FDA

Calcium Acetate

Approved 26 Oct 2015OralCapsule

The FDA lists this product in 14 strengths and forms.

Indications

1. INDICATIONS & USAGE Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )

Contraindications

4. CONTRAINDICATIONS Patients with hypercalcemia.

Hypercalcemia. ( 4 )

Warnings and precautions

5. WARNINGS AND PRECAUTIONS

Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 5.1 )
Hypercalcemia may aggravate digitalis toxicity. ( 5.2 )

5.1Hypercalcemia Patients

with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate (calcium acetate capsules). Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate capsules. An overdose of calcium acetate capsules 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 calcium acetate capsules 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 calcium acetate capsules 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 calcium acetate capsules 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 calcium acetate capsules on the progression of vascular or soft tissue calcification has not been determined.

At a glance

Brand name: Calcium Acetate
Route: Oral
Dosage form: Capsule
Applicant: MPP Pharma
Status: Prescription
FDA approval: 26 Oct 2015
Application: ANDA203179-001

Warnings and precautions

5. WARNINGS AND PRECAUTIONS

Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 5.1 )
Hypercalcemia may aggravate digitalis toxicity. ( 5.2 )

5.1Hypercalcemia Patients

Adverse reactions

6. ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]

The most common (> 10%) adverse reactions are hypercalcemia, nausea, and vomiting. ( 6.1 )
In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC. at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate capsules were studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, crossover study with 69 enrolled ESRD hemodialysis patients.

Adverse reactions (>2% on treatment) from these trials are presented in Table 1. Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis Preferred Term Total adverse reactions reported for calcium acetate n=167 (n%) 3-mo, open-label study of calcium acetate n=98 (n%) Double blind, placebo-controlled, cross-over study of calcium acetate n=69 Calcium acetate (n%) Placebo (n%) Nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) Vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) Hypercalcemia 21 (12.6) 16 (16.3) 5 (7.2) 0 (0.0) Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting.

More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate capsules induced hypercalcemia. Isolated cases of pruritus have been reported, which may represent allergic reactions.

6.2Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.

Calcium Acetate

Indications

Contraindications

Warnings and precautions

5.1Hypercalcemia Patients

At a glance

Two medicines in one question?

Calcium Acetate

Indications

Contraindications

Warnings and precautions

5.1Hypercalcemia Patients

At a glance

Two medicines in one question?

5.2Concomitant Use with Medications

Interactions

Pregnancy and breastfeeding

8.1PREGNANCY Pregnancy Category C

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information