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Eptinezumab-jjmr

Class: Calcitonin Gene-related Peptide (CGRP) Antagonists
Brands: Vyepti

Medically reviewed by Drugs.com. Last updated on March 16, 2020.

Introduction

Eptinezumab-jjmr is a calcitonin gene-related peptide (CGRP) antagonist.

Uses for Eptinezumab-jjmr

Eptinezumab-jjmr has the following uses:

Eptinezumab-jjmr is indicated for the preventive treatment of migraine in adults.1

Eptinezumab-jjmr Dosage and Administration

General

Eptinezumab-jjmr is available in the following dosage form(s) and strength(s):

Injection: 100 mg/mL solution in a single-dose vial.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration
  • Must dilute before use. For intravenous infusion only.1

  • 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.1

  • Dilute only in 100 mL of 0.9% sodium chloride injection, USP.1

Cautions for Eptinezumab-jjmr

Contraindications

Eptinezumab-jjmr is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients.1

Warnings/Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with eptinezumab-jjmr in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. If a hypersensitivity reaction occurs, consider discontinuing eptinezumab-jjmr, and institute appropriate therapy. 1

Specific Populations

Pregnancy

Risk Summary: There are no adequate data on developmental risks associated with the use of eptinezumab-jjmr in pregnant women.1

No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically.1

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.1

Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.1

Animal Data: When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (MRHD) of 300 mg, on a body weight basis (mg/kg).1

When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. The higher dose tested (150 mg/kg) is 30 times the MRHD, on a mg/kg basis.1

Lactation

Risk Summary: There are no data on the presence of eptinezumab-jjmr 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 eptinezumab-jjmr and any potential adverse effects on the breastfed infant from eptinezumab-jjmr or from the underlying maternal condition.1

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.1

Geriatric Use

Clinical studies of eptinezumab-jjmr did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.1

Common Adverse Effects

The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Eptinezumab-jjmr is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.1

Advice to Patients

Advise the patient to read the FDA-approved patient labeling.1

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, can occur. Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur.1

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant.1

Lactation

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed.1

Additional Information

AHFSfirstRelease. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Eptinezumab-jjmr

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Concentrate, for injection, for IV infusion

100 mg /1 mL

Vyepti

Lundbeck Pharmaceuticals LLC

AHFS Drug Information. © Copyright 2021, Selected Revisions March 16, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Lundbeck Pharmaceuticals LLC. Vyepti (eptinezumab-jjmr) INTRAVENOUS prescribing information. 2020 Feb. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79065861-6aa5-4d1f-829f-3a6471286b36

Frequently asked questions