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Important Safety Information

RELPAX is contraindicated for patients with:

  • History of coronary artery disease (CAD) or coronary artery vasospasm
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing medication
  • Hypersensitivity to RELPAX (angioedema and anaphylaxis seen)
  • Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir

RELPAX may cause the following:

  • Myocardial ischemia/infarction, Prinzmetal’s angina. These events may occur even in patients without known disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, administer first dose of RELPAX in a medically supervised setting.
  • Arrhythmias: discontinue RELPAX if these disturbances occur.
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness commonly occur after treatment with RELPAX and are usually non-cardiac in origin. Perform a cardiac evaluation if these patients are at cardiac risk.
  • Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported with RELPAX. Discontinue the use of RELPAX if any of these events occur.
  • Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
  • Serotonin syndrome may occur with RELPAX particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). Discontinue RELPAX if serotonin syndrome is suspected.

In clinical trials, the most common adverse events reported with treatment with RELPAX 40 mg compared with placebo were dizziness (6% vs 3%), somnolence (6% vs 4%), asthenia (5% vs 3%), and nausea (5% vs 5%).

RELPAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Indication

RELPAX is a serotonin (5-HT 1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura. RELPAX should be used only after a clear diagnosis of migraine has been established. It is not recommended for the prophylactic treatment of migraine or for the treatment of cluster headache.

Please see full Prescribing Information.

Important Safety Information

RELPAX is contraindicated for patients with:

  • History of coronary artery disease (CAD) or coronary artery vasospasm
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing medication
  • Hypersensitivity to RELPAX (angioedema and anaphylaxis seen)
  • Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir

RELPAX may cause the following:

  • Myocardial ischemia/infarction, Prinzmetal’s angina. These events may occur even in patients without known disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, administer first dose of RELPAX in a medically supervised setting.
  • Arrhythmias: discontinue RELPAX if these disturbances occur.
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness commonly occur after treatment with RELPAX and are usually non-cardiac in origin. Perform a cardiac evaluation if these patients are at cardiac risk.
  • Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported with RELPAX. Discontinue the use of RELPAX if any of these events occur.
  • Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
  • Serotonin syndrome may occur with RELPAX particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). Discontinue RELPAX if serotonin syndrome is suspected.

In clinical trials, the most common adverse events reported with treatment with RELPAX 40 mg compared with placebo were dizziness (6% vs 3%), somnolence (6% vs 4%), asthenia (5% vs 3%), and nausea (5% vs 5%).

RELPAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Indication

RELPAX is a serotonin (5-HT 1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura. RELPAX should be used only after a clear diagnosis of migraine has been established. It is not recommended for the prophylactic treatment of migraine or for the treatment of cluster headache.

Please see full Prescribing Information.

For help with the RELPAX $10 Co-pay Card, call 1-800-926-5334 or write:

Pfizer, Attn: RELPAX
PO Box 2225
Morrisville, PA 19067-8025
www.pfizer.com

Imitrex (sumatriptan succinate) is a registered trademark of GlaxoSmithKline.

References: 1. Diener H-C, Ryan R, Sun W, Hettiarachchi J. The 40-mg dose of eletriptan: comparative efficacy and tolerability versus sumatriptan 100 mg. Eur J Neurol. 2004;11:125-134. 2. Mathew NT, Schoenen J, Winner P, Muirhead N, Sikes CR. Comparative efficacy of eletriptan 40 mg versus sumatriptan 100 mg. Headache. 2003;43:214-222. 3. Sandrini G, Färkkilä M, Burgess G, Forster E, Haughie S, for the Eletriptan Steering Committee. Eletriptan vs sumatriptan: a double-blind, placebo-controlled, multiple migraine attack study. Neurology. 2002;59:1210-1217. 4. Visser WH, Terwindt GM, Reines SA, Jiang K, Lines CR, Ferrari MD, for the Dutch/US Rizatriptan Study Group. Rizatriptan vs sumatriptan in the acute treatment of migraine: a placebo-controlled, dose-ranging study. Arch Neurol. 1996;53:1132-1137. 5. Tfelt-Hansen P, Teall J, Rodriguez F, et al, on behalf of the Rizatriptan 030 Study Group. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Headache. 1998;38:748-755. 6. Geraud G, Olesen J, Pfaffenrath V, et al, on behalf of the Study Group. Comparison of the efficacy of zolmitriptan and sumatriptan: issues in migraine trial design. Cephalalgia. 2000;20:30-38. 7. Cabarrocas X, Zayas JM, Suris M, for and on behalf of the Almotriptan Comparative Study Group. Equivalent efficacy of oral almotriptan, a new 5-HT1B/1D agonist, compared with sumatriptan 100 mg. Headache. 1998;38:377-378.