Included as part of the PRECAUTIONS section.
Patients with end stage renal disease may develop
hypercalcemia when treated with calcium, including calcium acetate (PHOSLYRA).
Avoid the concurrent use of calcium supplements, including calcium-based
nonprescription antacids, with PHOSLYRA.
An overdose of PHOSLYRA 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 PHOSLYRA 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 PHOSLYRA 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 PHOSLYRA 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 PHOSLYRA 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 a solid dose formulation of calcium acetate; all
cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P)
product below 55 mg2/dL2 .
Concomitant Use With Medications
Hypercalcemia may aggravate digitalis toxicity.
PHOSLYRA contains maltitol (1 g per 5 mL) and may induce
a laxative effect, especially if taken with other products containing maltitol.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No carcinogenicity, mutagenicity, or fertility studies
have been conducted with calcium acetate.
Use In Specific Populations
Pregnancy Category C
PHOSLYRA contains calcium acetate. Animal reproduction
studies have not been conducted with PHOSLYRA, and there are no adequate and
well controlled studies of PHOSLYRA 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. PHOSLYRA
treatment, as recommended, is not expected to harm a fetus if maternal calcium
levels are properly monitored during and following treatment.
Labor And Delivery
The effects of PHOSLYRA on labor and delivery are
PHOSLYRA contains calcium acetate and is excreted in
human milk. Human milk feeding by a mother receiving Phoslyra is not expected
to harm an infant, provided maternal serum calcium levels are appropriately
Safety and effectiveness of PHOSLYRA in pediatric
patients have not been established.
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 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, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.