“The classical actions of vitamin D – which by itself is inactive – are due to the functions of the active metabolite, calcitriol.²”

Rocaltrol is calcitriol and therefore ‘ready for action’ since it is the active metabolite of vitamin D^1,2

Rocaltrol is indicated in renal osteodystrophy¹

• Rocaltrol is indicated for the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy

A rationale for Rocaltrol in renal osteodystrophy

• Calcitriol, the biologically active form of vitamin D, is produced in the kidneys^2,4
• Vitamin D products, such as over-the-counter vitamin D, need to be activated⁵
• The defective production of calcitriol in chronic renal failure contributes to abnormalities of mineral metabolism, found in renal osteodystrophy¹
• Rocaltrol provides active calcitriol, therefore conversion in the kidneys is not required^1,5
• Calcitriol is the most active vitamin D metabolite available¹

Rocaltrol dosage in renal osteodystrophy¹

• The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response, so as to avoid hypercalcaemia
• Initial daily dose: 0.25 mcg of Rocaltrol
• In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient
• If no satisfactory response in the biochemical parameters and clinical manifestations of the disease is observed within 2–4 weeks, the daily dosage may be increased by 0.25 mcg at 2–4-week intervals
• During this period, serum calcium levels should be determined at least twice weekly. Should they rise to 1 mg/100 ml (250 μmol/l) above normal (9–11 mg/100 ml or 2250–2750 μmol/l), or if serum creatinine rises to >120 μmol/l, stop Rocaltrol immediately until normocalcaemia ensues
• Most patients respond to between 0.5 mcg and 1.0 mcg daily
• Rocaltrol pulse therapy: an initial dosage of 0.1 mcg/kg/week split into two or three equal doses given at the end of the dialysis has been shown to be effective in patients with renal osteodystrophy refractory to continuous therapy. Do not exceed a maximum total cumulative dosage of 12 mcg/week

Refer to the Summary of Product Characteristics for more information

Rocaltrol is indicated in osteoporosis¹

• Rocaltrol is indicated for the treatment of established post-menopausal osteoporosis

A rationale for Rocaltrol in osteoporosis

• The process of making vitamin D in the skin becomes less efficient with age⁶
• A reduced appetite may also lessen vitamin D intake from food⁶
• Rocaltrol requires no metabolism in the kidneys – it is calcitriol and ready for action⁵

Use with other osteoporosis treatments¹

• If dietary intake of vitamin D is inadequate, a supplement such as Rocaltrol can provide active calcitriol¹ as an adjunct to osteoporosis treatments such as bisphosphonates⁷

Rocaltrol dosage in osteoporosis

• The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response, so as to avoid hypercalcaemia¹
• Recommended dose: 0.25 mcg twice daily¹ – Serum calcium and creatinine levels should be determined at 1, 3 and 6 months and then at 6-monthly intervals

Rocaltrol tolerability profile¹

Since calcitriol exerts vitamin D activity, adverse effects may occur that are similar to those seen when an excessive dose of vitamin D is taken.

The most commonly reported adverse reaction from investigational studies and post-marketing surveillance is hypercalcaemia. 15 years' post-marketing surveillance noted an occurrence rate of 0.001% or less.

• Very common (≥1/10): hypercalcaemia
• Common (≥1/100 to <1/10): headache, abdominal pain, nausea, rash, urinary tract infection

Rocaltrol should not be used:¹

• In any disease associated with hypercalcaemia
• In patients with metastatic calcification
• In patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the constituent excipients
• Where there is evidence of vitamin D toxicity

Minimising potential of hypercalcaemia¹

• In order to avoid an excessive dose of vitamin D, all other vitamin D preparations, compounds and their derivatives should be withheld during Rocaltrol treatment
• Patients and families should be advised regarding adherence to the prescribed diet and understand how to recognise hypercalcaemia symptoms
• If serum calcium levels rise to 1 mg/100 ml (250 μmol/l) above normal or serum creatinine rises to >120 μmol/l, discontinue treatment immediately until normocalcaemia ensues
• Due to the short biological half-life of calcitriol, normalisation of elevated serum calcium has been shown to occur within a few days of treatment withdrawal; i.e. much faster than in treatment with vitamin D3 preparations
• If switching from a long-acting vitamin D preparation (e.g. ergocalciferol [vitamin D2] or colecalciferol [vitamin D3]) to Rocaltrol, it may take several months for the ergocalciferol level in the blood to return to the baseline value – caution should be exercised due to the risk of hypercalcaemia in this period

For full details refer to the Summary of Product Characteristics