Renophos (Sevelamer Hydrochloride )

Therapeutic Group: Urological Anti-BPH

Each tablet contains Sevelamer Hydrochloride INN 400 mg.

The active ingredient in Renophos Tablets is Sevelamer hydrochloride, a polymeric phosphate binder intended for oral administration. Sevelamer hydrochloride is hydrophilic, but insoluble in water. Sevelamer hydrochloride has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. Sevelamer binds phosphate to a similar extent. Since Sevelamer does not contain aluminum, it does not cause aluminum intoxication.

Renophos is indicated for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).

Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer is 800 to 1600 mg, which can be administered as one or two 800 mg Sevelamer tablets or two to four 400 mg Sevelamer tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder. Table 1. Starting dose for dialysis patients not taking a phosphate binder. Serum Phosphorus Sevelamer 800 mg Sevelamer 400 mg > 5.5 and 5.5 and 1 tablet three times daily with meals 2 tablets three times daily with meals ≥ 7.5 and 2 tablets three times daily with meals 3 tablets three times daily with meals ≥ 9.0 mg/dL 2 tablets three times daily with meals 4 tablets three times daily with meals Patients switching from calcium acetate: Table 2 gives recommended starting doses of Sevelamer based on a patients current calcium acetate dose. Table 2. Starting dose for dialysis patients switching from calcium acetate to Sevelamer. Calcium Acetate 667 mg (Tablets per meal) Sevelamer 800 mg (Tablets per meal) Sevelamer 400 mg (Tablets per meal) 1 tablet 1 tablet 2 tablets 2 tablets 2 tablets 3 tablets 3 tablets 3 tablets 5 tablets Dose titration for all patients taking Sevelamer: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/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 dose > 5.5 mg/dL 5.5 mg/dL Increase 1 tablet per meal at 2 week intervals 3.5 - 5.5 mg/dL Maintain current dose Decrease 1 tablet per meal

Sevelamer may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.

The safety and efficacy of Sevelamer in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer is used in patients with these GI disorders.

Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction. It is contraindicated in patients known to be hypersensitive to Sevelamer hydrochloride or any of its constituents.

Pregnancy: Pregnancy Category C. Lactation: No adequate and controlled studies have been conducted using Sevelamer in nursing mothers. Sevelamer should be used during breastfeeding only if the potential benefit justifies the potential risks. Drug Interaction Sevelamer has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.

There are no reported overdosages of Sevelamer in patients. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.

Each box contains 5 blister strips of 4 tablets.