D.H.E. 45 (injection)

D.H.E. 45 is a medicine made from ergot alkaloids that is used to treat a migraine or cluster headache attack. D.H.E. 45 will not stop headaches from happening or lower the number of attacks.

This medicine is not meant for common tension headaches or for everyday use.

D.H.E. 45 may also be used for reasons that are not mentioned in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with D.H.E. 45 (injection).

You should not use D.H.E. 45 if you are allergic to it or similar medicines (ergotamine, ergonovine, methylergonovine, and others), or if you have:

• heart disease, chest pain (angina), coronary artery disease, a history of a heart attack or stroke;
• circulation problems such as peripheral vascular disease;
• uncontrolled high blood pressure;
• sepsis (a severe reaction to an infection);
• severe liver or kidney disease;
• if you are allergic to D.H.E. 45 or other ergot medicine (ergonovine, ergotamine, methylergonovine); or
• if you have had vascular surgery.

Some drugs should not be used with D.H.E. 45. Your treatment plan may change if you also use:

• an antibiotic such as clarithromycin or erythromycin;
• antifungal medicine such as itraconazole or ketoconazole; or
• antiviral medicine for HIV or hepatitis C.

Tell your doctor if you have ever had:

• blood circulation problems in your arms, hands, legs, or feet;
• chest pain, shortness of breath;
• liver or kidney disease; or
• risk factors for coronary artery disease (high blood pressure, high cholesterol, diabetes, menopause, smoking, family history of coronary artery disease, being overweight, being over 40 and a man).

D.H.E. 45 can affect blood circulation to your uterus. Tell your doctor if you are pregnant or plan to become pregnant. Do not use D.H.E. 45 if you are pregnant.

Do not breastfeed while using this medicine, and for at least 3 days after your last dose. Talk with your doctor about the best way to feed your baby.

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

D.H.E. 45 may cause serious side effects. Call your doctor right away if you have:

• signs of a blood clot--sudden numbness or weakness on one side of the body, problems with vision or speech, pain or swelling in one leg;
• numbness or tingling in your fingers or toes;
• muscle pain in your arms or legs;
• leg weakness;
• fast or slow heartbeats;
• chest pain or tightness, shortness of breath;
• swelling or itching;
• stomach cramps, diarrhea that may be bloody;
• severe headache; or
• discoloration or skin changes in your hands or feet.

Common side effects of D.H.E. 45 may include:

• headache, dizziness, anxiety;
• diarrhea;
• numbness, tingling, burning pain;
• increased blood pressure;
• rash, increased sweating; or
• flushing (sudden warmth, redness, or tingly feeling).

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

D.H.E. 45 is injected under the skin or into a muscle. This medicine is sometimes injected into a vein by a healthcare provider.

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

Prepare an injection only when you are ready to give it. Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

If you still have a headache after 1 injection, you may use up to 2 more injections (spaced 1 hour apart), until your headache goes away.

Call your doctor if you still have a headache after 3 injections.

If you have another headache in the same day, you may use the medicine again if at least 6 hours have passed since your last injection.

Do not use more than a total of 3 injections in 24 hours, or more than 6 injections in 1 week.

You may need medical tests to check your heart function.

Store at room temperature away from moisture, heat, and light. Do not use past the expiration date.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

D.H.E. 45 is used as needed. If you have a dosing schedule and miss a dose, skip it. Do not take two doses at once.

Do not use more than 3 injections in one day or 6 injections in one week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Do not use D.H.E. 45 within 24 hours before or after using another migraine headache medicine. This includes another ergot medicine (ergotamine, methylergonovine) or "triptan" medicine (such as almotriptan, eletriptan).

Grapefruit may interact with D.H.E. 45 and cause side effects. Avoid consuming grapefruit products.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect D.H.E. 45, especially:

• heart or blood pressure medication;
• nicotine gum or patches;
• an antidepressant; or
• medicine to treat an infection.

This list does not include everything. Many drugs can affect D.H.E. 45. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here. Be sure to inform your doctor about all other medicines you are using.