Dihydroergotamine Mesylate Spray

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

To date, there have been no reports of acute overdosage with this drug. Due to the risk of vascular spasm, exceeding the recommended dosages of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is to be avoided. Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage.

In general, the symptoms of an acute Migranal® (dihydroergotamine mesylate, USP) Nasal Spray overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with Migranal® (dihydroergotamine mesylate, USP) Nasal Spray. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain.

In laboratory animals, significant lethality occurs when dihydroergotamine is given at I.V. doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits.

Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians' Desk Reference® (PDR). *

Migranal®
(dihydroergotamine mesylate, USP) Nasal Spray.

The solution used in Migranal® (dihydroergotamine mesylate, USP) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.

Please read this information carefully before using your Migranal® (dihydroergotamine mesylate, USP) Nasal Spray for the first time. Keep this information handy for future reference. This leaflet does not contain all of the information on Migranal® (dihydroergotamine mesylate, USP) Nasal Spray. Your pharmacist and/or health care provider can provide more detailed information.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray has been evaluated in a limited number of patients long term (e.g., 1 year or longer).

Purpose of your Medication

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is intended to treat an active migraine headache. Do not try to use it to prevent a headache if you have no symptoms. Do not use it to treat common tension headache or a headache that is not at all typical of your usual migraine headache. Administration of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, should not exceed the dosing guidelines and should not be used for chronic daily administration. There have been reports of fibrosis (stiffening) in the lung or kidney areas in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs (the class of drugs to which Migranal® (dihydroergotamine mesylate, USP) Nasal Spray belongs) has been associated with heart valvular fibrosis. Rare cases have also been reported in association with the use of injectable dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with heart valvular fibrosis.

Do not use Migranal® (dihydroergotamine mesylate, USP) Nasal Spray if you:

• Are pregnant or nursing.
• have any disease affecting your heart, arteries, or circulation.
• are taking certain anti-HIV medications (protease inhibitors)
• are taking a macrolide antibiotic such as troleandomycin, clarithromycin or erythromycin.

Important questions to consider before using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray

Please answer the following questions before you use your Migranal® (dihydroergotamine mesylate, USP) Nasal Spray. If you answer YES to any of these questions or are unsure of the answer, you should talk to your doctor before using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray.

• Do you have high blood pressure?
• Do you have chest pain, shortness of breath, heart disease, or have you had any surgery on your heart arteries?
• Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or are you postmenopausal or a male over 40)?
• Do you have any problems with blood circulation in your arms or legs, fingers, or toes?
• Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you sexually active and not using birth control? Are you breast feeding?
• Have you ever had to stop taking this or any other medication because of an allergy or bad reaction?
• Are you taking any other migraine medications, erythromycin or other antibiotics, or medications for blood pressure prescribed by your doctor, or other medicines obtained from your drugstore without a doctor's prescription?
• Do you smoke?
• Have you had, or do you have, any disease of the liver or kidney?
• Is this headache different from your usual migraine attacks?
• Are you using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray or other dihydroergotamine mesylate containing drugs on a daily basis?
• Are you taking a protease inhibitor for HIV therapy?
• Are you taking a macrolide class of antibiotic?

Serious or potentially life-threatening reductions in blood flow to the brain or extremities have been reported rarely due to interactions between Migranal® (dihydroergotamine mesylate, USP) Nasal Spray and protease inhibitors or macrolide antibiotics.

REMEMBER TO TELL YOUR DOCTOR IF YOU HAVE ANSWERED YES TO ANY OF THESE QUESTIONS BEFORE YOU USE Migranal® (dihydroergotamine mesylate, USP) NASAL SPRAY.

Side Effects To Watch Out For

In clinical trials, most migraine patients have used Migranal® (dihydroergotamine mesylate, USP) Nasal Spray without serious side effects. You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray. These side effects are temporary and usually do not require you to stop using Migranal (dihydroergotamine mesylate spray) ® (dihydroergotamine mesylate, USP) Nasal Spray. Although the following reactions rarely occur, they can be serious and should be reported to your physician immediately:

• Numbness or tingling in your fingers and toes
• Pain, tightness, or discomfort in your chest
• Muscle pain or cramps in your arms and legs
• Weakness in your legs
• Temporary speeding or slowing of your heart rate
• Swelling or itching

Dosing Information

• Each vial contains one complete dose of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, which is 1 spray in each nostril followed in 15 minutes by an additional spray in each nostril, for a total of 4 sprays.
• Studies have shown no benefit from acute doses greater than 2.0 mg (4 sprays) for a single administration. The safety of doses greater than 3.0 mg in a 24 hour period has not been established.
• The safety of doses greater than 4.0 mg in a 7-day period has not been established.
• Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, should not be used for chronic daily administration.

Learn what to do in case of an Overdose

If you have used more medication than you have been instructed, contact your doctor, hospital emergency department, or nearest poison control center immediately.

How to use the Migranal® (dihydroergotamine mesylate, USP) Nasal Spray

1. Use available training materials.
   • Read and follow the instructions in the administration instructions which are provided with the Migranal® (dihydroergotamine mesylate, USP) Nasal Spray package before attempting to use the product.
   • If there are any questions concerning the use of your Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, ask your doctor or pharmacist, or call the Migranal® (dihydroergotamine mesylate, USP) Nasal Spray Information Line at 1-888-MY-RELIEF (1-888-697-3543) for training in the use of the spray.
2. Check the contents of the package:
   • 6 Nasal Spray Vials
   • 6 Nasal Sprayers
   • Administration Instructions
   • Package Insert
3. Assemble the sprayer: Assemble your nasal sprayer only when you are ready to use it.
   • Lift tab to bend back blue cover. In one piece, completely remove the blue cover and metal seal in a circular motion. Keeping the vial upright, remove rubber stopper. Set vial aside.
   • Remove plastic cover from the bottom of pump unit. Insert spray pump into vial and turn clockwise until securely fastened.
4. Using the sprayer:
   • Remove cap from spray unit. Holding the vial upright, point nasal sprayer away from face and pump 4 times before using. DO NOT PUMP MORE THAN 4 TIMES. (Although some medication will spray out, there is enough medication in each vial to allow you to prepare your nasal spray pump properly and still receive a full treatment of MIGRANAL (dihydroergotamine mesylate spray) .)
   • Spray once into each nostril. Do not tilt head back or sniff through your nose while spraying or immediately after. Wait 15 minutes. Spray once again into each nostril.
5. After completing these instructions:
   • Carefully dispose of the nasal spray pump with the vial.

• Once a Migranal® (dihydroergotamine mesylate, USP) Nasal Spray vial has been opened, it must be thrown away after 8 hours. Storing Migranal® (dihydroergotamine mesylate, USP) Nasal Spray
• Keep medication in a safe place away from children
• Keep Migranal® (dihydroergotamine mesylate, USP) Nasal Spray away from heat and light.
• Do not expose Migranal® (dihydroergotamine mesylate, USP) Nasal Spray to temperatures over 77°F.
• Never refrigerate or freeze Migranal® (dihydroergotamine mesylate, USP) Nasal Spray.
• Do not keep an opened Migranal® (dihydroergotamine mesylate, USP) Nasal Spray vial for more than 8 hours.

Check the expiration date printed on the vial containing medication. If the expiration date has passed, do not use it.

Answers to patients' questions about Migranal®(dihydroergotamine mesylate, USP) Nasal Spray

What if I need help in using my Migranal® (dihydroergotamine mesylate, USP) Nasal Spray?

If you have any questions or if you need help in opening, putting together, or using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, speak to your doctor or pharmacist, or call the Migranal® (dihydroergotamine mesylate, USP) Nasal Spray Information Line at 1-888-MY-RELIEF (1-888-697-3543) or visit www.migranal (dihydroergotamine mesylate spray) .com.

How much medication should I use and how often?

Each vial contains one complete dose of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, which is 1 spray in each nostril, followed by an additional spray in each nostril 15 minutes later for a total of 4 sprays. Do not use more than this amount unless instructed to do so by your doctor. Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is not intended for chronic daily use.

Why do I have to prime or pump the Nasal Sprayer 4 times before using? Am I wasting the medication?

You have to prime the Nasal Sprayer 4 times to make sure that you get the proper amount of medication when you use it. Although you will see some medication spray out, there is still enough medication in each vial to allow you to prepare your sprayer properly and still receive a full dose of Migranal® (dihydroergotamine mesylate, USP) Nasal Spray.

Can I assemble the medication vial and the Nasal Sprayer so it is ready before I need to use it?

No. The brown (amber) glass vial containing your medication must remain unopened until you are ready to use it. It may not be fully effective if opened and not used within 8 hours.

Can I reuse my Migranal (dihydroergotamine mesylate spray) ® (dihydroergotamine mesylate, USP) Nasal Sprayer?

No. After completing the full dose, you must carefully dispose of your Migranal® (dihydroergotamine mesylate, USP) Nasal Sprayer and the opened vial. You should use a new unit for your next migraine attack. Each Unit contains a new Nasal Sprayer, and a vial of Migranal (dihydroergotamine mesylate spray) ® (dihydroergotamine mesylate, USP) Nasal Spray medication.

Can I use Migranal® (dihydroergotamine mesylate, USP) Nasal Spray if I have a stuffy nose, cold, or allergies?

Yes. Migranal® (dihydroergotamine mesylate, USP) Nasal Spray can be used if you have a stuffy nose, cold, or allergies. However, if you are taking any medications for your cold, or allergies, even those you can buy without a doctor's prescription, speak with your doctor before using Migranal® (dihydroergotamine mesylate, USP) Nasal Spray.

Do I need to sniff the medication when I spray it in my nostril?

No, you should not sniff because Migranal® (dihydroergotamine mesylate, USP) Nasal Spray should remain in the nose so that it can be absorbed into the bloodstream through the lining of the nose.

If you have any other unanswered questions about Migranal (dihydroergotamine mesylate spray) ® (dihydroergotamine mesylate, USP) Nasal Spray, consult your doctor or pharmacist.

This medication can harm an unborn baby or a nursing baby. Do not use dihydroergotamine nasal if you are pregnant or breast-feeding.

Do not use this medication if you are allergic to dihydroergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, a serious infection, if you have recently had heart or blood vessel surgery.

Using certain medications together with dihydroergotamine can cause severe decreases in blood flow and lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, ischemic bowel disease, liver or kidney disease, or risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Do not use this medication if you are allergic to dihydroergotamine or other ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use dihydroergotamine nasal if you are pregnant or breast-feeding, or if you have:

• a history of heart disease, angina (chest pain), blood circulation problems, coronary artery disease (hardening of the arteries), or history of a heart attack or stroke;
• uncontrolled high blood pressure;
• severe liver or kidney disease;
• a serious infection called sepsis; or
• if you have recently had heart or blood vessel surgery (such as bypass surgery).

Using certain medications together with dihydroergotamine can cause even greater decreases in blood flow than dihydroergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use dihydroergotamine if you are also using any of the following medications:

• conivaptan (Vaprisol);
• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);
• an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
• an antidepressant such as nefazodone;
• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or
• HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using dihydroergotamine, tell your doctor if you have:

• breathing problems;
• high blood pressure;
• ischemic bowel disease;
• liver disease;
• kidney disease; or
• coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category X. This medication can cause birth defects. Do not use dihydroergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Dihydroergotamine passes into breast milk and may be harmful to a nursing infant. Dihydroergotamine may also decrease milk production. Do not use dihydroergotamine if you are breast-feeding a baby.

Your pharmacist can provide more information about dihydroergotamine nasal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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