se of sumatriptan injection. Approximately 82% and 65% of patients treatedwith sumatriptan 6 mg had headache relief and were pain free within 2 hours, respectively.
Table 3 shows the 1- and 2-hour efficacy results for sumatriptan injection 6 mg in Studies 2 and
3.
Table 3: Proportion of Patients with Pain Relief and Relief of Migraine Symptoms after 1
and 2 Hours of Treatment in Studies 2 and 3
1-Hour Data
Study 2 Study 3
Placebo
(n = 190)
Sumatriptan
Injection
6 mg
(n = 384)
Placebo
(n = 180)
Sumatriptan
Injection
6 mg
(n = 350)
Patients with pain relief (Grade 0/1) 18% 70%a 26% 70%a
Patients with no pain 5% 48%a 13% 49%a
Patients without nausea 48% 73%a 50% 73%a
Patients without photophobia 23% 56%a 25% 58%a
Patients with little or no clinical 34% 76%a 34% 76%a
disabilityb
2-Hour Data
Study 2 Study 3
Placeboc
Sumatriptan
Injection
6 mgd Placeboc
Sumatriptan
Injection
6 mgd
Patients with pain relief (Grade 0/1) 31% 81%a 39% 82%a
Patients with no pain 11% 63%a 19% 65%a
Patients without nausea 56% 82%a 63% 81%a
Patients without photophobia 31% 72%a 35% 71%a
Patients with little or no clinical 42% 85%a 49% 84%a
disabilityb
a P<0.05 versus placebo. b A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impairedor ability to work and function normally. c Includes patients that may have received an additional placebo injection 1 hour after the initial injection. d Includes patients that may have received an additional 6 mg of sumatriptan injection 1 hour after the initialinjection.
Sumatriptan injection also relieved photophobia, phonophobia (sound sensitivity), nausea, andvomiting associated with migraine attacks.
The efficacy of sumatriptan injection was unaffected by whether or not the migraine wasassociated with aura, duration of attack, gender or age of the patient, or concomitant use ofcommon migraine prophylactic drugs (e.g., beta-blockers).
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TOSYMRA 10 mg (NDC 67857-812-62) contains sumatriptan and is supplied as a ready-touse,single-dose, disposable unit.
Each carton contains 6 units (NDC 67857-812-61) and a Patient Information andInstructions for Use leaflet.
16.2 Storage and Handling
Store between 20°C and 25°C (68°F and 77°F). Excursions permitted between 15°C and 30°C
(59°F and 86°F).
Do not store in the refrigerator or freezer. Do not test before use.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use).
Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-RelatedEvents, Arrhythmias, and Cerebrovascular EventsInform patients that TOSYMRA may cause serious cardiovascular side effects such asmyocardial infarction or stroke. Although serious cardiovascular events can occur withoutwarning 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 and should ask for medical advice when observing any indicative sign orsymptoms are observed. Apprise patients of the importance of this follow-up [see Warningsand Precautions (5.1, 5.2, 5.4, 5.5, 5.8)].
Hypersensitivity Reactions
In |
