Vyepti
Pronunciation: vye ep' tee
Generic name: eptinezumab-jjmr
Dosage form: injection single-dose vial (100 mg/mL)
Drug class: CGRP inhibitors
What is Vyepti?
Vyepti (eptinezumab-jjmr) is used to prevent migraines and is given as an IV infusion every 3 months (four times a year). Vyepti infusion helps reduce monthly migraine days for chronic migraines and episodic migraines in adults so that you may have more migraine-free days.
Vyepti 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, Vyepti reduces monthly migraine days.
Vyetpi infusion received FDA approval on February 22, 2020.
Vyepti side effects
The most common Vyepti side effects are stuffy nose, scratchy throat, and allergic reactions.
Serious Vyepti side effects are 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
These are not all of the possible side effects of Vyepti 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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Who should not receive Vyepti?
Before using this medicine, tell your healthcare professional about all of your medical conditions.
You should not receive Vyepti infusion if you are allergic to the active ingredient eptinezumab-jjmr or any of the ingredients in Vyepti. 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 Vyepti infusion will harm your unborn baby.
There is a pregnancy registry for women who take Vyepti. The purpose of this registry is to collect information about your 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 Vyepti?
- Vyepti is given by intravenous (IV) infusion in your vein by a healthcare provider in a healthcare setting.
- Vyepti infusions take approximately 30 minutes and are given every 3 months.
If you have questions about your infusion schedule, ask your healthcare provider.
Vyepti Dosage Information
The recommended Vyepti dosage is 100mg IV infusion every 3 months. Some patients may benefit from a 300 mg intravenous infusion every 3 months.
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 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.
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.
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
Vyepti 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 Vyepti.
Vyepti (eptinezumab-jjmr) - Lundbeck Seattle BioPharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/mL |
Popular FAQ
How long does it take Vyepti to work?
Vyepti can work as quickly as the first day or week after your first infusion to help prevent your migraine headache pain. Continue reading
Does Vyepti cause weight gain?
No, weight gain was not seen in safety studies of Vyepti lasting up to one year long. In general, Vyepti is well tolerated, with less than 2% of patients dropping out of clinical studies due to side effects. Continue reading
Can Vyepti cause fatigue?
No, Vyepti has not been shown to cause fatigue in clinical studies conducted by the manufacturer. Unusual tiredness or weakness may occur if you have an allergic reaction to Vyepti. Tell your doctor right away if you have these side effects during after Vyepti infusion. Continue reading
How long do Vyepti infusions take?
Vyepti intravenous (IV) infusions take about 30 minutes and are given 4 times per year (every 3 months). You will receive the infusion at your doctor’s office or at a special infusion center, and the total time spent there may be longer than 30 minutes. Continue reading
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.