Get your patient on Emgality (Galcanezumab-Gnlm)
Dosage & administration
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Emgality prescribing information
EMGALITY® is a calcitonin-gene related peptide antagonist indicated in adults for the:
[preventive treatment of migraine. 1.1]
1.1 MigraineEMGALITY is indicated for the preventive treatment of migraine in adults.
[treatment of episodic cluster headache. 1.2]
1.2 Episodic Cluster HeadacheEMGALITY is indicated for the treatment of episodic cluster headache in adults.
- 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]
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
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.
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
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.
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients
[see Warnings and Precautions 5.1]
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]
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients
[, Adverse Reactions 6.1]
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.
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]
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).
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 inTable 2. EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.
ap<0.001 | ||||
bN = 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 | 9.2 |
| Mean change from baseline | -4.7 | -2.8 | -4.3 | -2.3 |
| Difference from placeboa | -1.9 | -2.0 | ||
≥50% Migraine Headache Days Responders (over Months 1 to 6) | ||||
| % Respondersa | 62% | 39% | 59% | 36% |
≥75% Migraine Headache Days Responders (over Months 1 to 6) | ||||
| % Respondersa | 39% | 19% | 34% | 18% |
100% Migraine Headache Days Responders (over Months 1 to 6) | ||||
| % Respondersa | 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) | ||||
| Baseline | 51.4 | 52.9 | 52.5 | 51.4 |
| Mean change from baselineb | 32.4 | 24.7 | 28.5 | 19.7 |
| Difference from placeboa | 7.7 | 8.8 | ||
aLeast-square means and 95% confidence intervals are presented.
aLeast-square means and 95% confidence intervals are presented.
Figure 3shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 1. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 4shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 2. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Study 3 (NCT02614261) included adults with a history of chronic migraine (≥15 headache days per month with ≥8 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 over a 3-month treatment period. 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. A subset of patients (15%) was allowed to use one concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll.
The study excluded 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 endpoint was the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period. The secondary endpoints were 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 3-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 3-month treatment period, and the impact of migraine on daily activities as assessed by the mean change from baseline in the MSQ v2.1 Role Function-Restrictive domain score at Month 3. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.
In Study 3, a total of 1113 patients (946 female, 167 male) ranging in age from 18 to 65 years, were randomized. A total of 1037 patients completed the 3-month double-blind phase. The mean number of monthly migraine headache days at baseline was approximately 19.
EMGALITY 120 mg demonstrated statistically significant improvement for the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period, and in the mean percentage of patients reaching at least 50% reduction from baseline in the number of monthly migraine headache days over the 3-month treatment period, as summarized inTable 3. EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.
ap<0.001 | ||
EMGALITY 120 mg N = 273 | Placebo N =538 | |
Monthly Migraine Headache Days (over Months 1 to 3) | ||
| Baseline migraine headache days | 19.4 | 19.6 |
| Mean change from baseline | -4.8 | -2.7 |
| Difference from placeboa | -2.1 | |
≥50% Migraine Headache Days Responders (over Months 1 to 3) | ||
| % Respondersa | 28% | 15% |
Study 3 utilized a sequential testing procedure to control the Type-I error rate for the multiple secondary endpoints. Once a secondary endpoint failed to reach the required level for statistical significance, formal hypothesis testing was terminated for subsequent endpoints, and p-values were considered nominal only. In Study 3, EMGALITY 120 mg was not significantly better than placebo for the proportion of patients with ≥75% or 100% reduction in migraine headache days. Patients treated with EMGALITY 120 mg showed a nominally greater reduction in the number of monthly migraine headache days that acute medication was taken (-4.7 for EMGALITY 120 mg vs. -2.2 for placebo; nominal p-value <0.001), and the mean change from baseline in the MSQ Role Function-Restrictive Domain score at Month 3 was nominally greater in patients treated with EMGALITY 120 mg than in patients on placebo (21.8 for EMGALITY 120 mg vs. 16.8 for placebo; nominal p-value <0.001).
aLeast-square means and 95% confidence intervals are presented.
Figure 6shows the distribution of change from baseline in the mean number of monthly migraine headache days for the 3-month study period in bins of 3 days by treatment group. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
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 1summarizes the adverse reactions that occurred within up to 6 months of treatment in the migraine studies.
aInjection 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 reactionsa | 18 | 13 |
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]
The efficacy of EMGALITY was evaluated for the treatment of episodic cluster headache in a randomized, 8-week, double-blind, placebo-controlled study (Study 4).
Study 4 (NCT02397473) included adults who met the International Classification of Headache Disorders 3rdedition (beta version) diagnostic criteria for episodic cluster headache and had a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks during the prospective 7-day baseline period. All patients were randomized in a 1:1 ratio to receive once-monthly subcutaneous injections of EMGALITY 300 mg or placebo. Patients were allowed to use certain specified acute/abortive cluster headache treatments, including triptans, oxygen, acetaminophen, and NSAIDs during the study.
The study excluded patients on other treatments intended to reduce the frequency of cluster headache attacks; patients with medication overuse headache; patients with ECG abnormalities compatible with an acute cardiovascular event or conduction delay; and patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. In addition, patients with any history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical evidence of peripheral vascular disease; or diagnosis of Raynaud’s disease were excluded.
The primary efficacy endpoint for Study 4 was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3. A secondary endpoint was the percentage of patients who achieved a response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3.
In Study 4, a total of 106 patients (88 males, 18 females) ranging in age from 19 to 65 years were randomized and treated. A total of 90 patients completed the 8-week double-blind phase. In the prospective baseline phase, the mean number of weekly cluster headache attacks was 17.5, and was similar across treatment groups.
EMGALITY 300 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo, as summarized inTable 4
EMGALITY 300 mg N = 49 | Placebo N = 57 | |
Mean Reduction in Weekly Cluster Headache Attack Frequency (over Weeks 1 to 3) | ||
| Prospective Baseline Cluster Headache Attack Frequency | 17.8 | 17.3 |
| Mean change from baseline | -8.7 | -5.2 |
| Difference from placebo | -3.5 | |
| p-value | 0.036 | |
≥50% Weekly Cluster Headache Attack Frequency Responders (at Week 3) | ||
| % Responders | 71.4% | 52.6% |
| Difference from placebo | 18.8% | |
| p-value | 0.046 | |
aAbbreviations: BL = baseline; LS = least square; SE = standard error.
Figure 8shows the distribution of the average percent change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 in bins of 25%, by treatment group, in Study 4.
aN = number of intent to treat patients with non-missing average percentage change from baseline in weekly cluster headache attack frequency over weeks 1 to 3.
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.
[, and Patient Counseling Information 17]
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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
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 5.2]
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 5.3]
[see Use in Specific Populations 8.1]
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.
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
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.
Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
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 (Cave, 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 Cave, ss64 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 Cave, ss34 or 16 times that in humans at 120 mg or 300 mg, respectively.
For more information go to www.emgality.com or call 1-800-LillyRx (1-800-545-5979).
Literature revised: 10/2025
Copyright © 2018, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents
EMG-0009-USPI-20251021
[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]
5.1 Hypersensitivity ReactionsHypersensitivity 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
Hypersensitivity reactions can occur days after administration and may be prolonged.[see Contraindications 4]
4 CONTRAINDICATIONSEMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients
[, Adverse Reactions 6.1]
6.1 Clinical Trials ExperienceBecause 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.
MigraineThe 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
Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean age was 41 years at study entry.[see Clinical Studies 14.1]
14.1 MigraineThe 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 MigraineStudy 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 inTable 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 ap<0.001
bN = 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 1Study 2EMGALITY120 mgN = 210PlaceboN = 425EMGALITY120 mgN = 226PlaceboN = 450Monthly Migraine Headache Days (over Months 1 to 6)Baseline migraine headache days 9.2 9.1 9.1 9.2 Mean change from baseline -4.7 -2.8 -4.3 -2.3 Difference from placeboa -1.9 -2.0 ≥50% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 62% 39% 59% 36% ≥75% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 39% 19% 34% 18% 100% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 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)Baseline 51.4 52.9 52.5 51.4 Mean change from baselineb 32.4 24.7 28.5 19.7 Difference from placeboa 7.7 8.8 Figure 1: Change from Baseline in Monthly Migraine Headache Days in Study 1aaLeast-square means and 95% confidence intervals are presented.
Figure 2: Change from Baseline in Monthly Migraine Headache Days in Study 2aaLeast-square means and 95% confidence intervals are presented.
Figure 3shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 1. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 3: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 by Treatment Group in Study 1Figure 4shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 2. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 4: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 by Treatment Group in Study 2Figure 1 Figure 2 Figure 3 Figure 4 Chronic MigraineStudy 3 (NCT02614261) included adults with a history of chronic migraine (≥15 headache days per month with ≥8 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 over a 3-month treatment period. 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. A subset of patients (15%) was allowed to use one concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll.
The study excluded 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 endpoint was the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period. The secondary endpoints were 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 3-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 3-month treatment period, and the impact of migraine on daily activities as assessed by the mean change from baseline in the MSQ v2.1 Role Function-Restrictive domain score at Month 3. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.
In Study 3, a total of 1113 patients (946 female, 167 male) ranging in age from 18 to 65 years, were randomized. A total of 1037 patients completed the 3-month double-blind phase. The mean number of monthly migraine headache days at baseline was approximately 19.
EMGALITY 120 mg demonstrated statistically significant improvement for the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period, and in the mean percentage of patients reaching at least 50% reduction from baseline in the number of monthly migraine headache days over the 3-month treatment period, as summarized inTable 3. EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.
Table 3: Efficacy Endpoints in Study 3 ap<0.001
EMGALITY120 mgN = 273PlaceboN =538Monthly Migraine Headache Days (over Months 1 to 3)Baseline migraine headache days 19.4 19.6 Mean change from baseline -4.8 -2.7 Difference from placeboa -2.1 ≥50% Migraine Headache Days Responders (over Months 1 to 3)% Respondersa 28% 15% Study 3 utilized a sequential testing procedure to control the Type-I error rate for the multiple secondary endpoints. Once a secondary endpoint failed to reach the required level for statistical significance, formal hypothesis testing was terminated for subsequent endpoints, and p-values were considered nominal only. In Study 3, EMGALITY 120 mg was not significantly better than placebo for the proportion of patients with ≥75% or 100% reduction in migraine headache days. Patients treated with EMGALITY 120 mg showed a nominally greater reduction in the number of monthly migraine headache days that acute medication was taken (-4.7 for EMGALITY 120 mg vs. -2.2 for placebo; nominal p-value <0.001), and the mean change from baseline in the MSQ Role Function-Restrictive Domain score at Month 3 was nominally greater in patients treated with EMGALITY 120 mg than in patients on placebo (21.8 for EMGALITY 120 mg vs. 16.8 for placebo; nominal p-value <0.001).
Figure 5: Change from Baseline in Monthly Migraine Headache Days in Study 3aaLeast-square means and 95% confidence intervals are presented.
Figure 6shows the distribution of change from baseline in the mean number of monthly migraine headache days for the 3-month study period in bins of 3 days by treatment group. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 6: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 3 by Treatment Group in Study 3Figure 6 Figure 6 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 1summarizes 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 aInjection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus.
Adverse ReactionEMGALITY 120 mgMonthly(N=705)%PlaceboMonthly(N=1451)%Injection site reactionsa 18 13 Episodic Cluster HeadacheEMGALITY was studied for up to 2 months in a placebo-controlled trial in patients with episodic cluster headache (Study 4)
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.[see Clinical Studies 14.2]
14.2 Episodic Cluster HeadacheThe efficacy of EMGALITY was evaluated for the treatment of episodic cluster headache in a randomized, 8-week, double-blind, placebo-controlled study (Study 4).
Study 4 (NCT02397473) included adults who met the International Classification of Headache Disorders 3rdedition (beta version) diagnostic criteria for episodic cluster headache and had a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks during the prospective 7-day baseline period. All patients were randomized in a 1:1 ratio to receive once-monthly subcutaneous injections of EMGALITY 300 mg or placebo. Patients were allowed to use certain specified acute/abortive cluster headache treatments, including triptans, oxygen, acetaminophen, and NSAIDs during the study.
The study excluded patients on other treatments intended to reduce the frequency of cluster headache attacks; patients with medication overuse headache; patients with ECG abnormalities compatible with an acute cardiovascular event or conduction delay; and patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. In addition, patients with any history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical evidence of peripheral vascular disease; or diagnosis of Raynaud’s disease were excluded.
The primary efficacy endpoint for Study 4 was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3. A secondary endpoint was the percentage of patients who achieved a response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3.
In Study 4, a total of 106 patients (88 males, 18 females) ranging in age from 19 to 65 years were randomized and treated. A total of 90 patients completed the 8-week double-blind phase. In the prospective baseline phase, the mean number of weekly cluster headache attacks was 17.5, and was similar across treatment groups.
EMGALITY 300 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo, as summarized inTable 4
Table 4: Efficacy Endpoints in Study 4 EMGALITY300 mgN = 49PlaceboN = 57Mean Reduction in Weekly Cluster Headache Attack Frequency (over Weeks 1 to 3)Prospective Baseline Cluster Headache Attack Frequency 17.8 17.3 Mean change from baseline -8.7 -5.2 Difference from placebo -3.5 p-value 0.036 ≥50% Weekly Cluster Headache Attack Frequency Responders (at Week 3)% Responders 71.4% 52.6% Difference from placebo 18.8% p-value 0.046 Figure 7: Mean Change in Weekly Cluster Headache Attack Frequency over Weeks 1 to 3 in Study 4aaAbbreviations: BL = baseline; LS = least square; SE = standard error.
Figure 8shows the distribution of the average percent change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 in bins of 25%, by treatment group, in Study 4.
Figure 8: Distribution of the Average Percent Change from Baseline in Weekly Cluster Headache Attack Frequency over Weeks 1 to 3 in Study 4aaN = number of intent to treat patients with non-missing average percentage change from baseline in weekly cluster headache attack frequency over weeks 1 to 3.
Figure 7 Figure 8 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.
[, and Patient Counseling Information 17]
17 PATIENT COUNSELING INFORMATIONAdvise 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
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 5.2]
5.2 HypertensionDevelopment 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.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 5.3]
5.3 Raynaud's PhenomenonDevelopment 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.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]
8.1 PregnancyPregnancy Exposure RegistryThere 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 SummaryThere 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 ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
DataAnimal DataWhen 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 (Cave, 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 Cave, ss64 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 Cave, ss34 or 16 times that in humans at 120 mg or 300 mg, respectively.
For more information go to www.emgality.com or call 1-800-LillyRx (1-800-545-5979).
Literature revised: 10/2025
Eli Lilly and Company, Indianapolis, IN 46285, USAUS License Number 1891Copyright © 2018, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents
EMG-0009-USPI-20251021
- [Hypertension: New-onset or worsening of pre-existing hypertension may occur. 5.2]
- [Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. 5.3]
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [and Warnings and Precautions 5.1]
[see Contraindications 4]
4 CONTRAINDICATIONSEMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients
[see Warnings and Precautions 5.1]
5.1 Hypersensitivity ReactionsHypersensitivity 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]Hypersensitivity reactions can occur days after administration and may be prolonged.[, Adverse Reactions 6.1]
6.1 Clinical Trials ExperienceBecause 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.
MigraineThe 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
Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean age was 41 years at study entry.[see Clinical Studies 14.1]
14.1 MigraineThe 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 MigraineStudy 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 inTable 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 ap<0.001
bN = 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 1Study 2EMGALITY120 mgN = 210PlaceboN = 425EMGALITY120 mgN = 226PlaceboN = 450Monthly Migraine Headache Days (over Months 1 to 6)Baseline migraine headache days 9.2 9.1 9.1 9.2 Mean change from baseline -4.7 -2.8 -4.3 -2.3 Difference from placeboa -1.9 -2.0 ≥50% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 62% 39% 59% 36% ≥75% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 39% 19% 34% 18% 100% Migraine Headache Days Responders (over Months 1 to 6)% Respondersa 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)Baseline 51.4 52.9 52.5 51.4 Mean change from baselineb 32.4 24.7 28.5 19.7 Difference from placeboa 7.7 8.8 Figure 1: Change from Baseline in Monthly Migraine Headache Days in Study 1aaLeast-square means and 95% confidence intervals are presented.
Figure 2: Change from Baseline in Monthly Migraine Headache Days in Study 2aaLeast-square means and 95% confidence intervals are presented.
Figure 3shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 1. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 3: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 by Treatment Group in Study 1Figure 4shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins of 2 days, by treatment group, in Study 2. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 4: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 by Treatment Group in Study 2Figure 1 Figure 2 Figure 3 Figure 4 Chronic MigraineStudy 3 (NCT02614261) included adults with a history of chronic migraine (≥15 headache days per month with ≥8 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 over a 3-month treatment period. 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. A subset of patients (15%) was allowed to use one concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll.
The study excluded 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 endpoint was the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period. The secondary endpoints were 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 3-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 3-month treatment period, and the impact of migraine on daily activities as assessed by the mean change from baseline in the MSQ v2.1 Role Function-Restrictive domain score at Month 3. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.
In Study 3, a total of 1113 patients (946 female, 167 male) ranging in age from 18 to 65 years, were randomized. A total of 1037 patients completed the 3-month double-blind phase. The mean number of monthly migraine headache days at baseline was approximately 19.
EMGALITY 120 mg demonstrated statistically significant improvement for the mean change from baseline in the number of monthly migraine headache days over the 3-month treatment period, and in the mean percentage of patients reaching at least 50% reduction from baseline in the number of monthly migraine headache days over the 3-month treatment period, as summarized inTable 3. EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit over the EMGALITY 120 mg once-monthly dose.
Table 3: Efficacy Endpoints in Study 3 ap<0.001
EMGALITY120 mgN = 273PlaceboN =538Monthly Migraine Headache Days (over Months 1 to 3)Baseline migraine headache days 19.4 19.6 Mean change from baseline -4.8 -2.7 Difference from placeboa -2.1 ≥50% Migraine Headache Days Responders (over Months 1 to 3)% Respondersa 28% 15% Study 3 utilized a sequential testing procedure to control the Type-I error rate for the multiple secondary endpoints. Once a secondary endpoint failed to reach the required level for statistical significance, formal hypothesis testing was terminated for subsequent endpoints, and p-values were considered nominal only. In Study 3, EMGALITY 120 mg was not significantly better than placebo for the proportion of patients with ≥75% or 100% reduction in migraine headache days. Patients treated with EMGALITY 120 mg showed a nominally greater reduction in the number of monthly migraine headache days that acute medication was taken (-4.7 for EMGALITY 120 mg vs. -2.2 for placebo; nominal p-value <0.001), and the mean change from baseline in the MSQ Role Function-Restrictive Domain score at Month 3 was nominally greater in patients treated with EMGALITY 120 mg than in patients on placebo (21.8 for EMGALITY 120 mg vs. 16.8 for placebo; nominal p-value <0.001).
Figure 5: Change from Baseline in Monthly Migraine Headache Days in Study 3aaLeast-square means and 95% confidence intervals are presented.
Figure 6shows the distribution of change from baseline in the mean number of monthly migraine headache days for the 3-month study period in bins of 3 days by treatment group. A treatment benefit over placebo for EMGALITY is seen across a range of changes from baseline in monthly migraine headache days.
Figure 6: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 3 by Treatment Group in Study 3Figure 6 Figure 6 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 1summarizes 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 aInjection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus.
Adverse ReactionEMGALITY 120 mgMonthly(N=705)%PlaceboMonthly(N=1451)%Injection site reactionsa 18 13 Episodic Cluster HeadacheEMGALITY was studied for up to 2 months in a placebo-controlled trial in patients with episodic cluster headache (Study 4)
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.[see Clinical Studies 14.2]
14.2 Episodic Cluster HeadacheThe efficacy of EMGALITY was evaluated for the treatment of episodic cluster headache in a randomized, 8-week, double-blind, placebo-controlled study (Study 4).
Study 4 (NCT02397473) included adults who met the International Classification of Headache Disorders 3rdedition (beta version) diagnostic criteria for episodic cluster headache and had a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks during the prospective 7-day baseline period. All patients were randomized in a 1:1 ratio to receive once-monthly subcutaneous injections of EMGALITY 300 mg or placebo. Patients were allowed to use certain specified acute/abortive cluster headache treatments, including triptans, oxygen, acetaminophen, and NSAIDs during the study.
The study excluded patients on other treatments intended to reduce the frequency of cluster headache attacks; patients with medication overuse headache; patients with ECG abnormalities compatible with an acute cardiovascular event or conduction delay; and patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. In addition, patients with any history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical evidence of peripheral vascular disease; or diagnosis of Raynaud’s disease were excluded.
The primary efficacy endpoint for Study 4 was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3. A secondary endpoint was the percentage of patients who achieved a response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3.
In Study 4, a total of 106 patients (88 males, 18 females) ranging in age from 19 to 65 years were randomized and treated. A total of 90 patients completed the 8-week double-blind phase. In the prospective baseline phase, the mean number of weekly cluster headache attacks was 17.5, and was similar across treatment groups.
EMGALITY 300 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo, as summarized inTable 4
Table 4: Efficacy Endpoints in Study 4 EMGALITY300 mgN = 49PlaceboN = 57Mean Reduction in Weekly Cluster Headache Attack Frequency (over Weeks 1 to 3)Prospective Baseline Cluster Headache Attack Frequency 17.8 17.3 Mean change from baseline -8.7 -5.2 Difference from placebo -3.5 p-value 0.036 ≥50% Weekly Cluster Headache Attack Frequency Responders (at Week 3)% Responders 71.4% 52.6% Difference from placebo 18.8% p-value 0.046 Figure 7: Mean Change in Weekly Cluster Headache Attack Frequency over Weeks 1 to 3 in Study 4aaAbbreviations: BL = baseline; LS = least square; SE = standard error.
Figure 8shows the distribution of the average percent change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 in bins of 25%, by treatment group, in Study 4.
Figure 8: Distribution of the Average Percent Change from Baseline in Weekly Cluster Headache Attack Frequency over Weeks 1 to 3 in Study 4aaN = number of intent to treat patients with non-missing average percentage change from baseline in weekly cluster headache attack frequency over weeks 1 to 3.
Figure 7 Figure 8 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.
[, and Patient Counseling Information 17]
17 PATIENT COUNSELING INFORMATIONAdvise 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
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 5.2]
5.2 HypertensionDevelopment 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.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 5.3]
5.3 Raynaud's PhenomenonDevelopment 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.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]
8.1 PregnancyPregnancy Exposure RegistryThere 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 SummaryThere 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 ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
DataAnimal DataWhen 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 (Cave, 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 Cave, ss64 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 Cave, ss34 or 16 times that in humans at 120 mg or 300 mg, respectively.
For more information go to www.emgality.com or call 1-800-LillyRx (1-800-545-5979).
Literature revised: 10/2025
Eli Lilly and Company, Indianapolis, IN 46285, USAUS License Number 1891Copyright © 2018, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents
EMG-0009-USPI-20251021
- Hypertension
- Raynaud's Phenomenon
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.
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
The carcinogenic potential of galcanezumab-gnlm has not been assessed.
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).
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 |
INSTRUCTIONS FOR USE |
EMGALITY® [em-GAL-it-ē] |
(galcanezumab-gnlm) |
injection, for subcutaneous use |
Prefilled Syringe |
This Instructions for Use contains information on how to inject EMGALITY |
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This Instructions for Use is for patients with episodic cluster headache. |
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For subcutaneous injection only. |
Important Information You Need to Know Before Injecting EMGALITY |
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INSTRUCTIONS FOR USE |
Before you use the EMGALITY prefilled syringe, read and carefully follow all the step-by-step instructions. |
Parts of the EMGALITY Prefilled Syringe |
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Step 1 Preparing to Inject EMGALITY | |
Step 1a Take the Prefilled Syringes from the refrigerator Take 3 EMGALITY prefilled syringes from the refrigerator. Check your prescription.
Leave the needle caps on until you are ready to inject. Leave the prefilled syringes at room temperature for 30 minutes before injecting. Do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight.
Do not shake. | |
Step 1b Gather Supplies For each injection you will need:
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Step 1c Inspect the Prefilled Syringe 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 prefilled syringe, and throw away (dispose of) as directed by your healthcare provider or pharmacist if:
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Expiration Date  | |
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. |
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Step 2 Injecting EMGALITY | ||
Step 2a Uncap |  | |
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Step 2b Insert |  | |
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Step 2c Inject |  | ||
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Step 3 Disposing of EMGALITY Step 3a Throw away the used prefilled syringe | |||
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Commonly Asked Questions | ||
Q. | What if I see air bubbles in my EMGALITY prefilled syringe? | |
A. | It is normal to have air bubbles in the prefilled syringe. EMGALITY is injected under your skin (subcutaneous injection), so these air bubbles will not harm you. | |
Q. | What if there is a drop of liquid on the tip of the needle when I remove the needle cap? | |
A. | It is okay to see a drop of liquid on the tip of the needle. | |
Q. | What if I cannot push in the plunger? | |
A. | If the plunger is stuck or damaged: | |
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Q. | What if there is a drop of liquid or blood on my skin after my injection? | |
A. | This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.
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Q. | How can I tell if my injection is complete? | |
A. | When your injection is complete: | |
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If you have more questions about how to use the EMGALITY prefilled syringe: | ||
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Storing EMGALITY | |
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Read the full Prescribing Information and Patient Information for EMGALITY inside this box to learn more about your medicine. | |
| Eli Lilly and Company | ||
| Indianapolis, IN 46285, USA | ||
| US License Number 1891 | ||
EMGALITY® is a registered trademark of Eli Lilly and Company. | ||
Copyright © 2019, 2025, Eli Lilly and Company. All rights reserved. | ||
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This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 11/2025 | ||
EMG-0002-PFS-100MG-IFU-20251119 |
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
