SEVEL

Sevelamer Carbonate INN

UROGENITAL » ANTI-HYPERPHOSPHATEMIC » PHOSPHATE BLINDER

INDICATION

Sevelamer Carbonate is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

DOSAGE AND ADMINISTRATION

Patients Not Taking a Phosphate Binder: The recommended starting dose of Sevelamer Carbonate is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer Carbonate Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Sevelamer Carbonate for patients not taking a phosphate binder.

Table 1. Starting Dose for Dialysis Patients Not Taking Phosphate Binder.

Serum Phosphorus	Sevelamer Carbonate 800 mg
> 5.5 and < 7.5 mg/dL	1 tablets three times daily with meals
>7.5 and < 9.0 mg/dL	2 tablets three times daily with meals
>9.0 mg/dL	2 tablets three times daily with meals

Switching from Sevelamer Hydrochloride tablets: For patients switching from Sevelamer Hydrochloride tablets to Sevelamer Carbonate tablets use the same dose. Patients switching From Calcium Acetate: Table 2 gives recommended starting doses of Sevelamer Carbonate based on a patients current calcium acetate dose.

Table 2. Starting Dose for Dialysis Patients Switching from Calcium Acetate to Sevelamer Carbonate:

Calcium Acetate 667 mg (Tablets per meal)	SevelamerCarbonate 800 mg (Tablets per meal)
1 tablet	1 tablets
2 tablets	2 tablets
3 tablets	3 tablets

Dose Titration for all Patients taking evelamer Carbonate: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5mg/dL or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary. Table 3 gives a dose titration guideline.

Table 3. Dose Titration Guideline.

Serum Phosphorus	Sevelamer  Carbonate
> 5.5 mg/dL	Increase 1 tablet per meal at 2 week intervals.
3.5 – 5.5 mg/dL	Maintain current dose
< 3.5 mg/dL	Decrease 1 tablet per meal

OR AS DIRECTED BY THE PHYSICIAN.

COMPOSITION

Each film-coated tablet contains Sevelamer Carbonate INN 800 mg.