A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Renagel Indications, Dosage, Storage, Stability - Sevelamer Hcl
Renagel Indications, Dosage, Storage, Stability - Sevelamer Hcl
INDICATIONS AND USAGE
Renagel is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis. The safety and efficacy of Renagel in CKD patients who are not on hemodialysis have not been studied. In hemodialysis patients, Renagel decreases the incidence of hypercalcemic episodes relative to patients on calcium treatment.
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 |
³7.5 and < 9.0 mg/dL |
2 tablets three times daily with meals |
3 tablets three times daily with meals |
³9.0 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 permeal |
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, hypromel-lose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 800 mg Tablets arepackaged 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, hypromel-lose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel® 400 mg Tablets arepackaged 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.
Distributed by: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 USA, Tel. (800) 847-0069, 4777, 032204R02, Issued 2/04
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