Renafos Special Precautions

The safety and efficacy of sevelamer carbonate has not been known in children below the age of 18 years.
The safety and efficacy of sevelamer carbonate have not been known in adult patients with chronic kidney disease not on dialysis with serum phosphorus <1.78 mmol/l.
Therefore sevelamer carbonate is currently not recommended for use in these patients.
The safety and efficacy of sevelamer carbonate have not been known in patients with the following disorders: Dysphagia; Swallowing disorders; Severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion; Active inflammatory bowel disease; Major gastrointestinal tract surgery.
Therefore caution should be exercised when sevelamer is used in these patients.
Intestinal obstruction and ileus/subileus: Constipation may be a proceeding symptom. Patients who are constipated should be monitored carefully while being treated with sevelamer.
The treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Fat-soluble vitamins: Patients with chronic kidney disease may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary intake and the severity of their disease.
It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be given if necessary. It is recommended that chronic kidney disease patients not on dialysis are given vitamin D supplements (approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken apart from their dose of sevelamer carbonate. In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Folate deficiency: There is possibility of folate deficiency during long-term sevelamer carbonate treatment.
Hypocalcaemia/hypercalcaemia: Patients with chronic kidney disease may develop hypocalcaemia or hypercalcaemia. Sevelamer carbonate does not contain any calcium. Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Metabolic acidosis: Patients with chronic kidney disease are predisposed to developing metabolic acidosis. Monitoring of serum bicarbonate levels is therefore recommended.
Peritonitis: Peritonitis is a known complication in patients receiving peritoneal dialysis. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Swallowing and choking difficulties: Caution should be exercised when sevelamer carbonate is used in patients with difficulty swallowing.
Anti-arrhythmic and anti-seizure medicinal products: Caution should be exercised when prescribing sevelamer carbonate to patients also taking anti-arrhythmias and anti-seizure medicinal products (see "Interactions").
Hypothyroidism: Closer monitoring of patients with hypothyroidism coadministered with sevelamer carbonate and levothyroxine is recommended (see "Interactions").
Long-term chronic treatment: The potential absorption and accumulation of sevelamer during long-term chronic treatment (>one year) cannot be totally excluded (see "Pharmacology: Pharmacokinetics under Actions").
Hyperparathyroidism: Sevelamer carbonate is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism, sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as supplement. 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Effects on Ability to Drive and Use Machines: Sevelamer has no or negligible influence on the ability to drive and use machines.