging in age from 18 to 65 years, were randomized. A total of 785 patients completed the 6-month double-blind phase. In Study 1 and Study 2, the mean migraine frequency at baseline was approximately 9 migraine days per month, and was similar across treatment groups.

EMGALITY 120 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 6-month period, as summarized in Table 2 . EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose. Table 2: Efficacy Endpoints in Studies 1 and 2 a p<0.001 b N = 189 for EMGALITY 120 mg and N = 377 for placebo in Study 1; N = 213 for EMGALITY 120 mg and N = 396 for placebo in Study 2.

Study 1 Study 2 EMGALITY 120 mg N = 210 Placebo N = 425 EMGALITY 120 mg N = 226 Placebo N = 450 Monthly Migraine Headache Days (over Months 1 to 6) Baseline migraine headache days 9.2 9.1 9.1

9.2Mean change from baseline -4.7 -2.8 -4.3 -2.3 Difference from placebo a -1.9 -2.0 ≥50% Migraine Headache Days Responders (over Months 1 to 6) % Responders a 62% 39% 59% 36% ≥75% Migraine Headache Days Responders (over Months 1 to 6) % Responders a 39% 19% 34% 18% 100% Migraine Headache Days Responders (over Months 1 to 6) % Responders a 16% 6% 12% 6% Monthly Migraine Headache Days that Acute Medication was Taken (over Months 1 to 6) Mean change from baseline (days) a -4.0 -2.2 -3.7 -1.9 MSQ Role Function-Restrictive Domain Score (over Months 4 to 6) Baselin… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 163 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of galcanezumab-gnlm has not been assessed. Mutagenesis Genetic toxicology studies of galcanezumab-gnlm have not been conducted. Impairment of Fertility When galcanezumab-gnlm (0, 30, or 250 mg/kg) was administered to male rats by subcutaneous injection prior to and during mating, no adverse effects on fertility was observed.

The higher dose tested was associated with a plasma exposure (C ave, ss ) 8 or 4 times that in humans at the recommended human dose (RHD) for migraine (120 mg) or episodic cluster headache (300 mg), respectively. When galcanezumab-gnlm was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg; 0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on fertility were observed. The highest dose tested (250 mg/kg) was associated with a plasma C ave, ss 38 or 18 times that in humans at 120 mg or 300 mg, respectively.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 160 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of galcanezumab-gnlm has not been assessed. Mutagenesis Genetic toxicology studies of galcanezumab-gnlm have not been conducted. Impairment of Fertility When galcanezumab-gnlm (0, 30, or 250 mg/kg) was administered to male rats by subcutaneous injection prior to and during mating, no adverse effects on fertility was observed.

The higher dose tested was associated with a plasma exposure (C ave, ss ) 8 or 4 times that in humans at the recommended human dose (RHD) for migraine (120 mg) or episodic cluster headache (300 mg), respectively. When galcanezumab-gnlm was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg; 0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on fertility were observed. The highest dose tested (250 mg/kg) was associated with a plasma C ave, ss 38 or 18 times that in humans at 120 mg or 300 mg, respectively.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 06/2026 PATIENT INFORMATION EMGALITY ® (em-GAL-it-ē) (galcanezumab-gnlm) injection, for subcutaneous use What is EMGALITY? EMGALITY is a prescription medicine used in adults for the: preventive treatment of migraine. treatment of episodic cluster headache.

It is not known if EMGALITY is safe and effective in children. Who should not use EMGALITY? Do not use EMGALITY if you are allergic to galcanezumab-gnlm or any of the ingredients in EMGALITY.

See the end of this Patient Information for a complete list of ingredients in EMGALITY. Before you use EMGALITY, tell your healthcare provider if you: have high blood pressure. have circulation problems in your fingers and toes. are pregnant or plan to become pregnant. It is not known if EMGALITY will harm your unborn baby.

Pregnancy Registry : There is a pregnancy registry for women who take EMGALITY. The purpose of this registry is to collect information about the health of you and your baby. You may enroll yourself by calling 1-833-464-4724 or by visiting www.migrainepregnancyregistry.com.

Or you may talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. It is not known if EMGALITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using EMGALITY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use EMGALITY? See the Instructions for Use that come with EMGALITY prefilled pen or prefilled syringe about how to use EMGALITY the right way. Use EMGALITY exactly as your healthcare provider tells you to.

EMGALITY is given by injection under the skin (subcutaneous injection). Inject EMGALITY in your stomach area (abdomen), thigh, back of the upper arm, or buttocks. Your healthcare provider should show you or a caregiver how to prepare and inject EMGALITY the right way before you start to use it.

EMGALITY comes in 2 different types of devices: a single-dose (1 time) prefilled pen a single-dose (1 time) prefilled syringe Your healthcare provider will prescribe the type that is best for you. If you have questions about injecting the medicine, talk to your pharmacist or healthcare provider. If you are using the EMGALITY 120 mg prefilled pen or prefilled syringe for migraine: Inject EMGALITY 1 time each month.

For the first dose (loading dose), you will get 2 separate injections one time, right after each other. You will need 2 prefilled pens or 2 prefilled syringes for your first dose (1-time loading dose). For your regular monthly dose, you will get 1 injection.

You will need 1 prefilled pen or 1 prefilled syringe for your regular monthly dose. If you miss a dose of EMGALITY, inject the missed dose as soon as possible. Then inject EMGALITY 1 month from the date of your last dose to get back on a monthly dosing schedule.

If you have questions about your schedule, ask your healthcare provider. If you are using the EMGALITY 100 mg prefilled syringe for episodic cluster headache: You will get 3 separate injections, right after each other, using 3 prefilled syringes for each of your doses. Use EMGALITY at the start of a cluster period and then every month until the end of the cluster period.

If you miss a dose of EMGALITY, inject the missed dose as soon as possible. Then, if the cluster headache period has not yet ended, inject EMGALITY 1 month after your last dose to get back on a monthly dosing schedule. If you have questions about when you should use EMGALITY, ask your healthcare provider.

What are the possible side effects of EMGALITY? EMGALITY may cause serious side effects, including: Allergic reactions. Allergic reactions, inc… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE EMGALITY ® [em-GAL-it-ē] (galcanezumab-gnlm) injection, for subcutaneous use Prefilled Pen This Instructions for Use contains information on how to inject EMGALITY This Instructions for Use is for patients with migraine. For subcutaneous injection only. Important Information You Need to Know Before Injecting EMGALITY Your healthcare provider or nurse should show you how to prepare and inject EMGALITY using the Pen.

Do not inject yourself or someone else until you have been shown how to inject EMGALITY. Keep this Instructions for Use and refer to it as needed. Each EMGALITY Pen is for one-time use only.

Do not share or reuse your EMGALITY Pen. You may give or get an infection. The Pen contains glass parts.

Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection.

Your healthcare provider may help you decide where on your body to inject your dose. You can also read the “ Choose your injection site ” section of these instructions to help you choose which area can work best for you. If you have vision or hearing problems, do not use EMGALITY Pen without help from a caregiver.

See “ Storing EMGALITY ” for important storage information. INSTRUCTIONS FOR USE Before you use the EMGALITY Pen, read and carefully follow all the step-by-step instructions. Parts of the EMGALITY Pen Step 1 Preparing to Inject EMGALITY Step 1a Take the Pen from the refrigerator Check your prescription.

EMGALITY comes as a single-dose prefilled Pen. You will need 2 Pens for your first dose ( 1-time loading dose ). You will need 1 Pen for your monthly dose.

Put the original package with any unused Pens back in the refrigerator. Leave the base cap on until you are ready to inject. Leave the Pen at room temperature for 30 minutes before injecting.

Do not microwave the Pen, run hot water over it, or leave it in direct sunlight. Do not shake. Step 1b Gather Supplies For each injection you will need: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps disposal container.

See “ After You Inject Your Medicine .” Step 1c Inspect the Pen and the medicine Make sure you have the right medicine. The medicine inside should be clear. Its color may be colorless to slightly yellow to slightly brown.

Do not use the Pen, and throw away (dispose of) as directed by your healthcare provider or pharmacist if: it looks damaged the medicine is cloudy, is discolored, or has small particles the Expiration Date (Exp.) printed on the label has passed (see Figure A ) the medicine is frozen Figure A Step 1d Prepare for injection Wash your hands with soap and water before you inject your EMGALITY. Make sure a sharps disposal container is close by. Step 1e Choose your injection site Your healthcare provider can help you choose the injection site that is best for you.

Figure B You may inject the medicine into your stomach area (abdomen). Do not inject within 2 inches of the belly button (navel) (see Figure B ). You may inject the medicine into the front of your thighs.

This area should be at least 2 inches above the knee and 2 inches below the groin. Another person may give you the injection in the back of your upper arm, or buttocks (see Figure B ). Do not inject in the exact same spot.

For example, if you are giving 2 injections for your first dose (1-time loading dose) and want to use the same body site for the two separate injections, choose a different injection spot. If your first injection was in your abdomen, your next injection could be in another area of your abdomen. Do not inject into areas where the skin is tender, bruised, red, or hard.

Clean your injection site with an alcohol wipe. Let the injection site dry before you inject. Step 2 Injecting EMGALITY Step 2a Uncap the Pen Figure C Make sure the Pen is locked.

Leave the base cap on until you are ready to inject. Twist off the base cap (see Figure C ) and throw it away in your household trash. Do not put the base cap back on – this could damage the needle.… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.2 ) 06/2026

📄 Package Label / Principal Display Panel 129 words ▾

PACKAGE CARTON – EMGALITY Autoinjector 120 mg NDC 0002-1436-11 EMGALITY ® (galcanezumab-gnlm) injection 120 mg/mL 1 x 120 mg/mL Single-Dose prefilled pen For Subcutaneous Use Only Single-Dose Only Rx only Lilly PACKAGE CARTON – EMGALITY Autoinjector 120 mg

PACKAGE CARTON – EMGALITY Prefilled Syringe 120 mg NDC 0002-2377-11 EMGALITY ® (galcanezumab-gnlm) injection 120 mg/mL 1x 120 mg/mL Single-Dose prefilled syringe For Subcutaneous Use Only Single-Dose Only Rx only Lilly PACKAGE CARTON – EMGALITY Prefilled Syringe 120 mg

PACKAGE CARTON – EMGALITY Prefilled Syringe 100 mg NDC 0002-3115-09 EMGALITY ® (galcanezumab-gnlm) 100 mg/mL injection All 3 syringes must be administered to receive the 300 mg dose. 3 x 100 mg/mL Single-Dose prefilled syringe For Subcutaneous Use Only Single-Dose Only Rx only Lilly PACKAGE CARTON – EMGALITY Prefilled Syringe 100 mg

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 syringe00002-2377-11 28,149 Rx · $22,218,176
1 ml this page00002-2377-00 No Medicaid data
Drug total (last 4 qtrs): 28,149 Rx · 30,905 units · $22,218,176 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 Emgality Pen (matched by generic name) — 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 Emgality Pen. CMS lists 2 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
$83.55M
Claims incl. refills
90K
Beneficiaries
43.2K
Spend / beneficiary
$1,933.69
Spend / claim
$928.72
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 Galcanezumab-gnlm — the ingredient across all brands.

Top reported reactions

Injection Site Pain7,524
Migraine3,057
Underdose2,917
Headache2,448
Injection Site Haemorrhage1,608
Injection Site Erythema1,128
Accidental Underdose1,068

Age at onset

Neonate2
Infant6
Child1
Adolescent64
Adult6,413
Elderly1,157

Reporter sex

31,311 reports

Serious outcomes

Hospitalization1,122
Death85
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,640 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.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Eli Lilly and Company supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Eli Lilly and Company. 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 1 other package presentation of this same product, including 1 syringe (00002-2377-11). 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?
Eli Lilly and Company 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.
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.
← 00002-2340-01 · Eli 00002-2415-00 · 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.