Fosrenol(R) Demonstrates Effective Phosphate Control With as Few as Three Tablets a Day (y 2)

Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.

No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced.

Fosrenol should not be used during pregnancy.

It is unknown whether lanthanum is excreted in human breast milk. The excretion of lanthanum in milk has not been studied in animals. Breast feeding is not recommended when the mother is treated with Fosrenol.

Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol for up to 4.5 years, rising levels of lanthanum were noted over time . No clinical data are available on deposition of lanthanum in other tissues. Safety data exceeding 24 months are currently limited. The risk/benefit from longer-term administration should be carefully considered.

Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol.

Approximately 24% of all ESRF patients who participated in registration clinical studies, reported a drug related adverse reaction, as determined by the investigator. No individual ADR was reported at a frequency greater than 10%. The most commonly reported ADRs (>1/100, 1/10) are gastrointestinal reactions such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking Fosrenol with food and generally abated with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction.

Shire

Shire is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing and marketing products in the areas of attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI), renal diseases and human genetic therapies. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's website: www.shire.com.

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