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 in adult patients 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.
The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Fosrenol oral powder can be used in patients who have difficulty chewing the tablets (see section 4.4).
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 a chewable tablet 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 levels is reached, with regular monitoring thereafter.
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 4718mg 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.
White cylindrical HDPE bottles containing a rayon coil fitted with a tamper evident, child resistant polypropylene screw cap.
Pack sizes:
Fosrenol 500 mg chewable tablets: 20, 45 tablets. Multipack containing 90 (2 packs of 45) chewable tablets.
Fosrenol 750 mg chewable tablets: 15, 45 tablets. Multipack containing 90 (6 packs of 15) chewable tablets.
Fosrenol 1000 mg chewable tablets: 10, 15 tablets. Multipack containing 90 (6 packs of 15) chewable tablets.
Not all pack sizes may be marketed.
No special requirements.
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