PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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Table 3Treatment-Emergent Adverse Events in Subcutaneous Placebo-ControlledClinical Trials Reported by at Least 1% of Patients with MigrainePlaceboIMITREX ® 6 mgNumber of Patients 615 1432Number of Migrane Attacks Treated 742 2540Symptoms of Potentially Cardiac Origin• Chest Sensations* 1.6% 5.7%• Neck/Throat/Jaw Sensations* 1.3% 12.0%• Upper Limb Sensations* 2.0% 6.8%Neurological• Head/Face Sensations* 3.7% 16.6%• Dizziness 3.7% 7.9%• Headache 0.7% 3.4%• Drowsiness 1.8% 2.9%Gastrointestinal• Nausea 5.9% 9.4%• Hyposalivation 2.8% 3.3%Musculoskeletal• Muscle Atrophy Weakness & Tiredness NR 1.7%Ear / Nose and Throat• Throat & Tonsil Symptoms 0.3% 1.0%Respiratory• Breathing Disorders 0.8% 1.3%Non-Site Specific• Sensations* (body region unspecified) 15.9% 39.0%• Injection Site Reactions** 10.4% 24.7%• Limb Sensations* 1.5% 6.0%• Malaise/Fatigue 2.3% 4.7%• Sweating 1.1% 1.7%• Trunk Symptoms* 0.5% 1.4%* The term “sensations” encompasses adverse events described as pain & discomfort, pressure, heaviness, constriction,tightness, heat/burning or cold sensation, paresthesia, hypoesthesia, numbness, flushing and strange sensations.NR = Not Reported** Includes transient injection site pain, stinging/burning, swelling, erythema, bruising and bleeding.October 21, 2014Page 14 of 58
Table 4Treatment-Emergent Adverse Events in Intranasal Placebo-ControlledClinical Trials Reported by at Least 1% of Patients with MigrainePlacebo IMITREX ®5 mgIMITREX ®10 mgIMITREX ®20 mg**Number of Patients 741 496 1007 1638Number of Migraine Attacks Treated 1047 933 1434 2070Symptoms of Potentially Cardiac Origin• Chest Sensations* 0.3% 1.0% 0.7% 0.6%• Neck/Throat/Jaw Sensations* 1.2% 0.6% 1.6% 2.3%Neurological• Head/Face Sensations* 0.8% 1.4% 2.4% 2.4%• Dizziness 1.2% 1.6% 1.5% 1.2%• Headache 0.7% 1.4% 0.9% 0.8%• Migraine 2.6% 3.2% 2.4% 1.8%Gastrointestinal• Nausea 10.4% 14.3% 9.6% 8.3%• Vomiting 7.6% 11.1% 9.6% 6.8%Ear, Nose & Throat• Sensitivity to Noise 3.1% 4.4% 2.5% 1.5%• Nasal Signs & Symptoms 1.3% 3.0% 1.6% 1.8%• Infections 0.9% 1.8% 1.3% 0.5%• Upper Respiratory Inflammation 0.5% 1.0% 0.6% 0.7%• Throat & Tonsil Symptoms 0.8% 0.2% 1.0% 0.7%Non-Site Specific• Sensations* (body region unspecified) 1.8% 2.4% 2.7% 2.4%• Malaise/Fatigue 1.3% 1.8% 1.3% 0.8%• Descriptions of odour or taste 1.8% 15.3% 20.2% 20.8%* The term “sensations” encompasses adverse events described as pain & discomfort, pressure, heaviness, constriction,tightness, heat/burning or cold sensation, paresthesia, hypoesthesia, numbness, flushing and strange sensations.** Includes patients receiving up to 3 doses of 20 mg.IMITREX ® is generally well tolerated. Most of the events were transient in nature andresolved within 45 minutes of subcutaneous administration and within 2 hours of oral orintranasal administration.Of the 3630 patients treated with IMITREX ® Nasal Spray in clinical trials, there was onereport of a coronary vasospasm related to IMITREX ® administration.Other Events Observed During Clinical TrialsMinor disturbances of liver function tests have occasionally been observed withsumatriptan treatment. There is no evidence that clinically significant abnormalitiesoccurred more frequently with sumatriptan than with placebo.Dyspnea has commonly been observed following sumatriptan treatment.Post-Market Adverse Drug ReactionsThe following section enumerates potentially important adverse events that have occurredin clinical practice and that have been reported spontaneously to various surveillancesystems. The events enumerated represent reports arising from both domestic andnondomestic use of sumatriptan. These events do not include those already listed in theADVERSE REACTIONS section above. Because the reports cite events reportedOctober 21, 2014Page 15 of 58
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