VISTELLA

What it is

VISTELLA is a medicine containing calcifediol monohydrate, with each capsule containing 255 micrograms of calcifediol. It is an orange soft gelatin capsule containing a clear, low viscosity liquid and free from particles. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment of vitamin D deficiency in adults, and maintenance treatment as required.

Dosing overview

The standard dose is one capsule (255 micrograms of calcifediol) once a month. Higher doses may be necessary in some patients after analytical verification of the extent of vitamin D deficiency, with the maximum dose not exceeding one capsule per fortnight. Once plasma levels of 25(OH)D are stabilised within the desired range, treatment should be discontinued or the frequency of administration lowered. Serum concentrations of 25(OH)D should be monitored after initiation of treatment, usually after three to four months or as per doctor's recommendations. VISTELLA must not be administered daily.

Key safety warnings

An appropriate dietary calcium intake is required for adequate clinical response, and parameters including serum calcium, phosphorus and alkaline phosphatase, as well as urinary calcium and phosphorus in 24 hours, should be monitored in addition to 25(OH)D. A decrease in serum levels of alkaline phosphatase normally precedes the onset of hypercalcemia. Use of VISTELLA in patients with chronic kidney disease should be accompanied by periodic monitoring of serum calcium and phosphorus, and hypercalcemia prevention. In cases of severe renal impairment (creatinine clearance of less than 30 mL/min) a very significant reduction in the pharmacological effects may occur. Special caution is required in patients with heart failure, with constant monitoring of serum calcium especially in those on digitalis, because hypercalcemia may occur and arrhythmias can appear; twice weekly tests are recommended at the beginning of treatment. Use of vitamin D by people with primary hyperparathyroidism increases the risk of hypercalcaemia and hypercalciuria, and serum calcium should be monitored closely. Patients with sarcoidosis, tuberculosis or other granulomatous diseases should be administered VISTELLA with caution, since these conditions lead to greater sensitivity to vitamin D effects; serum and urinary calcium concentrations must be monitored.

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients. Hypercalcemia (serum calcium greater than 2.620 mmol/L) or hypercalciuria, calcium lithiasis, and hypervitaminosis D.

PBS listing

No PBS listing information is available in the provided documents.

Regulatory history

The TGA approved VISTELLA (calcifediol) for the treatment of vitamin D deficiency in adults and for maintenance treatment as required on 16 July 2024, with the product subsequently entered onto the ARTG on 6 March 2025. The quality evaluation found VISTELLA to be a stable soft gelatin capsule containing 255 micrograms of calcifediol, with manufacturing sites having appropriate GMP clearances. Nonclinical evaluation found no objection to registration, with calcifediol's primary pharmacology aligning with known vitamin D functions and its safety profile being acceptable when 25(OH)D levels are monitored.