trudhesa
Trudhesa (Dihydroergotamine Mesylate) is an ergotamine derivative used to treat Cluster Headache, Postpartum Hemorrhage, Orthostatic Hypotension, Migraine Disorders.
Dihydroergotamine Mesylate · by Impel Pharms
Available as a generic: Dihydroergotamine Mesylate
Key facts
- Active ingredient
- Dihydroergotamine Mesylate
- Drug class
- Ergotamine Derivative
- Form
- Spray/Inhaler, metered
- Strength
- Dihydroergotamine Mesylate 0.725MG/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Impel Pharms
- Half-life
- about 9 to 13 hours, depending on the form (how long it stays in your system)
- What the pharmacy pays
- ~$34.84 per ml — not your price
- FDA application
- NDA213436
- FDA boxed warning
- Yes — see the boxed warning
What is Trudhesa?
From the FDA label:TRUDHESA (dihydroergotamine mesylate) nasal spray is a single-dose, drug-device combination product containing a dihydroergotamine mesylate drug constituent and a nasal spray device constituent. The chemical name for dihydroergotamine mesylate is ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethanesulfonate. Its molecular weight is 679.78, and its molecular formula is C 33 H 37 N 5 O 5 ∙CH 4 O 3 S. The chemical structure is: Dihydroergotamine mesylate The drug constituent is a dihydroergotamine mesylate solution. Each milliliter (mL) of solution contains dihydroergotamine mesylate 4.0 mg (equivalent to 3.43 mg dihydroergotamine), and the following inactive ingredients: caffeine (10.0 mg), carbon dioxide (q.s.), dextrose (50.0 mg), and water (q.s. to 1.0 mL). TRUDHESA nasal spray, after assembly and priming, delivers 0.725 mg dihydroergotamine mesylate per spray. A total dose of 1.45 mg of dihydroergotamine mesylate is delivered in 2 sprays. The nasal spray device contains hydrofluoroalkane-134a (HFA) propellant. Chemical Structure
How to use
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 strongly recommended that administration of the first dose of TRUDHESA take place in the setting of an equipped healthcare facility. 2.3 Important Administration Instructions TRUDHESA is for nasal administration only and must not…
Side effects
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 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ]. WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS See full prescribing information for complete boxed warning. 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. ( 4 , 5.1 , 7.1 )
Warnings
Important safety information
Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities: In patients with risk factors, consider 1 st dose administration under medical supervision with electrocardiogram. ( 2.2 , 5.2 ) Cerebrovascular Adverse Reactions and Fatalities: Cerebral hemorrhage, subarachnoid hemorrhage and stroke have been reported; discontinue TRUDHESA if suspected. ( 5.3 ) Other Vasospasm Related Adverse Reactions: TRUDHESA may cause vasospasm or elevation in blood pressure. Discontinue if signs or symptoms of vasoconstriction develop. ( 5.4 , 5.5 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.6 ) Preterm Labor: Advise pregnant women of the risk. ( 5.7 , 8.1 ) Fibrotic Complications: Pleural and retroperitoneal fibrosis 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. ( 5.8 ) Local Irritation: If severe local irritation occurs for no other attributable reasons, suspend TRUDHESA until resolution. ( 5.9 ) 5.1 Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors, including protease inhibitors, macrolide antibiotics, and antifungals. 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 [see Contraindications (4) and Drug Interactions (7.1) ] . 5.2 Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities The potential for adverse cardiac adverse reactions exists with TRUDHESA treatment. Serious adverse cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine mesylate. These events have included acute myocardial infarction, life-threatening disturbances of cardiac rhythm (e.g., ventricular tachycardia and ventricular fibrillation), coronary artery vasospasm, and transient myocardial ischemia. Prior to initiation of TRUDHESA, a cardiovascular evaluation is recommended to determine if the patient is free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. If, during the cardiovascular evaluation, the patient's medical history (including risk factors), or electrocardiographic investigation, findings are consistent with coronary artery vasospasm or myocardial ischemia, TRUDHESA should not be administered [see Contraindications (4) ] . For patients with risk factors predictive of coronary artery disease (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of TRUDHESA take place in the setting of an equipped healthcare facility, unless the patient has previously received dihydroergotamine mesylate. During the interval immediately following the first use of TRUDHESA, an electrocardiogram is recommended in those patients with risk factors because ischemia can occur in the absence of clinical symptoms. 5.3 Cerebrovascular Adverse Reactions and Fatalities The potential for adverse cerebrovascular adverse reactions exists with TRUDHESA treatment. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with dihydroergotamine mesylate; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the dihydroergotamine mesylate having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). Discontinue TRUDHESA if a cerebrovascular event is suspected. 5.4 Other Vasospasm Related Adverse Reactions TRUDHESA, like other ergot alkaloids, may cause vasospastic reactions other than coronary artery vasospasm. Myocardial, peripheral vascular, and colonic ischemia have been reported with dihydroergotamine mesylate. Dihydroergotamine mesylate associated vasospastic phenomena may also cause muscle pains, numbness, coldness, pallor, and cyanosis of the digits. In patients with compromised circulation, persistent vasospasm may result in gangrene or death. TRUDHESA should be discontinued immediately if signs or symptoms of vasoconstriction develop. Patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud's syndrome, following the use of any 5-HT agonist, including TRUDHESA, should be evaluated by a healthcare provider. 5.5 Increase in Blood Pressure Significant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with dihydroergotamine mesylate. TRUDHESA is contraindicated in patients with uncontrolled hypertension [see Contraindications (4) ] . An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT 1 agonist in a study evaluating subjects undergoing cardiac catheterization. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Preterm Labor Based on the mechanism of action of dihydroergotamine and findings from the published literature, TRUDHESA may cause preterm labor. Avoid use of TRUDHESA during pregnancy [see Use in Specific Populations (8.1) ]. 5.8 Fibrotic Complications The potential for fibrotic complications exists with TRUDHESA treatment. There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs has been associated with cardiac valvular fibrosis. Rare cases have also been reported in association with the use of dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with cardiac valvular fibrosis. Administration of TRUDHESA should not exceed the dosing guidelines and should not be used for chronic daily administration [see Dosage and Administration (2.1) ]. 5.9 Local Irritation Local irritative symptoms were reported in 52% of patients treated with at least one dose of TRUDHESA in an open-labeled trial, which allowed repeated use of TRUDHESA over 6 to 12 months. The most common local irritative symptoms (at least 1% of patients) were nasopharyngitis (21%), rhinitis (19%), nasal discomfort (7%), product taste abnormal/dysgeusia (6%), sinusitis (5%), sinus discomfort (4%), olfactory test abnormal [defined based on a change in score at a prespecified threshold on the University of Pennsylvania Smell Identification Test (UPSIT)] (4%), epistaxis (3%), pharyngitis (3%), nasal mucosal disorder (2%), change in smell (1%), ear discomfort (1%), and rhinorrhea (1%). If a severe local irritation event occurs for no other attributable reasons, TRUDHESA should be temporarily suspended until the event…
Who should not take Trudhesa
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 pressure [see Warnings and Precautions (5.5) ] Concomitant use of strong CYP3A4 inhibitors ( 4 ) Patients with ischemic heart disease or coronary artery vasospasm ( 4 ) Patients with uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment ( 4 ) Patients with hypersensitivity to ergot alkaloids ( 4 ) Concomitant use of other 5-HT 1 agonists (e.g., sumatriptan) or ergotamine-containing or ergot-type medications within 24 hours ( 4 ) Concomitant use of peripheral and central vasoconstrictors ( 4 )
Overdose — what happens if you take too much
10.1 Symptoms Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. In general, the symptoms of an acute TRUDHESA overdose are similar to those of an ergotamine overdose, although there may be less pronounced nausea and vomiting with TRUDHESA. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain. In laboratory animals, dihydroergotamine was lethal when given at intravenous doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits. 10.2 Treatment Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage. Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 TRUDHESA should not be taken within 24 hours of each other [see Contraindications (4) ] . 7.3 Beta Blockers There have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. 7.4 Vasoconstrictors TRUDHESA is contraindicated for use with peripheral and central vasoconstrictors because the combination may cause synergistic elevation of blood pressure [see Warnings and Precautions (5.5) ] . 7.5 Nicotine Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy [see Warnings and Precautions (5.1 , 5.5) ] . 7.6 Selective Serotonin Reuptake Inhibitors Weakness, hyperreflexia, and incoordination have been reported rarely when 5-HT 1 agonists have been coadministered with selective serotonin reuptake inhibitors (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline).
How long does Dihydroergotamine Mesylate stay in your body?
The elimination half-life of dihydroergotamine mesylate is about 9 to 13 hours, depending on the form — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The injection label states a terminal half-life of about 9 hours after intramuscular or intravenous dosing, with a multi-exponential decline. Nasal forms read slightly longer because absorption is slower: the nasal spray label gives about 10 hours (biphasic decline) and the Atzumi nasal powder label gives an apparent half-life of about 13 hours. The major metabolite, 8'-beta-hydroxydihydroergotamine, binds adrenergic and 5-HT receptors as strongly as the parent drug and is equally potent at constricting veins, so its effects can outlast what the parent's half-life suggests — but the label explicitly says its pharmacokinetics have not been quantified, so no metabolite half-life exists in the labeling. No studies have been done on how kidney or liver impairment, age, sex, or race change these numbers; the drug is contraindicated outright in severe hepatic or renal impairment. Clearance is 1.5 L/min and mainly hepatic (excreted in bile and feces; only 6-7% of unchanged drug appears in urine), so liver disease and CYP3A4 inhibitors such as ritonavir, clarithromycin, and erythromycin are the real-world drivers of accumulation. There is no extended-release dihydroergotamine.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Dihydroergotamine Mesylate Injection, USP — FDA label, Clinical Pharmacology (DailyMed).
Drug class
May treat (source: NIH RxClass)
See how Trudhesa ranks — best-rated ergotamine derivative for:
Dosage forms
Spray/Inhaler, metered
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Trudhesa treat?
- Trudhesa (Dihydroergotamine Mesylate) may be used to treat cluster headache, postpartum hemorrhage, orthostatic hypotension, migraine disorders, xerostomia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Trudhesa cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $34.84 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Trudhesa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Trudhesa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Trudhesa?
- Trudhesa is marketed by Impel Pharms. You can see Impel Pharms's full profile, rating, and other products on pharmaranks.
- Is Trudhesa a brand-name or generic drug?
- Trudhesa is a brand-name product with the active ingredient Dihydroergotamine Mesylate. Lower-cost generic equivalents containing Dihydroergotamine Mesylate are available — ask your pharmacist.
- Is Trudhesa available over the counter?
- No. Trudhesa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Trudhesa come in?
- Trudhesa is currently marketed as spray/inhaler, metered, per the FDA's National Drug Code Directory.
- What class of drug is Trudhesa?
- Trudhesa is classified as ergotamine derivative, per the FDA's Established Pharmacologic Class.
- Is Trudhesa FDA-registered?
- Trudhesa is on record with the U.S. FDA under application number NDA213436. You can verify this on its official FDA label.
- Is Trudhesa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Trudhesa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Trudhesa?
- Trudhesa's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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