FOSRENOL

Fosrenol is for oral administration. 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. Adults, including elderly (> 65 years) 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 to 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. 1). 2, but no recommendation on posology can be made.

Hepatic impairment The effect of hepatic impairment on Fosrenol pharmacokinetics has not been assessed. 2).

The safety of lanthanum carbonate for use in patients has been examined in a number of clinical studies. 2).

The following convention was used for frequency of adverse drug reactions:

Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). Infections and infestations Uncommon Gastroenteritis, laryngitis Blood and lymphatic system disorders Uncommon Eosinophilia Endocrine disorders Uncommon Hyperparathyroidism Metabolism and nutrition disorders Common Hypocalcaemia Uncommon Hypercalcaemia, hyperglycaemia, hyperphosphataemia, hypophosphataemia, anorexia, appetite increased Nervous system disorders Very Common Headache Uncommon Dizziness, taste alteration Ear and labyrinth disorders Uncommon Vertigo Gastrointestinal disorders* Very Common Abdominal pain, diarrhoea, nausea, vomiting Common Constipation, dyspepsia, flatulence, Uncommon Ileus, subileus, intestinal obstruction, irritable bowel syndrome, oesophagitis, stomatitis, loose stools, indigestion, gastrointestinal disorder (not otherwise specified), dry mouth, tooth disorder, eructation Rare Intestinal perforation Skin and subcutaneous tissue disorders Uncommon Alopecia, sweating increased Musculoskeletal and connective tissue disorders Uncommon Arthralgia, myalgia, osteoporosis General disorders and administration site conditions Uncommon Asthenia, chest pain, fatigue, malaise, peripheral oedema, pain, thirst.

Investigations Uncommon Blood aluminium increased, increase in GGT, increases in hepatic transaminases, alkaline phosphatase increased, weight decrease. 6%).

Post-marketing experience:

During post-approval use of Fosrenol, cases of allergic skin reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, allergic skin reactions were seen in both Fosrenol and placebo/active comparator groups at a frequency of very common (≥1/10).

Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. 1). Cases of lanthanum deposition in gastrointestinal mucosa, mainly after long term use, have been reported. Lanthanum deposition in gastroduodenal mucosa is demonstrated endoscopically as whitish lesions of different sizes and shapes.

Also, various pathological features were identified in gastroduodenal mucosa with lanthanum deposition, such as chronic or active inflammation, glandular atrophy, regenerative changes, foveolar hyperplasia, intestinal metaplasia and neoplasia.

The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile. 8). , constipation, diabetic gastroparesis) and when used with medications known to potentiate these effects.

During treatment with lanthanum carbonate, physicians and patients should remain alert for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distension which may indicate bowel obstruction, ileus or subileus.

Treatment with lanthanum carbonate should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal signs and symptoms. Patients with acute peptic ulcer, ulcerative colitis, Crohn’s disease, or bowel obstruction were not included in clinical studies with Fosrenol.

Patients with renal insufficiency may develop hypocalcaemia. Fosrenol does not contain calcium. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.

Lanthanum is not metabolised by liver enzymes but it is most likely excreted in the bile. 3). As the liver is the principal organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended. Fosrenol should be discontinued if hypophosphataemia develops.

Hypersensitivity to lanthanum carbonate hydrate or to any of the excipients. Hypophosphataemia.