ROCALTROL

What it is

Rocaltrol contains calcitriol 0.25 micrograms per capsule. The capsules are soft and opaque, coloured half brown-orange to red-orange and half white to grey-yellow or grey-orange.

Approved indications

— Treatment of established osteoporosis diagnosed by objective measuring techniques such as densitometry, or by radiographic evidence of a traumatic fracture. — Prevention of corticosteroid-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in significant bone loss. — Treatment of hypocalcaemia in patients with uraemic osteodystrophy, hypoparathyroidism and hypophosphataemic rickets.

Dosing overview

The optimal daily dose of Rocaltrol must be carefully determined for each patient and indication, with dosage optimisation accompanied by regular monitoring of serum calcium concentration. For corticosteroid-induced osteoporosis, dietary calcium intake should not exceed 1000 mg per day.

Key safety warnings

A strong relationship exists between calcitriol therapy and the development of hypercalcaemia, with up to 40% of patients receiving calcitriol treatment in some trials of uraemic osteodystrophy becoming hypercalcaemic. Chronic hypercalcaemia can lead to generalised vascular calcification, nephrocalcinosis and other soft-tissue calcification. As serum calcium nears hypercalcaemic levels, the dosage of Rocaltrol should be substantially reduced or treatment stopped altogether until normocalcaemia ensues; if hypercalcaemia occurs, the drug should be immediately discontinued. Since Rocaltrol is the most potent metabolite of vitamin D available, other vitamin D compounds should be withheld during treatment to avoid the development of hypervitaminosis D. Although adequate dietary intake of calcium is important in patients with postmenopausal osteoporosis, calcitriol increases calcium absorption in these patients and calcium supplements may lead to hypercalcaemia and are not recommended unless dietary intake is clearly inadequate. Special care should be taken when administering Rocaltrol to patients with renal dysfunction, with more frequent monitoring appropriate in these patients. Paediatric patients on long-term treatment with calcitriol are at risk of development of nephrocalcinosis, with the risk increasing with younger age at commencement of therapy and higher doses of calcitriol needed.

Contraindications

Hypercalcaemia or Vitamin D toxicity. Hypersensitivity to calcitriol or drugs of the same class, or any of the excipients in Rocaltrol.

PBS listing

Rocaltrol 0.25 microgram capsules are listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$17.12.

Regulatory history

Rocaltrol calcitriol 0.25 microgram capsules were first registered on the ARTG on 18 March 2003.