5.2  Arrhythmias 10 OVERDOSAGE
5.3  Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure 11 DESCRIPTION
5.4  Cerebrovascular Events 12 CLINICAL PHARMACOLOGY
5.5  Other Vasospasm Reactions 12.1 Mechanism of Action
5.6  Medication Overuse Headache 12.2 Pharmacodynamics
5.7  Serotonin Syndrome 12.3 Pharmacokinetics
5.8  Increase in Blood Pressure 13 NONCLINICAL TOXICOLOGY
5.9  Hypersensitivity Reactions 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
5.10  Seizures 13.2 Animal Toxicology and/or Pharmacology
5.11 Local Irritation 14 CLINICAL STUDIES
6 ADVERS E REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING
6.1  Clinical Trials Experience 16.1 How Supplied
6.2  Postmarketing Experience 16.2 Storage and Handling
7  DRUG INTERACTIONS 17 PATIENT COUNSELING INFORMATION
7.1  Ergot-Containing Drugs
7.2  Monoamine Oxidase-A Inhibitors *Sections or subsections omitted from the full prescribing information
7.3  Other 5-HT1 Agonists are not listed.
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response tothe first migraine attack treated with TOSYMRA, reconsider the diagnosis before
TOSYMRA is administered to treat any subsequent attacks.
TOSYMRA is not indicated for the preventive treatment of migraine.
TOSYMRA is not indicated for the treatment of cluster headache.
2 DOSAGE AND ADMINISTRATION
The recommended dose of TOSYMRA is 10 mg given as a single spray in one nostril.
The maximum cumulative dose that may be given in a 24-hour period is 30 mg, with doses ofTOSYMRA separated by at least 1 hour. TOSYMRA may also be given at least 1 hour followinga dose of another sumatriptan product.
3 DOSAGE FORMS AND STRENGTHS
Single-dose nasal spray device delivering 10 mg of sumatriptan.
4 CONTRAINDICATIONS
TOSYMRA is contraindicated in patients with:
Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, ordocumented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina[see Warnings and Precautions (5.1)].
Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessoryconduction pathway disorders [see Warnings and Precautions (5.2)].
History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilarmigraine because these patients are at a higher risk of stroke [see Warnings and Precautions(5.4)].
Peripheral vascular disease [see Warnings and Precautions (5.5)].
Ischemic bowel disease [see Warnings and Precautions (5.5)].
Uncontrolled hypertension [see Warnings and Precautions (5.8)].
Recent use (i.e., within 24 hours) of ergotamine-containing medicati