Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) 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.
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 level in patients | Total daily dose of sevelamer carbonate to be taken over 3 meals per day |
|---|---|
| 1.78-2.42 mmol/l (5.5-7.5 mg/dl) | 2.4 g* |
| >2.42 mmol/l (>7.5 mg/dl) | 4.8 g* |
* Plus subsequent titrating, see section "Titration and maintenance"
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Patients taking sevelamer carbonate should adhere to their prescribed diets.
In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
No dosage adjustment is necessary in the elderly population.
No studies have been performed in patients with hepatic impairment.
The safety and efficacy of Renvela in children below the age of 6 years or in children with a BSA below 0.75 m² have not been established. Not data are available.
The safety and efficacy of Renvela in children over 6 year of age and a BSA >0.75 m² have been established. Current available data are described in section 5.1.
For paediatric patients the oral suspension should be administered, as tablet formulations are not appropriate for this population.
Oral use.
Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration. Renvela should be taken with food and not on an empty stomach.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions. In CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single daily dose.
The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including mainly constipation and other known gastrointestinal disorders.
Appropriate symptomatic treatment should be provided.
3 years.
Keep the bottle tightly closed in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.
HDPE bottles with a polypropylene cap and a foil induction seal. Each bottle contains 30 tablets or 180 tablets.
Packs of 1 bottle of 30 or 180 tablets (without outer carton) and a multipack containing 180 (6 bottles of 30) tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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