Eptinezumab
Brand name: Vyepti (vye ep' tee)
Dosage form: injection for infusion
Drug class: CGRP inhibitors
What is eptinezumab?
Eptinezumab (Vyepti) is a prescription medicine used for migraine prevention, to reduce monthly migraine days for chronic migraines and episodic migraines in adults. Eptinezumab is given as an IV infusion every 3 months (four times a year).
Eptinezumab is from a class of medicines called calcitonin gene-related peptide antagonists.
Eptinezumab infusion works by blocking a protein called calcitonin gene-related peptide (CGRP), which is involved in migraines. CGRP levels increase during a migraine attack and may also be involved in the start of a migraine. It is thought that by blocking CGRP, eptinezumab reduces monthly migraine days.
Eptinezumab brand name is Vyepti, by Lundbeck Seattle BioPharmaceuticals.
Eptinezumab-jjmr infusion received FDA approval on February 22, 2020.
Eptinezumab side effects
The most common eptinezumab side effects are a stuffy nose, scratchy throat, and allergic reactions.
Serious eptinezumab side effects are allergic reactions. Allergic reactions can happen after receiving this medicine. 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
These are not all of the possible side effects of eptinezumab infusion. Ask your pharmacist or healthcare provider for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking this medicine
Before using this medicine, tell your healthcare professional about all of your medical conditions, especially if you have:
- high blood pressure
- circulation problems in your fingers and toes
You should not receive this infusion if you are allergic to the active ingredient eptinezumab-jjmr or any of the ingredients in this infusion. See the end of this page for a complete list of ingredients.
Pregnancy
Tell your healthcare provider if you are pregnant, plan to become pregnant, or become pregnant, as it is not known if eptinezumab infusion will harm your unborn baby.
There is a pregnancy registry for women who take this medicine. The purpose of this registry is to collect information about you and your baby's health. You may enroll yourself by calling 1-855-810-8549 or talk to your healthcare provider about how you can participate in this registry.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Vyepti passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while using this medicine.
How will I receive eptinezumab?
Eptinezumab is given by intravenous (IV) infusion into your vein by a healthcare provider in a healthcare setting.
Infusions take approximately 30 minutes and are given every 3 months.
If you have questions about your infusion schedule, ask your healthcare provider.
Eptinezumab dosage information
The recommended eptinezumab dosage is 100mg IV infusion every 3 months. Some patients may benefit from a 300 mg intravenous infusion every 3 months.
Dilution Instructions
Eptinezumab 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 the unused portion remaining in the vial.
Vyepti is available as: 100 mg/mL solution in a single-dose vial, which needs to be diluted.
Dilution for 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.
Dilution for 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. During this time, solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze.
Ingredients
Active ingredient: eptinezumab-jjmr
Vyepti 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.
Storage
Store a single-dose vial at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze or shake.
Store diluted solution at 0°C to 25°C (68°F to 77°F). Do not freeze. Diluted solution must be infused within 8 hours
Company
Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc., 11804 North Creek Parkway South, Bothell, WA 98011
Eptinezumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for eptinezumab.
Vyepti (eptinezumab-jjmr) - Lundbeck Seattle BioPharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/mL |
View Vyepti information in detail.
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.