EMGALITY galcanezumab-gnlm 120 mg/mL Injection, Solution, 1 syringe — NDC 0002-1436-11 (Billing 00002-1436-11)
This is a package of 1 syringe of EMGALITY galcanezumab-gnlm 120 mg/mL Injection, Solution from Eli Lilly and Company, marketed since Sep 2018 and currently FDA-listed; retail pharmacies pay about $734.28 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 078996
- GCN: 40418
- GPI-14 (Medi-Span): 6770203530D520
- HICL (First Databank): 045281
- AHFS class code: 28:32.12.00
- RxCUI (RxNorm): 2058872
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Calcitonin gene-related peptide (CGRP) antagonists class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Galcanezumab-gnlm injection is used to help prevent migraine headaches (severe, throbbing headaches that may cause nausea and sensitivity to sound or light). It is also used to treat the symptoms of a cluster headache (severe headaches usually on one side of the head or around one eye). Galcanezumab-gnlm injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes migraine and cluster headaches.
Read the full MedlinePlus article ↗- 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?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $734.283 | $734.28 / 1 ml |
| Medicaid paysCMS SDUD · 12 mo | $716.29 | $716.29 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $731.06 | $731.06 / 1 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00002-1436-11 You're viewing this Main listing | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $734.28 / mL | $734.28 | 2018-09-27 | — | Active |
| 00002-1436-61 0002-1436-61 | 2 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE Sample | — | — | 2018-09-27 | — | Active |
| 00002-1436-00 0002-1436-00 | 1 mL in 1 SYRINGE | — | — | — | — | 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 this package?
How does this package differ from NDC 00002-1436-00?
What NDC number is used to bill for this package of EMGALITY galcanezumab-gnlm 120 mg/mL Injection, Solution?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Emgality 120 mg/mLthis 00002-1436-11 | Eli | 1 syringe | $734.283 | — | Availability likely | — |
| Emgality 120 mg/mL 00002-2377-11 | Eli | 1 syringe | $734.421 | — | Availability likely | +0% |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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.
🛈 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.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Sep 27, 2030 |
Is there a biosimilar for EMGALITY 120 MG/ML PEN?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
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.
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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.
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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.
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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.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
12.2Pharmacodynamics There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm.
🔬 Clinical Studies ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
Warnings and Precautions ( 5.2 ) 06/2026
📄 Package Label / Principal Display Panel ▾
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