Emgality

What is Emgality?¹

Emgality is a medication used to prevent migraines and treat cluster headaches in adult patients. It contains a monoclonal antibody called a calcitonin gene-related peptide (CGRP) receptor antagonist.²

Normally, when CGRP binds to its receptor, it initiates a series of actions that cause the symptoms experienced during migraine and episodic cluster headaches. Emgality works as an antagonist, preventing CGRP from binding to its receptor and thus blocking its action.³

Emgality is available in two pre-filled, single-use forms — a pen and a syringe. Both types can be self-administered at home. When your doctor prescribes Emgality, they’ll show you how to administer it. Often, they arrange for the first dose to be given in the office to make sure you feel comfortable doing it on your own.

This drug is geared toward prevention. It provides relief for people struggling with chronic migraines and cluster headaches, but it doesn’t cure these conditions.

What is Emgality used to treat?

Emgality is used as a preventative treatment for migraines. Migraines are recurring headaches characterized by moderate-to-severe throbbing or pulsing head pain, often accompanied by other symptoms, such as nausea, vomiting, and sensitivity to light and sound.

What You Need To Know About Migraines

Emgality can be administered on a regular schedule to reduce the number of migraine episodes patients are experiencing or stop them from recurring altogether. This drug is explicitly given for prevention and is not used for pain relief once a migraine occurs.⁴

The drug is also used to treat episodic cluster headaches, a severe type of headache that comes on suddenly. It’s characterized by a sharp, stabbing, or burning pain that’s felt on one side of the head, often around one eye. Other symptoms may include a swollen, red, watery eye, a droopy eyelid, facial flushing or redness, and a runny or congested nose on one side.

The term “episodic” in the name refers to the fact that patients with the condition experience multiple attacks within a certain period, which may be weeks or months, followed by a period of remission.⁵

Emgality dosage forms and strengths

Emgality is available in two injectable forms — pens and syringes. Each type contains a single dose of the medication. The strength you use will depend on the condition you're treating. Always follow your doctor's recommendations to prevent over or underdosing and any associated complications.⁶

Single-dose pre-filled pen 

• 120mg/mL

Single-dose pre-filled syringe

• 100mg/mL

• 120mg/mL

Recommended dosing for Emgality

Your doctor will determine which dose is right for you. Typical dosing schedules are as follows:

For migraine prevention

People taking Emgality for migraine prevention will take an initial loading dose of 240mg (two injections of 120mg each, one immediately after the other). Subsequent doses of 120mg are administered once monthly for maintenance, a regimen that can be continued indefinitely to prevent recurrent migraine episodes.

For episodic cluster headache treatment

Those taking Emgality for cluster headaches will begin with a loading dose of 300mg (three consecutive injections of 100mg each). Subsequent doses of 300mg are given once monthly during the cluster period. This is not usually an ongoing therapy, as treatment is paused during periods of remission.

How do you take Emgality?

Both forms of Emgality are delivered through a subcutaneous (under the skin) injection.⁷

Your doctor may administer the first dose (loading dose) at their office, or you may choose to do it yourself at home. A member of your care team will explain how to administer the injection yourself. Subsequent doses are usually given at home.

When self-administering, you may find it easier to inject Emgality into your abdomen or thigh. If you have help, the person giving your medication may inject the drug into your buttock, back, or upper arm. Ensure you choose a location that’s free of irritation and bruising. Try to choose a spot within your chosen injection area where you haven’t injected recently.

Before administering Emgality, let the pen or syringe sit at room temperature for 30 minutes. Don’t expose it to a heat source to speed up the process, and don’t shake it. Always clean the injection site with an alcohol wipe before administering your Emgality injection.

Seeing results

When using Emgality to prevent migraines, you'll likely start seeing results within the first month of initiation. However, you may have to wait up to six months to experience its full effects.⁸

When Emgality is taken for cluster headaches, there may be improvement within a week of starting treatment. However, it may take up to three weeks to achieve optimal results. 

Who should not take Emgality?

Emgality is available by prescription only, so you’ll need to meet with your doctor before you start taking it. While the drug is generally well-tolerated when taken as directed, Emgality is not suitable for everyone.⁹

Some people taking Emgality experience hypersensitivity reactions, including rashes, hives, swelling of the lips, throat, or face, vomiting, shortness of breath, and loss of consciousness.

At your appointment, let your doctor know if you’ve ever experienced an allergic reaction to Emgality or other medications. Emgality is contraindicated in people with known hypersensitivity to any of the drug’s active or inactive ingredients.

Many inactive ingredients (ones that don’t have a therapeutic effect within your body) are commonly included in drug formulations, so you must inform your doctor of any drug sensitivities you have, not just past reactions to Emgality.

Hypersensitivity reactions may occur hours to days after administration, and they may be prolonged. If you notice any signs of hypersensitivity, seek immediate medical attention.

Potential side effects of Emgality

Some people experience unwanted side effects while taking Emgality. Common side effects are usually mild and resolve without intervention. If you develop severe or lasting side effects, speak with your doctor.

Common side effects

Injection site reactions are the most common adverse effects. You may experience one or more of the following at the injection site after administering Emgality:¹⁰ ¹¹

• Pain

• Itching

• Warmth/heat

• Redness

• Swelling 

Severe side effects

Severe side effects are typically those associated with an allergic reaction, which may include one or more of the following:

• Shortness of breath

• Rash

• Hives

• Widespread itching

• Vomiting

• Swelling of the face, eyes, lips, mouth, tongue, or throat

• Difficulty breathing

• Loss of consciousness

Before taking your first dose, it's essential to discuss with your doctor the potential side effects and what to do if they occur. If you notice adverse effects after taking Emgality, you should contact your doctor. Additionally, you can report any adverse effects you experience to the FDA at 1-800-FDA-1088.

Overdose

Call the National Poison Control helpline if you’ve taken too much Emgality. If someone in your care has overdosed on Emgality and is unconscious, has had a seizure, or is struggling to breathe, call 911.¹² ¹³

Long-term use of Emgality

Emgality doesn’t cure migraine or cluster headaches, and the drug is typically taken long-term. People with episodic cluster headaches usually stop taking Emgality during periods of remission and start treatment again once their symptoms return.¹⁴ ¹⁵

Emgality during pregnancy and breastfeeding

There aren't enough human studies to determine if Emgality is safe during pregnancy. However, animal studies have shown no adverse effects on the offspring.¹⁶

Similarly, there’s insufficient information on whether Emgality passes into breast milk. And there is no data available on its safety in infants and young children.

Thus, if you're pregnant, breastfeeding, or planning to become pregnant, speak with your doctor about the possible effects of Emgality before starting the medication. If you become pregnant while taking Emgality, consult your doctor before taking your next dose. Your prescriber will weigh the benefits and risks to determine the best treatment plan for you.

There is an optional pregnancy registry that monitors pregnancy outcomes in women who take Emgality during pregnancy. If you become pregnant and choose to continue taking Emgality after discussing the potential risks and benefits with your doctor, you can enroll in the registry by calling 1-800-464-4724 or visiting the registry’s website.¹⁷

Missed doses

If you miss a dose of Emgality, take the missed dose as soon as you remember. Then, take your next dose one month later. 

Speak with your doctor if you have any questions about the missed dose. If you struggle with remembering to take your medications, consider using a calendar or setting a reminder on your phone to help you remember.

Drug interactions

Drug interactions can affect how a medication works or increase the risk or severity of side effects. Fortunately, Emgality is a monoclonal antibody that generally does not interact with other drugs or supplements due to the way it is processed in the body.

Unlike other drugs that are broken down by the liver, Emgality is metabolized inside your body’s cells.

Can I drink alcohol while taking Emgality?

There's currently no adequate research on the possible interactions between Emgality and alcohol. However, alcohol is known to lessen the effectiveness of certain drugs, and this may be the case with Emgality.

Further, alcohol triggers migraines for many people, even when consumed in small amounts. If alcohol is a migraine trigger for you, avoiding it may reduce the frequency or severity of your episodes.¹⁸

What to discuss with your doctor before starting Emgality

Emgality is available by prescription only, so you’ll need to meet with your doctor before you start taking it. At your appointment, you’ll discuss everything about the drug, including the dosage, administration techniques, possible side effects, and what to expect if it is working. If there’s anything you’re curious or unsure about, don’t hesitate to ask questions. 

Topics you should address at your appointment include the following:

• Any health conditions you have. Certain conditions may affect how your body handles or responds to certain medications.

• Any upcoming surgeries or medical procedures, including dental.

• All medications, supplements, vitamins, and herbs you take routinely or occasionally.

• Any medical or non-medical allergies you have. Be sure to mention any allergic reactions you’ve had to other medications in the past.

• Current or planned pregnancy or breastfeeding.

Stopping Emgality

If you take Emgality for migraines, stopping it may cause your symptoms to return to pretreatment levels. Therefore, you should speak with your doctor about other treatment options before stopping Emgality.

If you take Emgality for episodic cluster headaches, you’ll stop taking the drug temporarily during periods of remission. If you stop it during an active period, your symptoms will likely return to pretreatment levels. Your doctor can recommend alternative treatment options if you no longer wish to take Emgality.

Drug approval history¹⁹

• 2018: The US FDA approves Emgality for the prevention of migraines

• 2019: The US FDA approves Emgality for the treatment of episodic cluster headaches

Tips for taking Emgality

It’s important to follow your doctor's or pharmacist's instructions when taking Emgality. However, the following tips can help you take the drug safely and optimize its effectiveness while reducing the risk of side effects:

• Your doctor or a member of your care team will show you how to administer Emgality. Don’t start taking the drug until you’re confident in administering it. If you’re uneasy, ask for a second demonstration in the office.

• Confirm the strength and expiration date. Always check your pen or syringe to make sure you’re taking the correct dose and taking it before it expires.

• Store Emgality in the refrigerator. It should be kept between 36° and 46°F. Don’t freeze the pen or syringe, and don’t expose it to direct sunlight or heat. Remove your medication from the refrigerator and let it warm to room temperature for 30 minutes before taking it. Do not heat or microwave your medications.

• Use each syringe or pen once. Administer the contents entirely and dispose of the used syringe safely according to your doctor or pharmacist’s advice.

Emgality frequently asked questions

Does Emgality work immediately?

Emgality isn’t the type of medication you take to relieve your pain and other symptoms right away. If you’re seeking quick relief for migraines or cluster headaches, ask your doctor which pain relief options are suitable for you.

What are the side effects of Emgality?

Emgality may cause unwanted side effects at the injection site, including swelling, hives, itching, rash, and warmth and redness of the skin.

When do Emgality side effects start?

Common side effects at the injection site occur fairly soon after administering the medication. Severe side effects signaling an allergic reaction may occur from hours to days after taking Emgality.²⁰