Dihydroergotamine Mesylate (dye-hye-droe-er-GOT-a-meen MES-i-late)

Treats migraine headaches with or without aura and cluster headaches.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin (usually in the middle of the thighs), muscle, or through a needle placed into a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use only when you have a migraine. Do not use this medicine for regular headaches.
• 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 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.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the medicine at room temperature, away from heat and direct light.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nelfinavir, ritonavir, or troleandomycin.
• Some medicines can affect how this medicine works. Tell your doctor if you are using clotrimazole, fluconazole, fluoxetine, fluvoxamine, nefazodone, propranolol, saquinavir, or zileuton.
• 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.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment and for 3 days after the last dose.
• Tell your doctor if you have high blood pressure, high cholesterol, diabetes, a history of stroke, or a family history of heart disease. Tell your doctor if you smoke.
• This medicine helps stop migraine headaches. It does not relieve pain or stop other kinds of headaches.
• This medicine may cause the following problems:
  • Brain problems, including cerebral ischemia
  • Increased risk of stroke, heart attack, or heart rhythm problems
  • Stomach problems, including retroperitoneal fibrosis
  • Lung problems, including pleural fibrosis
  • Increased blood pressure
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that may be dangerous until you know how the medicine affects you.
• Your headaches may become worse if you use headache medicine for 10 or more days per month. This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change or loss of consciousness, drowsiness, lightheadedness, fainting, fast, slow, or uneven heartbeat, seizures, cold, clammy skin
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating
• Confusion, sudden or severe headache, trouble seeing, speaking, or walking
• Fast, pounding, or uneven heartbeat, chest pain, wheezing or trouble breathing
• Lightheadedness, dizziness, fainting
• Muscle pain or weakness
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Stomach pain, change in how much or how often you urinate, loss of appetite, lower back pain, nausea, vomiting, weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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