Renvela

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sevelamer carbonate

Available from:

Sanofi B.V.

ATC code:

V03AE02

INN (International Name):

sevelamer carbonate

Therapeutic group:

All other therapeutic products

Therapeutic area:

Hyperphosphatemia; Renal Dialysis

Therapeutic indications:

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 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.

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2009-06-09

Patient Information leaflet

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENVELA 800 MG FILM-COATED TABLETS
sevelamer carbonate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to you doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Renvela is and what it is used for
2. What you need to know before you take Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information
1.
WHAT RENVELA IS AND WHAT IT IS USED FOR
Renvela contains sevelamer carbonate as the active substance. It binds
phosphate from food in the digestive
tract and so reduces serum phosphorus levels in the blood.
This medicine is used to control hyperphosphataemia (high blood
phosphate levels) in:
•
adult patients on dialysis (a blood clearance technique). It can be
used in patients undergoing
haemodialysis (using a blood filtration machine) or peritoneal
dialysis (where fluid is pumped into the
abdomen and an internal body membrane filters the blood);
•
patients with chronic (long-term) kidney disease who are not on
dialysis and have a serum (blood)
phosphorus level equal to or above 1.78 mmol/l.
This medicine should be used with other treatments such as calcium
supplements and vitamin D to prevent
the development of bone disease.
Increased levels of serum phosphorus can lead to hard deposits in your
body called calcification. These
deposits can stiffen your blood vessels and make it harder for blood
to be pumped around the body.
Increased serum phosphorus can also lead to itchy skin, red eyes, bone
pain and fractures.
2.
WHAT YOU NEED TO KNOW BEF

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Renvela 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg sevelamer carbonate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white oval tablet, engraved with “RV800” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 D
3
or one of its analogues to control the development of renal bone
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Starting dose _
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.
_Titration and maintenance _
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.
3
In clinical pr