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Uses

Vascular Headaches

Acute treatment of migraine attacks with or without aura.

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.

Safety and efficacy not established for management of cluster headaches.

Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.

Administration not recommended within 72 hours of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir). (See Interactions.)

Dosage

Available as eletriptan hydrobromide; dosage expressed in terms of eletriptan.

Adults

Vascular Headaches

Migraine

Oral

20 or 40 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 40-mg dose. In clinical studies, doses >40 mg were effective but were associated with increased risk of adverse effects.

If headache recurs, additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 80 mg in any 24-hour period.

If patient does not respond to first dose, additional doses are unlikely to provide benefit for the same headache.

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 40 mg as a single dose; do not exceed 80 mg in any 24-hour period.

Safety of treating an average of >3 headaches per 30-day period has not been established.

Special Populations

Dosage in Hepatic Impairment

Dosage adjustment not necessary in patients with mild to moderate hepatic impairment. Contraindicated in those with severe hepatic impairment.

Cautions

Contraindications

• Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
• Coronary artery vasospasm (e.g., Prinzmetal variant angina).
• Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).
• Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).
• Peripheral vascular ischemia (e.g., ischemic bowel disease).
• Hemiplegic or basilar migraine.
• Treatment within previous 24 hours with another 5-HT₁ receptor agonist or ergot alkaloid. (See Specific Drugs under Interactions.)
• Severe hepatic impairment (Child-Pugh grade C).
• Known hypersensitivity to eletriptan or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.

Interactions

Do not use within at least 72 hours of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir). (See Interactions.)

Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician's office, possibly followed by ECG) unless patient previously received the drug.

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.

Patients with symptoms suggestive of angina after receiving eletriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration is resumed and such signs or symptoms recur, ECG evaluation recommended.

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists. Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud's phenomenon) occur following administration.

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension. Transient increases in BP reported with eletriptan doses ≥60 mg; may be more pronounced in patients with renal impairment and geriatric patients.

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea). (See Specific Drugs under Interactions.)

General Precautions

Ocular Effects

Possible accumulation of eletriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into human milk. Caution advised if eletriptan is used.

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.

Geriatric Use

No substantial differences in efficacy or safety relative to younger adults; however, limited clinical experience in patients ≥65 years of age. Increases in BP may be more pronounced.

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.

Renal Impairment

Increases in BP may be more pronounced.

Common Adverse Effects

Asthenia, headache, nausea, paresthesia, dizziness, somnolence, dry mouth, flushing or feeling of warmth, pain/pressure sensations (i.e., chest pain [tightness/pressure], abdominal pain/discomfort/stomach pain/cramps/pressure), dyspepsia, dysphagia (i.e., throat tightness, difficulty swallowing).