Vyepti

Generic name: eptinezumab-jjmr (injection, for intravenous use)
Drug class: CGRP inhibitors

Medically reviewed by  A Ras MD.

What is Vyepti?

Vyepti is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if Vyepti is safe and effective in children.

Description

Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in Pichia pastoris yeast cells by recombinant DNA technology.

VYEPTI (eptinezumab-jjmr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to brownish-yellow solution, for intravenous infusion. VYEPTI is supplied as a 100 mg/mL single-dose vial. Each mL contains 100 mg eptinezumab-jjmr formulated in L-histidine (1 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 80 (0.15 mg), sorbitol (40.5 mg), and Water for Injection, USP, at a pH of 5.8.

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.

Who should not usee Vyepti?

Do not receive Vyepti if you are allergic to eptinezumab-jjmr or any of the ingredients in Vyepti. See the end of this Patient Information guide for a complete list of ingredients in Vyepti.

What should I tell my healthcare provider before using Vyepti?

Before you receive Vyepti, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Vyepti will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Vyepti passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Vyepti.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Vyepti?

• Vyepti will be given by a healthcare provider in a healthcare setting.
• Vyepti is given by intravenous (IV) infusion in your vein.
• Vyepti will be given over 30 minutes every 3 months.

If you have questions about your infusion schedule, ask your healthcare provider.

What are the possible side effects of Vyepti?

Vyepti may cause serious side effects, including:

• Allergic reactions. Allergic reactions can happen after receiving Vyepti. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:
  • rash
  • swelling of your face, lips, tongue or throat
  • trouble breathing
  • hives
  • redness in your face

The most common side effects of Vyepti include:

• stuffy nose and scratchy throat
• allergic reactions

These are not all of the possible side effects of Vyepti.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Vyepti

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information guide.

You can ask your pharmacist or healthcare provider for information about Vyepti that is written for health professionals.

What are the ingredients in Vyepti?

Active ingredient: eptinezumab-jjmr

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.

The vial stopper is not made with natural rubber latex.

Label

PRINCIPAL DISPLAY PANEL

• NDC 67386-130-51
• VYEPTITM (vye ep’ tee)
• (eptinezumab-jjmr)
• injection, for intravenous use
• 100 mg/mL

SRC: NLM .