Fosrenol Chewable Tablets 500mg

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Therapeutic

Prescription Only

TABLET, CHEWABLE

**DOSAGE AND ADMINISTRATION** Patients should adhere to recommended diets in order to control phosphate and fluid intake. Tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Adults, including elderly (>65 years) For patients taking FOSRENOL for the first time, the starting dose may be determined individually based on serum phosphate concentration as indicated below: Pre-treatment serum phosphate levelRecommended initial daily dose of FOSRENOL>1.8 and ≤2.4 mmol/L750 mg>2.4 and ≤2.9 mmol/L1500 mg>2.9 mmol/L2250 mg FOSRENOL should be taken with or immediately after food, with the daily dose divided between meals, i.e. three times daily. 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. Control of serum phosphate level has been demonstrated at doses from 750 mg with most patients achieving acceptable serum phosphate levels at 1500 – 3000 mg lanthanum per day. Hepatic impairment The effect of hepatic impairment on FOSRENOL pharmacokinetics has not been formally 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 PRECAUTIONS and PHARMACOLOGY, Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children and Adolescents The safety and efficacy of FOSRENOL has not been established in patients below the age of 18 years.