ressure, very rarely associated with significant clinical events (4.4, 5.7)
Use with caution in patients with a known hypersensitivity to sulfonamides (5.8)
ADVERSE REACTIONS
The most common adverse reactions (≥1% and greater than placebo) are:
In adults: nausea, dry mouth and paresthesia (6.1)
In adolescents: dizziness, somnolence, headache, paresthesia, nausea and vomiting (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Do not use AXERT® and ergotamine-containing or ergot-type medications within 24 hours of each other (4.5, 7.1)
Do not use AXERT® and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other (4.6, 7.2)
SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans (5.5, 7.3)
Ketoconazole: use single dose of AXERT® 6.25 mg; maximum AXERT® daily dose 12.5 mg (7.4)
USE IN SPECIFIC POPULATIONS
Pregnancy: based on animal data, may cause fetal harm (8.1)
Nursing mothers: use AXERT® with caution (8.3)
Pediatric use: AXERT® has not been studied in children under 12 years (8.4)
Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose (8.5)
Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (2.2, 8.6)
Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (2.3, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Acute Treatment of Migraine Attacks
1.2 Important Limitations
2 DOSAGE AND ADMINISTRATION
2.1 Acute Treatment of Migraine Attacks
2.2 Hepatic Impairment
2.3 Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease
4.2 Cerebrovascular Syndromes
4.3 Peripheral Vascular Disease
4.4 Uncontrolled Hypertension
4.5 Ergotamine-Containing and Ergot-Type Medications
4.6 Concomitant Use With 5-HT1 Agonists (e.g., Triptans)
4.7 Hemiplegic or Basilar Migraine
4.8 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events
5.2 Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw
5.3 Cerebrovascular Events and Fatalities
5.4 Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia
5.5 Serotonin Syndrome
5.6 Medication Overuse Headache
5.7 Increases in Blood Pressure
5.8 Hypersensitivity to Sulfonamides
5.9 Impaired Hepatic or Renal Function
5.10 Binding to Melanin-Containing Tissues
5.11 Corneal Opacities
6 ADVERSE REACTIONS
6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled AXERT® Clinical Trials
6.2 Other Adverse Reactions Observed in AXERT® Clinical Trials
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Ergot-Containing Drugs
7.2 5-HT1 Agonists (e.g., Triptans)
7.3 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors
7.4 Ketoconazole and Other Potent CYP3A4 Inhibitors
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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