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TOSYMRA is a brand name for Sumatriptan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of…
Verbatim from this product's FDA label. Tap a section to expand.
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 of TOSYMRA separated by at least 1 hour.
TOSYMRA may also be given at least 1 hour following a dose of another sumatriptan product. Single dose of 10 mg of nasal spray ( 2 ) Maximum dose in a 24-hour period: 30 mg; separate doses by at least one hour ( 2 )
1 ) Additional common adverse reactions with TOSYMRA include application site reactions, dysgeusia, and throat irritation. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Placebo-Controlled Trials with Sumatriptan Injection Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials in patients with migraine (Studies 2 and 3) following either a single 6 mg dose of sumatriptan injection or placebo.
Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1:
Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3) Adverse Reaction Sumatriptan Injection 6 mg Subcutaneous (n = 547) % Placebo (n = 370) % Atypical sensations 42 9 Tingling 14 3 Warm/hot sensation 11 4 Burning sensation 7 <1 Feeling of heaviness 7 1 Pressure sensation 7 2 Feeling of tightness 5 <1 Numbness 5 2 Feeling strange 2 <1 Tight feeling in head 2 <1 Cardiovascular Flushing 7 2 Chest discomfort 5 1 Tightness in chest 3 <1 Pressure in chest 2 <1 Ear, nose, and throat Throat discomfort 3 <1 Discomfort: nasal cavity/sinuses 2 <1 Miscellaneous Jaw discomfort 2 0 Musculoskeletal Weakness 5 <1 Neck pain/stiffness 5 <1 Myalgia 2 <1 Neurological Dizziness/vertigo 12 4 Drowsiness/sedation 3 2 Headache 2 <1 Skin Sweating 2 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions. Adverse Reactions in Studies with TOSYMRA In an open-label study that was designed to evaluate the local tolerability of TOSYMRA, repeated use of TOSYMRA was allowed over the course of 6 months.
1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina The use of TOSYMRA is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan.
Some of these reactions occurred in patients without known CAD. 5-HT 1 agonists, including TOSYMRA, may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. , increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving TOSYMRA.
If there is evidence of CAD or coronary artery vasospasm, TOSYMRA is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of TOSYMRA.
For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA. 2 Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists.
Discontinue TOSYMRA if these disturbances occur. TOSYMRA is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. 3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.
However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of TOSYMRA is contraindicated in patients shown to have CAD and those with Prinzmetal's variant angina. 4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities.
1) ] . 2) ] . 4) ] . 5) ] . 5) ] . 8) ] . 3) ] . 3) ] . 9) ] . 3) ] . , another triptan) or of an ergotamine-containing medication ( 4 ) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor ( 4 ) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) ( 4 ) Severe hepatic impairment ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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11) ] . 2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular :
Hypotension, palpitations.
Neurological :
Dystonia, tremor.
In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not.
, stroke, hemorrhage, TIA). Discontinue TOSYMRA if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed with migraine or in patients who present with atypical symptoms, exclude other potentially serious neurological conditions.
TOSYMRA is contraindicated in patients with a history of stroke or TIA. 5 Other Vasospasm Reactions TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome.
In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional TOSYMRA. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists.
Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists have not been clearly established. , ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).
Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
4) ] . , nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue TOSYMRA if serotonin syndrome is suspected. 8 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension.
Monitor blood pressure in patients treated with TOSYMRA. TOSYMRA is contraindicated in patients with uncontrolled hypertension. 9 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema and anaphylaxis, 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. TOSYMRA is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan.
10 Seizures Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent.
TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. 11 Local Irritation Local irritative symptoms were reported in approximately 46% of patients treated with TOSYMRA in an open-label trial which allowed repeated use of TOSYMRA over the course of 6 months.
Of these, the most common local irritative symptoms were application site reaction (36%), dysgeusia (21%), and throat irritation (5%). 5% of the cases were reported as severe.