Renvela

Renvela Special Precautions

sevelamer

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
Full Prescribing Info
Special Precautions
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore Renvela is currently not recommended for use in these patients.
The safety and efficacy of Renvela have not been established 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 Renvela is used in these patients.
Intestinal obstruction and ileus/subileus: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with Renvela. Renvela treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Fat-soluble vitamins: Patients with CKD 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 Renvela 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 CKD 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 Renvela. 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 at present insufficient data to exclude the possibility of folate deficiency during long term Renvela treatment.
Hypocalcaemia/hypercalcaemia: Patients with CKD may develop hypocalcaemia or hypercalcaemia. Renvela 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. As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended.
Peritonitis: Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality. Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinical study with sevelamer hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control group. 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: Uncommon reports of difficulty swallowing the Renvela tablet have been reported. Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities. Caution should be exercised when Renvela is used in patients with difficulty swallowing. The use of Renvela powder for oral suspension in patients with a history of difficulty swallowing should be considered.
Hypothyroidism: Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothryroxine is recommended (see Interactions).
Long-term chronic treatment: In a clinical trial of one year, no evidence of accumulation of sevelamer was seen. However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded (see Pharmacology: Pharmacokinetics under Actions).
Hyperparathyroidism: Renvela is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism Renvela should be used within the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Inflammatory Gastrointestinal Disorders: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis) associated with the presence of sevelamer crystals have been reported in literature. However, the causality of the sevelamer crystals in initiating such disorders has not been demonstrated. Sevelamer carbonate treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Effects on ability to drive and use machines: Sevelamer has no or negligible influence on the ability to drive and use machines.
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