MIGRANAL: Migraine Treatment That Works Differently

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migraine patients do not achieve adequate pain relief with certain treatments1
References:
  1. Baron EP, Tepper SJ. Revisiting the role of ergots in the treatment of migraine and headache. Headache. 2010;50(8):1353-1361.
  2. MIGRANAL [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America.
  3. Gallagher RM; Dihydroergotamine Working Group. Acute treatment of migraine with dihydroergotamine nasal spray. Arch Neurol. 1996;53(12):1285-1291.
  4. Viana M, Genazzani AA, Terrazzino S, Nappi G, Goadsby PJ. Triptan nonresponders: do they exist and who are they? Cephalalgia. 2013;33(11):891-896.
  5. Levy D, Jakubowski M, Burstein R. Disruption of communication between peripheral and central trigeminovascular neurons mediates the antimigraine action of 5HT1B/1D receptor agonists. Proc Natl Acad Sci U S A. 2004;101(12):4274-4279.
  6. Masterson CG, Durham PL. DHE repression of ATP-mediated sensitization of trigeminal ganglion neurons. Headache. 2010;50(9):1424-1439.
  7. Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, CSD, sensitization and modulation of pain. Pain. 2013;154(suppl 1).
  8. Kelley NE, Tepper DE. Rescue therapy for acute migraine, part 1: triptans, dihydroergotamine, and magnesium. Headache. 2012;52(1):114-128.
  9. Burstein R, Jakubowski M, Rauch SD. The science of migraine. J Vestib Res. 2011;21(6):305-314.
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.