Does Ubrelvy affect the liver?
No reports of clinically apparent liver injury were made during clinical development of Ubrelvy (ubrogepant) and none have been made since the drug’s launch in the US in 2019.
Ubrelvy is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist used to treat migraine headaches, which comes in the form of a tablet. Ubrelvy was specifically designed to be less likely to cause the liver toxicity (hepatotoxicity) issues associated with some other small molecule drugs from the same drug class.
No clinically relevant signs of liver toxicity were seen during a safety study that has been conducted to assess the hepatotoxicity of Ubrelvy in patients taking the drug daily or near daily. In addition, only 1-2 percent of the patients who took part in the clinical trials of the drug had mild-to-moderate serum aminotransferase elevations, which was consistent with the results seen in patients who received a placebo. Serum aminotransferase levels were measured to check for signs of drug-induced liver injury.
Can I take Ubrelvy if I have liver impairment?
Ubrelvy is metabolized by the liver, so exposure to the drug is increased by liver (hepatic) impairment. No dose adjustment is required for patients with mild to moderate liver impairment, but patients with severe liver impairment (Child-Pugh Class C) are recommended to take Ubrelvy 50mg for their initial dose and another 50mg second dose if required at least 2 hours later.
In patients without severe liver impairment, the recommended dose is 50-100mg initially. A second dose of 50-100mg may be taken at least 2 hours after the first dose if required. The maximum 24-hour dose for people without severe liver impairment is 200mg. It is not known if it is safe to use Ubrelvy to treat more than 8 migraines in 30 days.
References
- Smith B, Rowe J, Watkins PB, et al. Mechanistic Investigations Support Liver Safety of Ubrogepant. Toxicol Sci. 2020;177(1):84-93. doi:10.1093/toxsci/kfaa093.
- Goadsby PJ, Tepper SJ, Watkins PB, et al. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults. Cephalalgia. 2019;39(14):1753-1761. doi:10.1177/0333102419869918.
- LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Ubrogepant. [Updated 2021 Jul 20]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK572431/.
- Food and Drug Administration (FDA). Ubrelvy. [Accessed October 11, 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf.
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Drug information
- Ubrelvy Information for Consumers
- Ubrelvy prescribing info & package insert (for Health Professionals)
- Side Effects of Ubrelvy (detailed)