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ONE-ALPHA is a brand name for Alfacalcidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: metabolism due to impaired 1 α-hydroxylation such as when there is reduced renal function. The main indications are: a) Renal osteodystrophy b) Hyperparathyroidism (with bone disease) c) Hypoparathyroidism d) Neonatal hypocalcaemia e) Nutritional and malabsorptive rickets and osteomalacia f) Pseudo-deficiency…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage of One-Alpha Injection is the same as for One-Alpha in its oral presentations. 05 microgram/kg/day The dose of One-Alpha should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response.
Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations. 25 to 1 microgram per day. When administered as intravenous injection to patients undergoing haemodialysis the initial dosage for adults is 1 microgram per dialysis.
The maximum dose recommended is 6 micrograms per dialysis and not more than 12 micrograms per week. The injection should be administered into the return line from the haemodialysis machine at the end of each dialysis. (a) Renal bone disease: Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to One-Alpha.
Other therapeutic measures may be indicated. Before and during treatment with One-Alpha, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.
(b) Hyperparathyroidism: In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with One-Alpha for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia.
In order to decrease post-operative hypocalcaemia, One-Alpha should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs. (c) Hypoparathyroidism: In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with One-Alpha.
g. 3-5 micrograms) together with calcium supplements. 1 microgram/kg/day (followed by careful titration), in severe cases, doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful.
5 times above the adult range indicates active disease. (e) Nutritional and malabsorptive rickets and osteomalacia: Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. The most frequently reported undesirable effects are various skin reactions such as pruritus and rash, hypercalcaemia, gastrointestinal pain/discomfort and hyperphosphataemia.
Renal failure has been reported post-marketing. Undesirable effects are listed by MedDRA system organ class (SOC) and the individual undesirable effects are listed starting with the most frequently reported one. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10 Common ≥1/100 to < 1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Metabolism and nutrition disorders Common: Hypercalcaemia Hyperphosphataemia Psychiatric disorders Not known: Confusional state Nervous system disorders Uncommon: Headache Rare: Dizziness Gastrointestinal disorders Common: Abdominal pain and discomfort Uncommon: Diarrhoea Vomiting Constipation Nausea Skin and subcutaneous tissue disorders Common: Rash* Pruritus *Various types of rash such as erythematous, maculo- papular and pustular have been reported Not known: Urticaria Musculoskeletal and connective tissue disorders Uncommon: Myalgia Renal and urinary disorders Common: Hypercalciuria Uncommon: Nephrolithiasis/ Nephrocalcinosis Not known: Renal impairment (including acute renal failure) General disorders and administration site conditions Uncommon: Fatigue/asthenia/malaise Calcinosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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During treatment with One-Alpha, serum calcium and serum phosphate levels should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. PTH, alkaline phosphatase and calcium phosphates 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 muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea and vomiting, constipation, polyuria, sweating, headache, polydipsia, hypertension and somnolence.
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 solution for injection contains up to 160 mg ethanol per dose (corresponding to 4 micrograms of alfacalcidol), which is equivalent to 10 vol%. 7 ml wine. The small amount of ethanol in One-Alpha will not have any noticeable effect.
1. Hypercalcaemia, metastatic calcification.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia: Although large doses of parent vitamin D would be required, effective doses of One- Alpha are similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia.
(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia: Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with One-Alpha at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention.
Phosphate supplements may also be required in some patients. Method of administration One-Alpha Injection should be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.
14 mmol sodium per dose (corresponding to 4 micrograms of alfacalcidol). Products containing less than 1 mmol sodium (23 mg) per dose are considered essentially ‘sodium-free’. 1 micrograms/kg/day of alfacalcidol). Caution should be exercised in children less than 4 weeks of age, in particular if the child is given other medicines that contain propylene glycol or alcohol.