Migraine is a disorder that causes repeated attacks of headache and other symptoms, such as nausea and sensitivity to light or sound. People with episodic migraine have fewer than 15 headache days per month, while people with chronic migraine have at least 15 headache days per month.
Ajovy (fremanezumab-vfrm) is a medicine used to prevent migraine. It is given as an injection under the skin either once a month or once every three months.
Below are common questions and answers about how Ajovy works, how to use it, and what benefits were seen in clinical studies.
How Does Ajovy Work?
Ajovy belongs to a group of medicines that target calcitonin gene-related peptide (CGRP), a protein involved in migraine.
The active ingredient in Ajovy, fremanezumab, is a type of medicine called a monoclonal antibody. It attaches to CGRP and blocks CGRP from binding to its receptors. Blocking CGRP in this way can help prevent migraine attacks.
Ajovy is a preventive medicine. It is used on a regular schedule to reduce future migraine attacks rather than to stop a migraine that has already started.
How Do I Use Ajovy?
Ajovy comes as a single-dose prefilled autoinjector or prefilled syringe. Each contains 225 milligrams (mg) of Ajovy.
For adults, a health care provider may prescribe one of two dosing options:
- Monthly dose: 225 mg once a month
- Quarterly dose: 675 mg once every three months — this dose is given as three 225-mg injections, one after another
The usual dosage for children and teens aged 6-17 years who weigh at least 45 kg (about 99 pounds) is 225 mg once a month. Quarterly dosing (once every three months) is not FDA-approved for people under 18.
Ajovy is injected under the skin of the abdomen, thigh, or upper arm. Avoid areas that are tender, bruised, red, or firm. If your dose requires more than one injection, the injections can be given in the same general area but should not be given in the exact same spot.
People who are 13 years or older may be able to inject Ajovy themselves after receiving training. A caregiver or health care provider can also give the injection. For children aged 6-12 years, an adult or health care provider must give Ajovy.
Keep Ajovy refrigerated until you’re ready to use it. Before an injection, take it out of the refrigerator, and let it sit at room temperature for about 30 minutes. Do not warm it with hot water, a microwave, or another heat source. Keep it out of direct sunlight.
If needed, Ajovy can stay at room temperature in its original carton for up to seven days. Once it has been stored at room temperature, do not put it back in the refrigerator.
How Was Ajovy Studied in Adults With Episodic Migraine?
A three-month clinical trial was done to test how well Ajovy worked in adults with episodic migraine. Participants were aged 18-70 years and had 6-14 headache days during the month before treatment, including at least four migraine days.
Participants were randomly assigned to one of three treatments:
- Ajovy 225 mg once a month
- Ajovy 675 mg once at the beginning of the three-month study
- A placebo injection containing no active medicine
Neither the participants nor the researchers knew which treatment each person received. People could continue using medicines to treat migraine attacks as needed. About 21% were also allowed to continue one other preventive migraine medicine.
The study included 875 adults. The average age was about 42 years. Most (about 85%) of the participants were female, and the rest were male. Before treatment, participants averaged about nine migraine days per month.
The main goal was to see how much the average number of migraine days per month changed during the three months of treatment. Researchers also looked at how many people had their average number of migraine days reduced by at least half and how often they needed medicine to treat an acute headache.
What benefits were seen for episodic migraine?
Both Ajovy dosing schedules reduced migraine days more than the placebo did.
Fewer migraine days. People using Ajovy monthly had about 3.7 fewer migraine days per month, while those receiving the quarterly regimen had about 3.4 fewer days. People receiving the placebo had about 2.2 fewer migraine days per month.
More people had their migraine days cut by at least half. About 48% of people using Ajovy monthly and 44% of those receiving quarterly Ajovy had at least 50% fewer migraine days, compared with about 28% receiving the placebo.
Less need for acute headache medicine. Days using acute headache medicine fell by about three days per month with either Ajovy regimen, compared with about 1.6 days with the placebo.
Your results may be different from those seen in the study.
How Was Ajovy Studied in Adults With Chronic Migraine?
Another three-month clinical trial included 1,130 adults with chronic migraine. Participants were aged 18-70 years and had at least 15 headache days per month.
Participants were randomly assigned to receive monthly Ajovy, quarterly Ajovy, or a placebo. In this study, people assigned to monthly Ajovy received a 675-mg starting dose followed by 225 mg at weeks four and eight. (Note that the currently approved monthly dose for adults is 225 mg and does not require this starting dose.)
Most participants were female (about 87%-88%). The average age was about 41 years. Before treatment, participants had about 20 headache days of any severity per month. About 13 days per month involved headaches of at least moderate severity, and about 16 were migraine days.
The main goal was to measure the change in the monthly average number of headache days of at least moderate severity. Researchers also measured migraine days, use of acute headache medicine, and how many people had their monthly average number of moderate or severe headache days cut by at least half.
What benefits were seen for chronic migraine?
Ajovy reduced headache and migraine frequency more than the placebo did.
Fewer moderate or severe headache days. Monthly Ajovy reduced the monthly average number of these headache days by about 4.6 days per month, while quarterly Ajovy reduced them by about 4.3 days. The placebo reduced them by about 2.5 days.
Fewer migraine days. The average number of migraine days fell by about five days per month with either Ajovy regimen, compared with about 3.2 days with the placebo.
More people had their headache days cut by at least half. About 41% of people using monthly Ajovy and 38% using quarterly Ajovy had at least 50% fewer moderate or severe headache days on average per month, compared with 18% receiving the placebo.
Less need for acute headache medicine. Days using acute headache medicine fell by about 4.2 days per month on average with monthly Ajovy and 3.7 days with quarterly Ajovy, compared with about 1.9 days with the placebo.
Your results may differ from those seen in the study.
How Was Ajovy Studied in Children and Teens?
Ajovy was also studied in children and teens aged 6-17 years with episodic migraine. To enter the study, participants had to have had migraine for at least six months and no more than 14 headache days per month. They also had to have at least four headache days per month before the study began.
Participants received either Ajovy or a placebo once a month for three months.
About 235 children and teens participated in the study. Their average age was about 13 years, and slightly more than half were female. The researchers described participants’ races as 77% White, 7% non-White, and 17% with race unknown or not reported.
Before treatment, participants averaged about 7.5-7.8 migraine days per month.
The main goal was to measure how much the average number of migraine days per month changed over three months.
What benefits were seen in children and teens?
Ajovy reduced the number of migraine days more than the placebo did.
Fewer migraine days. Participants using Ajovy had about 2.5 fewer migraine days per month, compared with 1.4 fewer days with the placebo.
More participants had their migraine days cut by at least half. About 47% of those using Ajovy had at least 50% fewer migraine days, compared with 27% using the placebo.
Less use of acute headache medicine. Days using acute headache medicine fell by about 2.1 days per month with Ajovy, compared with about one day with the placebo.
Fewer moderate or severe headache days. These fell by about 2.6 days per month with Ajovy, compared with 1.5 days with the placebo.
Your child’s results may differ from those seen in the study.
Can I Use Ajovy to Treat a Migraine Attack?
No. Ajovy is used regularly to prevent migraine. It is not an acute or rescue treatment for stopping a migraine attack that has already started.
Your health care provider can help you make a separate plan for treating migraine attacks that happen while you are using Ajovy.
How Will I Know if Ajovy Is Working?
Keeping track of your migraine and headache days can help show how well Ajovy is working. A headache diary can also help you track how often you need medicine to treat an acute migraine.
In studies, researchers looked at several signs of benefit, including fewer migraine or headache days and less use of acute headache medicine. Some measures improved during the first month of treatment.
Your health care provider can review your migraine pattern over time and help you decide whether Ajovy is working well for you and whether your current dosing schedule still makes sense. Be sure to let your health care provider know of any changes in your migraine symptoms or if you have any bothersome side effects. For more details about possible risks, see our article on Ajovy side effects.
Is There Any Cost Assistance Available?
Patient support programs may be available from the drugmaker of Ajovy to reduce the cost. Visit this website or call 844-310-4170 to see if you’re eligible for savings offers or financial assistance.
