Eliphos

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals such as phosphate, and aid in their removal from the body.

Calcium acetate is used to control phosphate levels to keep them from getting too high in people with kidney failure.

Calcium acetate may also be used for purposes not listed in this medication guide.

This section provides information on the proper use of a number of products that contain calcium acetate. It may not be specific to Eliphos. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take this medicine with meals.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Follow carefully any diet program your doctor may recommend.

If you are taking other medicines, take them at least 1 hour before or 3 hours after you take calcium acetate oral liquid. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For too much phosphate in the blood:
  • For oral dosage form (solution):
    • Adults—At first, the dose is usually 10 milliliters (mL) with each meal. The dose is adjusted by your doctor depending on how high your blood phosphorus level is.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—2 tablets three times a day with meals. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid after 24 months.

Eliphos® is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

The recommended initial dose of Eliphos® for the adult dialysis patient is 2 tablets with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.

Patients with hypercalcemia.

Hypercalcemia

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 × P) product below 55 mg2/dL2.

Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

Pregnancy

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 (5.1)]. 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 following treatment.

Labor and Delivery

The effects of Eliphos® on labor and delivery are unknown.

Nursing Mothers

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 monitored.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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 therapy.

Eliphos® Tablets (calcium acetate) A round, white tablet for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.
Tablet NDC 63717-910-02- Bottles of 200.

STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled Room Temperature"].