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^® .

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.

Specific drug interaction studies have not been conducted. Magnesium-containing antacids and Hectorol^® should not be used concomitantly because such use may lead to the development of hypermagnesemia (see WARNINGS). Although not examined specifically, enzyme inducers (such as glutethimide and phenobarbitol) may affect the 25-hydroxylation of Hectorol^® and may necessitate dosage adjustments. Cytochrome P450 inhibitors (such as ketoconazole and erythromycin) may inhibit the 25-hydroxylation of Hectorol^® . Hence, formation of the active Hectorol^® moiety may be hindered.

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