Does Emgality cause side effects?

Emgality (galcanezumab-gnlm) is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand used for the preventive treatment of migraine in adults.

Common side effects of Emgality include injection site reactions such as pain, redness, and itching.

Serious side effects of Emgality include allergic reactions such as itching, rash, hives, trouble breathing, and swelling of the face, mouth, tongue, or throat

There are no listed drug interactions of Emgality. There are no adequate data on the developmental risk associated with the use of Emgality in pregnant women. There are no data on the presence of Emgality in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Emgality and any potential adverse effects on the breastfed infant from Emgality or from the underlying maternal condition.

What are the important side effects of Emgality?

Emgality may cause serious side effects, including: Allergic reactions

Allergic reactions, including itching, rash, hives, and trouble breathing, can happen after receiving Emgality. This can happen days after using Emgality. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, which may be part of an allergic reaction:

  • swelling of the face, mouth, tongue, or throat
  • trouble breathing

The most common side effects of Emgality include:

  • injection site reactions

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Emgality. For more information, ask your healthcare provider or pharmacist.

Emgality side effects list for healthcare professionals

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity Reactions

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

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). 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 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-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 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.

What drugs interact with Emgality?

No Information Provided

Summary

Emgality (galcanezumab) is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand used for the preventive treatment of migraine in adults. Common side effects of Emgality include injection site reactions such as pain, redness, and itching. Serious side effects of Emgality include allergic reactions such as itching, rash, hives, trouble breathing, and swelling of the face, mouth, tongue, or throat. There are no listed drug interactions of Emgality. There is no data on the safety of Emgality in pregnant or breastfeeding women.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 3/4/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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