WARNINGS AND PRECAUTIONS
Use Caution in Patients with Gastrointestinal Disorders
The safety of Renvela has not been established in
patients with dysphagia, swallowing disorders, severe
gastrointestinal (GI) motility disorders including severe
constipation, or major GI tract surgery. Uncommon cases of bowel
obstruction and perforation have been reported.
Monitor Serum Chemistries
Bicarbonate and chloride levels should be
monitored.
Monitor for Reduced Vitamins D, E, K (clotting factors) and Folic Acid Levels
In preclinical studies in rats and dogs, sevelamer
hydrochloride, which contains the same active moiety as
sevelamer carbonate, reduced vitamins D, E, and K (coagulation
parameters) and folic acid levels at doses of 6—10
times the recommended human dose. In short-term clinical trials,
there was no evidence of reduction in serum levels of vitamins.
However, in a one-year clinical trial, 25-hydroxyvitamin D
(normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL
to 34 ± 22 ng/mL (p<0.01) with sevelamer
hydrochloride treatment. Most (approximately 75%)
patients in sevelamer hydrochloride clinical trials received
vitamin supplements, which is typical of patients on
dialysis.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C: There are no adequate and well-controlled
studies in pregnant women. Sevelamer products should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
The effect of sevelamer
hydrochloride 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 sevelamer hydrochloride during
organogenesis, reduced or irregular ossification of fetal bones,
probably due to a reduced absorption of fat-soluble vitamin D,
occurred at a dose approximately equal to the maximum clinical trial
dose of 13 g on a body surface area basis. In pregnant rabbits given
oral doses of sevelamer hydrochloride by gavage during organogenesis,
an increase of early resorptions occurred at dose approximately twice
the maximum clinical trial dose on a body surface area basis
[see
Nonclinical Toxicology
]
.
Labor and Delivery
No sevelamer hydrochloride treatment-related effects on
labor and delivery were seen in animal studies
[see
Nonclinical Toxicology
]
. The effects of sevelamer carbonate on labor and delivery
in humans is unknown.
Pediatric Use
The safety and efficacy of Renvela has not been
established in pediatric patients.
Geriatric Use
Clinical studies of Renvela 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.
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