Bondronat

Ready for action

Indicated for
the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy1
and
the treatment of established
post-menopausal osteoporosis1

Why is Rocaltrol (calcitriol) ready for action?

“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 D1,2

Ready for action in renal osteodystrophy

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 kidneys2,4
  • 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 required1,5
  • 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

Ready for action in post-menopausal osteoporosis

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

Reassuring tolerability

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

References



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Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to ATNAHS Pharma UK Ltd on 00 44 (0) 1279 406759, or by email to athnahspv@diamondpharmaservices.com

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