D.H.E. 45

Generic name: Dihydroergotamine
Drug class: Antimigraine agents

Usage of D.H.E. 45

Dihydroergotamine injection is used to treat migraine headaches with or without aura and cluster headaches. Dihydroergotamine is not an ordinary pain reliever. It will not relieve pain other than from migraine headaches.

This medicine is available only with your doctor's prescription.

D.H.E. 45 side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Dizziness

headache

numbness or tingling in the arms or legs

trouble thinking, speaking, or walking

weakness

Incidence not known

Chest pain, discomfort, or tightness

confusion

continuing or severe abdominal or stomach pain

continuing or severe nausea and vomiting

increased frequency of urination

lower back or side pain

pain or discomfort in the arms, jaw, back, or neck

stroke

sweating

trouble breathing

vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

change or loss of consciousness

cold clammy skin

confusion as to time, place, or person

decreased awareness or responsiveness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

hallucinations

headache

holding false beliefs that cannot be changed by fact

nausea

nervousness

numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds

pale or blue lips, fingernails, or skin

pounding in the ears

seizures

severe sleepiness

slow or fast heartbeat

stomach pain

sweating

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning or tingling sensation, dryness, soreness, or pain in the nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking D.H.E. 45

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dihydroergotamine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of dihydroergotamine injection in geriatric patients.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Almotriptan

Amprenavir

Atazanavir

Boceprevir

Clarithromycin

Cobicistat

Cocaine

Darunavir

Delavirdine

Dobutamine

Dopamine

Eletriptan

Ephedrine

Epinephrine

Erythromycin

Fosamprenavir

Frovatriptan

Idelalisib

Indinavir

Itraconazole

Ketoconazole

Letermovir

Levoketoconazole

Lidocaine

Lopinavir

Midodrine

Mifepristone

Naratriptan

Nefazodone

Nelfinavir

Nirmatrelvir

Norepinephrine

Phenylephrine

Phenylpropanolamine

Posaconazole

Propylhexedrine

Pseudoephedrine

Ritonavir

Rizatriptan

Saquinavir

Saralasin

Sumatriptan

Telaprevir

Telithromycin

Tipranavir

Troleandomycin

Vasopressin

Voriconazole

Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Adagrasib

Alefacept

Asciminib

Avacopan

Azithromycin

Conivaptan

Crizotinib

Dabrafenib

Daridorexant

Dexfenfluramine

Eluxadoline

Enzalutamide

Erdafitinib

Fedratinib

Fexinidazole

Fluconazole

Fluvoxamine

Fosnetupitant

Imatinib

Ivacaftor

Lanreotide

Lefamulin

Lenacapavir

Lorlatinib

Lumacaftor

Mavacamten

Mitotane

Mobocertinib

Netupitant

Octreotide

Omaveloxolone

Palbociclib

Pazopanib

Phenobarbital

Pirtobrutinib

Primidone

Propatyl Nitrate

Ranolazine

Ribociclib

Ritlecitinib

Selpercatinib

Sibutramine

Sotorasib

Taurursodiol

Tocilizumab

Trofinetide

Tucatinib

Voxelotor

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Nitroglycerin

Propranolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Relate drugs

How to use D.H.E. 45

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into one of your muscles, under your skin (usually in the middle of the thighs), or through a needle placed in one of your vein.

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Do not use this medicine for a regular headache that is different from your usual migraine. Talk to your doctor about what to do for regular headaches.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

How to prepare the injection.

The proper use of disposable syringes.

How to give the injection.

How long the injection can be stored at home.

Check the liquid in the vial. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.

If you feel much better after a dose of this medicine, but your headache comes back or gets worse after a while, wait at least 1 hour before using another dose.

If you get another migraine headache after you have used this medicine, do not use a second dose unless it has been more than 6 hours from the last dose.

Tell your doctor if you use other medicine to treat migraines, including sumatriptan. You should not use sumatriptan or other ergot medicines within 24 hours of using dihydroergotamine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (solution):

For migraine or cluster headaches:

Adults—1 milliliters (mL) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. However, the dose should not be more than 6 mL per week.

Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw the vial away 1 hour after opening. Do not save unused medicine from an opened vial.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Warnings

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Do not use this medicine together with clarithromycin (Biaxin®), erythromycin (Erythrocin®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nelfinavir (Viracept®), ritonavir (Norvir®), or troleandomycin (Tao®).

This medicine may cause brain problems (eg, cerebral ischemia). Check with your doctor right away if you have confusion, headache, sudden, severe, and continuing, or nausea and vomiting.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: blurred vision, change in consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position, hallucinations, headache, holding false beliefs that cannot be changed by fact, nervousness, numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds, irregular, fast or slow, or shallow breathing, loss of consciousness, pale, clammy skin, pounding in the ears, seizures, stomach pain, sweating, trouble breathing, unusual excitement, nervousness, or restlessness, unusual tiredness or weakness, or vomiting.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using this medicine could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

This medicine may cause stomach problems (eg, retroperitoneal fibrosis). Check with your doctor right away if you have continuing or severe stomach pain, increased frequency of urination, continuing loss of appetite, lower back pain, continuing or severe nausea and vomiting, or weakness.

Check with your doctor right away if you have chest pain or tightness, or trouble breathing. These may be symptoms of a lung problem (eg, pleural fibrosis).

This medicine may increase your risk of having heart rhythm problems, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Using too much of this medicine or any other migraine medicines (eg, triptans, opioids, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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