ADVERSE REACTIONS
Hectorol Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral Hectorol) from two 12-week, open-label, single-arm, multi-centered studies. (Dosage titrated to achieve target plasma iPTH levels, see CLINICAL PHARMACOLOGY / Clinical Studies.)
Because there was no placebo group included in the studies of Hectorol Injection, the table below provides the adverse event incidence rates from placebo-controlled studies of oral Hectorol.
Adverse Events Reported by >/=2% of Hectorol Treated
Patients and More Frequently Than Placebo
During the Double-blind Phase of Two Clinical Studies
| Adverse Event |
Hectorol (n=61)
%
|
Placebo (n=61)
%
|
| Body as a Whole |
|
Abscess
|
3.3
|
0.0
|
|
Headache
|
27.9
|
18.0
|
|
Malaise
|
27.9
|
19.7
|
| Cardiovascular System |
|
Bradycardia
|
6.6
|
4.9
|
| Digestive System |
|
Anorexia
|
4.9
|
3.3
|
|
Constipation
|
3.3
|
3.3
|
|
Dyspepsia
|
4.9
|
1.6
|
|
Nausea/Vomiting
|
21.3
|
19.7
|
| Musculo-Skeletal System |
|
Arthralgia
|
4.9
|
0.0
|
| Metabolic and Nutritional |
|
Edema
|
34.4
|
21.3
|
|
Weight increase
|
4.9
|
0.0
|
| Nervous System |
|
Dizziness
|
11.5
|
9.8
|
|
Sleep disorder
|
3.3
|
0.0
|
| Respiratory System |
|
Dyspnea
|
11.5
|
6.6
|
| Skin |
|
Pruritus
|
8.2
|
6.6
|
|
A patient who reported the same medical term more than once was counted only once for that medical term.
|
|
Potential adverse effects of Hectorol are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
EARLY
Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, and metallic taste.
LATE
Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias and, rarely, overt psychosis.
|
