Migranal (nasal)

Migranal is used to treat migraine headaches with or without aura in adults. This nasal medicine will only treat a headache that has already started. It will not prevent headaches or decrease the number of attacks.

Migranal should not be used to treat any headache that feels different from your usual migraine headaches.

Migranal may also be used for reasons not mentioned in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with Migranal (nasal).

You should not use Migranal if you are allergic to it or similar medicines (ergotamine, ergonovine, methylergonovine, and others), or if you have or have ever had:

• heart disease, angina (chest pain), blood circulation problems, coronary artery disease (clogged arteries), or a heart attack or stroke;
• uncontrolled high blood pressure;
• a serious infection called sepsis;
• vascular surgery;
• narrowing of blood vessels in the legs, arms, stomach, or kidneys (peripheral vascular disease); or
• severe liver or kidney disease.

Some drugs should not be used with Migranal. Your treatment plan may change if you also use:

• medicines that raise your blood pressure or constrict your blood vessels;
• an antibiotic such as troleandomycin, 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;
• 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); or
• liver or kidney disease.

Migranal may cause preterm labor. Tell your doctor if you are pregnant or plan to become pregnant. Do not use Migranal if you are pregnant.

Do not breastfeed while using this medicine, and for at least 3 days after your last dose.

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

Migranal may cause serious side effects. Call your doctor right away if you experience:

• numbness, cold feeling, or pale appearance of your fingers or toes;
• sudden or severe stomach pain, weight loss, nausea, vomiting, constipation, bloody diarrhea, fever;
• severe headache, blurred vision, pounding in your neck or ears;
• burning sensation in the nose, mouth, throat, and changed sense of taste;
• fast or slow heart rate;
• swelling or itching;
• signs of a blood clot—sudden numbness or weakness on one side of the body, chest pain, issues with vision or speech, pain or swelling in one leg; or
• symptoms of a heart attack—chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects of Migranal may include:

• pain, bruising, swelling, or irritation where the medicine was applied;
• drowsiness;
• dizziness;
• nausea, vomiting, diarrhea;
• runny nose;
• changed sense of taste; or
• sore throat.

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.

Migranal 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 first dose may be given in a medical setting where any serious side effects can be quickly treated.

You should use Migranal as soon as your headache begins, but it may be given at any time during the migraine episode.

Before your first use, prime the nasal spray device with 4 sprays into the air, away from your face.

Trudhesa: apply one spray in each nostril then another spray in each nostril 1 hour later only if your headache comes back or if you only get some relief from your headache. Use a new nasal spray device for the second dose.

Migranal: apply one spray in each nostril followed by another spray in each nostril 15 minutes later, for a total of 4 sprays.

You may need medical tests to check your heart function.

The nasal spray vial should be thrown away 8 hours after it has been opened.

Store at room temperature away from moisture, heat, and light. Do not keep this medicine in a refrigerator and do not freeze.

Migranal (nasal) is used as needed and does not require a daily dosing schedule.

Do not use more than 2 doses of Trudhesa in 24 hours or more than 3 doses in 7 days.

Do not use more than 6 sprays of Migranal in 24 hours or more than 8 sprays in 7 days.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of overdose may include slow breathing, changes in blood pressure, confusion, hallucinations, agitation, seizures, coma, nausea, vomiting, stomach pain, and pain, numbness, cold feeling, or pale appearance of your fingers or toes.

Do not use Migranal within 24 hours before or after using another migraine headache medicine, including:

• another ergot medicine such as ergotamine, ergonovine, methylergonovine; or
• almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, or rizatriptan.

Grapefruit may interact with Migranal and cause side effects. Avoid consuming grapefruit products.

Tell your doctor about all the medicines you are currently taking. Many drugs can impact Migranal, especially:

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

This list is not complete and many other drugs may affect Migranal. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.