Trudhesa 4 mg/mL

Dihydroergotamine mesylate · SPRAY, METERED · Impel Pharmaceuticals LLC

No Recall History

Plain English

Trudhesa is a spray, metered containing dihydroergotamine mesylate at 4 mg/mL, taken nasal. Manufactured by Impel Pharmaceuticals LLC.

Key Facts

Brand Name: Trudhesa
Generic Name: Dihydroergotamine mesylate
NDC Code (Product): 77530-725
Manufacturer: Impel Pharmaceuticals LLC
Strength: 4 mg/mL
Dosage Form: SPRAY, METERED
Route: NASAL
Marketing Status
Application #: NDA213436
Marketing Start: 09/24/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective522 reports

nausea329 reports

off label use319 reports

hyperhidrosis296 reports

nightmare282 reports

sedation282 reports

product use in unapproved indication236 reports

nephrolithiasis193 reports

migraine103 reports

dyspnoea85 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TRUDHESA is indicated for the acute treatment of migraine with or without aura in adults. TRUDHESA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use : TRUDHESA is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine. ( 1 ) Limitations of Use TRUDHESA is not indicated for the preventive treatment of migraine. TRUDHESA is not indicated for the management of hemiplegic or basilar migraine.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dose of TRUDHESA is 1.45 mg (administered as one metered spray of 0.725 mg into each nostril). ( 2.1 ) The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses within a 24-hour period or 3 doses within 7 days. ( 2.1 ) Prior to initiation, a cardiovascular evaluation is recommended. ( 2.2 ) TRUDHESA is for nasal administration only. ( 2.3 ) Assemble and prime (i.e., pumped 4 times) before use. ( 2.3 ) Use TRUDHESA immediately after priming and then discard. ( 2.3 ) 2.1 Dosing Information The recommended dose of TRUDHESA is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril). The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses of TRUDHESA within a 24-hour period or 3 doses within a 7-day period. 2.2 Assessment Prior to First Dose Prior to initiation of TRUDHESA, a cardiovascular evaluation is recommended [see Warnings and Precautions (5.2) ] . For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, it is stro…

Contraindications

4 CONTRAINDICATIONS TRUDHESA is contraindicated in patients: with concomitant use of strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, or indinavir), macrolide antibiotics (e.g., erythromycin or clarithromycin), and antifungals (ketoconazole or itraconazole) [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina [see Warnings and Precautions (5.4) ] with uncontrolled hypertension [see Warnings and Precautions (5.5) ] with peripheral arterial disease with sepsis following vascular surgery with severe hepatic impairment with severe renal impairment with known hypersensitivity to ergot alkaloids with recent use (i.e., within 24 hours) of other 5-HT 1 agonists (e.g., sumatriptan) or ergotamine-containing or ergot-type medications [see Drug Interactions (7.2) ] with concomitant use of peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood …

Drug Interactions

7 DRUG INTERACTIONS Beta Blockers/Nicotine: May potentiate/provoke vasoconstriction ( 7.3 , 7.5 ) Selective Serotonin Reuptake Inhibitors: Weakness, hyperreflexia, and incoordination may occur with coadministration. ( 7.6 ) 7.1 CYP3A4 Inhibitors There have been rare reports of serious adverse events in connection with the coadministration of intravenous administration of dihydroergotamine and strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, indinavir), macrolide antibiotics (e.g., erythromycin, clarithromycin), and antifungals (e.g., ketoconazole, itraconazole), resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities [see Warnings and Precautions (5.1) ] . The use of strong CYP3A4 inhibitors with dihydroergotamine is contraindicated [see Contraindications (4) ] . Administer moderate CYP3A4 inhibitors (e.g., saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, clotrimazole) with caution. 7.2 Triptans Triptans (serotonin [5-HT] 1B/1D receptor agonists) have been reported to cause coronary artery vasospasm, and its effect could be additive with TRUDHESA. Therefore, triptans and TRUD…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors [see Boxed Warning and Warnings and Precautions (5.1) ] Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, and Fatalities [see Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions and Fatalities [see Warnings and Precautions (5.3) ] Other Vasospasm Related Adverse Reactions [see Warnings and Precautions (5.4) ] Increase in Blood Pressure [see Warnings and Precautions (5.5) ] Medication Overuse Headache [see Warnings and Precautions (5.6) ] Preterm Labor [see Warnings and Precautions (5.7) ] Fibrotic Complications [see Warnings and Precautions (5.8) ] Local Irritation [see Warnings and Precautions (5.9) ] Most common adverse reactions (greater than 1%) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Impel NeuroPharma Inc at 1-833-878-3437 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Bec…

Frequently Asked Questions

What is Trudhesa used for?

Trudhesa contains Dihydroergotamine mesylate. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is Trudhesa a controlled substance?

Trudhesa is not classified as a controlled substance by the DEA.

What is the generic name for Trudhesa?

The generic name for Trudhesa is Dihydroergotamine mesylate. There are 11 other brand versions of Dihydroergotamine mesylate.

What is the NDC code for Trudhesa 4 mg/mL?

The NDC (National Drug Code) for Trudhesa 4 mg/mL is 77530-725, listed by Impel Pharmaceuticals LLC.

Product NDC

77530-725

Package NDC

77530-725-00

Other Dihydroergotamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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