NATPARA Safety Profile
Adverse reactions reported in NATPARA clinical trials1
Adverse Reactions Reported in ≥5% of Patients and Occurring More Commonly With NATPARA Compared to Placebo in Phase 3 Study (REPLACE)1
Common Adverse Reactions Associated With NATPARA Use in Patients With Hypoparathyroidism1
Adverse Reaction
Placebo
(n=40)
%
NATPARA
(n=84)
%
Paraesthesia
25
31
Hypocalcemia*
23
27
Headache
23
25
Hypercalcemia*
3
19
Nausea
18
18
Hypoaesthesia
10
14
Diarrhea
3
12
Vomiting
0
12
Arthralgia
10
11
Hypercalciuria*
8
11
Pain in extremity
8
10
Upper respiratory tract infection
5
8
Abdominal pain upper
3
7
Sinusitis
5
7
Blood 25-hydroxycholecalciferol decreased
3
6
Hypertension
5
6
Hypoaesthesia facial
3
6
Neck pain
3
6
Hypocalcemia combines reported events of hypocalcemia and blood calcium decreased, hypercalciuria combines reported events of hypercalciuria and urine calcium increased, and hypercalcemia combines reported events of hypercalcemia and blood calcium increased.
-
Hypercalcemia1
- In the overall pivotal trial a greater proportion of patients on NATPARA had albumin-corrected serum calcium above the normal range (8.4–10.6 mg/dL)
- More patients randomized to NATPARA had hypercalcemia in both the titration and maintenance phase of the studya
-
Hypocalcemia1
- The risk of hypocalcemia increases with NATPARA withdrawal. At the end of the trial, NATPARA and placebo were withdrawn; calcium and active vitamin D were returned to baseline doses; and patients were followed for 4 weeks
- During this withdrawal phase, 20 subjects (24%) previously randomized to NATPARA experienced adverse reactions of hypocalcemia in the post-treatment phase compared to 3 (8%) on placebo
All trial participants underwent a 50% reduction in active vitamin D dose at randomization.
Reference: 1. NATPARA [package insert]. Shire Pharmaceuticals, Inc.