LANTHANUM

Posology Lanthanum is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Other dosage forms are available in the market for patients who have difficulty chewing the tablets.

Adults, including elderly (> 65 years) Lanthanum should be taken with food or immediately after, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Lanthanum is presented as a chewable tablet therefore avoiding the need to take additional fluid.

Serum phosphate levels should be monitored and the dose of lanthanum carbonate titrated every 2 to 3 weeks until an acceptable serum phosphate level 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. 1). 2, but no recommendation on posology can be made.

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

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.

4. Post marketing experience During post-approval use of lanthanum carbonate, 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 lanthanum carbonate and placebo/active comparator groups at a frequency of very common. Although there have been a number of additional isolated reactions reported, none of these are considered unexpected in this patient population.

Tissue deposition of lanthanum has been shown with lanthanum carbonate 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.

Data on lanthanum carbonate in clinical studies beyond 2 years is currently limited. However, treatment of subjects with lanthanum carbonate for up to 6 years has not demonstrated a change in the benefit/risk profile. 8). , constipation, diabetic gastroparesis) and in subjects with medications known to potentiate these effects, should only be used after careful consideration.

3). For all subjects, 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 during treatment with lanthanum carbonate.

Withdrawal of lanthanum carbonate is recommended in patients who develop severe constipation or other severe gastrointestinal signs and symptoms, irrespective of predisposing conditions. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with lanthanum carbonate.

2). Serious gastrointestinal complications have been reported in association with unchewed or incompletely chewed Lanthanum tablets. Patients with renal insufficiency may develop hypocalcaemia. Lanthanum does not contain calcium. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.

1. Hypophosphataemia. Bowel obstruction.