ADVERSE REACTIONS
Dialysis:
Hectorol® has been evaluated for safety in clinical studies in 165 patients with chronic kidney disease on hemodialysis. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol® for four to six months (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in 3.3% of 61 patients treated with placebo for two months. Adverse events occurring in the Hectorol® group at a frequency of 2% or greater and more frequently than in the placebo group are presented in the following table:
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)
% |
|---|
| A patient who reported the same medical term more than once was counted only once for that medical term. |
| 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 |
Predialysis:
Hectorol® has been evaluated for safety in clinical studies in 55 patients (27 active and 28 placebo) with chronic kidney disease, Stages 3 or 4. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in one (3.7%) of 27 patients treated with Hectorol® for 24 weeks (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in three (10.7%) of 28 patients treated with placebo for 24 weeks. Adverse events occurring in the Hectorol® group at a frequency of 5% or greater and more frequently than in the placebo group are as follows: Body as a Whole – Infection, Chest Pain; Digestive System – Constipation, Dyspepsia; Hematologic and Lymphatic – Anemia; Metabolic and Nutritional – Dehydration; Nervous System – Depression, Hypertonia, Insomnia, Paresthesia; Respiratory System – Cough increased, Dyspnea, Rhinitis.
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, metallic taste, and anorexia.
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, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
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