• Ajovy is a brand (trade) name for fremanezumab (also called fremanezumab-vfrm) which is a biologic monoclonal antibody that may be used to prevent migraine headaches in adults.
• Ajovy (fremanezumab) works by blocking the effect of a protein, called CGRP (calcitonin gene-related peptide) which is involved in pain transmission, inflammation, and blood vessel dilation and is highly prevalent in the sensory nerves of the head and neck. Levels of CGRP increase during a migraine attack and it may also play a causative role in the induction of migraine attacks. Ajovy binds to the CGRP molecule and prevents it from binding to the CGRP receptor. This helps to prevent the development of a migraine headache and associated pain.
• Ajovy belongs to the class of medicines known as CGRP inhibitors. There are two types of CGRP inhibitors – monoclonal antibodies and CGRP receptor antagonists (gepants). Ajovy is a monoclonal antibody, which is a collection of identical proteins that have been developed to only target one substance in the body (in this case CGRP).

• May be used to prevent migraine headaches in adults.
• Ajovy was the second CGRP inhibitor to be approved (September 2018).
• Ajovy is long-acting and may be given as a single dose (225mg) once monthly or as three consecutive doses (total dose 675mg) once every 3 months. Ajovy is administered by subcutaneous (under the skin) injection into the stomach (abdomen) area, upper arm, or thigh.
• Easy to self-administer.
• No drug interactions.
• Available as a single-dose prefilled autoinjector or syringe. Both formulations are 225mg/1.5mL.
• Research has not shown Ajovy to affect the immune system or lower immunity nor to cause hair loss.
• Unlikely to cause liver or kidney damage.
• Does not appear to cause constipation nor increase blood pressure, like Aimovig.
• The autoinjector and prefilled syringe do not contain latex.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Injection site reactions (pain, redness, or swelling) are the most common side effects reported with Ajovy, affecting up to 45% of all people using Ajovy.
• Hypersensitivity reactions, including rash, itching, and urticaria has been reported in people administered Ajovy in clinical trials. Most reactions were mild to moderate although some required corticosteroid treatment or discontinuation. Avoid in people with previous hypersensitivity reactions to Ajovy.
• There is the potential for immunogenicity with Ajovy and antibody formation. Anti-drug antibodies were detected in 1.6% of people in one long-term open-label study but the data was too limited to show if these antibodies compromised the efficacy or safety of Ajovy.
• It is not known if Ajovy will harm an unborn baby or pass into breast milk. Women with migraines may be at higher risk of preeclampsia and gestational high blood pressure during pregnancy. There is a pregnancy register that monitors outcomes in women exposed to Ajovy during pregnancy; call 1-8333-927-2605 or visit www.tevamigrainepregnancyregistry.com

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Ajovy is injected under the skin once a month or once every 3 months (given as 3 consecutive injections) to prevent migraines. The injection may be given into your stomach area (abdomen), thigh, or upper arm and you can learn to give yourself injections at home.
• Ajovy is available as an autoinjector or prefilled syringe. An autoinjector is a device that typically contains one prefilled dose of medicine in a spring-loaded syringe. You, or your caregiver, can learn to give this medicine at home. Many patients prefer autoinjectors over single-use syringes as they are easier to use and may cause less worry.
• Do not use Ajovy until your health care provider has shown you the right way to inject your medicine. Do not use an Ajovy autoinjector or prefilled syringe injection if the solution inside looks cloudy, has changed colors, or has particles in it. Do not shake the autoinjector or syringe.
• Take Ajovy out of the refrigerator 30 minutes before injecting your dose. Do not heat in water or the microwave. Wash your hands with soap and water before you give the injection. Choose an injection site, for example, your stomach area (at least 2 inches away from your belly button), your thigh, or your upper arm (if someone else is injecting). Use an alcohol wipe to clean the area you plan to inject and let it dry. Do not inject Ajovy into an area that is tender, bruised, hard, tattooed, or red.
• To use the Ajovy autoinjector: Pull the cap off of the autoinjector no more than 5 minutes before you use it. Place the autoinjector on your skin area at about a 90-degree angle (straight up and down). Firmly push the autoinjector down onto the skin and keep holding it down for about 30 seconds until the injection is complete. You will first hear a click which indicates that the injection has started and the blue plunger will start to move. About 15 seconds after the first click, the plunger will have moved to the bottom of the viewing window. Wait another 10 seconds before removing the autoinjector from your skin by lifting it straight up. After you remove the autoinjector from your skin, the needle will be automatically covered. Once you have used the dose, place the autoinjector or syringe in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Sharps containers can be purchased online or at retail shops. Keep Ajovy out of the reach of children and pets.
• If the site is bleeding, press a cotton ball or gauze firmly on the skin. Apply an adhesive bandage (“Band-Aid”) if needed. Do not rub the injection site.
• When you remove the autoinjector, if the window is not blue or if it seems like the medicine is still injecting, you may not have received a full dose. Call your health care provider immediately.
• Ajovy should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. If removed from the refrigerator, Ajovy can be kept at room temperature (up to 30°C [86°F]) in the original carton and must be used within 7 days. Throw away Ajovy that has been left at room temperature for more than 7 days. Do not freeze. Do not shake. Do not put the autoinjector back in the refrigerator after it has reached room temperature.
• If you miss a dose of Ajovy, administer it as soon as possible. Do not double your dose to make up for missed dose. Thereafter, your Ajovy dose can be scheduled monthly (or three monthly if using the higher dosage) from the date of your last dose. If you have questions about your dose or when to administer it, call your doctor.
• Although there is not a specific warning against consuming alcohol with Ajovy, alcohol may trigger or worsen a migraine headache in many people, especially red wine, beer, and hard liquor. Limit your alcohol intake or avoid alcohol.
• Be aware of other foods or substances that can worsen migraines, such as excessive caffeine, some aged cheeses or processed foods (especially those that contain tyramine), food additives such as the artificial sweetener aspartame, preservatives like sulfites, and the flavor enhancer monosodium glutamate (MSG).
• Call your health care provider or get emergency medical help right away if you experience swelling of the face, mouth, tongue, or throat or have trouble breathing. These are all signs of a possible allergic reaction.
• If you are pregnant or intend to become pregnant, tell your doctor as it is not known if Ajovy will harm an unborn baby. Also, talk to your doctor about breastfeeding your baby while you are self-administering Ajovy.

• Ajovy is given by injection subcutaneously (under the skin), to avoid degradation by the stomach. Because it is a large molecule, it takes longer to start working, and works in the lining of the brain rather than in the brain itself.
• Ajovy has been studied for the prevention of episodic (4-14 migraine days per month) and chronic migraine (15 or more migraine days per month) headaches.
• In a 3-month study of patients with episodic migraine, patients who received Ajovy 225mg monthly or 675mg every three months had an average of 3 to 4 fewer migraine days compared to about 2 fewer migraine days per month for those taking an inactive placebo.
• In a chronic migraine study, researchers found that patients using Ajovy had 4 to 5 fewer days with migraine headaches over one month. This compared to 2 to 3 fewer migraine days with those taking an inactive placebo.
• In addition, many patients taking Ajovy were able to reduce their monthly migraine days by 37% or more, compared to 18% of those taking the placebo.

There are currently no documented interactions with Ajovy, according to the product information.

Ajovy is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

You should refer to the prescribing information for Ajovy for any updates or newly noted interactions.