Sevelamer carbonate 2,4g & 800 mg

Fosquel®

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THERAPEUTIC INDICATION THERAPEUTIC FORM POSOLOGY administration form Presentations

THERAPEUTIC INDICATION

Fosquel® is indicated:

  • For the control of hyperphosphatemia in adult patients receiving hemodialysis or peritoneal dialysis.
  • For the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are not on dialysis with a serum phosphorus level ≥ 1.78 mmol/l and in pediatric patients (> 6 years of age and with a surface area (BSA)> 0.75 m2) with chronic kidney disease.
  • Fosquel® should be used in the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 di-hydroxy vitamin D3 or one of its analogues to control the development of kidney bone disease.
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THERAPEUTIC FORM

FOSQUEL® 2,4 g powder for oral suspension and whitish to yellowish.

FOSQUEL® 800 mg oval film-coated tablets, white to off-white colour, with no partition slot.

POSOLOGY

Adults
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. Fosquel® should be taken three times a day with meals:

Serum phosphorus level in patients  Daily dose of sevelamer carbonate to take in 3 meals a 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*

* In addition to a subsequent dose adjustment, see section “Dose adjustment and maintenance”

Children / adolescents (> 6 years with a body surface area (BSA)> 0.75 m2).
The recommended starting dose of sevelamer carbonate for children is between 2.4 and 4.8 g per day based on the patient’s BSA. Fosquel® should be taken three times a day with meals or snacks.

BSA (m2)  Daily dose of sevelamer carbonate to take in 3 meals a day
> 0,75 hasta < 1,2 2,4 g**
≥ 1,2 4,8 g**

** In addition to a subsequent dose adjustment, see section “Dose adjustment and maintenance”

For patients on prior treatment with phosphorus binders (containing sevelamer hydrochloride or calcium), Fosquel® should be administered on a gram basis with serum phosphorus levels monitored to ensure optimal daily doses.

Dose adjustment and maintenance:

For adult patients, serum phosphorus levels should be monitored and the dose of sevelamer carbonate adjusted by increasing 0.8 g three times a day (2.4 g / day) every 2-4 weeks until a phosphorus concentration is reached acceptable serum, performing regular monitoring afterwards. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose in adults is expected to be approximately 6 g per day.

Children / adolescents (> 6 years with BSA> 0.75 m2).
For pediatric patients, serum phosphorus levels should be monitored and the sevelamer carbonate dose adjusted according to the patient’s increase in BSA, three times a day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring. later.

Pediatric dose based on BSA (m2)

BSA (m2) Initial dose Fit increases / decreases
> 0,75 to < 1,2 0,8 g three times a day 0.4g up / down adjustment
three times a day
≥ 1,2 1,6 g three times a day 0.8g up / down adjustment
three times a day

Patients taking sevelamer carbonate must adhere to prescribed diets.

administration form

FOSQUEL® 2,4 g powder for oral suspension

Each 2.4 g sachet of powder should be dispersed in 60 ml of water before administration. The suspension is whitish to yellowish in color and has a citrus flavor. Fosquel® should be taken with food and not on an empty stomach.

FOSQUEL® 800 mg film-coated tablets

Orally. The tablets should be swallowed intact and should not be crushed, chewed or fragmented before administration. Fosquel® should be taken with food and not on an empty stomach.

Presentations

FOSQUEL® 2,4 g comes in a box with 90 powder envelopes for oral suspension.

FOSQUEL® 800 mg comes in a box with 180 film-coated tablets.

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