Renagel

RENAGEL- sevelamer hydrochloride tablet
Atlantic Biologicals Corps

1 INDICATIONS AND USAGE

RENAGEL (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied. ® 1


1
Renagel is a Registered Trademark of Genzyme Corporation.

2 DOSAGE AND ADMINISTRATION

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

Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder
Serum Phosphorus Renagel ® 800 mg Renagel ® 400 mg

> 5.5 and < 7.5 mg/dL

1 tablet three times daily with meals

2 tablets three times daily with meals

≥ 7.5 and < 9.0 mg/dL

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

. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose. Patients Switching From Calcium AcetateTable 2

Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel
Calcium Acetate 667 mg (Tablets per meal)
Renagel 800 ® mg (Tablets per meal)
Renagel ® 400 mg (Tablets per meal)

1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

. 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. gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams. Dose Titration for All Patients Taking RenagelTable 3

Table 3. Dose Titration Guideline
Serum Phosphorus
Renagel Dose ®

>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

3 DOSAGE FORMS AND STRENGTHS

800 mg and 400 mg Tablets.

4 CONTRAINDICATIONS

Renagel is contraindicated in patients with bowel obstruction.

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Events

Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders. Cases of bowel obstruction and perforation have also been reported with sevelamer use. Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery were not included in the Renagel clinical studies.

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