MigraineActive ingredient
Fremanezumab
CGRP ligand antibody1 FDA label read
Fremanezumab is sold as Ajovy and differs from its neighbours on two practical points: its label offers a quarterly dosing option alongside the monthly one, and it is the only preventive antibody in this category whose label covers pediatric patients - episodic migraine in patients 6 to 17 years old who weigh 45 kg or more.
Highlights of the labels
- Ajovy
- Preventive treatment of migrainecovers migraine
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| AjovyTeva Pharmaceuticals USA, Inc. | What its label approvesPreventive treatment of migraineCovers migraine | SupplyPrescription | Label version5 June 2026 |
How it works
Fremanezumab is a humanized monoclonal antibody that binds the CGRP ligand and blocks its binding to the receptor, the same point of attack as Emgality. It is injected under the skin.
Mechanism of action, Ajovy label
Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
What the FDA approved it for
The approved uses, as worded in the label.
AJOVY is a calcitonin gene-related peptide antagonist indicated for: the preventive treatment of migraine in adults, and the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
Forms and strengths
The presentations and strengths listed in the label.
- AJOVY is a sterile, clear to opalescent, colorless to slightly yellow solution, available as follows:
- Injection: 225 mg/1.5 mL single-dose prefilled autoinjector Injection: 225 mg/1.5 mL single-dose prefilled syringe Injection: 225 mg/1.5 mL solution in a single-dose prefilled autoinjector.
- Injection: 225 mg/1.5 mL solution in a single-dose prefilled syringe.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- For subcutaneous use only. Recommended dosage: Adults: Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage; 225 mg monthly or 675 mg every 3 months (quarterly). The 675 mg quarterly dosage is administered as three consecutive injections of 225 mg each.
- Pediatric patients 6 to 17 years of age and who weigh 45 kg or more: 225 mg monthly
- Administer in the abdomen, thigh, or upper arm subcutaneously.
- See Dosage and Administration for important administration instructions.
Most common adverse reactions
The adverse reactions the label reports as most common.
- most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
- most common adverse reactions in the clinical trials for the preventive treatment of migraine (incidence at least 5% and greater than placebo) were injection site reactions.
- most common adverse reactions of AJOVY observed in Study 3 were injection site reactions.
Warnings and precautions
The warnings and precautions section of the label.
- Hypersensitivity Reactions: Most reactions were reported from within hours to one month after administration. If hypersensitivity occurs, consider discontinuing AJOVY and institute appropriate therapy.
- Constipation with Serious Complications: Serious complications of constipation may occur.
- Hypertension: New-onset or worsening of pre-existing hypertension may occur.
- Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur.
Contraindications
Situations in which the label states the medication must not be used.
- AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
- Reactions have included anaphylaxis and angioedema.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women.
Generic or brand
There is no generic fremanezumab: it is a biologic approved under a biologics license application, and copies of biologics reach the market as biosimilars, under their own approvals.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Ajovy is a brand biologic. Acquisition cost is per injection at brand level; the monthly and quarterly regimens use the same 225 mg syringes. What a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per milliliter | Brand$508.21 (range $506.39 to $508.61, 102 listings) |
Median of 102 listings. Effective dates 2026-01-01 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- What are Ajovy's dosing options?
- Adults may use either of two subcutaneous regimens: 225 mg monthly, or 675 mg every 3 months given as three consecutive injections. Pediatric patients aged 6 to 17 weighing 45 kg or more: 225 mg monthly.
- Which preventive antibody covers children?
- Ajovy: its label includes preventive treatment of episodic migraine in pediatric patients 6 to 17 years of age weighing at least 45 kg. The Emgality and Aimovig labels cover adults.
- How does Ajovy differ from Emgality?
- Both bind the CGRP molecule itself. The documents differ in reach: Ajovy adds a quarterly option and a pediatric indication; Emgality adds episodic cluster headache and uses a loading dose. The comparison page sets the two labels side by side.
Other medications under migraine
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Ajovy
Teva Pharmaceuticals USA, Inc.. Label version 24, effective 5 June 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.