Uses

What is Trudhesa used for?

Trudhesa (dihydroergotamine) is a medicine commonly used to treat migraine headaches, with or without aura.

Trudhesa may also be used for other conditions as determined by your healthcare provider.

Trudhesa is also available as a different nasal spray and as an injection. See Dihydroergotamine nasal and Dihydroergotamine for more information.

How does Trudhesa work (mechanism of action)?

When you have a migraine headache, the blood vessels in your brain get wider, causing pain and swelling. There are also changes in brain chemicals, such as serotonin. Trudhesa may work by targeting serotonin receptors in the brain, which may help shrink the blood vessels and reduce pain.

How is Trudhesa supplied (dosage forms)?

Trudhesa is available as a nasal spray that delivers 0.725 mg per spray.

How should I store Trudhesa?

Trudhesa should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not refrigerate or freeze. 

Keep Trudhesa in the original packaging until ready to use. Trudhesa vials must be thrown away 8 hours after opening.

Side Effects

What are the most common side effects of Trudhesa?

The most common side effects of Trudhesa are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Runny or stuffy nose
  • Nausea, vomiting, or diarrhea
  • Change in how things taste
  • Local irritation (see below)
  • Dizziness
  • Drowsiness
  • Sore throat

There may be other side effects of Trudhesa that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Trudhesa?

While less common, the most serious side effects of Trudhesa are described below, along with what to do if they happen.

Severe Allergic Reactions. Trudhesa may cause allergic reactions, which can be serious. Stop using Trudhesa and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Attack, Other Heart Problems, and Stroke. Trudhesa can increase your risk of heart attack, other heart problems (such as an abnormal heart rhythm), or stroke, which can lead to death. Stop using Trudhesa and get emergency help if you have any of the following symptoms.

  • Chest pain, pressure, or tightness
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, neck, jaw, throat, or stomach
  • Unusual sweating
  • Nausea or vomiting
  • Feeling dizzy or lightheaded
  • Weakness or numbness on one side of your body
  • Loss of vision in one or both eyes
  • Sudden, severe headache with no known cause
  • Slurred speech or trouble understanding speech

Blood Flow Problems. Trudhesa can reduce blood flow to many areas of the body, which can be serious. Stop using Trudhesa and tell your healthcare provider right away if you have any of the following symptoms.

  • Tingling, numbness, or change in color of fingers or toes
  • Muscle pain or weakness
  • Sudden or severe stomach pain
  • Weight loss
  • Constipation or diarrhea
  • Nausea or vomiting
  • Fever

Increased Blood Pressure. Trudhesa may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while using this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea/vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Medicine Overuse Headache. Using too much Trudhesa may cause your headaches to happen more often or to get worse. This is called medicine overuse headache or rebound headache. If you notice your migraines happen daily or more frequently than before, or if they are getting worse, contact your healthcare provider.

Tissue Changes. Trudhesa can cause a buildup of scar tissue and inflammation around the lungs, stomach, or other organs, which is called fibrosis. This can happen in people using daily or high doses of this medicine. Do not use more medicine than prescribed or use it daily long-term.

Local Irritation. Trudhesa can cause irritation to the nasal passages, which can sometimes be severe. Contact your healthcare provider if you experience any of the following symptoms that bother you.

  • Runny or stuffy nose
  • Sore throat
  • Burning feeling in your nose, mouth, and throat
  • Change in taste or smell
  • Nasal or sinus discomfort
  • Ear discomfort

Warnings & Precautions

Who should not use Trudhesa?

Allergies to Ingredients. People who are allergic to any of the following should not use Trudhesa.

  • Trudhesa
  • Dihydroergotamine
  • Any other medicine known as an ergot alkaloid
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Trudhesa.

Drug Interactions. Trudhesa should not be used while you are using certain other medicines. If you use Trudhesa with certain other medicines, it can cause severe blood flow problems to your feet or legs. This is a serious condition called peripheral ischemia, which can lead to symptoms such as cramping, pain, tingling, weakness or heaviness in your legs or feet. It can also lead to stroke or death. Before using Trudhesa, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details. 

Kidney Problems. Trudhesa should not be used if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough to use this medicine.

Liver Problems. Trudhesa should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to use this medicine.

Heart Problems. Trudhesa should not be used if you have or have had heart problems, including chest pain (angina), a heart attack, uncontrolled high blood pressure, or coronary artery vasospasm.  Tell your healthcare provider if you have any of these problems.

Blood Vessel Problems. Trudhesa should not be used if you have certain problems with your arteries or veins (peripheral vascular disease) or you have had vascular surgery. Discuss these issues with your healthcare provider to help them decide if you should be using Trudhesa.

Other Types of Headache. Not all headaches can be treated with Trudhesa. In particular, hemiplegic and basilar headaches should not be treated with Trudhesa. Talk with your healthcare provider if you are unsure if you have these types of headaches.

What should I know about Trudhesa before using it?

Do not use Trudhesa unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Do not use more of this medicine than prescribed, and do not use it every day. Using it more often than prescribed may increase the risk of serious side effects.

Do not share Trudhesa with other people, even if they have the same condition as you. It may harm them.

Keep Trudhesa out of the reach of children.

Trudhesa should not be used to prevent migraines. Trudhesa should be used as soon as possible once you have migraine symptoms, but can be used at any point during a migraine.

Trudhesa is used by spraying the medicine into your nostrils. Make sure you read the instructions that come with Trudhesa for details regarding assembling, priming, and use. Knowing how to use Trudhesa before you need it may be helpful when you are having a migraine headache. If you have any questions, contact your healthcare provider.

It may be helpful to keep a headache journal where you write down when you get your migraines and when you use Trudhesa. This information could be used with your healthcare provider to determine how the medicine is working for you.

Trudhesa should not be injected.

What should I tell my healthcare provider before using Trudhesa?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Trudhesa is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

Pregnancy. Trudhesa may cause preterm labor and should be avoided during pregnancy. Tell your healthcare provider right away if you are or plan to become pregnant.

Breastfeeding. Do not use Trudhesa while you are breastfeeding and for 3 days after your last dose. Trudhesa may pass into breast milk or reduce your breast milk supply. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Trudhesa?

For more information about Trudhesa, you can visit the manufacturer’s website at www.trudhesa.com or call them at 833-TRUDHESA.

Interactions

Does Trudhesa interact with foods or drinks?

Trudhesa can interact with grapefruit juice. Tell your healthcare provider if you eat grapefruit or drink grapefruit juice before using Trudhesa.

It is unknown if drinking alcohol will affect Trudhesa. The risk of drowsiness or dizziness may be increased if you drink alcohol while using Trudhesa.

Does Trudhesa interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Trudhesa.

  • A macrolide antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), fluconazole (Diflucan), or voriconazole (Vfend), which is medicine used to treat fungal infections 
  • A protease inhibitor, such as ritonavir (Norvir) or nelfinavir (Viracept), which is a medicine commonly used to treat HIV
  • Any other ergot, such as ergotamine (Ergomar), which is a medicine used to treat migraine
  • A triptan, such as sumatriptan (Imitrex and others), eletriptan (Relpax), and others, which is a medicine commonly used to treat migraines
  • A beta-blocker, such as metoprolol (Lopressor, Toprol XL, and others), atenolol (Tenormin), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
  • A vasoconstrictor, such as pseudoephedrine, which is a medicine that may be used for nasal congestion and can cause blood vessels to narrow
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
  • Nicotine, which can be found in cigarettes, vapes, or products that help you stop smoking

Many other medicines may alter the blood levels of Trudhesa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Trudhesa. Always check with your healthcare provider.

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Overdose/Missed Dose

What should I do if I accidentally use too much Trudhesa?

If you or someone else has used too much Trudhesa, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Trudhesa?

Trudhesa is meant to be used only when needed. Use it as your healthcare provider recommends. Do not use double or extra doses.

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