Data from FDA - Curated by EPG Health - Last updated 04 March 2018

Indication(s)

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

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Advisory information

contraindications
4 CONTRAINDICATIONS Renagel is contraindicated in patients with bowel obstruction. Renagel is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. Bowel obstruction. (4) Known hypersensitivity to sevelamer hydrochloride or to any of the excipients. (4)
Adverse reactions
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-control group (n=101). Overall adverse reactions among those treated with sevelamer hydrochloride occurring in >5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%), and constipation (8%). A total of 27 patients treated with sevelamer and 10 patients treated with comparator withdrew from the study due to adverse reactions. Based on studies of 8 to 52 weeks, the most common reason for withdrawal from Renagel was gastrointestinal adverse reactions (3%–16%). In 143peritoneal dialysis patients studied for 12 weeks, most adverse reactions were similar to adverse reactions observed in hemodialysis patients. The most frequently occurring treatment-emergent serious adverse reaction was peritonitis (8 reactions in 8 patients [8%] in the sevelamer group and 2 reactions in 2 patients [4%] on active control). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions. Patients on peritoneal dialysis should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of sevelamer hydrochloride (Renagel®): hypersensitivity, pruritus, rash, abdominal pain, fecal impaction and uncommon cases of ileus, intestinal obstruction, and intestinal perforation. Appropriate medical management should be given to patients who develop constipation or have worsening of existing constipation to avoid severe complications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

Usage information

Dosing and administration
2 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) 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. 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
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: The effect of Renagel on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses of Renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred. In pregnant rabbits given oral doses of Renagel by gavage during organogenesis, an increase of early resorptions occurred [see Nonclinical Toxicology (13.1)]. 8.2 Labor and Delivery No Renagel treatment-related effects on labor and delivery were seen in animal studies. The effects of Renagel on labor and delivery in humans are not known [see Nonclinical Toxicology (13.1)]. 8.4 Pediatric Use The safety and efficacy of Renagel has not been established in pediatric patients. 8.5 Geriatric Use Clinical studies of Renagel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Interactions

7 DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between Renagel® and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3)]. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate-release or an extended-release product. Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range. Table 4: Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from Renagel Dosing Recommendations Ciprofloxacin Take at least 2 hours before or 6 hours after sevelamer Mycophenolate mofetil Take at least 2 hours before sevelamer 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 Renagel. (7)

More information

Category Value
Authorisation number NDA021179
Agency product number GLS2PGI8QG
Orphan designation No
Product NDC 68151-4295
Date Last Revised 14-02-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 857218
Marketing authorisation holder Carilion Materials Management