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Does Emgality cause side effects?
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.
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
|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.
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.
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Related Disease Conditions
Migraine headache is a type of headache associated with a sensitivity to light, smells, or sounds, eye pain, severe pounding on one side of the head, and sometimes nausea and vomiting. The exact cause of migraine headaches is not known. Triggers for migraine headaches include certain foods, stress, hormonal changes, strong stimuli (loud noises), and oversleeping. Treatment guidelines for migraines include medicine, pain management, diet changes, avoiding foods that trigger migraines, staying hydrated, getting adequate sleep, and exercising regularly. Prevention of migraine triggers include getting regular exercise, drinking water daily, reducing stress, and avoiding trigger foods.
Migraines and Seizures (Symptoms, Auras, Medication)
Migraines are a type of headache and seizures are the main symptom of epilepsy. Migraine headaches and seizures are two different neurological problems that have similar signs, symptoms, and auras, for example, sensitivity to light (photophobia) and sound, irritability, nausea, and vomiting. Symptoms unique to migraine and migraine auras are water retention, problems sleeping, appetite changes, and talkativeness. Symptoms unique to seizure and seizures auras are depression, a feeling of heaviness, a feeling that a seizure is approaching, and depression. Many of the symptoms of migraine and seizures are the same, however, seizures do not cause migraines; however, people who have seizures are twice as likely to have migraines and vice-versa. People who have migraines are twice as likely to have seizures, and people with seizures are twice as likely to have migraines; however, one condition does not cause the other.
Migraine and Stroke
Migraine headache is a type of headache in which the exact cause is not known; however, they may be inherited, and certain foods and environmental factors can trigger and may contribute them. A stroke (brain attack) happens when a blood vessel in the brain leaks, bursts, or becomes blocked, which can be caused by many other health problems. Both migraines and strokes can can cause severe head pain (migraine pain usually is only on one side of the head). Migraine aura symptoms may mimic or feel like a stroke or mini-stroke (transient ischemic attack, TIA) because they have similar symptoms and signs like severe headache, numbness in the legs, feet, arms, hands, or face, nausea, vomiting, and dizziness. Other migraine aura symptoms include vision problems like flashing lights or blind spots in one eye. The main difference between migraine headache and stroke symptoms and signs is that a migraine headaches usually come on gradually while a stroke symptoms come on suddenly and unexpectedly.
Abdominal Migraines in Children and Adults
Abdominal Migraines in Children and Adults
Abdominal migraine in adults and children is a variant of migraine headaches. Abdominal migraine in children generally occurs in children who have a family history of migraines. Causes of abdominal migraine is not known. Symptoms of abdominal migraine include acute, severe, midline abdominal pain, nausea, vomiting, paleness, and inability to eat. Abdominal migraine is diagnosed through patient history, family history, and ruling out other medical causes. Treatment of abdominal migraine include tricyclic antidepressants and triptans.
Migraine vs. Headache: Differences and Similarities
Headaches are the most common reason why a person goes to the doctor or other healthcare professional for treatment. There are different types of headaches, for example, migraine, tension, and cluster headaches. The most common type of headache is tension headache. Migraine is much less common. There are few similarities between migraine and other headaches, for example, the severity of the pain can be the same, mild, moderate, or severe; and they can occur on one side or both sides of the head. However, there are many differences between migraine and other types of headaches. Migraine headaches also have different names, for example, migraine with aura and menstrual migraine. Symptoms of migraine that usually aren't experienced by a person with another type of headache include nausea, vomiting, worsens with mild exercise, debilitating pain, eye pain, throbbing head pain. Migraine trigger include light, mild exercise, strong smells, certain foods like red wine, aged cheese, smoked meats, artificial sweeteners, chocolate, alcohol, and dairy products, menstrual period, stress, oversleeping, and changes in barometric pressure. Untreated migraine attacks usually last from 4 to 72 hours, but may last for weeks. Most headaches resolve within 24-48 hours. Doctors don't know exactly what causes migraine headaches; however, other headaches like tension headaches have more specific triggers and causes. Additional tests usually are required to diagnose migraine from other types of headaches, diseases, or other medical problems. Most headaches can be treated and cured with home remedies like essential oils, massage, and over-the-counter pain medication like acetaminophen (Tylenol) and NSAIDs (nonsteroidal anti-inflammatory drugs) like naproxen (Aleve, Anaprox, Naprosyn) or ibuprofen (Advil, Midol, Motrin). Most headaches resolve with OTC and home remedy treatment, while your doctor may need to prescribe medication to treat your migraines. If you have the "worst headache of your life," seek medical care immediately.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.