Important Safety Information

WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Trudhesa with strong CYP3A4 inhibitors is contraindicated.

Indication

Trudhesa is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

Trudhesa is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine.

Contraindications

Trudhesa is not recommended in patients with:

• Concomitant use of strong CYP3A4 inhibitors such as protease inhibitors (eg, ritonavir, nelfinavir, or indinavir) and macrolide antibiotics (eg, erythromycin or clarithromycin)
• Ischemic heart disease or coronary artery vasospasm
• Uncontrolled hypertension, known peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
• Hypersensitivity to ergot alkaloids
• Concomitant use of other 5-HT₁ agonists (eg, sumatriptan) or ergotamine-containing or ergot-type medications within 24 hours
• Concomitant use of peripheral and central vasoconstrictors

Warnings and Precautions

Trudhesa may cause:

• Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Trudhesa under medical supervision (including the use of an electrocardiogram)
• Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection
• Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure
• Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Trudhesa should not exceed the dosing guidelines or be used for chronic daily administration
• Medication overuse headache: Detoxification may be necessary
• Preterm labor: Advise pregnant women of the risk
• Local irritation: Local irritation has been reported following administration of Trudhesa

Most Common Adverse Reactions

Most common adverse reactions (incidence >1%) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.

Use in Special Populations

Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Trudhesa use during pregnancy.

Lactation: Patients should not breastfeed during treatment with Trudhesa and for 3 days after the last dose.

Please see the Trudhesa Full Prescribing Information, including Boxed Warning and Medication Guide.

The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at www.trudhesaHCP.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.