FDA Approves Ergot-Derivative Nasal Spray to Treat Acute Migraine
By Jessica Pyhtila, PharmD, BCGP, BCPS
The FDA recently approved a dihydroergotamine mesylate nasal spray, to be sold under the brand name Trudhesa, for the treatment of migraine with or without aura in adults. The drug is the newest formulation of this ergot derivative, which was first approved in 1946. Trudhesa joins Migranal as the second brand-name ergot derivative in an intranasal formulation.
Like other ergot derivatives, Trudhesa carries a Black Box Warning against the use of the agent with strong CYP3A4 inhibitors. Coadministration can increase the risk for cerebral and peripheral ischemia secondary to vasospasm. Strong CYP3A4 inhibitors include clarithromycin, ketoconazole, and atazanavir.
The manufacturer recommends that providers order a cardiovascular evaluation for the patient before prescribing the agent.
Trudhesa comes in a single-use spray container. The spray should be assembled and primed by pumping it 4 times. The recommended dose is 1.45 mg, to be administered as a single 0.725 mg spray in each nostril. The dose may be repeated if needed, after at least an hour has elapsed since the previous dose. The patient should not use more than 2 doses (4 total sprays) within 24 hours, or 3 doses (6 total sprays) within 7 days. The spray should be discarded immediately after use.
Trudhesa should be avoided in patients with a history of:
— Present use of a CYP3A4 inhibitor, per the Black Box Warning
— Present pregnancy or breastfeeding
— Uncontrolled hypertension, ischemic heart disease, coronary artery vasospasm, peripheral arterial disease, or status-post vascular surgery
— Sepsis
— Severe hepatic or renal impairment
— Past 24-hour use of other 5-HT1 agonists, such as triptans like rizatriptan (Maxalt)
— Present use of vasoconstrictors like phenylephrine, midodrine, nicotine, or pseudoephedrine
Trudhesa’s most common side effects include rhinitis, nausea, dysgeusia, nasal irritation, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
References:
Food and Drug Administration. “Trudhesa.” September 2021. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213436s000lbl.pdf
