Is Ubrogepant approved by the FDA?
Yes, Ubrogepant, marketed under the brand name Ubrelvy, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Ubrogepant on December 23, 2019. This medication is used for the acute treatment of migraine attacks with or without aura in adults.
What is Ubrogepant?
Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It is specifically designed to treat migraine headaches once they start but is not used to prevent migraines. It works by blocking the CGRP protein, which is involved in migraine pathophysiology, thereby reducing pain and other migraine symptoms such as nausea, light sensitivity, and sound sensitivity.
Uses of Ubrogepant
Ubrogepant is prescribed for the acute treatment of migraine attacks in adults. It can be taken with or without food, and most patients can take a second dose two hours after the first if needed. However, it is not intended for the preventive treatment of migraine headaches.
Who Should Not Take Ubrogepant?
Patients should avoid Ubrogepant if they are taking strong CYP3A4 inhibitors, such as:
- Ketoconazole
- Clarithromycin
- Itraconazole
Patients should consult their healthcare provider to ensure it is safe to take Ubrogepant with their current medications.
Precautions and Interactions
Before taking Ubrogepant, patients should inform their healthcare provider about any existing medical conditions, especially liver or kidney problems. It is also crucial to discuss any other medications being taken, including prescription, over-the-counter drugs, vitamins, and herbal supplements, as several medications can interact with Ubrogepant.
Side Effects of Ubrogepant
Common side effects include:
- Nausea
- Sleepiness
More severe side effects should be reported to a healthcare provider immediately. Patients may also report side effects to the FDA at 1-800-FDA-1088.
Pregnancy and Breastfeeding
The effects of Ubrogepant on pregnant women and breastfeeding mothers are not well established. Women who are pregnant, planning to become pregnant, or breastfeeding should consult their healthcare provider before starting Ubrogepant.
Storage
Ubrogepant should be stored at room temperature between 68ºF to 77ºF (20ºC to 25ºC) and kept out of reach of children.
Conclusion
Ubrogepant (Ubrelvy) is an FDA-approved medication effective for the acute treatment of migraines in adults. Approved on December 23, 2019, it offers relief from migraine symptoms but is not intended for migraine prevention. Patients should discuss their full medical history and current medications with their healthcare provider to ensure safe use.
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