Migraine and headache:

Indications for: TRUDHESA

Acute treatment of migraine with or without aura.

Limitations of Use:

Not for the preventative treatment of migraine. Not for the management of hemiplegic or basilar migraine.

Adult Dosage:

2 sprays into the nose (1 spray of 0.725mg in each nostril), may repeat at least 1hr later if needed; max 2 doses (4 sprays) within 24hrs or 3 doses (6 sprays) within 7 days.

Children Dosage:

Not established.

TRUDHESA Contraindications:

Ischemic heart disease. Coronary artery vasospasm (eg, Prinzmetal's angina). Uncontrolled hypertension. Peripheral artery disease. Sepsis. Post-vascular surgery. Severe hepatic or renal impairment. Concomitant strong CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, itraconazole) or other vasoconstrictors. Within 24 hours of other ergot-type drugs or 5-HT1 agonists (eg, sumatriptan).

Boxed Warning:

Peripheral ischemia following coadministration with strong CYP3A4 inhibitors.

TRUDHESA Warnings/Precautions:

Increased risk of serious peripheral ischemia with concomitant strong CYP3A4 inhibitors. Perform cardiovascular evaluation prior to initiation. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with risk factors of coronary artery disease (eg, postmenopausal women, men over age 40, hypercholesterolemia, hypertension, obesity, diabetes, smokers, strong family history). Cerebrovascular events (eg, stroke, hemorrhage, transient ischemic attack). Compromised circulation. Withhold therapy if severe local irritation event occurs; permanently discontinue if the event does not resolve or recurs with re-challenge. Elderly. Pregnancy: may cause preterm labor; avoid. Nursing mothers: not recommended (during and for 3 days after the last dose).

TRUDHESA Classification:

Ergot alkaloid.

TRUDHESA Interactions:

Other ergots, 5-HT1 agonists, strong CYP3A4 inhibitors, other vasoconstrictors: see Contraindications. Potentiated by moderate CYP3A4 inhibitors (eg, saquinavir, nefazodone, fluconazole, fluoxetine, fluvoxamine, grapefruit juice, zileuton, clotrimazole); use caution. May be potentiated by propranolol, nicotine. Rarely: may cause weakness, hyperreflexia, and incoordination with concomitant SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline).

Adverse Reactions:

Rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, diarrhea; myocardial and peripheral ischemia, vasoconstriction, local irritation; rare: fibrotic complications.

Generic Drug Availability:


How Supplied:

Nasal spray—4 single-dose units (vial + device)