One-Alpha Special Precautions

During treatment with One-Alpha, serum calcium and serum phosphate levels should be monitored regularly. PTH, alkaline phosphatase and the calcium x phosphate product should be monitored as clinically indicated.
Hypercalcaemia might appear in patients treated with One-Alpha. For this reason, patients should be informed about the clinical symptoms connected with hypercalcaemia. Signs of hypercalcaemia are anorexia, fatigue, nausea and vomiting, constipation or diarrhoea, polyuria, sweating, headache, polydipsia, hypertension, somnolence and vertigo.
Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week).
One-Alpha may then be restarted at a reduced dose (half the previous dose) with monitoring of calcium.
Prolonged hypercalcaemia may aggravate arteriosclerosis, cardiac valve sclerosis or nephrolithiasis and therefore prolonged hypercalcaemia should be avoided when One-Alpha is used in these patients. Transient or even long-lasting deterioration of kidney function has been observed. One-Alpha should also be used with caution in patients with calcification of pulmonary tissue as this may result in cardiac disease.
In patients with renal bone disease or severely reduced renal function, a phosphate binding agent could be used simultaneously with alfacalcidol to prevent increased serum phosphate and potential metastatic calcification.
One-Alpha should be used with caution in patients with granulomatous diseases such as sarcoidosis where the sensitivity to vitamin D is increased due to increased hydroxylation activity.
Concurrent use of digitalis glycosides in the presence of hypercalcaemia due to vitamin D administration increases the potential for cardiac arrhythmias.
One-Alpha capsules contain sesame oil as an excipient. Sesame oil may rarely cause severe allergic reactions.
Effects on the ability to drive and use machines: Alfacalcidol has no or negligible direct influence on the ability to drive and use machines. However, the patient should be informed that dizziness may occur during treatment and take this account while driving and using machines.
Impairment of Fertility: There are no clinical studies on the effect of One-Alpha on fertility. A pre-clinical study did not show an effect on fertility in rats.