Dihydroergotamine

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dihydroergotamine and call your doctor at once if you have a serious side effect such as:

• fast or slow heart rate, swelling or itching in any part of your body;
• chest pain spreading to the arm or shoulder, and nausea, sweating, or general ill feeling;
• sudden numbness or weakness, sudden headache, confusion, or problems with vision, speech, or balance;
• leg weakness, muscle pain in your arms or legs;
• numbness, tingling, and a pale or blue-colored appearance in your fingers or toes;
• stomach cramps, diarrhea that may be bloody;
• cough with stabbing chest pain and trouble breathing; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath).

Less serious side effects may include:

• headache, dizziness, feeling anxious;
• diarrhea;
• sweating, mild skin rash, redness or tingly feeling under your skin.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using dihydroergotamine nasal and call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
• muscle pain in your arms or legs, leg weakness;
• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
• swelling or itching in any part of your body;
• stomach cramps, diarrhea that may be bloody; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• dizziness;
• nausea, vomiting;
• runny nose;
• altered sense of taste; or
• soreness or irritation in your nose.

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.

Use exactly as prescribed by your doctor. Never use more than your prescribed dose of dihydroergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Dihydroergotamine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use dihydroergotamine injection as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may use a second injection after 1 hour has passed, and a third injection if needed after another hour has passed (a total of 3 injections).

If you still have migraine symptoms after using 3 injections, call your doctor before using any more. If your headache goes away and then comes back, you may use the medication again if it has been at least 6 hours since your last injection.

Do not use more than a total of 3 injections of this medication in any 24-hour period. Do not use more than a total of 6 injections over a period of 7 days.

Dihydroergotamine injection should be clear and colorless. Do not use if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

If you use dihydroergotamine long-term, your doctor may want to check your heart function periodically using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart.

Store at room temperature away from moisture, heat, and light. Do not use if the expiration date on the label has passed.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Dihydroergotamine is not for daily use.

Dihydroergotamine nasal spray is absorbed quickly through your nasal passages and is for use only in the nose. The nasal spray liquid should not be injected into the body.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Dihydroergotamine nasal comes in a bottle (vial) with a nasal sprayer attachment. Do not open the vial and attach the sprayer until you are ready to use the medication. A new vial and sprayer should be used for each new headache episode.

Before using the medicine, prime the nasal spray by pumping exactly 4 sprays into the air.

Use the first dose of dihydroergotamine as soon as you notice headache symptoms, or after an attack has already begun. Use one spray in each nostril, and after 15 minutes use a second spray in each nostril, for a total of 4 sprays.

Do not tilt your head back while you are using the nasal spray, and do not sniff through your nose during use or just after use. Throw away the vial and sprayer after you finish using it to treat one headache episode, or no longer than 8 hours after opening the vial.

If you still have migraine symptoms after using a total of 4 sprays, call your doctor before using any more. Do not use more than 6 total sprays of dihydroergotamine nasal in any 24-hour period. Do not use more than 8 total sprays of this medication over a period of 7 days.

If you use dihydroergotamine nasal long-term, your doctor may want to check your heart function periodically using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart. This will help your doctor determine if it is still safe for you to use this medication. Do not miss any scheduled visits to your doctor.

Do not share this medication with another person, even if they have the same headache symptoms you have. Dihydroergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches.

Store at room temperature away from moisture and heat. Do not keep this medicine in a refrigerator or freezer.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of dihydroergotamine can be fatal. Overdose symptoms may include some of the serious side effects listed in this medication guide.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of dihydroergotamine can be fatal.

Since dihydroergotamine is used on an as-needed basis, you are not likely to miss a dose. Do not use more than 3 injections of dihydroergotamine per day or more than 6 injections per week.

Since dihydroergotamine is used on an as-needed basis, you are not likely to miss a dose.

Do not use more than 6 sprays of dihydroergotamine nasal per day or more than 8 sprays per week.

This is not a complete list of Dihydroergotaminedrug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dihydroergotamine falls into category X:

It has been shown that women taking Dihydroergotamine during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

• DHE
• Dihydroergotamine Mesylate

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as mesylate:

D.H.E. 45: 1 mg/mL (1 mL)

Generic: 1 mg/mL (1 mL)

Solution, Nasal, as mesylate:

Migranal: 4 mg/mL (1 mL)

Generic: 4 mg/mL (1 mL)

Refer to adult dosing.

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: Use is contraindicated.

Serious and life-threatening peripheral ischemia have been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.

Concerns related to adverse effects:

• Cardiac valvular fibrosis: Ergot alkaloids have been associated with fibrotic valve thickening (eg, aortic, mitral, tricuspid); usually associated with long-term, chronic use.

• Cardiovascular effects: May cause vasospastic reactions associated with symptoms of muscle pains, numbness, coldness, pallor, and cyanosis of the digits; myocardial and peripheral vascular ischemia have been reported. In patients with compromised circulation, persistent vasospasm may result in gangrene or death. Evaluate patients who experience signs or symptoms suggestive of angina following administration for the presence of CAD or a predisposition to variant angina before receiving additional doses. Similarly, evaluate patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome. Significant hypertension has been reported (rarely) in patient with and without a history of hypertension. Adverse cardiac events, including acute myocardial infarction, life-threatening disturbance of cardiac rhythm, and death have been rarely reported.

• Cerebrovascular events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have also occurred (in some cases resulted in fatalities) following use of the injection.

• Pleural/retroperitoneal fibrosis: Rare cases of pleural and/or retroperitoneal fibrosis have been reported with prolonged daily use.

Disease-related concerns:

• Cardiovascular disease: Do not give to patients with risk factors for CAD until a cardiovascular evaluation has been performed; if evaluation is satisfactory, the healthcare provider should administer the first dose and cardiovascular status should be periodically evaluated.

Concurrent drug therapy issues:

• CYP3A4 inhibitors: [US Boxed Warning]: Ergot alkaloids are contraindicated with potent inhibitors of CYP3A4 (includes protease inhibitors, azole antifungals, and some macrolide antibiotics); concomitant use associated with an increased risk of vasospasm leading to cerebral ischemia and/or ischemia of the extremities.

Dosage form specific issues:

• Nasal Spray: Local irritation to nose and throat (usually transient and mild-moderate in severity) can occur; long-term consequences on nasal or respiratory mucosa have not been extensively evaluated.