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Hectorol (doxercalciferol injection) Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral Hectorol (doxercalciferol injection) ) 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 (doxercalciferol injection) Injection, Table 4 provides the adverse event incidence rates from placebo-controlled studies of oral Hectorol (doxercalciferol injection) .

Table 4: Adverse Events Reported bv z 2% of Hectorol (doxercalciferol injection) Treated Patients and More Freauentlv Than Placebo Durino 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 (doxercalciferol injection) 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.