Words 'Frequently asked questions'
Close up partial product image of Trudhesa® Precision Olfactory Delivery (POD®)
What is Trudhesa®?

Trudhesa is a prescription medicine used for the acute treatment of migraine with or without aura in adults.

  • Trudhesa is not used to prevent migraine
  • Trudhesa is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines

It is not known if Trudhesa is safe and effective in children.

Is Trudhesa right for me?

Trudhesa might be right for you if:

  • You have rapid-onset migraine attacks
  • Your migraine attacks come back within 24 hours after taking medication
  • You have nausea, vomiting, or other GI-related issues, during or in between migraine attacks
  • You need relief that starts quickly and lasts for days, time after time

If any of these apply, ask your HCP if Trudhesa may be right for you.

If you’re interested in Trudhesa and want your HCP to know more about it, download Trudhesa 101 for your HCP.

How does Trudhesa work?

Trudhesa is a unique combination of proven medication and one-of-a-kind delivery for pain freedom that can start quickly and last for days, time after time. The medication in Trudhesa is called DHE or dihydroergotamine mesylate, and it’s been used for years by specialists to work when nothing else will. Trudhesa and its Precision Olfactory Delivery (POD®) is designed to gently and consistently deliver the right amount of medication to the upper nasal space. This area of the nose is rich in blood vessels so medication can be quickly absorbed into your circulation.

If I’m taking preventive medication for migraine (such as anti-CGRP medications), can I also take Trudhesa for breakthrough migraine attacks?

Before taking Trudhesa in conjunction with any other medication, be sure to consult with your HCP as to whether or not they can be taken together.

What kind of results can I expect with Trudhesa?

If you’re like many people in the Trudhesa study, you may be pain free within 2 hours (some experienced relief in as little as 15 minutes) and remain pain free for as long as 2 days. All with a single dose. Trudhesa was also shown to provide reliable relief. And to work whether it’s taken early in a migraine attack or several hours into one.

*Exploratory efficacy outcomes are based on patient reports and post hoc analyses from a phase 3, open-label safety study of Trudhesa.
How quickly does Trudhesa work?

In the Trudhesa study, many people reported getting freedom from migraine symptoms such as pain or their most bothersome symptom within 2 hours, while some reported getting relief in as soon as 15 minutes.

*Exploratory efficacy outcomes are based on patient reports and post hoc analyses from a phase 3, open-label safety study of Trudhesa.
How do I take Trudhesa?

POD is designed to do the work for you. Before using Trudhesa, download the Instructions for use. Please also watch the "Be Direct" video, which takes you through the process.

For complete dosing and administration information, please see the Trudhesa Medication Guide.

What should I tell my healthcare provider (HCP) before using Trudhesa?

Before using Trudhesa, tell your HCP if you are pregnant, nursing, or plan to become pregnant. Be sure to tell your doctor about any medications you take as certain medicines may be contraindicated, which means they should not be taken together with Trudhesa. Especially tell your HCP if you take:

  • sumatriptan
  • fluconazole
  • propranolol or other medicines that can lower your heart rate
  • ergot-type medicine
  • grapefruit juice
  • any medicines that can increase your blood pressure
  • saquinavir
  • zileuton
  • selective serotonin reuptake inhibitors
  • nefazodone
  • nicotine

These are not all of the medicines that could affect how Trudhesa works. Your HCP can tell you if it is safe to take Trudhesa with other medicines.

For a complete list of information you should tell your HCP before using Trudhesa, please see the Trudhesa Medication Guide.

What is the medication in Trudhesa?

The medication in Trudhesa is called dihydroergotamine mesylate or DHE. It has been used for over 70 years by specialists for how quickly it works, how long it works, and how reliably it relieves migraine attacks.

What are the most common side effects of Trudhesa?

The most common side effects of Trudhesa include:

  • runny nose
  • nausea
  • abnormal taste
  • application site reactions
  • dizziness
  • vomiting
  • sleepiness
  • sore throat
  • diarrhea

These are not all the possible side effects Trudhesa.
Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What medicines may be harmful if taken together with Trudhesa?

Do not take Trudhesa with strong CYP3A4 inhibitors.

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.

Tell your HCP about all the medications you are taking.

Do not take Trudhesa if you have taken any of the following medicines in the last 24 hours: sumatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamine, or ergotamine-type medicines.

For a complete list of medications that may be harmful if taken together with Trudhesa, please refer to the Medication Guide.

Are there certain health conditions when taking Trudhesa would not be advised?

Before you take Trudhesa, tell your HCP about all of your medical conditions, including if you:

  • have high blood pressure
  • have liver problems
  • have kidney problems
  • smoke
  • are pregnant or plan to become pregnant. You should not take Trudhesa if you are pregnant. Trudhesa may cause preterm labor. Trudhesa is not recommended during pregnancy. Talk to your HCP right away if you are pregnant or want to become pregnant
  • are breastfeeding or plan to breastfeed. Trudhesa may reduce breast milk supply and pass into your breast milk. Trudhesa may be harmful to your baby. Do not breastfeed your baby while taking Trudhesa and for 3 days after you use Trudhesa. Talk with your HCP about the best way to feed your baby if you take Trudhesa

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP will decide if you can take Trudhesa with your other medicines.

How can I save on Trudhesa?

If you have commercial insurance, you will be automatically enrolled in the Trudhesa Direct Savings Program and will receive Trudhesa for as little as $0 per prescription.* Copay savings will be automatically applied, starting with the very first prescription, without the need to carry a copay card.

*If you have commercial medical insurance, your first prescription is guaranteed for $0 per prescription.

Can I take Trudhesa if I’m pregnant or nursing?

Do not use Trudhesa if you are pregnant, nursing, or plan to become pregnant.

How can I get Trudhesa?

Trudhesa needs to be prescribed by your HCP. Many headache specialists, neurologists, and primary care physicians will be familiar with Trudhesa. If not, however, you can download Trudhesa 101 for your HCP. It details all the vital information they need to know about Trudhesa that can help you both decide if Trudhesa is right for you.

Will Trudhesa work if I take it a couple hours after my migraine attack has started?

Trudhesa was reported to provide reliable relief of migraine symptoms in some people, whether it was taken early in a migraine attack or several hours into one.

Can I recycle an empty POD®?

Like most medical devices, POD is made up of multiple parts and currently cannot be recycled. However, the outer plastic case can be recycled along with all cardboard shipping and storage boxes that are identified with the appropriate recycling symbol.

How should I store Trudhesa?

Keep Trudhesa away from heat and light.

  • Store Trudhesa at room temperature between 68°F to 77°F (20°C to 25°C)
  • Do not refrigerate or freeze
  • After a Trudhesa vial has been opened, it must be thrown away after 8 hours

Keep Trudhesa and all medicines out of the reach of children.

Do not throw Trudhesa into fire or incinerators as the canister inside the device may explode.

Close up partial product image of Trudhesa® Precision Olfactory Delivery (POD®)

Stay Informed

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.
Indication
Trudhesa is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.
Do not use Trudhesa if you:
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir)
  • Are taking a macrolide antibiotic such as clarithromycin or erythromycin
  • Are taking certain antifungals such as ketoconazole or itraconazole
  • Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours
  • Have taken any medications that constrict your blood vessels or raise your blood pressure
  • Have severe liver or kidney disease
  • Are allergic to ergotamine or dihydroergotamine
Before taking Trudhesa, tell your doctor if:
  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
  • You have or had any disease of the liver or kidney.
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
  • This headache is different from your usual migraine attacks.

The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.

Contact your doctor immediately if you experience:

  • Numbness or tingling in your fingers and toes
  • Severe tightness, pain, pressure, heaviness, or discomfort in your chest
  • Muscle pain or cramps in your arms or legs
  • Cold feeling or color changes in 1 or both legs or feet
  • Sudden weakness
  • Slurred speech
  • Swelling or itching

The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.