United States - English - NLM (National Library of Medicine)

vifor pharma, inc. - patiromer (unii: 1fq2ry5yhh) (patiromer - unii:1fq2ry5yhh) - patiromer 8.4 g - veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. limitation of use: veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see clinical pharmacology (12.2)] . veltassa is contraindicated in patients with a history of a hypersensitivity reaction to veltassa or any of its components [see adverse reactions (6.1)]. risk summary veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk. risk summary veltassa is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. the safety and effectiveness of veltassa for lowering serum potassium levels have been established in pediatric patients ages 12 years and older. use of veltassa for this indication is supported by evidence from an adequate and well-controlled study in adults, with additional pharmacodynamic and safety data in pediatric patients aged 12 years and older [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.3)]. safety and efficacy have not been established in pediatric patients below the age of 12 years. although the pediatric study included 9 patients 6 to less than 12 years of age, the dosing regimen that was evaluated in these patients did not appear to be effective in reducing serum potassium levels in this age group after 2 weeks. the starting dose of veltassa in this age group was 2 g/day and the median dose at day 14 was 6 g/day. in this age group the mean change in serum potassium from baseline to day 14 was -0.1 meq/l (95% ci -0.7, 0.4). because the available data are not sufficient to determine a safe and effective dosing regimen in patients 6 to less than 12 years of age, labeling recommendations cannot be provided for this age group. of the 666 patients treated with veltassa in clinical studies, 60% were age 65 and over, and 20% were age 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. patients age 65 and older reported more gastrointestinal adverse reactions than younger patients. of the 666 adult patients treated with veltassa in clinical studies, 93% had chronic kidney disease (ckd). all 14 pediatric patients ages 12 years and older treated with veltassa in the clinical study had chronic kidney disease. no special dosing adjustments are needed for patients with renal impairment.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

vifor fresenius medical care renal pharma uk ltd - calcium acetate; magnesium carbonate heavy - oral tablet - 435mg ; 235mg

Canada - English - Health Canada

vifor fresenius medical care renal pharma ltd - iron (sucroferric oxyhydroxide) - tablet (chewable) - 500mg - iron (sucroferric oxyhydroxide) 500mg - phosphate-removing agents