Fremanezumab

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

• 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.ICD-10: G43.909

• 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 )].contraindicated

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 ) 2.1 Recommended 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.

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 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity 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 )] . 5.2 Hypertension 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.

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 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] 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 . 6.1 Clinical 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.

8.1 Pregnancy 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.

Metabolism

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.

• Sep 14, 2018BLABLA761089Teva Pharms Usa

1. 1Accidental Exposure To Product1,43813%
2. 2Injection Site Pain1,28012%
3. 3Migraine9879.0%
4. 4Drug Ineffective8888.1%
5. 5Headache7206.6%
6. 6Injection Site Erythema6345.8%
7. 7Device Leakage5595.1%
8. 8Injection Site Pruritus4834.4%
9. 9Device Malfunction4784.4%
10. 10Fatigue4714.3%
11. 11Nausea4634.2%
12. 12Injection Site Swelling4323.9%
13. 13Drug Dose Omission By Device4153.8%
14. 14Incorrect Dose Administered By Device3873.5%
15. 15Dizziness3753.4%

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Fremanezumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• New Methods for Evaluating Preventive Migraine Treatment
  Recruiting · Interventional · 60 enrolled · University of Aarhus
  NCT07071506updated 2026-05-19
• Fremanezumab, Migraine and Sleep
  Terminated · Phase 4 · Interventional · 22 enrolled · Beth Israel Deaconess Medical Center
  NCT04693533updated 2026-02-27
• Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
  Active not recruiting · Phase 4 · Interventional · 72 enrolled · Brigham and Women's Hospital
  NCT06173661updated 2026-02-27
• A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
  Completed · Phase 3 · Interventional · 506 enrolled · Teva Branded Pharmaceutical Products R&D LLC
  NCT04530110updated 2026-02-13
• A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age
  Completed · Phase 3 · Interventional · 292 enrolled · Teva Branded Pharmaceutical Products R&D, Inc.
  NCT04464707updated 2025-12-19
• A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
  Completed · Phase 3 · Interventional · 365 enrolled · Teva Branded Pharmaceutical Products R&D, Inc.
  NCT05458011updated 2025-11-26
• Migraine Medication Effects on Urinary Symptoms
  Enrolling by invitation · Observational · 200 enrolled · The Cleveland Clinic
  NCT06212661updated 2025-10-01
• Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
  Recruiting · Observational · 350 enrolled · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  NCT06459648updated 2025-09-24
• Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
  Recruiting · Observational · 700 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT07159750updated 2025-09-08

Frequently asked questions

How does Fremanezumab work?

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

What is Fremanezumab used for?

According to FDA labeling, Fremanezumab carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Fremanezumab?

Fremanezumab is classified as Calcitonin gene-related peptide (CGRP) antagonists, Antibody-Receptor Interactions, Decreased Calcitonin Secretion.

What are the brand names for Fremanezumab?

Fremanezumab is marketed under brand names including Ajovy.

What are the contraindications for Fremanezumab?

Fremanezumab labeling lists contraindications including: 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 )].. Always consult the full prescribing information and a clinician.