Vyepti
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Vyepti is a Calcitonin Gene-Related Peptide (CGRP) Antagonist that is FDA approved for the treatment of migraine in adults.. Common adverse reactions include Nasopharyngitis and Hypersensitivity reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indication: Preventive treatment of migraine in adults.
Dosage: 100 mg administered intravenously over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vyepti in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vyepti in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vyepti in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vyepti in pediatric patients.
Contraindications
Serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in Vyepti. Reactions have included angioedema.
Warnings
Hypersensitivity Reactions: Including angioedema, urticaria, facial flushing, and rash. Most occurred during infusion and were not serious but often led to discontinuation or required treatment.
Hypertension: New-onset or worsening of pre-existing hypertension may occur.
Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur.
Adverse Reactions
Clinical Trials Experience
Nasopharyngitis and Hypersensitivity reactions.
Postmarketing Experience
There is limited information regarding Vyepti Postmarketing Experience in the drug label.
Drug Interactions
Eptinezumab is not expected to be metabolized by cytochrome P450 enzymes or to affect the pharmacokinetics of other drugs metabolized by these enzymes.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Vyepti in women who are pregnant.
Pregnancy Category (AUS): B1
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vyepti in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Vyepti during labor and delivery.
Nursing Mothers
Unknown if eptinezumab is present in human milk; the effects on the breastfed infant or milk production are unknown.
Pediatric Use
There is no FDA guidance on the use of Vyepti in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Vyepti in geriatric settings.
Gender
There is no FDA guidance on the use of Vyepti with respect to specific gender populations.
Race
There is no FDA guidance on the use of Vyepti with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Vyepti in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Vyepti in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Vyepti in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Vyepti in patients who are immunocompromised.
Administration and Monitoring
Administration
Dilute Vyepti in 100 mL of 0.9% Sodium Chloride Injection, USP.
Administer as an intravenous infusion over approximately 30 minutes every 3 months.
Monitoring
Monitor for hypersensitivity reactions during and after the infusion.
IV Compatibility
Vyepti is administered intravenously. Use an intravenous infusion set with a 0.2 micron or 0.22 micron in-line or add-on sterile filter.
Overdosage
In the event of an overdose, monitor the patient for any signs or symptoms of adverse reactions and provide supportive treatment as appropriate.
Pharmacology
There is limited information regarding Vyepti Pharmacology in the drug label.
Mechanism of Action
Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Structure
There is limited information regarding Vyepti Structure in the drug label.
Pharmacodynamics
The relationship between the pharmacodynamic activity and the mechanism(s) by which eptinezumab exerts its clinical effects is unknown.
Pharmacokinetics
Eptinezumab exhibits linear pharmacokinetics, and exposure increases proportionally with doses from 100 mg to 300 mg.
Nonclinical Toxicology
There is limited information regarding Vyepti Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Vyepti Clinical Studies in the drug label.
How Supplied
Form: Injection: 100 mg/mL solution in a single-dose vial.
Packaging: Carton containing one 100 mg/mL single-dose vial.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.
Do not freeze or shake.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Inform patients about the potential for hypersensitivity reactions and advise them to seek immediate medical attention if symptoms occur.
Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding.
Precautions with Alcohol
Alcohol-Vyepti interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Vyepti manufactured by Lundbeck Pharmaceuticals LLC.
Look-Alike Drug Names
There is limited information regarding Vyepti Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.