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). 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%).

Available human data on the use of RELPAX in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage.

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.

RELPAX is available by prescription only in 20 mg and 40 mg tablets.

Please see Full Prescribing Information and Patient Information.