potentially serious neurological conditions.
TOSYMRA is contraindicated in patients with a history of stroke or TIA.
5.5 Other Vasospasm Reactions
TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascularischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain andbloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experiencesymptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5HT1 agonist, rule out a vasospastic reaction before receiving additional TOSYMRA.
Reports of transient and permanent blindness and significant partial visionloss have beenreported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, acausal relationship between these events and the use of 5-HT1 agonists have not been clearlyestablished.
5.6 Medication Overuse Headache
Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of thesedrugs for 10 or more days per month) may lead to exacerbation of headache (medication overuseheadache). Medication overuse headache may present as migraine-like daily headaches, or as amarked increase in frequency of migraine attacks. Detoxification of patients, includingwithdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
5.7 Serotonin Syndrome
Serotonin syndrome may occur with TOSYMRA, particularly during co-administration withselective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors(SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions(7.4)].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation,hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure,hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/orgastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usuallyoccurs within minutes to hours of receiving a new or a greater dose of a serotonergicmedication. Discontinue TOSYMRA if serotonin syndrome is suspected.
5.8 Increase in Blood Pressure
Significant elevation in blood pressure, including hypertensive crisis with acute impairment oforgan systems, has been reported on rare occasions in patients treated with 5-HT1 agonists,including patients without a history of hypertension. Monitor blood pressure in patients treatedwith TOSYMRA. TOSYMRA is contraindicated in patients with uncontrolled hypertension.
5.9 Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patientsreceiving 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.
5.10 Seizures
Seizures have been reported following administration of sumatriptan. Some have occurred inpatients with either a history of seizures or concurrent conditions predisposing to seizures. Thereare also reports in patients where no such predisposing factors are apparent. TOSYMRA shouldbe used with caution in patients wi |
