Included as part of the PRECAUTIONS section.
Patients with end stage renal disease may develop
hypercalcemia when treated with calcium, including calcium acetate (ELIPHOS®). Avoid
the use of calcium supplements, including calcium-based nonprescription
antacids, concurrently with ELIPHOS®.
An overdose of ELIPHOS® may lead to progressive
hypercalcemia, which may require emergency measures. Therefore, early in the
treatment phase during the dosage adjustment period, monitor serum calcium
levels twice weekly. Should hypercalcemia develop, reduce the ELIPHOS dosage,
or discontinue the treatment, depending on the severity of hypercalcemia.
More severe hypercalcemia (Ca >12 mg/dL) is associated
with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated
by acute hemodialysis and discontinuing ELIPHOS® therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be
asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild
hypercalcemia is usually controlled by reducing the ELIPHOS® dose or temporarily
discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is
recommended as well.
Chronic hypercalcemia may lead to vascular calcification
and other soft-tissue calcification. Radiographic evaluation of suspected
anatomical regions may be helpful in early detection of soft tissue
calcification. The long term effect of ELIPHOS® on the progression of vascular
or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of
patients in a 3-month study of solid dose formulation of calcium acetate; all
cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca Ã P) product
below 55 mg2/dL2.
Concomitant Use With Medications
Hypercalcemia may aggravate digitalis toxicity.
Carcinogenesis, Mutagenesis, Impairment And Fertility
No carcinogenicity, mutagenicity, or fertility studies
have been conducted with calcium acetate.
Use In Specific Populations
Pregnancy Category C
ELIPHOS® contains calcium acetate. Animal reproduction
studies have not been conducted with calcium acetate tablets, and there are no
adequate and well controlled studies of calcium acetate tablets use in pregnant
women. Patients with end stage renal disease may develop hypercalcemia with
calcium acetate treatment [see WARNINGS AND PRECAUTIONS]. Maintenance of
normal serum calcium levels is important for maternal and fetal well being.
Hypercalcemia during pregnancy may increase the risk for maternal and neonatal
complications such as stillbirth, preterm delivery, and neonatal hypocalcemia
and hypoparathyroidism. ELIPHOS® treatment, as recommended, is not expected to
harm a fetus if maternal calcium levels are properly monitored during and
Labor And Delivery
The effects of ELIPHOS® on labor and delivery are
ELIPHOS® contains calcium acetate and is excreted in
human milk. Human milk feeding by a mother receiving ELIPHOS® is not expected
to harm an infant, provided maternal serum calcium levels are appropriately
Safety and effectiveness in pediatric patients have not
Clinical studies of calcium acetate did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other clinical experience has not identified
differences in responses between 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, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other drug