RENAGEL- sevelamer hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SEVELAMER HYDROCHLORIDE (UNII: GLS2PGI8QG) (SEVELAMER - UNII:941N5DUU5C)

Available from:

Genzyme Corporation

INN (International Name):

SEVELAMER HYDROCHLORIDE

Composition:

SEVELAMER HYDROCHLORIDE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Renagel ® 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 contraindicated in patients with bowel obstruction. Renagel is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. Risk Summary Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer hydrochloride may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementing with these vitamins. Data Animal data In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of Renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vit

Product summary:

Renagel ® (sevelamer hydrochloride) tablets are supplied as white, oval, film-coated, compressed tablets, imprinted with RENAGEL 800 containing 800 mg of sevelamer hydrochloride. Renagel 800 mg Tablets are packaged in bottles of 180 tablets. 1 Bottle of 180 ct 800 mg Tablets (NDC 58468-0021-1) Storage: Store at 25°C (77°F): excursions permitted to 15°C–30°C (59°F–86°F). Do not use Renagel after the expiration date on the bottle. [See USP controlled room temperature] Protect from moisture.

Authorization status:

New Drug Application

Summary of Product characteristics

RENAGEL- SEVELAMER HYDROCHLORIDE TABLET, FILM COATED
GENZYME CORPORATION
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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) TABLETS, 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 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 ( 3)
CONTRAINDICATIONS
Bowel obstruction. ( 4)
Known hypersensitivity to sevelamer hydrochloride or to any of the
excipients. ( 4)
WARNINGS AND PRECAUTIONS
Serious cases of dysphagia, bowel obstruction, bleeding
gastrointestinal ulcers, colitis, ulceration,
necrosis, 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)
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, separate
the timing of administration and
monitor clinical responses or blood levels of the concom