What Is Emgality?
Emgality (galcanezumab-gnlm) is a calcitonin-gene related peptide antagonist indicated for the preventive treatment of migraine in adults.
What Are Side Effects of Emgality?
Common side effects of Emgality include:
- injection site reactions such as pain, redness, and itching
Dosage for Emgality
The recommended dosage of Emgality is a 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg.
What Drugs, Substances, or Supplements Interact with Emgality?
Emgality may interact with other drugs. Tell your doctor all medications and supplements you use.
Emgality During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Emgality; it is unknown how it would affect a fetus. It is unknown if Emgality passes into breast milk. Consult your doctor before breastfeeding.Additional Information
Our Emgality (galcanezumab-gnlm) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
16 Surprising Headache Triggers and Tips for Pain Relief See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
An allergic reaction to galcanezumab can occur several days after an injection.
Common side effects may include:
- pain, redness, itching, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Who suffers more frequently from migraine headaches? See AnswerSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
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 [see Clinical Studies]. 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
| Adverse Reaction | EMGALITY 120 mg Monthly (N=705) % |
Placebo Monthly (N=1451) % |
| Injection site reactionsa | 18 | 13 |
| 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. | ||
Episodic Cluster Headache
EMGALITY was studied for up to 2 months in a placebo-controlled trial in patients with episodic cluster headache (Study 4) [see Clinical Studies]. 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 antigalcanezumab- gnlm antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro ligandbinding 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-galcanezumabgnlm 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 EMGALITYtreated 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 [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Skin and Subcutaneous Tissue Disorders — Rash.
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Emgality (Galcanezumab-gnlm Injection)
© Emgality Patient Information is supplied by Cerner Multum, Inc. and Emgality Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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