THERAPEUTIC INDICATIONS

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis, control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/l.

Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

POSOLOGY AND METHOD OF ADMINISTRATION

The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela must be taken three times per day with meals. Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Treatment will be continuous based on the need to control serum phosphOrus levels and the adult daily dose is expected to be an average of approximatetly 6g per day.

Tablets should be swallowed intact and should not be crushed, or chewed into pieces prior to administration. The powder should be dispersed in 30 ml of water per sachet prior to administration. Do not heat Renvela or add to hot foods or liquids.

CONTRAINDICATIONS

Hypersensitivity to the active substance or any of the excipients, Hypophosphataernia, and Bowel obstruction.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Renvela is not recommended in children below the age of 18 years, adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Patients who are dysphagia, swallowing disorders, severe gastrointestinal motility disorders , retention of gastric contents and abnormal or irregular bowel motion, active inflammatory bowel disease, and major gastrointestinal tract surgery 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. In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E, and K status should be assessed regularly.

Patients with CKD may develop hypocalcaemia or hypercalcaemia. Renvela is not indicated for the control of hyperparathyroidism. Renvela does not contain any calcium. Consider using Renvela powder for oral suspension in patients with a history of difficulty swallowing.

INTERACTIONS

Interaction studies have not been conducted in patients on dialysis.

Renvela contain the same active moiety as sevelamer hydrochloride, therefore, renvela should not be taken simultaneously with ciprofloxacin. Close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after withdrawal.

Patients receiving sevelamer carbonate and levothyroxine recommend to close monitoring of thyroid stimulating hormone (TSH).

Renvela had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Renvela is not absorbed and may affect the bioavailability of other medicinal products. Therefore, the medicinal product should be administered at least one hour before or three hours after Renvela, or the physician should consider monitoring blood levels.

PREGNANCY AND LACTATION

There are no data from the use of sevelamer in pregnant women, Renvela should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis.

It is unknown whether sevelamer is excreted in human breast milk.

There are no data from the effect of sevelamer on fertility in humans.

UNDESIRABLE EFFECTS

The most frequently occurring (> 5% of patients) undesirable effects is gastrointestinal disorders. For example, Very common: Nausea, vomiting, upper abdominal pain, constipation. Common: Diarrhea, dyspepsia, flatulence, abdominal pain.

OVERDOSE

No cases of overdose have been reported.

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Treatment of hyperphosphataemia. ATC code: VO3AE02.

Presentation

Renvela Film-coated tablet :

· 1 HDPE Bottles @ 30 tablets. Reg. No. DKI1542400117A1

Renvela Powder for oral suspension 0.8 g :

· 1 Carton @ 90 sachets, containing a single dose. Reg. No. DKI1542400238A1

Manufactured by

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford, Ireland

More detailed Information on request

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210

(021) 4892208 - 4895608

Date of revision: 170-Mar-2022 (Based on BPOM approval 06-Agt-2018) CCDSv 6.

This information is intended for Health Care Professional only. See local product information for full details information

RENVELA