ganogenesis, there was a decrease in pup survival.
The highest no-effect dose for this effect was 60 mg/kg/day. Oral treatment of pregnant rats withsumatriptan during the latter part of gestation and throughout lactation resulted in a decrease inpup survival. The highest no-effect dose for this finding was 100 mg/kg/day.
8.2 Lactation
Risk Summary
Sumatriptan is excreted in human milk following subcutaneous administration (see Data). Thereare no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan onmilk production.
The developmental and health benefits of breastfeeding should be considered along with themother’s clinical need for TOSYMRA and any potential adverse effects on the breastfed infantfrom sumatriptan or from the underlying maternal condition.
Clinical Considerations
Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hoursafter treatment with TOSYMRA.
Data
Following subcutaneous administration of a 6 mg dose of sumatriptan injection in 5lactating volunteers, sumatriptan was present in milk.
8.4 Pediatric Use
Safety and effectiveness of TOSYMRA in pediatric patients have not been established.
TOSYMRA is not recommended for use in patients younger than 18 years of age.
Two controlled clinical trials eva luated sumatriptan nasal spray (5 to 20 mg) in 1,248 pediatricmigraineurs 12 to 17 years of age who treated a single attack. The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in
pediatric patients. Adverse reactions observed in these clinical trials were similar in nature to
those reported in clinical trials in adults.
Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) eva luating oralsumatriptan (25 to 100 mg) in pediatric subjects 12 to 17 years of age enrolled a total of 701pediatric migraineurs. These trials did not establish the efficacy of oral sumatriptan comparedwith placebo in the treatment of migraine in pediatric patients. Adverse reactions observed inthese clinical trials were similar in nature to those reported in clinical trials in adults. Thefrequency of all adverse reactions in these patients appeared to be both dose- and age-dependent,with younger patients reporting reactions more commonly than older pediatric patients.
Postmarketing experience documents that serious adverse reactions have occurred in the pediatricpopulation after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports includereactions similar in nature to those reported rarely in adults, including stroke, visual loss, anddeath. A myocardial infarction has been reported in a 14-year-old male following the use of oralsumatriptan; clinical signs occurred within 1 day of drug administration. Clinical data to
determine the frequency of serious adverse reactions in pediatric patients who might receivesubcutaneous, oral, or intranasal sumatriptan are not presently available.
8.5 Geriatric Use
Clinical trials of sumatriptan did not include sufficient numbers of subjects aged 65 and over todetermine whether they respond differently from younger patients. Other reported clinicalexperience has not identified differences in responses between the elderly and younger subjects.
In general, dose selection for an elderly patient should be cautious, usually starting at the lowend of the dosing range, reflec |
