SUMATRIPTAN (Page 2 of 6)

5.7 Serotonin Syndrome

Serotonin syndrome may occur with Sumatriptan Nasal Spray, particularly during coadministration with selective 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/or gastrointestinal symptoms (e.g., 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 Sumatriptan Nasal Spray if serotonin syndrome is suspected.

5.8 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-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with sumatriptan. Sumatriptan Nasal Spray is contraindicated in patients with uncontrolled hypertension.

5.9 Local Irritation

Local irritative symptoms such as burning, numbness, paresthesia, discharge, and pain or soreness were reported in approximately 5% of patients in controlled clinical trials and were noted to be severe in about 1%. The symptoms were transient and generally resolved in less than 2 hours. Limited examinations of the nose and throat did not reveal any clinically noticeable injury in these patients. The consequences of extended and repeated use of Sumatriptan Nasal Spray on the nasal and/or respiratory mucosa have not been systematically evaluated in patients.

5.10 Anaphylactic/Anaphylactoid Reactions

Anaphylactic/anaphylactoid 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. Sumatriptan Nasal Spray is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan.

5.11 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. Sumatriptan Nasal Spray should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)]
Arrhythmias [see Warnings and Precautions (5.2)]
Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)]
Cerebrovascular events [see Warnings and Precautions (5.4)]
Other vasospasm reactions [see Warnings and Precautions (5.5)]
Medication overuse headache [see Warnings and Precautions (5.6)]
Serotonin syndrome [see Warnings and Precautions (5.7)]
Increase in blood pressure [see Warnings and Precautions (5.8)]
Local irritation [see Warnings and Precautions (5.9)]
Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.10)]
Seizures [see Warnings and Precautions (5.11)]

6.1 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.

Table 1 lists adverse reactions that occurred in worldwide placebo-controlled clinical trials in 3,419 patients with migraine. Only treatment-emergent adverse reactions that occurred at a frequency of 1% or more in the group treated with Sumatriptan Nasal Spray 20 mg and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1. Adverse Reactions Reported by at Least 1% of Patients and at a Greater Frequency than Placebo in Controlled Migraine Clinical Trials

Adverse Reaction

Percent of Patients Reporting

Sumatriptan

Nasal Spray

5 mg

(n = 496)

Sumatriptan

Nasal Spray

10 mg

(n = 1,007)

Sumatriptan

Nasal Spray

20 mg

(n = 1,212)

Placebo

(n = 704)

Atypical sensations

Burning sensation

0.4

0.6

1.4

0.1

Ear, nose, and throat

Disorder/discomfort of nasal cavity/sinuses

2.8

2.5

3.8

2.4

Throat discomfort

0.8

1.8

2.4

0.9

Gastrointestinal

Nausea and/or vomiting

12.2

11.0

13.5

11.3

Neurological

Bad/unusual taste

13.5

19.3

24.5

1.7

Dizziness/vertigo

1.0

1.7

1.4

0.9

The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

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