Skip to main content

Dialysis

Hectorol (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3 below:

Table 3: Adverse Events Reported by ≥ 2% of Hectorol® (doxercalciferol liquid filled capsule) 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
Musculoskeletal 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.

Pre-dialysis

Hectorol (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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.