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.
What side effects do I expect to see with Vyepti?
Safety studies included over 2,000 adult patients receiving either the 100 or 300 mg dose of Vyepti for migraine prevention.
The most common side effects were common cold symptoms like stuffy nose and scratchy throat (6% to 8% of patients taking Vyepti vs. 6% placebo) and allergic (hypersensitivity) reactions (1% to 2% of patients taking Vyepti vs. 0% placebo).
Some allergic reactions, such as anaphylaxis, may be serious. If you have symptoms of an allergic reaction, contact your doctor or emergency medical care right away. These symptoms can include:
- rash
- swelling of your face, lips, tongue or throat
- problems breathing
- hives
- redness (flushing) of your face
How is Vyepti given?
The recommended dose is 100 mg intravenously (IV) given every 3 months. Some patients may benefit from a higher dose of 300 mg. The infusion takes about 30 minutes and is only given by your healthcare provider.
Vyepti (eptinezumab-jjmr) is the first FDA-approved IV treatment for migraine prevention in adults.
How well does Vyepti work to prevent migraine?
In two Phase 3 clinical studies of Vyepti (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), researchers were looking to see how many fewer days of migraine headaches patients had over a 12-week period. At the start of the study, on average, patients had 8.6 migraine days per month.
- In the episodic migraine study, the number of mean monthly migraines dropped by 3.9 days for the 100 mg dose and by 4.3 days for the 300 mg dose, compared to 3.2 fewer days in the placebo group.
- In the chronic migraine study, the number of mean monthly migraines dropped by 7.7 days for the 100 mg dose and by 8.2 days for the 300 mg dose, compared to 5.6 fewer days in the placebo group.
Vyepti also exhibited a benefit over placebo for both the 100 and 300 mg doses of Vyepti as early as the first day after treatment. The percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days.
Vyepti is classified as a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Related: List of CGRP migraine medications