Important Safety Information
As with other 5-HT1 agonists, it is recommended that RELPAX not be given to patients with known or suspected ischemic heart disease, coronary artery disease, peripheral vascular disease, uncontrolled hypertension, severe hepatic impairment, history of cerebrovascular accident or transient ischemic attack.
RELPAX should not be administered to patients with hemiplegic or basilar migraine.
RELPAX should not be used within 24 hours of treatment with other 5-HT1 agonists, ergot-type medication, or in patients with known hypersensitivity to eletriptan or any of its inactive ingredients.
The maximum recommended single dose of RELPAX is 40 mg. The maximum daily dose should not exceed 80 mg.
RELPAX is metabolized by the CYP3A4 enzyme; RELPAX does not inhibit or induce CYP3A4. RELPAX should not be used within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir.
Potentially life-threatening serotonin syndrome may occur with triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).
RELPAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most common adverse events reported 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%).
Indication
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.
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.
