Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
189630168
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CALCIUM ACETATE
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
CLINICAL STUDIES SECTION
14 CLINICAL STUDIES
Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1-week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received calcium acetate tablet [667 mg] at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented.
Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim and Study Completion Time points|
a Values expressed as mean ± SE. | |||||
|
b Ninety-one patients completed at least 6 weeks of the study. | |||||
|
c ANOVA of difference in values at pre-study and study completion | |||||
|
** Parameter** |
** Pre-Study** |
** Week 4****b** |
** Week 8** |
** Week 12** |
** p-value****c** |
|
Phosphorus (mg/dL)a |
7.4 ± 0.17 |
5.9 ± 0.16 |
5.6 ± 0.17 |
5.2 ± 0.17 |
0.01 |
|
Calcium (mg/dL)a |
8.9 ± 0.09 |
9.5 ± 0.10 |
9.7 ± 0.10 |
9.7 ± 0.10 |
0.01 |
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum calcium increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of calcium acetate is shown in the Table 3.
Table 3: Serum Phosphorus and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm
|
Parameter |
Pre-Study |
Post-Treatment |
p-value****b | |
|
Calcium Acetate |
Placebo | |||
|
Phosphorus (mg/dL)a |
7.3 ± 0.18 |
5.9 ± 0.24 |
7.8 ± 0.22 |
<0.01 |
|
Calcium (mg/dL)a |
8.9 ± 0.11 |
9.5 ± 0.13 |
8.8 ± 0.12 |
<0.01 |
a Values expressed as mean ± SE.
b ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
Overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
Inform patients to take calcium acetate tablets with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety and efficacy to take the drug one hour before or three hours after calcium acetate tablets.
Distributed by:
Avet Pharmaceuticals Inc.
East Brunswick, NJ 08816
1.866.901.DRUG (3784)
51U000000262US04
Revised: 04/2021