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RELPAX®Highlights (eletriptan hydrobromide)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use RELPAX safely and effectively. See full prescribing information for RELPAX.

RELPAX® (eletriptan hydrobromide) tablets, for oral use
Initial U.S. Approval: 2002

INDICATIONS AND USAGE

RELPAX is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)

Limitations of Use:

  • Use only after a clear diagnosis of migraine has been established (1)
  • Not indicated for the prophylactic therapy of migraine (1)
  • Not indicated for the treatment of cluster headache (1)

DOSAGE AND ADMINISTRATION

  • Single dose: 20 mg or 40 mg (2)
  • Maximum single dose: 40 mg (2)
  • May repeat dose after 2 hours if needed; not to exceed 80 mg in any 24-hour period (2)

DOSAGE FORMS AND STRENGTHS

Tablets: 20 mg and 40 mg (3)

CONTRAINDICATIONS

  • History of coronary artery disease (CAD) or coronary artery vasospasm (4)
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4)
  • History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine (4)
  • Peripheral vascular disease (4)
  • Ischemic bowel disease (4)
  • Uncontrolled hypertension (4)
  • Within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing medication (4)
  • Hypersensitivity to RELPAX (angioedema and anaphylaxis seen) (4)
  • Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir (4)

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction or Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1)
  • Arrhythmias: Discontinue RELPAX if occurs (5.2)
  • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia; evaluate high risk patients for CAD (5.3)
  • Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue RELPAX if occurs (5.4)
  • Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue RELPAX if occurs (5.5)
  • Medication overuse headache: Detoxification may be necessary (5.6)
  • Serotonin syndrome: Discontinue RELPAX if occurs (5.7, 7.3)

ADVERSE REACTIONS

Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2020

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