Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Doxercalciferol is a synthetic vitamin D2 analog. It requires metabolic activation to form the active 1α, 25-dihydroxyvitamin D2 (1α,25-(OH)2D2) metabolite, which binds to the vitamin D receptor (VDR) to result in the selective activation of vitamin D responsive pathways. Vitamin D and Doxercalciferol have been shown to reduce PTH levels by inhibiting PTH synthesis and secretion.
Most common side effects are infection/bacterial infection/viral infection, constipation, rhinitis, anemia, cough, dyspnea, paresthesia, asthenia, insomnia, hypertonia and angina pectoris.
Hypercalcemia can occur during treatment with doxercalciferol and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. Anaphylaxis, with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath and cardiopulmonary arrest, has been reported in hemodialysis patients after administration of doxercalciferol. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a hypersensitivity reaction occur, discontinue and treat if indicated. Adynamic bone disease may develop and increase risk of fractures if intact PTH levels are suppressed to abnormally low levels. Monitor intact PTH levels to avoid oversuppression and adjust dose if needed. More frequent monitoring of intact PTH, calcium and phosphorus levels should be done in patients with hepatic impairment.
Overdosage of doxercalciferol may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. The treatment of acute overdosage should consist of supportive measures and discontinuation of doxercalciferol administration. Serum calcium levels should be measured until normal. It is expected that doxercalciferol is not removed from the blood by dialysis.
Keep away from the reach of children. Store in a cool (below 25°C) & dry place protected from light. After first use, unused portion can be stored for 3 days in a refrigerator at 2°C to 8°C if required.
