Trudhesa

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/29/2021
Trudhesa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Trudhesa?

Trudhesa (dihydroergotamine mesylate) Nasal Spray is an ergotamine derivative used to treat migraine with or without aura in adults.

What Are Side Effects of Trudhesa?

Side effects of Trudhesa include:

Dosage for Trudhesa

The recommended dose of Trudhesa Nasal Spray is 1.45 mg (administered as one metered spray of 0.725 mg into each nostril). The dose may be repeated, if needed, a minimum of 1 hour after the first dose.


Trudhesa In Children

Safety and effectiveness of Trudhesa Nasal Spray is in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Trudhesa?
 

Trudhesa Nasal Spray may interact with other medicines such as:

Tell your doctor all medications and supplements you use.


Trudhesa During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Trudhesa Nasal Spray. it may increase the risk of preterm delivery and may harm a fetus. It is unknown if Trudhesa Nasal Spray passes into breast milk; however, ergotamine, a related drug, is present in breast milk. Because of the potential for reduced milk supply and serious adverse events in the breastfed infant, including diarrhea, vomiting, weak pulse, and unstable blood pressure, breastfeeding is not recommended during treatment with Trudhesa Nasal Spray and for 3 days after the last dose. Breast milk supply during this time should be pumped and discarded.

Additional Information

Our Trudhesa (dihydroergotamine mesylate) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Trudhesa Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, and Fatalities [see WARNINGS AND PRECAUTIONS]
  • Cerebrovascular Adverse Reactions and Fatalities [see WARNINGS AND PRECAUTIONS]
  • Other Vasospasm Related Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]
  • Preterm Labor [see WARNINGS AND PRECAUTIONS]
  • Fibrotic Complications [see WARNINGS AND PRECAUTIONS]
  • Local Irritation [see WARNINGS AND PRECAUTIONS]

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 not reflect the rates observed in practice.

Adverse Reactions In Placebo-Controlled Trials With Dihydroergotamine (DHE) Mesylate Nasal Spray [see Clinical Studies]

Of the 1,796 patients and subjects treated with DHE nasal spray doses 2 mg or less in U.S. and foreign clinical studies, 26 (1.4%) discontinued because of adverse events. The adverse events associated with discontinuation were, in decreasing order of frequency: rhinitis (13), dizziness (2), facial edema (2), and one patient each due to cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paraesthesia.

Table 1 summarizes the incidence rates of adverse reactions reported by at least 1% of patients who received DHE nasal spray for the treatment of migraine during placebo-controlled, doubleblind clinical studies and were more frequent than in those patients receiving placebo. The most commonly reported adverse reactions (greater than 1% of patients who received DHE nasal spray) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. In most instances these events were transient and selflimited and did not result in patient discontinuation from a study.

Table 1 Adverse Reactions Reported by at Least 1% of the DHE Nasal Spray Treated Patients and Occurred more Frequently than in the Placebo-Group in the Migraine Placebo-Controlled Trials

DHE Nasal Spray
N=597
%
Placebo
N=631
%
Respiratory System
  Rhinitis 26 7
  Pharyngitis 3 1
Gastrointestinal System
  Nausea 10 4
  Vomiting 4 1
  Diarrhea 2 <1
Special Senses, Other
  Altered Sense of Taste 8 1
Application Site
  Application Site Reaction 6 2
Central and Peripheral Nervous System
  Dizziness 4 2
  Somnolence 3 2
Body as a Whole, General
  Hot Flashes 1 <1
  Asthenia 1 0
Musculoskeletal System
  Stiffness 1 <1

Adverse Reactions In Studies With Trudhesa

An open-label study in adults (18 to 66 years of age) was conducted to evaluate the safety and tolerability of TRUDHESA, repeated use of TRUDHESA was allowed over the course of 6 to 12 months. A total of 354 patients with migraine received at least one dose of TRUDHESA. One hundred and eighty-five patients treated on average at least two migraines per month for 6 months, and 55 patients treated on average at least two migraines per month for 12 months. Of the patients who received at least one dose of TRUDHESA, 185 (52.3%) patients experienced local irritative symptoms. Of these, the most common local irritative symptoms were nasopharyngitis, rhinitis, nasal discomfort, product taste abnormal/dysgeusia, sinusitis, sinus discomfort, olfactory test abnormal, epistaxis, pharyngitis, nasal mucosal disorder, change in smell, ear discomfort, and rhinorrhea [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of dihydroergotamine mesylate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Vasospasm, paresthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine. Cases of myocardial infarction and stroke have been reported following the use of dihydroergotamine mesylate [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

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]. The use of strong CYP3A4 inhibitors with dihydroergotamine is contraindicated [see CONTRAINDICATIONS]. Administer moderate CYP3A4 inhibitors (e.g., saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, clotrimazole) with caution.

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].

Beta Blockers

There have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.

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].

Nicotine

Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy [see WARNINGS AND PRECAUTIONS].

Selective Serotonin Reuptake Inhibitors

Weakness, hyperreflexia, and incoordination have been reported rarely when 5-HT1 agonists have been coadministered with selective serotonin reuptake inhibitors (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline).

Drug Abuse And Dependence

Controlled Substance

TRUDHESA contains dihydroergotamine (as the mesylate salt), which is not a controlled substance.

Abuse

Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Currently available data have not demonstrated drug abuse with dihydroergotamine. However, cases of drug abuse in patients on other forms of ergot therapy have been reported.

Dependence

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Currently available data have not demonstrated physical or psychological dependence with dihydroergotamine. However, cases of psychological dependence in patients on other forms of ergot therapy have been reported.

Read the entire FDA prescribing information for Trudhesa (Dihydroergotamine Mesylate Nasal Spray )

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© Trudhesa Patient Information is supplied by Cerner Multum, Inc. and Trudhesa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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