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What is Emgality (galcanezumab-gnlm) and how is it used?
Emgality is indicated for the preventive treatment of migraine in adults.
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 available in a single-dose prefilled pen or a single-dose prefilled syringe to deliver 120 mg galcanezumab-gnlm. Each mL is composed of 120 mg galcanezumab-gnlm; L-histidine, USP (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80, USP (0.5 mg); Sodium Chloride, USP (8.8 mg); Water for Injection, USP. The pH range is 5.3 - 6.3.
What are the side effects of Emgality (galcanezumab-gnlm)?
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.
What is the dosage of Emgality (galcanezumab-gnlm)?
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.
For subcutaneous injection only. Before you use the Emgality prefilled syringe, read and carefully follow all the step-by-step instructions. Important Information
- Your healthcare provider or nurse should show you how to prepare and inject Emgality using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject Emgality.
- Keep these Instructions for Use and refer to them as needed.
- Each Emgality prefilled syringe is for one-time use only. Do not share or reuse your Emgality prefilled syringe. You may give or get an infection.
- Your healthcare provider may help you decide where on your body to inject your dose. You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
- If you have vision problems, do not use Emgality prefilled syringe without help from a caregiver.
What drugs interact with Emgality (galcanezumab-gnlm)?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
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Is Emgality (galcanezumab-gnlm) safe to use while pregnant or breastfeeding?
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.
There are no data on the presence of galcanezumab-gnlm 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.
Emgality (galcanezumab-gnlm) is an injection to prevent migraines. Emgality is a monoclonal antibody that targets a neurotransmitter thought to play a role in migraines. Side effects include allergic reaction.
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Related Disease Conditions
Abdominal Migraines in Children and Adults
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 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.
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