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Drug Details

RENAGEL 800 mg Film-Coated Tablets

• Drug Class Description
  Treatment of hyperphosphatemia
• Generic Name
  Sevelamer
• Presentation
  Film-coated tablet The off-white, oval tablets are imprinted with Renagel 800 on one side.
• Description
  Each tablet contains 800 mg sevelamer.
• Indications
  Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
• Adult Dosage
  

  Adults and elderly (> 65 years)

  For patients who are not on phosphate binders, dosage is determined individually based on serum phosphate concentration as indicated in the table below:

  Serum phosphate level in patients not on phosphate binders	Starting dose of Renagel 800 mg tablets
  1.76 – 2.42 mmol/l (5.5-7.5 mg/dl)	1 tablet, 3 times per day
  	2 tablets, 3 times per day

  If Renagel is prescribed as an alternative phosphate binder, Renagel should be given in equivalent doses on a mg weight basis compared to the patient's previous calcium based phosphate binder. Serum phosphate levels should be closely monitored and the dose of Renagel adjusted accordingly with the goal of lowering serum phosphate to 1.76 mmol/l (5.5 mg/dl) or less. Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.

  The dose range may vary between 1 and 5 800 mg tablets per meal. The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.

  Patients should take Renagel with meals and adhere to their prescribed diets. The tablets must be swallowed whole. Do not chew.

• Child Dosage
  

  The safety and efficacy of this product has not been established in patients below the age of 18 years.

• Elderly Dosage
  See Adult Dosage
• Contra Indications
  

  • Hypersensitivity to sevelamer or to any of the excipients..

  • Hypophosphataemia or bowel obstruction.

• Special Precautions
  

  Efficacy and safety of Renagel has not been studied in children or in predialysis patients.

  The safety and efficacy of Renagel has not been studied in patients with swallowing disorders, untreated or severe gastroparesis, and retention of gastric contents. Renagel should only be used in these patients following careful assessment of benefit and risks.

  Efficacy and safety of Renagel has not been studied in patients with active inflammatory bowel disease, gastrointestinal motility disorders, abnormal or irregular bowel motion and patients with a history of major gastrointestinal surgery. Consequently, caution should be exercised when Renagel is used in patients with these disorders.

  In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with Renagel. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with Renagel. Renagel treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.

  Renagel alone is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D₃ or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.

  Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia. Renagel does not contain calcium. Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient. Elemental calcium should be given as a supplement in case of hypocalcaemia.

  Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels. In preclinical studies, sevelamer at the equivalent of 10 times the maximal human dose has been shown to reduce the absorption of vitamins D, E and K, and folic acid. Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary. Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.

  There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.

  Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus in the intestinal lumen. Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient. One gram of Renagel contains approximately 180 mg (5.1mEq) chloride.

  Patients with chronic renal failure are predisposed to developing metabolic acidosis. Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed. Closer monitoring of serum bicarbonate levels is therefore recommended.

  Very rare cases of hypothyroidism have been reported in patients co-administered Renagel and Levothyroxine. Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products.

  Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Renagel to patients also taking these medications.

  Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality. Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported. Therefore, patients on PD should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.

  As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded.

• Interactions
  

  Interaction studies have not been conducted in patients on dialysis.

  In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. However, the bioavailability of ciprofloxacin was decreased by approximately 50% when co-administered with Renagel in a single dose study. Consequently, Renagel should not be taken simultaneously with ciprofloxacin.

  Renagel may affect the bioavailability of other medicinal products. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with Renagel without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels.

• Adverse Drug Reactions
  

  In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks, the most frequently occurring ( 5% of patients) undesirable effects possibly or probably related to Renagel were all in the gastrointestinal disorders system organ class. Data possibly or probably related to Renagel from these studies (299 patients) and from uncontrolled clinical trials (384 patients) are listed by frequency in the table below. The reporting rate is classified as very common (1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (1/10,000, <1/1,000), very rare (<1/10,000), including isolated.

  Gastrointestinal disorders

  Very common (1/10) : Nausea, vomiting

  Common (1/100 to <1/10): Diarrhoea, dyspepsia, flatulence, upper abdominal pain, constipation

  Most of these events are commonly observed in patients Stage 5 Chronic Kidney Disease and are not necessarily attributable to Renagel.

  Post-marketing experience: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with Renagel.