Renvela Powder for Oral Suspension

Control of serum P in patients w/ CKD on dialysis & in ped patients (>6 yr & BSA of >0.75 m²) w/ CKD. Control of hyperphosphatemia in adult patients receiving hemo- or peritoneal dialysis. Adult CKD patients not on dialysis w/ serum P >1.78 mmol/L.

Adult 2.4-4.8 g daily based on clinical needs & P level. Must be taken tid. Childn ≥1.2 m² BSA 1.6 g/meal, ≥0.75-<1.2 m² BSA 0.8 g/meal. Must be taken tid. Patient previously on phosphate binders Give on a g for g basis w/ monitoring of serum P levels to ensure optimal daily doses.

Should be taken with food: Disperse in water (30 mL) prior to administration. Multiple sachets may be mixed together as long as the appropriate amount of water is used. Drink the prep w/in 30 min. Alternatively, mix powd w/ small amount of beverage/food (eg, 4 ounces/120 mL) & consume w/in 30 min. Do not heat (eg, microwave) or add to hot food/liqd.

Hypersensitivity. Hypophosphatemia or bowel obstruction.

Not recommended for use in adult patients w/ CKD not on dialysis w/ serum P <1.78 mmol/L. If therapy is initiated, monitor patients suffering w/ dysphagia; swallowing disorders; severe GI motility disorders including untreated or severe gastroparesis, retention of gastric contents & abnormal or irregular bowel motion; active inflammatory bowel disease; major GIT surgery. Re-evaluate treatment in patients who develop severe constipation or other severe GI symptoms. Peritonitis. Closely monitor patients w/ hypothyroidism. Not indicated for the control of hyperparathyroidism. Serious inflammatory disorders of different parts of the GIT (including serious complications eg, haemorrhage, perforation, ulceration, necrosis, colitis & colonic/caecal mass). Regularly assess serum vit A, D, E & K status in patients not taking supplemental vit; vit D supplements (approx 400 IU daily) is recommended in CKD patients not on dialysis. Monitoring of fat-soluble vit & folic acid is recommended in patients undergoing peritoneal dialysis. Monitor serum Ca & bicarbonate levels regularly. Pregnancy & lactation. Not recommended for use in childn <6 yr.

Nausea, vomiting, upper abdominal pain, constipation. Diarrhoea, dyspepsia, flatulence, abdominal pain.

Decreased bioavailability of ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil & tacrolimus in transplant patients. Very rarely, hypothyroidism w/ levothyroxine & increased phosphate levels w/ PPIs. Potential interaction w/ antiarrhythmics & anti-seizure medicinal products.

Antidotes & Detoxifying Agents

V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

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