Eptinezumab

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

• VYEPTI is indicated for the preventive treatment of migraine in adults.ICD-10: G43.909

• VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ] .contraindicated

Must dilute before use. For intravenous infusion only ( 2.1 , 2.2 ) Recommended dosage is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg every 3 months ( 2.1 , 2.3 ) Dilute only in 100 mL of 0.9% Sodium Chloride Injection ( 2.2 ) 2.1 Recommended Dosing The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months. 2.2 Dilution Instructions VYEPTI requires dilution prior to administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing VYEPTI solution for intravenous infusion. VYEPTI single-dose vials contain no preservative; discard unused portion remaining in the vial. Dilution 100 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. 300 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from each of 3 single-dose vials using a sterile needle and syringe. Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. Storage and Handling of Diluted Product Gently invert the VYEPTI solution to mix completely. Do not shake. Following dilution, VYEPTI solution must be infused within 8 hours.

Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate 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 angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy [see Contraindications (4) and Patient Counseling Information (17) ] . 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, 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. The CGRP antagonist was discontinued in many of the reported cases.

The following clinically significant adverse reactions are described elsewhere in 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 (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 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. The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524 patients were exposed to 100 mg or 300 mg. Across all doses, 1872 patients were exposed for at least 6 months and 991 patients were exposed for 12 months. In the placebo-controlled clinical studies (Study 1 and Study 2) of 1372 patients, 579 patients received at least one dose of VYEPTI 100 mg, 574 patients received at least one dose of VYEPTI 300 mg, and 588 patients received placebo [see Clinical Studies (14) ] . Approximately 86% were female, 89% were white, and the mean age was 40.4 years at study entry.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-855-810-8549 or by contacting the company at www.vyeptipregnancyregistry.lundbeck.com. Risk Summary There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages 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.

Metabolism

Eptinezumab-jjmr exhibits linear pharmacokinetics and exposure increases proportionally with doses from 100 mg to 300 mg after intravenous administration. Steady-state plasma concentration is attained after the first dose with a once every 3-month dosing schedule.

• Feb 21, 2020BLABLA761119Lundbeck Seattle Biopharmaceuticals, Inc.

1. 1Drug Ineffective2,00323%
2. 2Migraine1,41317%
3. 3Headache92711%
4. 4Therapeutic Response Shortened5356.3%
5. 5Nausea5256.1%
6. 6Fatigue4645.4%
7. 7Drug Effect Less Than Expected3494.1%
8. 8Throat Irritation3363.9%
9. 9Dizziness3243.8%
10. 10Pruritus2963.5%
11. 11Nasal Congestion2402.8%
12. 12Hypersensitivity1972.3%
13. 13Vomiting1952.3%
14. 14Dyspnoea1892.2%
15. 15Malaise1722.0%

The 10 most recently updated of 40 ClinicalTrials.gov registrations naming Eptinezumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
  Recruiting · Phase 3 · Interventional · 600 enrolled · H. Lundbeck A/S
  NCT05164172updated 2026-06-12
• Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
  Not yet recruiting · Phase 3 · Interventional · 96 enrolled · Rigmor Højland Jensen
  NCT07645833updated 2026-06-12
• A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
  Recruiting · Phase 3 · Interventional · 285 enrolled · H. Lundbeck A/S
  NCT04965675updated 2026-06-12
• A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
  Recruiting · Phase 3 · Interventional · 315 enrolled · H. Lundbeck A/S
  NCT05897320updated 2026-06-12
• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• Effectiveness and Tolerability of Eptinezumab
  Completed · Observational · 130 enrolled · University of Florence
  NCT06409845updated 2026-06-11
• A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications
  Active not recruiting · Phase 4 · Interventional · 164 enrolled · H. Lundbeck A/S
  NCT06701526updated 2026-05-13
• Facilitators and Barriers to Eptinezumab Administration in Thailand
  Completed · Observational · 30 enrolled · Chulalongkorn University
  NCT07035197updated 2026-04-08
• A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
  Completed · Phase 4 · Interventional · 608 enrolled · H. Lundbeck A/S
  NCT05452239updated 2026-01-29
• The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
  Recruiting · Observational · 50 enrolled · University of Florence
  NCT06628921updated 2026-01-21

Frequently asked questions

How does Eptinezumab work?

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

What is Eptinezumab used for?

According to FDA labeling, Eptinezumab carries indications including: VYEPTI is indicated for the preventive treatment of migraine in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Eptinezumab?

Eptinezumab is classified as Calcitonin gene-related peptide (CGRP) antagonists, Calcitonin Gene-related Peptide Antagonist, Antibody Interactions, Calcitonin Gene-related Peptide Antagonists.

What are the brand names for Eptinezumab?

Eptinezumab is marketed under brand names including Vyepti.

What are the contraindications for Eptinezumab?

Eptinezumab labeling lists contraindications including: VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.