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AJOVY fremanezumab-vfrm 225 mg/1.5mL Injection, 1.5 mL — NDC 51759-0202-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AJOVY fremanezumab-vfrm 225 mg/1.5mL Injection, 1.5 mL — NDC 51759-202-11 (Billing 51759-0202-11)

by Teva Pharmaceuticals USA, Inc. · 1 CONTAINER in 1 CARTON / 1.5 mL in 1 CONTAINER

This is a package of 1.5 mL of AJOVY fremanezumab-vfrm 225 mg/1.5mL Injection from Teva Pharmaceuticals USA, Inc., marketed since Mar 2020 and currently FDA-listed.

NDC 51759-0202-11
🏷️ FDA NDC (as labeled) 51759-202-11 billing pads the product segment with a zero
This package
Contains1.5 mL Pack sizes3 compare ↓
Also priced by: Part D plans $312.84/unit — full pricing hub ↓
Product page 51759-0202-10 Also comes in: 1.5 ml 51759-202-10 1.5 ml 51759-202-22
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 51759-202-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51759 labeler · 202 product · 11 package
Package marketed since
Mar 29, 2020
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Billing quantity
2 mL per package
Barcode (UPC-A, from the NDC)
3 5175920211 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51759-202-11
Product NDC 51759-202
11-digit billing NDC 51759020211
NCPDP billing unit ML — per mL (volume)
RxCUI 2056695, 2056700, 2287903, 2287905
UNII PF8K38CG54
Application # BLA761089
SPL Set ID 98e344ea-5916-4947-b6f2-4a76ccc04b6b
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-03-29
Route SUBCUTANEOUS
Dosage form INJECTION
Substance FREMANEZUMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 6770203020D520
GPI class Ajovy
GCN Seq No 080875
GCN 47862
HICL code 045236
Ingredient (HICL) Fremanezumab-Vfrm
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3F
Therapeutic class — specific (HIC3) Antimigraine Preparations
AHFS code 28:32.12.00
AHFS class Calcitonin Gene-Related Peptide Antag.
FDB label name AJOVY 225 MG/1.5 ML AUTOINJECT
FDB brand name Ajovy Autoinjector
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080875
  • GCN: 47862
  • GPI-14 (Medi-Span): 6770203020D520
  • HICL (First Databank): 045236
  • AHFS class code: 28:32.12.00
  • RxCUI (RxNorm): 2056695
Why two NDCs? The FDA registers this code as 51759-202-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51759-0202-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Calcitonin gene-related peptide (CGRP) antagonists class.

Drug family (ATC) Calcitonin gene-related peptide (CGRP) antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AJOVY 225 MG/1.5 ML AUTOINJECT Ingredient Fremanezumab-Vfrm
📖 What it is MedlinePlus · NLM

Fremanezumab-vfrm injection is used to help prevent migraine headaches (severe, throbbing headaches that may cause nausea and sensitivity to sound or light). Fremanezumab-vfrm injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes migraine headaches.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ajovy helps prevent migraine attacks before they start. It is for adults, and for children 6 to 17 who weigh at least 45 kg and have episodic migraine. It is not meant to treat a m...
  • It is an injection under the skin of your belly, thigh, or upper arm. Adults use a monthly or every-3-months schedule, and children use monthly. Let it warm up at room temperature...
  • Take it as soon as you can. Your next dose will then be counted from that date.
  • Injection site reactions like pain, hardness or redness are the most common. Call your doctor for a rash, hives or itching, severe constipation, rising blood pressure, or fingers a...
📖 Read our full Fremanezumab-vfrm Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $312.84 $312.84 / 1 container
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
51759-0202-10 51759-202-10 Main listing 1 CONTAINER in 1 CARTON / 1.5 mL in 1 CONTAINER $508.17 / mL $762.26 2020-03-29 — Active
51759-0202-11 You're viewing this 1 CONTAINER in 1 CARTON / 1.5 mL in 1 CONTAINER Sample — — 2020-03-29 — Active
51759-0202-22 51759-202-22 3 CONTAINER in 1 CARTON / 1.5 mL in 1 CONTAINER $507.45 / mL $2,283.51 2020-08-31 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1.5 mL — 1 container in 1 carton / 1.5 ml in 1 container.
How does this package differ from NDC 51759-0202-10?
Both are AJOVY fremanezumab-vfrm 225 mg/1.5mL Injection — the drug itself is identical. This page's package is the 1.5 mL one, while NDC 51759-0202-10 is the 1.5 ml package.
What NDC number is used to bill for this package of AJOVY fremanezumab-vfrm 225 mg/1.5mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ajovy 225 mg/1.5mL 51759-0204-10 Teva 1 syringe $508.507 — Availability likely —
Ajovy 225 mg/1.5mLthis 51759-0202-11 Teva 1.5 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2018
First FDA approval
Sep 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2030. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 14, 2018 ⏳ ~4 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Ajovyfremanezumab-vfrm
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2018 2020 2022 2024 2026 2028 2030
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateSep 14, 2030
Common questions
Is there a biosimilar for AJOVY 225 MG/1.5 ML AUTOINJECT?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Fremanezumab-vfrm Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EQL53S5L0F
    Disodium ethylenediaminediacetate is a chelating agent that binds to metal ions in medications. It's used to prevent metals like iron or copper from causing discoloration, spoilage, or reduced effectiveness of the drug.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
FDA applicationBLA761089 (BLA)
Labeler code51759
First marketedMar 2020
Product typeHuman Prescription Drug
Portfolio504 products on file

More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 51759

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 84 words ▾

1 INDICATIONS AND USAGE AJOVY is 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. 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. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION 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.

( 2.1 ) Pediatric patients 6 to 17 years of age and who weigh 45 kg or more : 225 mg monthly ( 2.1 ) Administer in the abdomen, thigh, or upper arm subcutaneously. ( 2.2 ) See Dosage and Administration for important administration instructions. ( 2.2 )

2.1Recommended Dosage Adults The recommended dosage in adults for the preventive treatment of migraine is administered by subcutaneous injection as one of the following options: 225 mg monthly, or 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. Pediatric Patients who are 6 to 17 Years of Age and who Weigh 45 kg or More: The recommended dosage for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more is administered by subcutaneous injection as follows: 225 mg monthly.

AJOVY is not approved in pediatric patients weighing less than 45 kg because of the lack of an appropriate strength presentation [see Clinical Studies (14) and How Supplied/Storage and Handling (16.1)] . Missed Dose If a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose.

2.2Important Administration Instructions AJOVY is for subcutaneous use only. AJOVY may be administered by healthcare providers, patients 13 years of age and older, and/or caregivers. In pediatric patients 6 to 12 years of age, AJOVY must be administered by a healthcare provider or adult caregiver.

Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use ] : Remove AJOVY from the refrigerator. Prior to use, allow AJOVY to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat source such as hot water or a microwave.

Do not use AJOVY if it has been at room temperature for 7 days or longer [see How Supplied/Storage and Handling ( 16.2 )]. Follow aseptic injection technique every time AJOVY is administered. Inspect AJOVY for particles or discoloration prior to administration [see Dosage Forms and Strengths ( 3 )] .

Do not use if the solution is cloudy, discolored, or contains particles. Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, you may use the same body site, but not the exact location of the previous injection.

Do not co-administer AJOVY with other injectable drugs at the same injection site.

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS 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. ( 3 ) Injection: 225 mg/1.5 mL solution in a single-dose prefilled syringe. ( 3 )

⛔ Contraindications 50 words ▾

4 CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )]. AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Most reactions were reported from within hours to one month after administration. If hypersensitivity occurs, consider discontinuing AJOVY and institute appropriate therapy. ( 5.1 ) Constipation with Serious Complications: Serious complications of constipation may occur.

( 5.2 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.3 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.4 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.

Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy [see Contraindications ( 4 )] .

5.2Constipation with Serious Complications Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including AJOVY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later in treatment.

The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications. Monitor patients treated with AJOVY for severe constipation and manage as clinically appropriate [see Patient Counseling Information (17)] . The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

5.3Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization.

Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. AJOVY was discontinued in many of the reported cases. Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

5.4Raynaud's Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Constipation with Serious Complications [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. Adults The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least 6 months, 775 patients for at least 12 months, and 138 patients for at least 15 months.

In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks [see Clinical Studies ( 14 )] . In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years. The 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.

The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies. Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for Either Dosing Regimen of AJOVY and At Least 2% Greater Than Placebo in Studies 1 and 2 Adverse Reaction AJOVY 225 mg Monthly (n=290) % AJOVY 675 mg Quarterly (n=667) % Placebo Monthly (n=668) % Injection site reactions a 43 45 38 a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema.

Pediatric Patients 6 to 17 Years of Age The safety of AJOVY was evaluated in 225 pediatric patients 6 to 17 years of age with episodic migraine who received at least one dose of AJOVY. Of these patients, 209 received AJOVY monthly for at least 6 months and 100 received AJOVY for at least 12 months. In the placebo-controlled trial (Study 3), 123 pediatric patients with episodic migraine were treated with AJOVY [see Clinical Studies (14)] .

The most common adverse reactions of AJOVY observed in Study 3 were injection site reactions. Hypersensitivity reactions were also observed. Overall, the safety profile in pediatric patients is similar to the known safety profile in adults.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of AJOVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: Constipation [see Warnings and Precautions ( 5.2 )] Immune System Disorders : Anaphylactic reactions and angioedema [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Vascular Disorders : Hypertension [see Warnings and Precautions ( 5.3 )] , Raynaud’s phenomenon [see Warnings and Precautions ( 5.4 )]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

AJOVY has a long half-life [see Clinical Pharmacology ( 12.3 )] . This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

Data Animal Data When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg. Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development.

The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg). Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg).

8.2Lactation Risk Summary There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition.

8.4Pediatric Use Episodic Migraine The safety and effectiveness of AJOVY have been established in an adequate and well-controlled study for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more (Study 3). The safety and efficacy profile of AJOVY in these patients was similar to the safety and efficacy profile seen in clinical trials in adults with migraine [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].

AJOVY is not approved in pediatric patients weighing less than 45 kg because of the lack of an appropriate strength presentation. The safety and effectiveness of AJOVY for the preventive treatment of episodic migraine in pediatric patients younger than 6 years of age have not been established. Chronic Migraine The safety and effectiveness of AJOVY for the preventive treatment of chronic migraine in pediatric patients have not been established.

Juvenile Animal Toxicity Data Subcutaneous administration of fremanezumab-v… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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.

AJOVY has a long half-life [see Clinical Pharmacology ( 12.3 )] . This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

Data Animal Data When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg. Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development.

The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg). Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Episodic Migraine The safety and effectiveness of AJOVY have been established in an adequate and well-controlled study for the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more (Study 3). The safety and efficacy profile of AJOVY in these patients was similar to the safety and efficacy profile seen in clinical trials in adults with migraine [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].

AJOVY is not approved in pediatric patients weighing less than 45 kg because of the lack of an appropriate strength presentation. The safety and effectiveness of AJOVY for the preventive treatment of episodic migraine in pediatric patients younger than 6 years of age have not been established. Chronic Migraine The safety and effectiveness of AJOVY for the preventive treatment of chronic migraine in pediatric patients have not been established.

Juvenile Animal Toxicity Data Subcutaneous administration of fremanezumab-vfrm (0, 50, 150, or 450 mg/kg) to juvenile rats once weekly from postnatal day (PND) 28 to PND 63 resulted in no adverse effects on growth, sexual maturation, or neurobehavioral or reproductive function. The highest dose tested was associated with plasma drug exposures (AUC) approximately 58 times that in pediatric patients at the recommended human dose (225 mg), when calculated on a monthly basis.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

12.2Pharmacodynamics The relationship between the pharmacodynamic activity and the mechanism(s) by which fremanezumab-vfrm exerts its clinical effects is unknown.

12.3Pharmacokinetics Absorption After single subcutaneous (SC) administrations of 225 mg, 675 mg, and 900 mg fremanezumab-vfrm, median time to maximum concentrations (t max ) was 5 to 7 days. Dose-proportionality, based on population PK, was observed between 225 mg to 900 mg. The geometric mean (%CV) for fremanezumab-vfrm maximum concentration (C max ) was 29.7 (13.7%) µg/mL and total systemic exposure (AUC 0-inf ) was 42.5 (17.5%) h*mg/mL following administration of 225 mg fremanezumab-vfrm.

The geometric mean (%CV) for fremanezumab-vfrm maximum concentration (C max ) was 104.8 (28.8%) µg/mL and total systemic exposure (AUC 0-inf ) was 132.8 (31.7%) h*mg/mL following administration of 675 mg fremanezumab-vfrm. Steady state was achieved by approximately 168 days (approximately 6 months) following 225 mg SC monthly and 675 mg SC quarterly dosing regimens. Median accumulation ratio, based on once-monthly and once-quarterly dosing regimens, is approximately 2.3 and 1.2, respectively.

Distribution Fremanezumab-vfrm has an apparent volume of distribution of approximately 6 liters, suggesting minimal distribution to the extravascular tissues. Metabolism Similar to other monoclonal antibodies, fremanezumab-vfrm is degraded by enzymatic proteolysis into small peptides and amino acids. Elimination Fremanezumab-vfrm apparent clearance was approximately 0.141 L/day.

Fremanezumab-vfrm was estimated to have a half-life of approximately 31 days. Specific Populations No clinically significant differences in fremanezumab-vfrm pharmacokinetics were predicted based on race (White, Black, Asian, and other races), sex, mild hepatic impairment (Child-Pugh Class A), and moderate hepatic impairment (Child-Pugh Class B). The effect of severe hepatic impairment (Child-Pugh Class C) on fremanezumab-vfrm pharmacokinetics is unknown.

Pediatric Patients Following subcutaneous administration of 225 mg AJOVY monthly in the pediatric population weighing 45 kg or more, the predicted steady state fremanezumab-vfrm exposures (maximum plasma concentration [C max ], area under the plasma concentration-time curve [AUC]) are similar to those of adults. Drug Interactions Fremanezumab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Additionally, the effects of medications for the acute treatment (specifically analgesics, ergots, and triptans) and preventive treatment of migraine were evaluated in a population PK model, and found not to influence fremanezumab exposure.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of fremanezumab-vfrm or of other fremanezumab products. In 3-month, placebo-controlled studies in adult patients, treatment-emergent anti-drug antibodies were observed in 0.4% (6 out of 1701) AJOVY-treated patients.

One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. In the long-term, open-label study, anti-drug antibodies were detected in 1.6% of patients (30 out of 1888). Out of 30 anti-drug antibody-positive patients, 17 had a neutralizing activity in their post-dose samples.

Although these data do not demonstrate an impact of anti-fremanezumab-vfrm antibody development on efficacy or safety of AJOVY in these patients, available data are t… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

📦 How Supplied / Storage and Handling 166 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous administration. AJOVY is not made with natural rubber latex. AJOVY is supplied as follows: Prefilled Autoinjector Pack of 1 autoinjector: 225 mg/1.5 mL single-dose prefilled autoinjector NDC 51759-202-10 Pack of 3 autoinjectors: 3 x 225 mg/1.5mL single-dose prefilled autoinjectors NDC 51759-202-22 Prefilled Syringe Pack of 1 syringe: 225 mg/1.5 mL single-dose prefilled syringe NDC 51759-204-10

16.2Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original outer carton to protect from light. If necessary, AJOVY may be kept in the original carton at room temperature up to 30°C (86°F) for a maximum of 7 days. After removal from the refrigerator, AJOVY must be used within 7 days or discarded.

Once stored at room temperature, do not place back in the refrigerator. Do not freeze. Do not expose to extreme heat or direct sunlight.

Do not shake.

📋 Description 126 words ▾

11 DESCRIPTION Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa.

AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe. Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Information on Preparation and Administration Instruct patients who are 13 years and older and/or caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled syringe [see Dosage and Administration ( 2.2 )]. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AJOVY.

Instruct patients who are prescribed the regimen of 675 mg every 3 months to administer the dosage as three consecutive subcutaneous injections of 225 mg each [see Dosage and Administration ( 2.1 )]. Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur up to 1 month after administration. Advise patients to contact their healthcare provider if signs or symptoms of hypersensitivity reactions occur and to seek immediate medical attention if they experience serious or severe hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] .

Constipation with Serious Complications Inform patients that constipation with serious complications can occur with AJOVY. Advise patients to contact their healthcare providers if they experience severe constipation [see Warnings and Precautions ( 5.2 )] . Hypertension Inform patients that hypertension can develop or pre-existing hypertension can worsen with AJOVY, and that they should contact their healthcare provider if they experience elevation in their blood pressure [see Warnings and Precautions ( 5.3 ) ] .

Raynaud's Phenomenon Inform patients that Raynaud’s phenomenon can develop or worsen with AJOVY. Advise patients to discontinue AJOVY and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon [see Warnings and Precautions ( 5.4 )] . Pregnancy Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy [see Use in Specific Populations ( 8.1 )] .

Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 US License No. 2016 AJOVY ® (fremanezumab-vfrm), its use, or its process of manufacture, may be protected by one or more United States patents, including US 8,007,794, US 8,586,045, US 9,896,502, US 10,519,224, and US 10,899,826. © 2026 Teva Pharmaceuticals USA, Inc.

AJO-013 Rev. 6/2026

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption After single subcutaneous (SC) administrations of 225 mg, 675 mg, and 900 mg fremanezumab-vfrm, median time to maximum concentrations (t max ) was 5 to 7 days. Dose-proportionality, based on population PK, was observed between 225 mg to 900 mg. The geometric mean (%CV) for fremanezumab-vfrm maximum concentration (C max ) was 29.7 (13.7%) µg/mL and total systemic exposure (AUC 0-inf ) was 42.5 (17.5%) h*mg/mL following administration of 225 mg fremanezumab-vfrm.

The geometric mean (%CV) for fremanezumab-vfrm maximum concentration (C max ) was 104.8 (28.8%) µg/mL and total systemic exposure (AUC 0-inf ) was 132.8 (31.7%) h*mg/mL following administration of 675 mg fremanezumab-vfrm. Steady state was achieved by approximately 168 days (approximately 6 months) following 225 mg SC monthly and 675 mg SC quarterly dosing regimens. Median accumulation ratio, based on once-monthly and once-quarterly dosing regimens, is approximately 2.3 and 1.2, respectively.

Distribution Fremanezumab-vfrm has an apparent volume of distribution of approximately 6 liters, suggesting minimal distribution to the extravascular tissues. Metabolism Similar to other monoclonal antibodies, fremanezumab-vfrm is degraded by enzymatic proteolysis into small peptides and amino acids. Elimination Fremanezumab-vfrm apparent clearance was approximately 0.141 L/day.

Fremanezumab-vfrm was estimated to have a half-life of approximately 31 days. Specific Populations No clinically significant differences in fremanezumab-vfrm pharmacokinetics were predicted based on race (White, Black, Asian, and other races), sex, mild hepatic impairment (Child-Pugh Class A), and moderate hepatic impairment (Child-Pugh Class B). The effect of severe hepatic impairment (Child-Pugh Class C) on fremanezumab-vfrm pharmacokinetics is unknown.

Pediatric Patients Following subcutaneous administration of 225 mg AJOVY monthly in the pediatric population weighing 45 kg or more, the predicted steady state fremanezumab-vfrm exposures (maximum plasma concentration [C max ], area under the plasma concentration-time curve [AUC]) are similar to those of adults. Drug Interactions Fremanezumab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Additionally, the effects of medications for the acute treatment (specifically analgesics, ergots, and triptans) and preventive treatment of migraine were evaluated in a population PK model, and found not to influence fremanezumab exposure.

🧬 Pharmacodynamics 20 words ▾

12.2Pharmacodynamics The relationship between the pharmacodynamic activity and the mechanism(s) by which fremanezumab-vfrm exerts its clinical effects is unknown.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Adults The efficacy of AJOVY was evaluated as a preventive treatment of episodic or chronic migraine in adult patients in two multicenter, randomized, 3-month, double-blind, placebo-controlled studies (Study 1 and Study 2, respectively). Episodic Migraine Study 1 (NCT 02629861) included adults with a history of episodic migraine (patients with <15 headache days per month). All patients were randomized (1:1:1) to receive subcutaneous injections of either AJOVY 675 mg every three months (quarterly), AJOVY 225 mg monthly, or placebo monthly, over a 3-month treatment period.

Patients were allowed to use acute headache treatments during the study. A subset of patients (21%) was allowed to use one additional concomitant preventive medication. The study excluded patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism.

The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Secondary endpoints included the proportion of patients reaching at least a 50% reduction in monthly average number of migraine days during the 3-month treatment period, the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period, and the mean change from baseline in the number of migraine days during the first month of the treatment period.

In Study 1, a total of 875 patients (742 females, 133 males), ranging in age from 18 to 70 years, were randomized. A total of 791 patients completed the 3-month double-blind phase. The mean migraine frequency at baseline was approximately 9 migraine days per month, and was similar across treatment groups.

Both monthly and quarterly dosing regimens of AJOVY demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 3-month period, as summarized in Table 3. Table 3: Efficacy Endpoints in Study 1 Study 1 Efficacy Endpoint AJOVY 225 mg Monthly (N=287) AJOVY 675 mg Quarterly (N=288) Placebo (N=290) Monthly migraine days (MMD) Baseline migraine days 8.9 9.2

9.1Change from baseline -3.7 -3.4 -2.2 Difference from placebo -1.5 -1.2 p-value <0.001 <0.001 ≥50% MMD responders % responders 47.7% 44.4% 27.9% Difference from placebo 19.8% 16.5% p-value <0.001 <0.001 Monthly acute headache medication days Change from baseline -3.0 -2.9 -1.6 Difference from placebo -1.4 -1.3 p-value <0.001 <0.001 Figure 1 displays the mean change from baseline in the average monthly number of migraine days in Study 1. Figure 1: Change from Baseline in Monthly Migraine Days in Study 1 a Figure 2 shows the distribution of change from baseline in mean monthly migraine days in bins of 2 days by treatment group in Study 1.

A treatment benefit over placebo for both doses of AJOVY is seen across a range of changes from baseline in monthly migraine days. Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 1 Chronic Migraine Study 2 (NCT 02621931) included adults with a history of chronic migraine (patients with ≥15 headache days per month). All patients were randomized (1:1:1) to receive subcutaneous injections of either AJOVY 675 mg starting dose followed by 225 mg monthly, 675 mg every 3 months (quarterly), or placebo monthly, over a 3-month treatment period.

Patients were allowed to use acute headache treatments during the study. A subset of patients (21%) was allowed to use one additional concomitant, preventive medication. The study excluded patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism.

The primary efficacy endpoint was the mean change from baseline in the month… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 91 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of fremanezumab-vfrm were not conducted. Mutagenesis Genetic toxicology studies of fremanezumab-vfrm were not conducted. Impairment of Fertility When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse effects on male or female fertility were observed.

The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 88 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of fremanezumab-vfrm were not conducted. Mutagenesis Genetic toxicology studies of fremanezumab-vfrm were not conducted. Impairment of Fertility When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse effects on male or female fertility were observed.

The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg.

📄 Patient Package Insert ~3 min read ▾

Patient Information AJOVY ® (a-JO-vee) (fremanezumab-vfrm) injection for subcutaneous use What is AJOVY? AJOVY is a prescription medicine used for the preventive treatment of: migraine in adults episodic migraine in children who are 6 to 17 years of age and who weigh 99 pounds (45 kg) or more. It is not known if AJOVY is safe and effective in children under 6 years of age.

Who should not use AJOVY? Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY. See the end of this leaflet for a complete list of the ingredients in AJOVY.

Before you use AJOVY, tell your healthcare provider if you: have high blood pressure. have circulation problems in your fingers and toes. are pregnant or plan to become pregnant. It is not known if AJOVY will harm your unborn baby. Pregnancy Registry: There is a registry for women who become pregnant during treatment with AJOVY.

The purpose of this registry is to collect information about the safety of AJOVY during pregnancy. Contact the registry as soon as you learn that you are pregnant or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll you in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com. are breastfeeding or plan to breastfeed.

It is not known if AJOVY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AJOVY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. How should I use AJOVY?

See the detailed Instructions for Use for information on how to prepare and inject a dose of AJOVY. Use AJOVY exactly as your healthcare provider tells you to use it. AJOVY is given by injection under your skin (subcutaneously).

Your healthcare provider should show you or your caregiver how to prepare and inject your dose of AJOVY before you or your caregiver give your AJOVY the first time. Your healthcare provider will tell you how much AJOVY to use and when to use it. Adults: Your healthcare provider will tell you if you should use AJOVY 225 mg one time every month or AJOVY 675 mg one time every 3 months.

If your prescribed dose is AJOVY 675 mg every 3 months, you must use 3 separate autoinjectors or 3 separate syringes. You will give 3 separate injections one time every 3 months. If you are giving 3 injections of AJOVY for your prescribed dose, you may use the same injection area for all 3 injections, but not the same spot.

Children 6 to 17 years of age who weigh 99 pounds (45 kg) or more: Use AJOVY 225 mg one time every month. Do not inject AJOVY in the same injection site that you inject other medicine. If you are switching from using AJOVY one time every month to one time every 3 months or if you are switching from using AJOVY one time every 3 months to one time every month, give the first dose of AJOVY on the day it was due to be given on your old schedule.

If you miss a dose of AJOVY, take it as soon as possible. If you need to take the dose late, you will need to change your schedule: if you take 225 mg of AJOVY, inject your next dose 1 month after the late dose. If you take 675 mg of AJOVY, inject your next dose 3 months after the late dose.

If you have questions about your schedule, ask your healthcare provider. What are the possible side effects of AJOVY? AJOVY may cause serious side effects, including: Allergic reactions.

Allergic reactions, including itching, rash, and hives, can happen within hours and up to 1 month after receiving AJOVY. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, mouth, tongue, or throat trouble breathing Constipat… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use AJOVY ® (a-JO-vee) (fremanezumab-vfrm) injection prefilled autoinjector, for subcutaneous use For subcutaneous injection only. Read and follow the Instructions for Use for your AJOVY prefilled autoinjector before you start using it and each time you get a refill. Important: AJOVY prefilled autoinjector is for single-time (one-time) use only.

Put AJOVY in a FDA-cleared sharps disposal or puncture-resistant container right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash. Before injecting, let AJOVY sit at room temperature for 30 minutes.

Keep AJOVY prefilled autoinjector out of the reach of small children. After you remove the protective cap from AJOVY, to prevent infection, do not touch the needle. Do not inject AJOVY in your veins (intravenously).

Do not re-use your AJOVY prefilled autoinjector as this could cause injury or infection. Do not share your AJOVY prefilled autoinjector with another person. You may give another person an infection or get an infection from them.

You or your caregiver may give AJOVY. You should not get your first dose of AJOVY until you or your caregiver receive training from a healthcare provider on the right way to use AJOVY. Storage Conditions: Store AJOVY in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep AJOVY in the carton it comes in to protect from light. If needed, AJOVY may be stored at room temperature up to 86°F (30°C) in the carton it comes in for up to 7 days. Do not use AJOVY if it has been out of the refrigerator for 7 days or longer.

Throw away (dispose of) AJOVY in a sharps disposal or puncture-resistant container if it has been out of the refrigerator for 7 days or longer. Once stored at room temperature, do not place back in the refrigerator. Do not freeze.

If AJOVY freezes, throw it away in a sharps disposal container. Keep AJOVY out of extreme heat and direct sunlight. Do not shake AJOVY.

AJOVY prefilled autoinjector (Before use). See Figure A. Figure A AJOVY prefilled autoinjector (After use).

See Figure B. Figure B The blue plunger moves down the viewing window during the injection. The blue plunger fills the window when the injection is complete.

Note : When the blue plunger has filled the viewing window you will still be able to see the gray stopper, as shown in Figure B. When injecting AJOVY, hold the prefilled autoinjector so that your hand does not cover the viewing window. Read this before you inject.

Step 1. Check the dose your healthcare provider has prescribed. AJOVY comes as a single-dose (one time) prefilled autoinjector.

Your healthcare provider will prescribe the dose that is best for you. If your healthcare provider has prescribed 225 mg of AJOVY each month for you, give 1 injection each month, using a 225 mg prefilled AJOVY autoinjector. If your healthcare provider has prescribed 675 mg of AJOVY every 3 months for you, give 3 separate injections, one after another, using a different 225 mg prefilled AJOVY autoinjector for each injection.

Give these injections 1 time every 3 months. Before you inject, always check the label of your single-dose prefilled autoinjector to make sure you have the correct medicine and the correct dose of AJOVY. If you are not sure of your dose, ask your healthcare provider.

How do I inject AJOVY? Step 2. Remove the prefilled autoinjector from the carton.

You may need to use more than 1 prefilled autoinjector depending on your prescribed dose. Remove the autoinjector from the carton (see Figure C). Do not shake the prefilled autoinjector at any time, as this could affect the way the medicine works.

Important: If there are any unused autoinjectors left in the carton, put the carton and unused autoinjectors back in the refrigerator. Figure C Step 3. Gather the supplies you will need to inject AJOVY.

Gather the following supplies (see Figure D) and the number of AJOVY 225 mg prefilled autoinjectors you will need to give your prescribed dose: - If your d… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 26 words ▾

RECENT MAJOR CHANGES Indications and Usage ( 1 ) 8/2025 Dosage and Administration ( 2.1 , 2.2 ) 8/2025 Warnings and Precautions ( 5.2 ) 6/2026

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled syringe NDC 51759- 204 -10 Rx only AJOVY ® (fremanezumab-vfrm) injection 225 mg/1.5 mL FOR SUBCUTANEOUS USE ONLY One single-dose prefilled syringe Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.

If needed, AJOVY ® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.

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PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled autoinjector NDC 51759- 202 -10 Rx only AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL FOR SUBCUTANEOUS USE ONLY One single-dose prefilled autoinjector Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.

If needed, AJOVY ® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.

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PACKAGE/LABEL DISPLAY PANEL,Carton of 3 prefilled autoinjectors NDC 51759- 202 -22 Rx only AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL FOR SUBCUTANEOUS USE ONLY 3 x 225 mg/1.5 mL single-dose prefilled autoinjectors Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.

If needed, AJOVY ® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1.5 ml51759-0202-10 178,679 Rx · $139,267,694
1.5 ml51759-0202-22 7,046 Rx · $13,867,189
1.5 ml this page51759-0202-11 No Medicaid data
Drug total (last 4 qtrs): 185,725 Rx · 315,363 units · $153,134,882 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ajovy Autoinjector (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ajovy Autoinjector. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$21.3M
Claims incl. refills
24.9K
Beneficiaries
12.8K
Spend / beneficiary
$1,662.72
Spend / claim
$853.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AJOVY (this brand).

Top reported reactions

Injection Site Pain1,318
Migraine1,048
Headache742
Injection Site Erythema663
Device Leakage565
Injection Site Pruritus500
Fatigue498

Reporter sex

0 reports
Male · 11%
Female · 88%
Unknown · 0%

Serious outcomes

Hospitalization829
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,162 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Teva Pharmaceuticals USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1.5 ml (51759-0202-10), 1.5 ml (51759-0202-22). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Pharmaceuticals USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51754-8888-04 · Exela 51759-0204-10 · Teva →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.