Dialysis: Hectorol^Ò has been evaluated for safety in clinical studies in 165 patients with chronic kidney disease on hemodialysis. In two placebo-controlled, double-blind, multicen-ter studies, discontinuation of therapy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol^Ò 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^Ò 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^Ò Treated Patients and More Frequently Than Placebo During the Double-blind Phase of Two Clinical Studies

A patient who reported the same medical term more than once was counted only once for that medical term. Predialysis: Hectorol^Ò 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^Ò 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^Ò 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^Ò 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:

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreati-tis, 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.

Specific drug interaction studies have not been conducted. Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; therefore, it may impair intestinal absorption of doxercalciferol. Magnesium-containing antacids and Hectorol^Ò should not be used concomitantly because such use may lead to the development of hypermagnesemia (see WARNINGS). The use of mineral oil or other substances that may affect absorption of fat may influence the absorption and availability of Hectorol^Ò. Although not examined specifically, enzyme inducers (such as glutethimide and phenobarbital) may affect the 25-hydroxy-lation of Hectorol^Ò and may necessitate dosage adjustments. Cytochrome P450 inhibitors (such as ketoconazole and erythromycin) may inhibit the 25-hydroxylation of Hectorol^Ò. Hence, formation of the active Hectorol^Ò moiety may be hindered.

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