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Important Safety Information
RELPAX is contraindicated for patients with:
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). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. 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.
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.