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Renagel (sevelamer hydrochloride) Tablet

2016-01-06 05:32:38 来源: 作者: 【大中小】浏览:351次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel.

Renagel (sevelamer hydrochloride) Tablet for Oral use
Initial U.S. Approval: 2000

INDICATIONS AND USAGE

•: Renagel ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1)

DOSAGE AND ADMINISTRATION

•: Starting dose is one or two 800 mg or two to four 400 mg tablets three times per day with meals. ( 2)
•: Adjust by one tablet per meal in two week intervals as needed to obtain serum phosphorus target 3.5 to 5.5 mg/dL. ( 2)

DOSAGE FORMS AND STRENGTHS

•: Tablets: 800 mg and 400 mg ( 3)

CONTRAINDICATIONS

•: In patients with bowel obstruction. ( 4)

WARNINGS AND PRECAUTIONS

Serious cases of dysphagia, bowel obstruction, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. ( 5.1)

ADVERSE REACTIONS

•: The most common reasons for discontinuing treatment were gastrointestinal adverse reactions. ( 6.1)
•: In a parallel design study, of 12 weeks duration, treatment emergent adverse reactions to Renagel Tablets in peritoneal dialysis patients included dyspepsia (12%), peritonitis (8%), diarrhea (5%), nausea (5%), constipation (4%), pruritus (4%), abdominal distension (3%), vomiting (3%), fatigue (3%), anorexia (3%), and arthralgia (3%). ( 6.1)
•: Similar reactions at similar rates occurred in hemodialysis and peritoneal dialysis patients. ( 6.1)
•: Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported. ( 6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-847-0069 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

•: When clinically significant drug interactions are expected, consider separation of the timing of administration and/or monitor clinical responses or blood levels of the concomitant medication. ( 7)
•: Sevelamer did not alter the pharmacokinetics of digoxin, enalapril, iron, metoprolol and warfarin. ( 7)
•: Sevelamer has demonstrated interaction with ciprofloxacin, and mycophenolate mofetil, and therefore these drugs should be dosed separately from Renvela. ( 7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2015

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Events

5.2 Monitor Serum Chemistries

5.3 Monitor for Reduced Vitamins D, E, K (clotting factors) and Folic Acid Levels

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Active-Control, Cross-Over Study in Hemodialysis Patients

14.2 Active-Control, Parallel Study in Hemodialysis Patients

14.3 Active-Control, Parallel Study in Peritoneal Dialysis Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Dosing Recommendations

17.2 Adverse Reactions

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

RENAGEL®1 (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: Renagel is a Registered Trademark of Genzyme Corporation.

2 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 or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® 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	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 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient's current calcium acetate dose.

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

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 3 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.