Renvela 2400 mg/1

SEVELAMER CARBONATE · POWDER, FOR SUSPENSION · Genzyme Corporation

No Recall History

Plain English

Renvela is a powder, for suspension containing sevelamer carbonate at 2400 mg/1, taken oral. Manufactured by Genzyme Corporation.

Key Facts

Brand Name: Renvela
Generic Name: SEVELAMER CARBONATE
NDC Code (Product): 58468-0131
Manufacturer: Genzyme Corporation
Strength: 2400 mg/1
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: NDA022318
Marketing Start: 08/12/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

constipation2,541 reports

diarrhoea1,030 reports

pruritus1,008 reports

nausea813 reports

chronic kidney disease676 reports

end stage renal disease671 reports

renal failure663 reports

death622 reports

vomiting526 reports

acute kidney injury508 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Starting dose of Renvela is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients and based on body surface area (BSA) category for pediatric patients. ( 2.1 ) Titrate by 0.8 g per meal in two-week intervals for adult patients as needed to obtain serum phosphorus target. ( 2.1 ) Titrate based on BSA category for pediatric patients in two-week intervals for 6 weeks and then every 4 weeks as needed to obtain serum phosphorus target. ( 2.1 ) 2.1 General Dosing Information Starting Dose for Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder. Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Renvela >5.5 and <7.5 mg/dL 0.8 g three times daily with meals ≥7.5 mg/dL 1.6 g three times daily with meals Dose Titration for Adult Patients Taking Renvela . Titrate the Renvela dose by 0.8 g three times per day with meals at two-week intervals as n…

Contraindications

4 CONTRAINDICATIONS Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Bowel obstruction. ( 4 ) Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between Renvela 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 5: 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 Renvela Dosing Recommendations Ciprofloxacin Take at least 2 hours before or 6 hours after sevelamer Mycophenolate …

Adverse Reactions

6 ADVERSE REACTIONS Most of the safety experience is with sevelamer carbonate tablets and sevelamer hydrochloride. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%), and constipation (8%). ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-847-0069 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There are limited clinical trial data on the safety of Renvela. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar. In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysi…

Frequently Asked Questions

What is Renvela used for?

Renvela contains SEVELAMER CARBONATE. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is Renvela a controlled substance?

Renvela is not classified as a controlled substance by the DEA.

What is the generic name for Renvela?

The generic name for Renvela is SEVELAMER CARBONATE. There are 12 other brand versions of SEVELAMER CARBONATE.

What is the NDC code for Renvela 2400 mg/1?

The NDC (National Drug Code) for Renvela 2400 mg/1 is 58468-0131, listed by Genzyme Corporation.

Product NDC

58468-0131

Package NDC

58468-0131-2

Other Sevelamer Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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