SEVELAMER CARBONATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SEVELAMER CARBONATE (UNII: 9YCX42I8IU) (SEVELAMER - UNII:941N5DUU5C)

Available from:

Aurobindo Pharma Limited

INN (International Name):

SEVELAMER CARBONATE

Composition:

SEVELAMER CARBONATE 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. Sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Risk Summary Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementation. Data Animal data In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500, or 1,000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose). Risk Summary Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see Clinical Pharmacology (12.2)] . Consider supplementation. The safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. In this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. Given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD. Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate in the trial. Sevelamer carbonate has not been studied in pediatric patients below 6 years of age. Clinical studies of sevelamer carbonate 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.

Product summary:

Sevelamer Carbonate Tablets, 800 mg for oral use is supplied as white to off-white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side, containing 800 mg of sevelamer carbonate on an anhydrous basis.                Bottles of 30               NDC 65862-921-30                Bottles of 180             NDC 65862-921-18                Bottles of 270             NDC 65862-921-27   Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVELAMER CARBONATE - SEVELAMER CARBONATE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVELAMER CARBONATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SEVELAMER
CARBONATE TABLETS.
SEVELAMER CARBONATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Sevelamer carbonate tablets are 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 AND ADMINISTRATION
Starting dose of sevelamer carbonate tablets 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg (3)
CONTRAINDICATIONS
Bowel obstruction. (4)
Known hypersensitivity to sevelamer carbonate, 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
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 AUROBINDO PHARMA