Ajovy (fremanezumab-vfrm)

Drugs

What is Ajovy?

Ajovy is a brand-name prescription medication that’s used to prevent migraine headaches in adults. It comes as a prefilled syringe. You can self-inject Ajovy, or receive Ajovy injections from a healthcare provider in your doctor’s office. Ajovy can be injected monthly or quarterly (once every three months).

Ajovy contains the drug fremanezumab, which is a monoclonal antibody. A monoclonal antibody is a kind of drug that’s created from immune system cells. It works by preventing some of your body’s proteins from functioning.

Ajovy can be used to prevent both episodic and chronic migraine headaches. In clinical studies, nearly 48 percent of people with episodic migraine headaches who received Ajovy cut their number of migraine days in at least half. About 41 percent of people with chronic migraine headaches had similar results.

The American Headache Society recommends the use of Ajovy to prevent migraine headaches in adults who are unable to reduce their number of migraine days enough with other medications. They also recommend Ajovy for people who aren’t able to take other migraine prevention medications because of side effects or drug interactions.

A new kind of drug

Ajovy is part of a new class of drugs known as calcitonin gene-related peptide (CGRP) antagonists. These drugs are the first medications created to prevent migraine headaches.

The Food and Drug Administration (FDA) approved Ajovy in September 2018. Ajovy was the second drug in the CGRP antagonist class that the FDA approved to help prevent migraine headaches.

There are also two other CGRP antagonists available. These drugs are called Emgality (galcanezumab) and Aimovig (erenumab). There’s a fourth CGRP antagonist called eptinezumab that’s also being studied. It’s expected to be approved by the FDA in the future.

Ajovy generic

Ajovy is available only as a brand-name medication. It’s not currently available in generic form.

Ajovy contains the drug fremanezumab, which is also called fremanezumab-vfrm. The reason “-vfrm” appears at the end of the name is to show that the drug is distinct from similar medications that may be created in the future. Other monoclonal antibodies are named in a similar way.

Ajovy uses

The U.S. Food and Drug Administration (FDA) approves prescription drugs such as Ajovy to treat or prevent certain conditions.

Ajovy for migraine headaches

The FDA has approved Ajovy to help prevent migraine headaches in adults. These headaches are severe. They’re also the main symptom of migraine, which is a neurological condition. Sensitivity to light and sound, nausea, vomiting, and trouble speaking are other symptoms that can occur with a migraine headache.

Ajovy is approved to prevent both chronic migraine headaches and episodic migraine headaches. The International Headache Society states that people who have episodic migraine headaches experience fewer than 15 migraine or headache days each month. People who have chronic migraine headaches, on the other hand, experience 15 or more headache days each month over at least 3 months. And at least 8 of these days are migraine days.

In clinical studies, nearly 48 percent of people with episodic migraine headaches who received Ajovy cut their number of migraine days in at least half. About 41 percent of people with chronic migraine headaches had similar results. In another study, up to 35 percent of people with chronic migraine headaches lessened to episodic migraine headaches after three months of Ajovy treatment.

Uses that are not approved

Ajovy may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Ajovy for cluster headaches

Ajovy is not FDA-approved to prevent cluster headaches, but it may be used off-label for this purpose.

Cluster headaches are painful headaches that occur in clusters (many headaches in a short time). These headaches can be chronic or episodic. People who have episodic cluster headaches have longer periods of being headache-free between clusters than people who have chronic cluster headaches.

A clinical study of Ajovy for chronic cluster headaches was stopped before the planned end-date because the drug was not effective in that study.

A clinical study to test Ajovy in preventing episodic cluster headaches is currently ongoing. And a long-term study is being done to test the safety of using Ajovy to prevent episodic (and chronic) cluster headaches. However, it’s still too early to know if Ajovy will be useful in preventing episodic cluster headaches.

Ajovy for vestibular headaches

Ajovy is not FDA-approved to treat or prevent vestibular headaches. Vestibular headaches are different from typical headaches in that they’re not painful most of the time. Instead, people who experience vestibular headaches may feel dizzy or have vertigo. These symptoms can last from seconds to hours.

Doctors may prescribe Ajovy for vestibular headaches, but the drug is not being tested in clinical studies of people with this condition. Currently, it’s not known if Ajovy works to help prevent or treat vestibular headaches.


Ajovy side effects

Ajovy can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Ajovy. This list does not include all possible side effects.

For more information on the possible side effects of Ajovy, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Ajovy are injection site reactions. This can include the following effects at the site where you inject the drug:

  • redness
  • itchiness
  • pain
  • tenderness

Injection site reactions are usually not severe or lasting. Many of these side effects may disappear within a couple of days or a few weeks. Talk with your doctor or pharmacist if your side effects are more severe or they don’t go away.

Serious side effects

It’s not common to have serious side effects from Ajovy, but it’s possible. The main serious side effect of Ajovy is a severe allergic reaction to the drug. See below for details.

Allergic reaction

As with most drugs, some people can experience an allergic reaction after they take Ajovy. Symptoms of a mild allergic reaction may include:

  • itchiness
  • skin rash
  • flushing (warmth and redness in your skin)

Severe allergic reactions to Ajovy are rare. Possible symptoms of a severe allergic reaction include:

  • swelling of your tongue, mouth, or throat
  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • trouble breathing

If you have a severe allergic reaction to Ajovy, call your doctor right away. If your symptoms feel life-threatening or if you think you’re having a medical emergency, call 911.

Fatigue

Clinical studies of Ajovy did not report fatigue (low energy) as a side effect of the drug. But fatigue is often a symptom that people experience before, during, or after migraine headaches.

A clinical study of people with migraine headaches showed that fatigue was more likely to occur in people who had more intense headaches.

If fatigue is a problem for you, ask your doctor how you can increase your energy levels.

Long-term side effects

Ajovy is a recently approved medication in a new class of drugs. As a result, there’s very little long-term research on Ajovy’s safety, and little known about its long-term effects. The longest clinical study (PS30) of Ajovy lasted one year, and people in the study did not report any serious side effects.

Injection site reaction was the most common side effect reported in the year-long study. People reported the following effects in the area where the injection was given:

  • pain
  • redness
  • bleeding
  • itchiness
  • bumpy or raised skin


Alternatives to Ajovy

There are other drugs available that can help prevent migraine headaches. Some may be a better fit for you than others. If you’d like to find an alternative to Ajovy, talk with your doctor. They can help you learn about other medications that might be right for you.

Here are some examples of other drugs that the FDA has approved to help prevent migraine headaches:

  • the beta-blocker propranolol (Inderal, Inderal LA)
  • the neurotoxin onabotulinumtoxinA (Botox)
  • certain seizure medications, such as divalproex sodium (Depakote) or topiramate (Topamax, Trokendi XR)
  • other calcitonin gene-related peptide (CGRP) antagonists: erenumab-aooe (Aimovig) and galcanezumab-gnlm (Emgality)

Here are some examples of other drugs that may be used off-label for migraine headache prevention:

  • certain seizure medications, such as valproate sodium
  • certain antidepressants, such as amitriptyline or venlafaxine (Effexor XR)
  • certain beta-blockers, such as metoprolol (Lopressor, Toprol XL) or atenolol (Tenormin)

CGRP antagonists

Ajovy is a new type of drug called a calcitonin gene-related peptide (CGRP) antagonist. In 2018, the FDA approved Ajovy to prevent migraine headaches, along with two other CGRP antagonists: Emgality and Aimovig. A fourth drug (eptinezumab) is expected to be approved soon.

How they work

The three CGRP antagonists that are currently available work in slightly different ways to help prevent migraine headaches.

CGRP is a protein in your body. It’s been linked with vasodilation (widening of blood vessels) and inflammation in the brain, which may result in migraine headache pain. To cause these effects in the brain, CGRP needs to bind (attach) to its receptors. Receptors are molecules on the walls of your brain cells.

Ajovy and Emgality work by attaching to the CGRP. This prevents the CGRP from attaching to its receptors. Aimovig, on the other hand, works by attaching to the receptors themselves. This keeps the CGRP from attaching to them.

By preventing CGRP from attaching to its receptor, these three drugs help prevent vasodilation and inflammation. As a result, they can help prevent migraine headaches.

Side by side

This chart compares some information about Aimovig, Ajovy, and Emgality. These drugs are the three CGRP antagonists that are currently approved to help prevent migraine headaches. To learn more about how Ajovy compares with these drugs, refer to the next section (“Ajovy vs. other drugs”).

Ajovy Aimovig Emgality
Approval date for migraine headache prevention September 14, 2018 May 17, 2018 September 27, 2018
Drug ingredient Fremanezumab-vfrm Erenumab-aooe Galcanezumab-gnlm
How it’s administered Subcutaneous self-injection using a prefilled syringe Subcutaneous self-injection using a prefilled autoinjector Subcutaneous self-injection using a prefilled pen or syringe
Dosing Monthly or every three months Monthly Monthly
How it works Prevents CGRP’s effects by binding to CGRP, which prevents it from binding to the CGRP receptor Prevents CGRP’s effects by blocking the CGRP receptor, which prevents CGRP from binding to it Prevents CGRP’s effects by binding to CGRP, which prevents it from binding to the CGRP receptor
Cost* $575/month or $1,725/quarter $575/month $575/month

*Prices can vary depending on your location, the pharmacy used, your insurance coverage, and manufacturer assistance programs.

Ajovy vs. other drugs

You may wonder how Ajovy compares to other medications that are prescribed for similar uses. Below are comparisons between Ajovy and several medications.

Ajovy vs. Aimovig

Ajovy contains the drug fremanezumab, which is a monoclonal antibody. Aimovig contains erenumab, which is also a monoclonal antibody. Monoclonal antibodies are drugs that have been made from immune system cells. They halt the activity of certain proteins in your body.

Ajovy and Aimovig work in slightly different ways. However, they both halt the activity of a protein called calcitonin gene-related peptide (CGRP). CGRP causes vasodilation (widening of blood vessels) and inflammation in the brain. These effects may result in migraine headaches.

By blocking CGRP, Ajovy and Aimovig help prevent vasodilation and inflammation. This may help prevent migraine headaches.

Uses

Ajovy and Aimovig are both FDA-approved to prevent migraine headaches in adults.

Forms and administration

The drugs Ajovy and Aimovig both come in the form of an injection that’s given under your skin (subcutaneous). You can inject the drugs yourself at home. Both of the drugs can be self- injected into three areas: the front of your thighs, the back of your upper arms, or your belly.

Ajovy comes in the form of a syringe that’s prefilled with a single dose. Ajovy can be given as one injection of 225 mg once a month. As an alternative, it can be given as three injections of 675 mg that are administered quarterly (once every three months).

Aimovig comes in the form of an autoinjector that’s prefilled with a single dose. It’s usually given as a 70-mg injection once a month. But a 140-mg monthly dose may be better for some people.

Side effects and risks

Ajovy and Aimovig work in similar ways and therefore cause some of the same side effects. They also cause some differing side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Ajovy, with Aimovig, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • no unique common side effects
  • Can occur with Aimovig:
    • constipation
    • muscle cramps or spasms
    • upper respiratory infections such as the common cold or sinus infections
    • flu-like symptoms
    • back pain
  • Can occur with both Ajovy and Aimovig:
    • injection site reactions such as pain, itchiness, or redness

Serious side effects

The primary serious side effect for both Ajovy and Aimovig is a severe allergic reaction. Such a reaction isn’t common, but it is possible. (For more information, see “Allergic reaction” in the “Ajovy side effects” section above).

Immune reaction

In clinical trials for both drugs, a small percentage of people experienced an immune reaction. This reaction caused their bodies to develop antibodies against Ajovy or Aimovig.

Antibodies are proteins in the immune system that attack foreign substances in your body. Your body can create antibodies to any foreign matter. This includes monoclonal antibodies. If your body creates antibodies to Ajovy or Aimovig, the medication may not work for you anymore.

In ongoing clinical studies, fewer than 2 percent of people developed antibodies to Ajovy. In clinical trials for Aimovig, more than 6 percent of people developed antibodies to the drug.

However, because Ajovy and Aimovig were approved in 2018, it’s still too early to know how common this effect might be and how it might affect how people use these drugs in the future.

Effectiveness

Ajovy and Aimovig are both effective at preventing migraine headaches, but they haven’t been directly compared in clinical trials.

However, migraine treatment guidelines recommend either drug as an option for certain people. These include people who have not been able to reduce their monthly migraine days enough with other medications. They also include people who can’t tolerate other medications because of side effects or drug interactions.

Episodic migraine headaches

Separate studies of Ajovy and Aimovig showed that both medications were effective for preventing episodic migraine headaches.

  • In a clinical study of Ajovy, around 48 percent of people with episodic migraine headaches who received monthly treatment with Ajovy cut their migraine days at least in half over 3 months. About 44 percent of people who received Ajovy every 3 months had similar results.
  • In clinical studies of Aimovig, about 40 percent of people with episodic migraine headaches who received 70 mg of the drug monthly cut their migraine days at least in half over 6 months. Up to 50 percent of people who received 140 mg had similar results.

Chronic migraine headaches

Separate studies of Ajovy and Aimovig also showed both medications were effective for preventing chronic migraine headaches.

  • In a 3-month clinical study of Ajovy, nearly 41 percent of people with chronic migraine headaches who received monthly Ajovy dosing had half as many migraine days or fewer after treatment. Around 37 percent of people who received Ajovy every 3 months had similar results.
  • In a 3-month clinical study of Aimovig, about 40 percent of people with chronic migraine headaches who received either 70 mg or 140 mg of the drug monthly had half as many migraine days or fewer.

Costs

Ajovy and Aimovig are both brand-name medications. There are no generic forms of either drug available. Brand-name medications generally cost more than generic forms.

Based on estimates from GoodRx.com, Ajovy and Aimovig cost roughly the same amount. The actual price you would pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Ajovy vs. Emgality

Ajovy contains fremanezumab, which is a monoclonal antibody. Emgality contains galcanezumab, which is also a monoclonal antibody. A monoclonal antibody is a kind of drug created from immune system cells. It halts the activity of certain proteins in your body.

Ajovy and Emgality both stop the activity of calcitonin gene-related peptide (CGRP). CGRP is a protein in your body. It causes vasodilation (widening of blood vessels) and inflammation in the brain, which may result in migraine headaches.

By stopping CGRP from working, Ajovy and Emgality help prevent vasodilation and inflammation in the brain. This may help prevent migraine headaches.

Uses

Ajovy and Emgality are both FDA-approved to prevent migraine headaches in adults.

Forms and administration

Ajovy comes in the form of a syringe that’s prefilled with a single dose. Emgality comes in the form of a single-dose prefilled syringe or pen.

Both of the drugs are injected under your skin (subcutaneous). You can self-inject Ajovy and Emgality at home.

Ajovy can be self-injected using one of two different schedules. It can be given as a single injection of 225 mg once per month, or as three separate injections (for a total of 675 mg) once every three months. Your doctor will choose the right schedule for you.

Emgality is given as a single injection of 120 mg, once per month. (The very first month’s dose is a two-injection dose totaling 240 mg.)

Both Ajovy and Emgality can be injected into three possible areas: the front of your thighs, the back of your upper arms, or your belly. In addition, Emgality can be injected into your buttocks.

Side effects and risks

Ajovy and Emgality are very similar drugs and cause similar common and serious side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Ajovy, with Emgality, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • no unique common side effects
  • Can occur with Emgality:
    • back pain
    • respiratory tract infection
    • sore throat
    • sinus infection
  • Can occur with both Ajovy and Emgality:
    • injection site reactions such as pain, itchiness, or redness

Serious side effects

A severe allergic reaction is the main serious side effect for Ajovy and Emgality. It’s not common to have such a reaction, but it is possible. (For more information, see “Allergic reaction” in the “Ajovy side effects” section above).

Immune reaction

In separate clinical trials for the drugs Ajovy and Emgality, a small percentage of people experienced an immune reaction. This immune reaction caused their bodies to create antibodies against the drugs.

Antibodies are immune system proteins that attack foreign matter in your body. Your body can create antibodies to any foreign substance. This includes monoclonal antibodies such as Ajovy and Emgality.

If your body creates antibodies to either Ajovy or Emgality, that drug may no longer work for you.

In an ongoing clinical study, less than 2 percent of people taking Ajovy developed antibodies to the drug. In clinical studies that lasted up to six months, 4.8 percent of people taking Emgality developed antibodies to the drug.

However, it’s still too soon to know how common this effect could be because Ajovy and Emgality were approved in 2018. It’s also too soon to know how it could affect how people use these two medications in the future.

Effectiveness

Ajovy and Emgality are both FDA-approved to prevent migraine headaches, but they have not been directly compared in clinical studies.

However, Ajovy and Emgality are each recommended by treatment guidelines for people who cannot take other medications because of side effects or drug interactions. They’re also recommended for people who can’t reduce their number of monthly migraine headaches enough with other drugs.

Episodic migraine headaches

Separate studies of Ajovy and Emgality showed effectiveness in preventing episodic migraine headaches.

  • In a clinical study of Ajovy, around 48 percent of people with episodic migraine headaches who received monthly Ajovy treatment cut their migraine days by at least half over 3 months. About 44 percent of people who received Ajovy every 3 months had similar results.
  • In clinical studies of Emgality, up to 62 percent of people with episodic migraine headaches reduced their number of migraine days by at least half. Up to 16 percent of people had no migraine days after 6 months of treatment.

Chronic migraine headaches

Separate studies of Ajovy and Emgality showed that they were both effective for preventing chronic migraine headaches.

  • In a 3-month clinical study of Ajovy, almost 41 percent of people with chronic migraine headaches who took Ajovy monthly had half as many migraine days or fewer. About 37 percent of people who took Ajovy every 3 months had similar results.
  • In a 3-month clinical study of Emgality, almost 30 percent of people had half as many migraine days or fewer.

Costs

Ajovy and Emgality are both brand-name medications. There are no generic forms of either drugs available at this time. Brand-name medications generally cost more than generics.

According to estimates from GoodRx.com, Emgality may cost more than Ajovy. The actual price you would pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Ajovy vs. Botox

Ajovy contains fremanezumab, which is a monoclonal antibody. A monoclonal antibody is a kind of drug created from immune system cells. Ajovy helps prevent migraine headaches by halting the activity of certain proteins that trigger migraines.

The main drug ingredient in Botox is onabotulinumtoxinA. This drug is part of a class of drugs known as neurotoxins. Botox works by temporarily paralyzing the muscles into which it’s injected. This effect on the muscles keeps pain signals from being switched on. It’s thought that this action helps prevent migraine headaches before they start.

Uses

The FDA has approved Ajovy to prevent chronic or episodic migraine headaches in adults.

Botox has been approved to prevent chronic migraine headaches in adults. Botox has also been approved to treat many conditions, including:

Forms and administration

Ajovy comes as a prefilled single-dose syringe. It’s given as an injection under your skin (subcutaneous) that you can give yourself at home, or have a healthcare provider give you at your doctor’s office.

Ajovy can be given on one of two different schedules: one 225-mg injection once per month, or three separate injections (total of 675 mg) once every three months. Your doctor will choose the right schedule for you.

Ajovy can be injected into three possible areas: the front of your thighs, the back of your upper arms, or your belly.

Botox is also given as an injection, but it’s always given in a doctor’s office. It’s injected into a muscle (intramuscular), usually every 12 weeks.

The sites where Botox is typically injected include on your forehead, above and near your ears, near your hairline at the base of your neck, and on the back of your neck and shoulders. At each visit, your doctor will usually give you 31 small injections into these areas.

Side effects and risks

Ajovy and Botox are both used to prevent migraine headaches, but they work in different ways in the body. Therefore, they have some similar side effects, and some different.

More common side effects

These lists contain examples of serious side effects that can occur with Ajovy, with Botox, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • few unique common side effects
  • Can occur with Botox:
    • flu-like symptoms
    • headache or worsening migraine headache
    • eyelid droop
    • facial muscle paralysis
    • neck pain
    • muscle stiffness
    • muscle pain and weakness
  • Can occur with both Ajovy and Botox:
    • injection site reactions

Serious side effects

These lists contain examples of serious side effects that can occur with Ajovy, with Xultophy, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • few unique serious side effects
  • Can occur with Botox:
    • spread of paralysis to nearby muscles*
    • trouble swallowing and breathing
    • serious infection
  • Can occur with both Ajovy and Botox:
    • serious allergic reactions

*Botox has a boxed warning from the FDA for spread of paralysis to nearby muscles following injection. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Chronic migraine headaches are the only condition that both Ajovy and Botox are used to prevent.

Treatment guidelines recommend Ajovy as a possible option for people who can’t decrease their number of migraine headaches enough with other medications. Ajovy is also recommended for people who aren’t able to tolerate other drugs because of their side effects or drug interactions.

The American Academy of Neurology recommends Botox as a treatment option for people with chronic migraine headaches.

Clinical studies have not directly compared the effectiveness of Ajovy and Botox. But separate studies showed both Ajovy and Botox to be effective in helping prevent chronic migraine headaches.

  • In clinical studies of Ajovy over 3 months, almost 41 percent of people with chronic migraine headaches cut their migraine days at least in half with monthly injections. Around 37 percent of people saw similar results with Ajovy injections every 3 months.
  • In clinical studies lasting 24 weeks, Botox decreased the number of headache days for people who had chronic migraine headaches by up to 9.2 days on average each month. In another study, for about 47 percent of people, their number of headache days was reduced by at least half.

Costs

Ajovy and Botox are both brand-name medications. There are no generic forms of either drug available at this time.

According to estimates from GoodRx.com, Ajovy may cost more than Botox. The actual price you would pay for either drug depends on your dose, insurance plan, your location, and the pharmacy you use.

Ajovy vs. Topamax

Ajovy contains fremanezumab, which is a monoclonal antibody. A monoclonal antibody is a type of drug created from immune system cells. Ajovy helps prevent migraine headaches by halting the activity of proteins that are thought to cause migraine headaches.

Topamax contains the drug topiramate. This is a type of anti-epileptic drug. It’s not well understood how topiramate works in preventing migraine headaches. It may work by decreasing the action of the brain’s overactive nerve cells that can cause migraine headaches.

Uses

Both Ajovy and Topamax are FDA-approved to prevent migraine headaches. Ajovy is approved for use in adults, while Topamax is approved for use in children and adults aged 12 and older.

Topamax is also approved to treat epilepsy.

Forms and administration

Ajovy comes as a prefilled single-dose syringe. It’s given as an injection under your skin (subcutaneous) that you can give yourself at home, or have a healthcare provider give you at your doctor’s office.

Ajovy can be given on one of two different schedules: one 225-mg injection once per month, or three separate injections (total of 675 mg) once every three months. Your doctor will choose the right schedule for you.

Topamax comes in the form of an oral capsule or a tablet. The typical dosage is 50 mg twice a day. But your doctor may first start you on a lower dose, and then increase your dosage to the usual amount over a few weeks.

Side effects and risks

Ajovy and Topamax work in different ways in the body and therefore have different side effects. Some of the common and serious side effects of both drugs are listed below. These lists do not include all possible side effects.

More common side effects

These lists contain examples of serious side effects that can occur with Ajovy, with Topamax, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • injection site reactions
  • Can occur with Topamax:
    • respiratory tract infection
    • sore throat
    • sinus infection
    • fatigue
    • paresthesia (feeling of “pins and needles”)
    • nausea
    • diarrhea
    • weight loss
    • loss of appetite
    • trouble concentrating
  • Can occur with both Ajovy and Topamax:
    • few similar common side effects

Serious side effects

These lists contain examples of serious side effects that can occur with Ajovy, with Topamax, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • few unique serious side effects
  • Can occur with Topamax:
    • vision problems, including glaucoma
    • decreased sweating (inability to regulate body temperature)
    • metabolic acidosis
    • suicidal thoughts and actions
    • thought problems such as confusion and memory issues
    • depression
    • increased seizures when drug is stopped suddenly (when it’s used for seizure treatment)
    • encephalopathy (brain disease)
    • kidney stones
  • Can occur with both Ajovy and Topamax:
    • serious allergic reactions

Effectiveness

The only purpose both Ajovy and Topamax are FDA-approved for is migraine headache prevention. While topirate is FDA-approved to prevent both chronic and episodic migraine headaches, treatment guidelines recommend it as an option for people with episodic migraine headaches.

The American Headache Society recommends Ajovy for people with episodic migraine or chronic migraine headaches who cannot take other medications because of side effects or drug interactions. Ajovy is also recommended for people who cannot reduce their number of migraine headaches enough with other medications.

Clinical studies haven’t directly compared the effectiveness of Ajovy and Topamax in preventing migraine headaches. However, the two drugs have been studied separately.

Episodic migraine headaches

Separate studies of Ajovy and Topamax showed that both were effective in helping to prevent episodic migraine headaches.

  • In a 3-month clinical study of Ajovy use in people with episodic migraine headaches, around 48 percent of people cut their number of migraine days at least in half with monthly treatment. Around 44 percent of people with received Ajovy every 3 months had similar results.
  • In clinical studies of Topamax use in people who had episodic migraine headaches, people ages 12 and older had about two fewer migraine headaches each month. And children ages 12 through 17 who had episodic migraine headaches had three fewer migraine headaches each month.

Chronic migraine headaches

Separate studies of the drugs showed that both Ajovy and Topamax were effective in preventing chronic migraine headaches.

  • In a clinical study of Ajovy, almost 41 percent of people with chronic migraine headaches had half as many migraine days or fewer with 3 months of monthly treatment. Nearly 37 percent of people who received treatment quarterly (every 3 months) had similar results.
  • A study examined the results of several clinical trials of Topamax. It found that in people who had chronic migraine headaches, the drug decreased the number of migraines or headaches by about five to nine each month.

Costs

Ajovy and Topamax are both brand-name medications. Brand-name medications usually cost more than generic medications. Ajovy is not available in generic form, but Topamax comes in a generic form called topiramate.

According to estimates on GoodRx.com, Topamax may cost more or less than Ajovy, depending on your dose. And topiramate, the generic form of Topamax, will cost less than either Topamax or Ajovy.

The actual price you would pay for any of these drugs depends on your dose, your insurance plan, your location, and the pharmacy you use.

Ajovy vs. sumatriptan

Ajovy contains the drug fremanezumab, which is a monoclonal antibody. A monoclonal antibody is a type of drug developed from immune system cells in a lab. Ajovy works to prevent migraine headaches by blocking the activity of certain proteins that cause migraine headaches.

Sumatriptan belongs to a class of medication called triptans. Triptans increase levels of a chemical called serotonin in your brain. Increased serotonin levels can help stop a migraine headache.

Uses

Ajovy is FDA-approved to prevent migraine headaches in adults.

Sumatriptan, on the other hand, is approved to treat moderate-to-severe migraine headaches in adults at the time they’re happening. It’s not used to prevent migraine headaches before they occur.

Forms and administration

Ajovy comes as a prefilled single-dose syringe. It’s given as an injection under your skin (subcutaneous) that you can give yourself at home, or have a healthcare provider give you at your doctor’s office.

Ajovy can be given on one of two different schedules: one 225-mg injection once per month, or three separate injections (total of 675 mg) once every three months. Your doctor will choose the right schedule for you.

Sumatriptan comes in the following forms:

  • oral tablet (Imitrex)
  • nasal spray (Imitrex)
  • nasal powder (Onzetra Xsail)
  • injection (Imitrex, Imitrex Statdose, Zembrace Symtouch)

There’s no recommended dosing schedule for sumatriptan. Instead, it’s taken at the beginning of a migraine headache. A second dose may be recommended two hours later, if the first dose doesn’t help improve migraine symptoms.

Side effects and risks

Ajovy and sumatriptan work in different ways and therefore have different side effects. Some of the common and serious side effects of both drugs are listed below. This list does not include all possible side effects.

More common side effects

These lists contain examples of serious side effects that can occur with Ajovy, with sumatriptan, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • few unique common side effects
  • Can occur with sumatriptan:
    • tingling, burning, or numbness in your hands or feet
    • flushing
    • nausea
    • chest, neck, and jaw tightness or discomfort
    • muscle pain
    • muscle weakness
    • dizziness
    • drowsiness
    • medication overuse headache
  • Can occur with both Ajovy and sumatriptan:
    • injection site reaction (for injectable sumatriptan)

Serious side effects

These lists contain examples of serious side effects that can occur with Ajovy, with sumatriptan, or with both drugs (when taken individually).

  • Can occur with Ajovy:
    • few unique serious side effects
  • Can occur with sumatriptan:
    • serious cardiovascular events such as stroke or heart attack
    • serotonin syndrome, with symptoms such as fast heart rate, tremor, or irritability
    • oincreased blood pressure
    • seizures
  • Can occur with both Ajovy and sumatriptan:
    • serious allergic reactions

Effectiveness

Ajovy and sumatriptan are not used for the same purpose and have not been compared in clinical studies. Ajovy is effective at preventing migraine headaches before they happen, while sumatriptan is effective at stopping a migraine headache that has already started.

The American Headache Society recommends sumatriptan as an option for adults who visit the emergency department for a migraine attack. Ajovy is recommended for people who have tried other drugs but found that those drugs couldn’t reduce the number of migraines days enough, or that they caused side effects or drug interactions.

Costs

Ajovy and sumatriptan are both available as brand-name medications. Sumatriptan is also available in a generic form, while Ajovy is not. Generic drugs typically cost less than brand-name medications.

According to estimates from GoodRx.com, Ajovy may cost more or less than sumatriptan, depending on which dosage form (tablet, injectable, nasal spray, nasal powder) of sumatriptan your doctor prescribes for you.

The actual cost you would pay for any of these drugs depends on your insurance plan, your location, and the pharmacy you use. For sumatriptan, it would also depend on the drug form used, your dose, and how often you use the drug.

Ajovy cost

As with all medications, prices for Ajovy can vary. To find current prices for Ajovy in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you would pay without insurance. Your actual cost will depend on your insurance coverage, your location, and the pharmacy you use.

Financial assistance

If you need financial support to pay for Ajovy, help is available.

Teva Pharmaceuticals, the manufacturer of Ajovy, has a savings offer that can help you pay less for Ajovy. For more information and to find out if you’re eligible, visit the program website.


Ajovy dosage

The following information describes the usual dosages for Ajovy. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosing schedule for you.

Drug forms and strengths

Ajovy comes in a single-dose prefilled syringe. Each syringe contains 225 mg of fremanezumab in 1.5 mL of solution.

Ajovy is given as an injection under your skin (subcutaneous). You can self-inject the drug at home, or a healthcare provider can give you the injection at your doctor’s office.

Dosage for migraine headache prevention

There are two recommended dosage schedules:

  • one 225-mg subcutaneous injection given every month, or
  • three 225-mg subcutaneous injections given together (one after another) once every three months

You and your doctor will determine the best dosing schedule for you, based on your preferences and lifestyle.

What if I miss a dose?

If you forget or miss a dose, administer the dose as soon as you remember. After that, resume the normal recommended schedule.

For example, if you’re on a monthly schedule, plan the next dose for four weeks after your makeup dose. If you’re on a quarterly schedule, administer the next dose 12 weeks after your makeup dose.

Will I need to use this drug long-term?

If you and your doctor determine that Ajovy is safe and effective for you, you may use the drug long-term to prevent migraine headaches.

How to take Ajovy

Ajovy is an injection that’s given under the skin (subcutaneous) once a month or once every three months. You can either administer the injection yourself at home, or have a healthcare provider give you the injections at your doctor’s office. The first time you get a prescription for Ajovy, your healthcare provider can explain how to inject the medication yourself.

Ajovy comes as a single-dose, 225-mg prefilled syringe. Each syringe contains only one dose and is meant to be used once and then discarded.

Below is information on how to use the prefilled syringe. For other information, video, and images of injection instructions, see the manufacturer’s website.

How to inject

Your doctor will prescribe either 225 mg once per month, or 675 mg once every three months (quarterly). If you’re prescribed 225 mg monthly, you will give yourself one injection. If you’re prescribed 675 mg quarterly, you’ll give yourself three separate injections one after another.

Preparing to inject

  • Thirty minutes before injecting the medication, remove the syringe from the refrigerator. This allows the drug to warm up and come to room temperature. Keep the cap on the syringe until you’re ready to use the syringe. (Ajovy can be stored at room temperature for up to 24 hours. If Ajovy is stored outside of the refrigerator for 24 hours without being used, don’t put it back into the refrigerator. Dispose of it in your sharps container.)
  • Don’t try to warm the syringe up faster by microwaving it or running hot water over it. Also, don’t shake the syringe. Doing these things can make Ajovy less safe and effective.
  • When you take the syringe out of its packaging, be sure to protect it from light.
  • While you wait for the syringe to warm up to room temperature, get gauze or a cotton ball, an alcohol wipe, and your sharps disposal container. Also, make sure you have the correct number of syringes for your prescribed dose.
  • Look at the syringe to make sure the drug isn’t cloudy or expired. The liquid should be clear to slightly yellow. It’s okay if there are bubbles. But if the liquid is discolored or cloudy, or if there are small solid pieces in it, don’t use it. And if there are any cracks or leaks in the syringe, do not use it. If needed, contact your doctor about getting a new one.
  • Use soap and water to wash your hands, and then choose the spot for your injection. You can inject under your skin into these three areas:
    • the front of your thighs (at least two inches above your knee or two inches below your groin)
    • the back of your upper arms
    • your belly (at least two inches away from your belly button)
  • If you want to inject the medication into the back of your arm, someone may need to inject the drug for you.
  • Use the alcohol wipe to clean the injection spot you’ve chosen. Be sure the alcohol is completely dry before you inject the drug.
  • If you’re giving yourself three injections, don’t give yourself any injections in the same spot. And never inject into areas that are bruised, red, scarred, tattooed, or hard to the touch.

Injecting Ajovy prefilled syringe

  1. Take the needle cap off of the syringe and throw it away in the trash.
  2. Gently pinch at least one inch of skin that you wish to inject.
  3. Insert the needle into the pinched skin at an angle of 45 to 90 degrees.
  4. Once the needle is inserted completely, use your thumb to slowly push the plunger as far as it will go.
  5. After injecting Ajovy, pull the needle straight out of the skin and release the fold of skin. To avoid sticking yourself, don’t recap the needle.
  6. Gently press the cotton ball or gauze onto the injection site for a few seconds. Don’t rub the area.
  7. Throw the used syringe and needle into your sharps disposal container right away.

Timing

Ajovy should be taken once every month or once every three months (quarterly), depending on what your doctor prescribes. It can be taken at any time of the day.

If you miss a dose, take Ajovy as soon as you remember. The next dose should be one month or three months after you take that one, depending on your recommended dosing schedule. A medication reminder tool can help you remember to take Ajovy on schedule.

Taking Ajovy with food

Ajovy can be taken with or without food.


How Ajovy works

Ajovy is a monoclonal antibody. This type of drug is a special immune system protein that’s made in a lab. Ajovy works by halting the activity of a protein called calcitonin gene-related peptide (CGRP). CGRP is involved in vasodilation (widening of blood vessels) and inflammation in your brain.

CGRP is believed to play a key role in causing migraine headaches. In fact, when people begin to get a migraine headache, they have high levels of CGRP in their bloodstream. Ajovy helps keep a migraine headache from starting by halting the activity of CGRP.

Most medications target (act on) numerous chemicals or parts of cells in your body. But Ajovy and other monoclonal antibodies only target one substance in the body. As a result, there may be fewer drug interactions and side effects with Ajovy. This may make it a good choice for people who can’t take other drugs because of side effects or drug interactions.

Ajovy may also be a good choice for people who have tried other drugs, but the drugs didn’t do enough to reduce their number of migraine days.

How long does it take to work?

It may take a few weeks for any migraine changes that Ajovy causes to become noticeable. And it may take several months for Ajovy to be fully effective.

The results of clinical studies showed that many people who took Ajovy experienced fewer migraine days within one month of taking their first dose. Over several months, the number of migraine days continued to decrease for people in the study.

Ajovy and alcohol

There is no interaction between Ajovy and alcohol.

However, for some people, drinking alcohol while taking Ajovy may seem to make the drug less effective. This is because alcohol is a migraine trigger for many people, and even small amounts of alcohol can cause a migraine headache for them.

If you find that alcohol causes more painful or more frequent migraine headaches, you should avoid drinks that contain alcohol.


Ajovy interactions

Many medications can interact with other drugs. These interactions can cause varying effects. For example, some drugs can cause problems with how well a different medication works. Other drugs can increase the severity or number of side effects.

But Ajovy doesn’t usually cause drug interactions because of how the body processes it.

Enzymes in the liver metabolize (break down) many drugs, supplements, and herbs. But the liver generally doesn’t break down monoclonal antibodies such as Ajovy. Instead, cells throughout the body break down these drugs.

Ajovy doesn’t usually interact with other medications because it’s broken down separately from them. But if you’re concerned about how Ajovy might interact with other medications that you take, discuss your concerns with your doctor.

There aren’t many drug interactions associated with Ajovy. However, it’s still a smart idea to tell your doctor and pharmacist about any prescription, over-the-counter, and other medications you take. And be sure to tell them if you take any vitamins, supplements, or herbs.

Ajovy and pregnancy

It isn’t known if Ajovy is safe to use during pregnancy. When Ajovy was given to pregnant females in animal studies, no risk was shown to the pregnancy. But the results of animal studies don’t always predict how a drug might affect humans.

If you’re pregnant or thinking about becoming pregnant, talk with your doctor. They can help determine if Ajovy is a good choice for you. You may need to wait to use Ajovy until you’re no longer pregnant.

Ajovy and breastfeeding

It’s unknown whether Ajovy passes into human breast milk. Therefore, it’s unclear whether Ajovy is safe to use while breastfeeding.

If you’re thinking about having Ajovy treatment while you’re breastfeeding, talk with your doctor about the possible benefits and risks. If you start taking Ajovy, you may have to stop breastfeeding.


Common questions about Ajovy

Here are answers to some frequently asked questions about Ajovy.

Can Ajovy be used to treat a migraine headache?

No, Ajovy is not a treatment for migraine headaches. Ajovy helps prevent migraine headaches before they start.

How is Ajovy different from other migraine drugs?

Ajovy differs from most other migraine drugs because it’s one of the first medications created to help prevent migraine headaches. Ajovy is part of a new class of drugs called calcitonin gene-related peptide (CGRP) antagonists.

Most other medications used to prevent migraine headaches were developed for different purposes, such as treating seizures, depression, or high blood pressure. Many of these drugs are used off-label to help prevent migraine headaches.

Ajovy also differs from most other migraine medications in that it’s injected once a month or once every three months. Most other drugs used to prevent migraine headaches come as tablets that you need to take once each day.

One alternative drug is Botox. Botox is also an injection, but you receive it once every three months in your doctor’s office. You can inject Ajovy yourself at home or have a healthcare provider give you the injection at your doctor’s office.

Also, Ajovy is a monoclonal antibody, which is a kind of drug created from immune system cells. The liver doesn’t break down these drugs, as it does with most other drugs used to prevent migraine headaches. This means that Ajovy and other monoclonal antibodies have fewer drug interactions than other medications that help prevent migraine headaches.

Does Ajovy cure migraine headaches?

No, Ajovy does not help cure migraine headaches. Currently, there are no drugs available that can cure migraine headaches. The migraine drugs that are available can help prevent or treat migraine headaches.

If I take Ajovy, can I stop taking my other preventive medications?

That depends. Everyone’s response to Ajovy is different. If the drug reduces the number of your migraine headaches down to a manageable amount, it’s possible that you may be able to stop using other preventive medications. But when you start taking Ajovy, your doctor will probably prescribe it together with other preventive drugs.

A clinical study found that Ajovy is safe and effective for use with other preventive medications. Other drugs that your doctor may prescribe with Ajovy include topiramate (Topamax), propranolol (Inderal), and certain antidepressants. Ajovy can also be used with onabotulinumtoxinA (Botox).

After you try Ajovy for two to three months, your doctor will probably talk with you to see how well the drug works for you. At that point, the two of you may decide that you should stop taking the other preventive medications, or that you should reduce your dosage for those drugs.

Is it safe to use Ajovy with Botox?

Yes. Ajovy can be used safely with Botox for people who don’t have enough of a reduction in migraine headaches with use of either of the medications used alone.

Can Ajovy treat migraine headaches with aura?

People who have migraine headaches with aura were included in Ajovy clinical studies. However, the studies were not designed to test whether Ajovy improves migraine headaches with aura specifically. Therefore, it’s not clear whether the people with auras had positive results with Ajovy.


Ajovy overdose

Injecting multiple doses of Ajovy can increase your risk of injection site reactions. If you’re allergic or hypersensitive to Ajovy, you may be at risk for a more serious reaction.

Overdose symptoms

Symptoms of an overdose can include:

  • severe pain, itchiness, or redness in area near injection
  • flushing
  • hives
  • angioedema (swelling under the skin)
  • swelling of the tongue, throat, or mouth
  • trouble breathing

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Ajovy warnings

Before taking Ajovy, talk with your doctor about your health history. You should not take Ajovy if you have a history of serious hypersensitivity reactions to Ajovy or any of its ingredients. A serious hypersensitivity reaction can cause symptoms such as:

  • skin rash
  • itchiness
  • trouble breathing
  • angioedema (swelling under the skin)
  • swelling of the tongue, mouth, and throat

Ajovy expiration

When Ajovy is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the container. This date is typically one year from the date the medication was dispensed.

The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications.

How long a medication remains good can depend on many factors, including how and where the medication is stored.

Ajovy syringes should be stored in the refrigerator in the original container to protect them from light. They can be safely stored in the refrigerator for up to 24 months, or until the expiration date listed on the container. Once taken out of the refrigerator, each syringe must be used within 24 hours.

If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Professional information for Ajovy

The following information is provided for clinicians and other healthcare professionals.

Mechanism of action

Ajovy (fremanezumab) is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and prevents the CGRP ligand from activating the receptor.

Pharmacokinetics and metabolism

Time to maximum concentration is five to seven days following subcutaneous injection. Steady state concentration is achieved by approximately six months after monthly or quarterly administration.

Ajovy is degraded to small peptides and amino acids via catabolism. Metabolism does not occur via cytochrome P450 pathways. Elimination half-life is approximately 31 days.

Contraindications

Ajovy is contraindicated in patients with a history of hypersensitivity reaction to the drug or any of its excipients.

Storage

Ajovy should be stored in the refrigerator at 36⁰F to 46⁰F (2⁰C to 8⁰C). Store in the original container to protect from light. Ajovy can be kept at room temperature (up to 77⁰F/25⁰C) for up to 24 hours. Once stored at room temperature, do not place back in the refrigerator. Do not freeze or shake. Let Ajovy sit at room temperature for 30 minutes prior to administration.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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