MIGRANAL Administration

Compact, portable form of dihydroergotamine (DHE)

  • MIGRANAL contains the same active ingredient1 found in the intravenous DHE used in emergency departments for severe migraine2
  • Compact spray bottle fits into pocket or purse

Avoids the gastrointestinal tract

  • Intranasally absorbed directly into bloodstream1
  • An option for patients experiencing nausea, vomiting, gastric paresis
  • Provides delivery option for migraine sufferers who would prefer not to take an oral medication that passes through the throat

Make the Most of 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.

 

 

INDICATIONS AND USAGE

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Migranal Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious and/or life-threatening peripheral ischemia has 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/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.

  • Migranal Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.
  • Migranal Nasal Spray also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications, or methysergide within the last 24 hours.
  • Migranal Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.
  • Migranal Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function.
  • Migranal Nasal Spray may cause fetal harm and possesses oxytocic properties and therefore, should not be administered to pregnant women and should not be used by nursing mothers.
  • Migranal Nasal Spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.
  • Migranal Nasal Spray should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.
  • Migranal Nasal Spray should only be used where a clear diagnosis of migraine headache has been established.
  • Migranal should not be used by patients with documented ischemic or vasospastic coronary artery disease. Migranal should not be administered unless a cardiovascular evaluation provides satisfactory clinical evidence that a patient with risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) is reasonably free of unrecognized coronary artery disease (CAD). Even for patients with a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Migranal take place in the setting of a medically staffed facility.
  • During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events. Serious cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine mesylate injection, but are extremely rare.
  • The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea, and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
Please click here for full Prescribing Information for Migranal Nasal Spray, 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.0065.USA.18

INDICATION AND USAGE

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Migranal Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

IMPORTANT SAFETY INFORMATION

WARNING

Serious and/or life-threatening peripheral ischemia has 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/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.

  • Migranal Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.
  • Migranal Nasal Spray also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications, or methysergide within the last 24 hours.
  • Migranal Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.
  • Migranal Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function.
  • Migranal Nasal Spray may cause fetal harm and possesses oxytocic properties and therefore, should not be administered to pregnant women and should not be used by nursing mothers.
  • Migranal Nasal Spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.
  • Migranal Nasal Spray should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.
  • Migranal Nasal Spray should only be used where a clear diagnosis of migraine headache has been established.
  • Migranal should not be used by patients with documented ischemic or vasospastic coronary artery disease. Migranal should not be administered unless a cardiovascular evaluation provides satisfactory clinical evidence that a patient with risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) is reasonably free of unrecognized coronary artery disease (CAD). Even for patients with a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Migranal take place in the setting of a medically staffed facility.
  • During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events. Serious cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine mesylate injection, but are extremely rare.
  • The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea, and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
Please click here for full Prescribing Information for Migranal Nasal Spray, including Boxed Warning and Patient Information.