Is Eptinezumab approved by the FDA?
Yes, Eptinezumab, marketed under the brand name Vyepti, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Eptinezumab on February 21, 2020. This approval provides a new option for the preventative treatment of migraine in adults, offering an intravenous solution for those who suffer from frequent migraine attacks.
What is Eptinezumab?
Eptinezumab is a medication used to prevent migraine headaches in adults. It belongs to a class of drugs known as CGRP (calcitonin gene-related peptide) inhibitors, which work by targeting and inhibiting the activity of CGRP, a molecule involved in migraine attacks.
Key Points:
- Brand Name: Vyepti
- Dosage Form: Intravenous solution (100 mg/mL)
- Administration: Given as an infusion into a vein by a healthcare provider, typically once every three months.
Usage and Administration
Eptinezumab is administered as an intravenous (IV) infusion. The initial dose is usually 100 mg, and it can be increased to 300 mg depending on the patient's response and healthcare provider's recommendation. The infusion process takes at least 30 minutes to complete and is performed once every three months.
Dosing Information:
- Initial Dose: 100 mg IV infusion every three months
- Maintenance Dose: 100 mg or 300 mg IV infusion every three months, based on patient needs
Side Effects
Common side effects of Eptinezumab include:
- Stuffy nose
- Throat irritation
- Allergic reactions such as rash, hives, and redness or swelling of the face, lips, tongue, or throat
Severe side effects may occur during the injection, such as feeling warm, itchy, or light-headed. Immediate medical help is necessary if any signs of a severe allergic reaction occur.
Warnings and Precautions
Before starting treatment with Eptinezumab, patients should inform their doctor about any medical conditions or allergies they have, as well as all medications they are currently taking. This is crucial to avoid potential drug interactions and ensure the safety and efficacy of the treatment.
Contraindications:
- Allergy to Eptinezumab, polysorbate 80, or sorbitol
Conclusion
Eptinezumab (Vyepti) is an FDA-approved medication for the preventative treatment of migraines in adults, providing an effective option for those seeking to reduce the frequency and severity of migraine attacks. Approved on February 21, 2020, Eptinezumab is administered via IV infusion every three months, offering a promising treatment for chronic migraine sufferers.
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