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 is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m²) with chronic kidney disease.
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 for adults 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"
The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based on the patient’s BSA category. Renvela must be taken three times per day with meals or snacks.
| BSA (m²) | Total daily dose of sevelamer carbonate to be taken over 3 meals/snacks per day |
|---|---|
| >0.75 to <1.2 | 2.4 g** |
| ≥1.2 | 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.
For adult patients, serum phosphorus 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.
In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily adult dose is expected to be an average of approximately 6 g per day.
For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated in increments based on patient’s BSA, three times per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Paediatric dose based on BSA (m²):
| BSA (m²) | Starting dose | Titration increases/decreases |
|---|---|---|
| >0.75 to <1.2 | 0.8 g three times daily | Titrate up/down by 0.4 g three times daily |
| ≥1.2 | 1.6 g three times daily | Titrate up/down by 0.8 g three times daily |
Patients taking sevelamer carbonate should adhere to their prescribed diets.
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. No data are available.
For paediatric patients with a <1.2 BSA (m²), the oral suspension should be administered, as tablet formulations were not tested in this population and therefore are not appropriate for this population.
Oral use.
Each sachet of 2.4 g of powder is to be dispersed in 60 mL of water prior to administration (see section 6.6). The suspension should be ingested within 30 minutes after being prepared. Renvela should be taken with food and not on an empty stomach.
As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 100 grams/120 ml) and consumed within 30 minutes. Do not heat Renvela powder (e.g. microwave) or add to heated foods or liquids.
If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.
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.
After reconstitution:
The oral suspension must be administered within 30 minutes.
The sachet has to be discarded after 24 hours of opening
The medicinal product does not require any special storage conditions.
Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.
Each sachet contains 2.4 g of sevelamer carbonate. Each carton contains 60 or 90 sachets.
Not all pack sizes may be marketed.
The powder should be dispersed in 60 mL of water per sachet prior to administration. The suspension powder is pale yellow with a citrus flavour.
The powder may also be pre-mixed with cold beverage or unheated food (see 4.2). The powder should not be heated (e.g. microwave).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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