Emgality Drug Information
Generic name: GALCANEZUMAB-GNLM
Uses of Emgality
Migraine
EMGALITY is indicated for the preventive treatment of migraine in adults.
Episodic Cluster Headache
EMGALITY is indicated for the treatment of episodic cluster headache in adults.
Dosage & Administration of Emgality
Recommended 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.
Recommended 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.
Important
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 : 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 . 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.
Side Effects of Emgality
Clinical 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 . 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) . 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.
Immunogenicity 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, an in vitro ligand-binding immunoassay was performed to detect neutralizing antibodies. In controlled studies with EMGALITY up to 6 months (Study 1, Study 2, and Study 3), the incidence of anti-galcanezumab-gnlm antibody development was 4.8% (33/688) in patients receiving EMGALITY once monthly (32 out of 33 of whom had in vitro neutralizing activity). With 12 months of treatment in an open-label study, up to 12.5% (16/128) of EMGALITY-treated patients developed anti-galcanezumab-gnlm antibodies, most of whom tested positive for neutralizing antibodies.
Although anti-galcanezumab-gnlm antibody development was not found to affect the pharmacokinetics, safety or efficacy of EMGALITY in these patients, the available data are too limited to make definitive conclusions.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of EMGALITY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to EMGALITY exposure. Immune System Disorders — Anaphylaxis, angioedema . Skin and Subcutaneous Tissue Disorders — Rash. Vascular Disorders — Hypertension , Raynaud's Phenomenon
Warnings & Cautions for Emgality
Hypersensitivity 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 . Hypersensitivity reactions can occur days after administration and may be prolonged.
Hypertension 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.
Raynaud'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.
Pregnancy Safety for Emgality
Pregnancy 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 of Emgality
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Contraindications for Emgality
is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients . EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Clinical Studies of Emgality
Migraine
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
Mean 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 -
MSQ Role Function-Restrictive Domain Score (over Months 4 to 6) Baseline 51.4
52.9 52.5
Mean change from baseline b 32.4 24.7 28.5 19.7 Difference from placebo
a 7.7
Figure 1: Change from Baseline in Monthly Migraine Headache Days in Study
1 a a Least-square means and 95% confidence intervals are presented. Figure 2: Change from Baseline in Monthly Migraine Headache Days in Study 2 a a Least-square means and 95% confidence intervals are presented. Figure 3 shows 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 1 Figure 4 shows 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 2 Figure 1 Figure 2 Figure 3 Figure 4 Chronic Migraine 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 in Table 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 a p<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
Mean change from baseline -4.8 -2.7 Difference from placebo a -2.1 ≥50%
Migraine Headache Days Responders (over Months 1 to 3) % Responders a 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 3 a a Least-square means and 95% confidence intervals are presented. Figure 6 shows 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 3 Figure 6 Figure 6
Episodic Cluster Headache
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 3 rd edition (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 in Table 4. Table 4: Efficacy Endpoints in Study 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
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 4 a a Abbreviations: BL = baseline; LS = least square; SE = standard error. Figure 8 shows 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 4 a a N = 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
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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