Tosymra FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 17, 2019.
Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.
Tosymra nasal spray is formulated using an excipient known as Intravail® which enhances systemic absorption of the drug resulting in a rapid onset of action and blood levels comparable to the subcutaneous injection formulation of sumatriptan.
Limitations of Use
Tosymra should only be used if a clear diagnosis of migraine has been established. It is not indicated for the preventive treatment of migraine or the treatment of cluster headache.
Dosage and Administration
- Single dose of 10 mg of nasal spray
- Maximum dose in a 24-hour period: 30 mg; doses must be separated by at least one hour
- History of coronary artery disease or coronary vasospasm
- Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication
- Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor
- Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
- Severe hepatic impairment
Warnings and Precautions
- Risk of Cardiovascular Side Effects Tosymra may cause serious cardiovascular side effects such as heart attack or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech.
- Medication Overuse Headache Use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache. Patients are encouraged to record headache frequency and drug use.
- Serotonin Syndrome Patients using Tosymra or other triptans should be aware of the risk of serotonin syndrome, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors.
- Hypertensive Crisis Increased blood pressure, including a sudden severe increase (hypertensive crisis) can occur in patients, including those with no history of high blood pressure.
- Hypersensitivity Reactions Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens.
- Seizures Tosymra should be used with caution in patients with epilepsy or a lowered seizure threshold. Seizures can also occur in patients taking sumatriptan who have never had seizures before.
- Ability to Perform Complex Tasks Treatment with Tosymra may cause somnolence and dizziness. Patients experiencing these symptoms should not drive a car, use machinery, or do anything requiring the need to be alert.
- Local Irritation Patients may experience irritation of their nose, mouth, and throat; and changes in taste.
Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness. Additional common adverse reactions with Tosymra include local reactions of the nose and mouth, dysgeusia (changes in taste), and throat irritation.
Development Timeline for Tosymra
|Jan 27, 2019||Approval FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine|
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