DOSAGE AND ADMINISTRATION
Patients Not Taking a Phosphate Binder. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one to two Renagel® 800 mg Tablets or two to four Renagel® 400 mg Tablets with each meal based on serum phosphorus level. Table 4 provides recommended starting doses of Renagel for patients not taking a phosphate binder.
Table 4. Starting Dose for 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
|
|
Patients Switching From Calcium Acetate. In a study in 84 ESRD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (mg for mg) of Renagel Capsules and calcium acetate. Table 5 gives recommended starting doses of Renagel based on a patient's current calcium acetate dose.
Table 5. Starting Dose for 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
|
|
Dose Titration for All Patients Taking Renagel. 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 6 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.
Table 6. 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
|
|
Drug interaction studies have demonstrated that Renagel Capsules have no effect on the bioavailability of digoxin, warfarin, enalapril, metoprolol, or iron. When administering any other oral drug for which alteration in blood levels could have a clinically significant effect on safety or efficacy, the drug should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels of the drug. (See PRECAUTIONS: Drug interactions.)
Do not use Renagel after the expiration date on the bottle.
|
HOW SUPPLIED
Renagel® 800 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with "RENAGEL 800," containing 800 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 800 mg Tablets are packaged in bottles of 180 tablets.
NDC 58468-0021-1 Bottle of 180 Tablets
Renagel® 400 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with "RENAGEL 400," containing 400 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 400 mg Tablets are packaged in bottles of 360 tablets.
NDC 58468-0020-1 Bottle of 360 Tablets
Storage
Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).
[See USP controlled room temperature]
Protect from moisture. Rx only
Distributed by:
genzyme
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
USA
Tel. (800) 847-0069
4777
032204R02
Issued 2/04
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