How to Use MIGRANAL

Why a nasal spray?

MIGRANAL is delivered through a compact and portable nasal spray. Nasal sprays provide several benefits; a nasal spray:

  • Is absorbed directly into the bloodstream rather than through the digestive tract.
    • May be used even with nausea or vomiting, when taking an oral medication may not be possible
    • Offers an option to patients who would prefer not to take an oral medication
  • Fits conveniently into pocket or purse.
  • Why choose MIGRANAL Nasal Spray?

  • MIGRANAL contains the same active ingredient1 found in the intravenous DHE used in emergency departments for severe migraines2

How should I use MIGRANAL?

Administration Instructions: How to Use MIGRANAL Nasal Spray1

Important: Do not assemble the nasal spray pump until the time of use. Once it has been opened, it must be discarded after 8 hours.

STEP 1

Lift tab to bend back blue cover (Figure 1). In one piece, completely remove the blue cover and metal seal in a circular motion (Figure 2). Keeping the vial upright, remove the rubber stopper (Figure 3). Set vial aside.

STEP 2

Remove plastic cover from bottom of pump unit (Figure 4). Insert spray pump into vial and turn clockwise until securely fastened (Figure 5).

STEP 3

Remove cap from spray unit (Figure 6). Holding the vial as shown in Figure 7, point the nasal sprayer away from face and pump 4 times before using (Figure 7). 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.)

STEP 4

Spray once into each nostril (Figure 8). Do not tilt head back or sniff through your nose while spraying or immediately after. Wait 15 minutes. Spray once again into each nostril.

After completing these instructions, carefully dispose of the nasal spray pump with vial.

To get the most out of MIGRANAL Nasal Spray

  • Allow medication to be absorbed in the lining of the nose
  • Do not tilt head or sniff (or inhale through the nose) while spraying.

 

 

INDICATION

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is used to treat an active migraine headache with or without aura. Do not use it to try to prevent a migraine if you have no symptoms, to treat a common tension headache, or to treat a migraine that is not typical of your usual migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Migranal Nasal Spray) and protease inhibitors and macrolide antibiotics have been reported rarely. As a result, these medications should not be taken together.

Do not use Migranal Nasal Spray if you:

  • Are pregnant or nursing
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors
  • Are taking a macrolide antibiotic such as troleandomycin, clarithromycin, or erythromycin
  • Have taken other medications for the treatment or prevention of migraine within the last 24 hours
  • Have severe liver or kidney disease
  • Experience hemiplegic or basilar migraines, which often cause paralysis or impairment of speech

Before taking Migranal Nasal Spray, tell your doctor if:

  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements
  • You have or had any disease of the liver or kidney
  • This headache is different from your usual migraine attacks

The use of Migranal Nasal Spray should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following use of injectable dihydroergotamine, the active ingredient in Migranal Nasal Spray, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Migranal Nasal Spray. Contact your doctor immediately if you experience:

  • 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
Please click here for full Prescribing Information, including Boxed Warning and Patient Information.
 
 
 

REFERENCES

  • 1.MIGRANAL [package insert]. Aliso Viejo, CA: Valeant Pharmaceuticals North America; 2014.
  • 2. Sumamo Schellenberg E, Dryden DM, Pasichnyk D, et al. Acute migraine treatment in emergency settings. Rockville, MD: Agency for Healthcare Research and Quality (US); 2012 Nov. Report No.: 12(13)-EHC142-EF.
  • 3.Silberstein SD; US Headache Consortium. Practice Parameter: evidence-based guidelines for migraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000;55(6):754-762.
  • 4. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society Evidence Assessment of migraine pharmacotherapies. Headache. 2015;55:3-20.

MIG.0043.USA.17

INDICATION

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is used to treat an active migraine headache with or without aura. Do not use it to try to prevent a migraine if you have no symptoms, to treat a common tension headache, or to treat a migraine that is not typical of your usual migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Migranal Nasal Spray) and protease inhibitors and macrolide antibiotics have been reported rarely. As a result, these medications should not be taken together.

Do not use Migranal Nasal Spray if you:

  • Are pregnant or nursing
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors
  • Are taking a macrolide antibiotic such as troleandomycin, clarithromycin, or erythromycin
  • Have taken other medications for the treatment or prevention of migraine within the last 24 hours
  • Have severe liver or kidney disease
  • Experience hemiplegic or basilar migraines, which often cause paralysis or impairment of speech

Before taking Migranal Nasal Spray, tell your doctor if:

  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements
  • You have or had any disease of the liver or kidney
  • This headache is different from your usual migraine attacks

The use of Migranal Nasal Spray should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following use of injectable dihydroergotamine, the active ingredient in Migranal Nasal Spray, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Migranal Nasal Spray. Contact your doctor immediately if you experience:

  • 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
Please click here for full Prescribing Information, including Boxed Warning and Patient Information.