PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

Table 1 Pharmacokinetic Parameters After Oral Administration of IMITREX ®50 mg to Healthy Volunteers and Moderately Hepatically Impaired PatientsParameterMean Ratio(hepatic impaired/healthy)n=890% CI p-valueAUC ∞C max*Statistically significant181%176%130 to 252%129 to 240%0.009*0.007*The pharmacokinetic parameters of 6 mg subcutaneous sumatriptan do not differstatistically between normal volunteers and moderately hepatically impaired subjects(Child Pugh B). All formulations of sumatriptan are contraindicated in patients withsevere hepatic impairment (see CONTRAINDICATIONS and DOSAGE ANDADMINISTRATION).Renal: The effects of renal impairment on the efficacy and safety of IMITREX DF ® andIMITREX ® have not been evaluated. Therefore, IMITREX DF ® and IMITREX ® are notrecommended in this patient population.Monitoring and Laboratory TestsNo specific laboratory tests are recommended for monitoring patients prior to and/or aftertreatment with IMITREX DF ® or IMITREX ® .ADVERSE REACTIONSSerious cardiac events, including some that have been fatal, have occurred followingthe use of 5-HT 1 agonists. These events are extremely rare and most have beenreported in patients with risk factors predictive of CAD. Events reported haveincluded coronary artery vasospasm, transient myocardial ischemia, myocardialinfarction, ventricular tachycardia, and ventricular fibrillation (seeCONTRAINDICATIONS and WARNINGS and PRECAUTIONS).Clinical Trial Adverse Drug ReactionsBecause clinical trials are conducted under very specific conditions the adversereaction rates observed in the clinical trials may not reflect the rates observed inpractice and should not be compared to the rates in the clinical trials of anotherdrug. Adverse drug reaction information from clinical trials is useful foridentifying drug-related adverse events and for approximating rates.Experience in Controlled Clinical Trials with IMITREX ®Typical 5-HT 1 Agonist Adverse Reactions: As with other 5-HT 1 agonists, IMITREX ®has been associated with sensations of heaviness, pressure, tightness or pain, which mayOctober 21, 2014Page 12 of 58