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