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warnings
WARNINGS Overdosage of any form of vitamin D, including doxercalciferol injection is dangerous (see OVERDOSAGE ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The serum calcium times serum phosphorus (Ca X P) product should be maintained at < 55 mg 2 /dL 2 in patients with chronic kidney disease. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Since doxercalciferol is a precursor for 1α,25-(OH) 2 D 2 , a potent metabolite of vitamin D 2 , pharmacologic doses of vitamin D and its derivatives should be withheld during doxercalciferol injection treatment to avoid possible additive effects and hypercalcemia. Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis. Uncontrolled serum phosphorus exacerbates secondary hyperparathyroidism and can lessen the effectiveness of doxercalciferol injection in reducing blood PTH levels. If hypercalcemia occurs after initiating doxercalciferol injection therapy, the dose of doxercalciferol injection and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating doxercalciferol injection, the dose of doxercalciferol injection should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for doxercalciferol injection under DOSAGE AND ADMINISTRATION .) Magnesium-containing antacids and doxercalciferol injection should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
ADVERSE REACTIONS Doxercalciferol injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral doxercalciferol) 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 doxercalciferol injection, Table 4 provides the adverse event incidence rates from placebo-controlled studies of oral doxercalciferol. Table 4: Adverse Events Reported by ≥ 2% of Doxercalciferol-Treated Patients and More Frequently than Placebo During the Double-Blind Phase of Two Clinical Studies Adverse Event A patient who reported the same medical term more than once was counted only once for that medical term. Doxercalciferol Injection (n = 61) % Placebo (n = 61) % Body as a Whole Abscess 3.3 0 Headache 27.9 18 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 Metabolic and Nutritional Edema 34.4 21.3 Weight Increase 4.9 0 Nervous System Dizziness 11.5 9.8 Sleep Disorder 3.3 0 Respiratory System Dyspnea 11.5 6.6 Skin Pruritus 8.2 6.6 Potential adverse effects of 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.