Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom
Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.
Fosrenol is for oral administration.
Fosrenol oral powder is intended to be mixed with a small quantity of soft food (e.g. applesauce or other similar food product) and consumed immediately (within 15 minutes). The sachet must not be opened until ready to use. Once mixed with food, Fosrenol oral powder must not be stored for future use. Fosrenol oral powder is insoluble and must not be dissolved in liquid for administration.
Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Fosrenol is presented as an oral powder intended to be mixed with soft food, therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Fosrenol titrated every 2-3 weeks until an acceptable serum phosphate level is reached, with regular monitoring thereafter. Dose titration may be performed with the chewable tablet presentation as these are available in a number of strengths allowing for smaller increases in dose.
Control of serum phosphate level has been demonstrated at doses starting from 750 mg per day. The maximum dose studied in clinical trials, in a limited number of patients, is 3750 mg. Patients who respond to lanthanum therapy, usually achieve acceptable serum phosphate levels at doses of 1500-3000 mg lanthanum per day.
The safety and efficacy of Fosrenol in children and adolescents below the age of 18 years have not been established (see section 4.8 and 5.1). Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
The effect of hepatic impairment on Fosrenol pharmacokinetics has not been assessed. Due to its mechanism of action and the lack of liver metabolism doses in hepatic impairment should not be modified, but patients should be monitored carefully (see sections 4.4 and 5.2).
No case of overdose has been reported. The highest daily dose of lanthanum administered to healthy volunteers during Phase I studies was 4718 mg given for 3 days. The adverse events seen were mild to moderate and included nausea and headache.
3 years.
This medicinal product does not require any special storage conditions.
2.1 g of oral powder in sachets formed from a polyethylene terephthalate/aluminium/polyethylene laminate.
Pack size: 90 sachets (Outer carton contains 9 cartons of 10 sachets).
No special requirements.
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