Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Alfacalcidol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for One-Alpha contains the active substance alfacalcidol. One-Alpha belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth. One-Alpha works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. One-Alpha is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat:
e One-Alpha® Do not have One-Alpha
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•
If you know that you have a condition called calcification. This means you have high levels of calcium in your body tissues. If you are unsure if any of the above apply to you, talk to your doctor before having One-Alpha. Warnings and precautions Talk to your doctor or nurse before having One-Alpha
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One-Alpha contains:
3.
One-Alpha®
One-Alpha will be given to you by a doctor or nurse. How much One-Alpha to have Your doctor or nurse will give you One-Alpha because it is an injection. This injection goes into your vein. This may be called IV (intravenous) by your doctor or nurse. At first you will have weekly blood tests to check the levels of some substances in your blood. These tests are to check the levels of calcium, an enzyme called alkaline phosphatase or the parathyroid hormone. This is so your doctor knows that you are having the dose that is right for you. When you are getting the correct dose you will not need blood tests so often. You may also have other tests such as X-rays. This is also so your doctor knows that the dose is right for you. Your doctor may adjust your dose. Your doctor may ask you to have more or less medicine depending on your test results. You may get too much calcium or phosphate in your blood when you have this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor will tell you not to have any more medicine. You will need to have some blood tests. When the blood tests are normal you can start your medicine again. It is important that you only have half the dose you had before. Adults and children weighing more than 20 kilograms: The usual starting dose is 1 microgram each day. People usually have between 1 and 3 micrograms each day. Most people have between 0.25 and 1 microgram each day once the blood test results show the medicine is working. If you have very low levels of calcium in your blood, the doctor may prescribe between 3 and 5 micrograms each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as One-Alpha. This will help to keep the right amount of calcium in your blood. Elderly: The usual starting dose is 0.5 microgram each day.
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Children: The dose depends on the weight of the child (called bodyweight). Newborn and premature babies: The usual starting dose is 0.05 to 0.1 microgram per kilogram of bodyweight each day. If the level of calcium in their blood is very low, up to 2 micrograms per kilogram of bodyweight may be needed each day. A dose of 0.1 microgram per kilogram bodyweight each day is used to stop low blood calcium levels in premature babies. Children weighing less than 20 kilograms: The usual starting dose is 0.05 microgram per kilogram bodyweight each day. If you have more One-Alpha than you should Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away. You may need to stop having this medicine. You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. If you forget to have One-Alpha Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse. If you have any further questions on the use of this medicine, please ask your doctor, pharmacist or nurse.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects to look out for: You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood. These side effects may affect up to 1 in 10 people:
Kidney problems:
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Headache Diarrhoea, vomiting, constipation, nausea Muscle pain Fatigue Calcinosis (deposits of calcium in the body) Feeling weak or unwell.
Rare possible side effects which may affect up to 1 in 1,000 people are:
with unknown frequency (cannot be estimated from the available data):
One-Alpha® • • • •
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that month. Store at 2 to 8oC (in a refrigerator). Keep the ampoule in the outer carton in order to protect it from light.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What One-Alpha contains
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You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What One-Alpha looks like and contents of the pack One-Alpha is a clear colourless solution for injection. One-Alpha comes in one-point-cut amber glass ampoules containing 0.5 or 1 ml. There are 10 ampoules in a carton. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom Manufacturer:
CENEXI SAS, 52 rue Marcel et Jacques Gaucher, 94120 Fontenaysous-Bois, France.
This leaflet was last revised in February 2022.
®
Registered Trade Mark
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One-Alpha 2 microgram/ml injection comes as injection containing 2microgram/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in One-Alpha 2 microgram/ml injection is alfacalcidol.
This leaflet reproduces the patient information leaflet approved for One-Alpha 2 microgram/ml injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
One-Alpha is indicated in all conditions where there is a disturbance of calcium 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 (D-dependent) rickets and osteomalacia
g) Hypophosphataemic vitamin D resistant rickets and osteomalacia.
Posology
The dosage of One-Alpha Injection is the same as for One-Alpha in its oral presentations.
Initial dose for all indications:
Adults and children over 20 kg bodyweight:
1 microgram/day
Elderly:
0.5 microgram/day
Neonates and premature infants:
0.05-0.1 microgram/kg/day
Children under 20 kg bodyweight:
0.05 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.
Maintenance doses are generally in the range of 0.25 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. Severe hypocalcaemia is corrected more rapidly with higher doses of One-Alpha (e.g. 3-5 micrograms) together with calcium supplements.
(d) Neonatal hypocalcaemia:
Although the normal starting dose of One-Alpha is 0.05-0.1 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. Levels of alkaline phosphatase approximately 7.5 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.
(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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypercalcaemia, metastatic calcification.
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%. The amount of ethanol in each dose of One-Alpha is equivalent to 4 ml beer or 1.7 ml wine. The small amount of ethanol in One-Alpha will not have any noticeable effect.
One-Alpha solution for injection contains 0.14 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'.
One-Alpha solution for injection contains 415 mg propylene glycol per ml which is equivalent to 20.75 mg/kg/day (corresponding to 0.1 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.
Thiazide diuretics and calcium containing preparations
Concurrent use of thiazide diuretics or calcium containing preparations may enhance the risk of hypercalcaemia. Calcium levels should be monitored.
Other vitamin D containing preparations
Concurrent use of other vitamin D containing preparations may enhance the risk of hypercalcaemia. Use of multiple vitamin D analogues should be avoided.
Anticonvulsants
Anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone) have enzyme-inducing effects resulting in an increased metabolism of alfacalcidol. Patients taking anticonvulsants may require larger doses of One-Alpha.
Magnesium-containing antacids
Absorption of magnesium-containing antacids may be enhanced by One-Alpha, increasing the risk of hypermagnesaemia.
Aluminium-containing preparations
One-Alpha may increase the serum concentration of aluminium. Patients taking aluminium containing preparations (e.g. aluminium hydroxide, sucralfate) should be monitored for signs of aluminium related toxicities.
Pregnancy
There is a limited amount of data from the use of alfacalcidol in pregnant women. Studies in animals have shown reproductive toxicity at high doses.
Therefore, One-Alpha is not recommended during pregnancy and in women of child- bearing potential not using contraception.
Breast-feeding
Although it has not been established, it is likely that increased amounts of 1,25- dihydroxyvitamin D will be found in the milk of lactating mothers treated with One- Alpha. This may influence calcium metabolism in the infant.
Consequently, breast-fed infants of alfacalcidol-using mothers should be monitored closely for hypercalcaemia.
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.
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 into account while driving or using machines.
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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Excessive intake of One-Alpha may lead to the development of hypercalcaemia, however, the effect is reversed rapidly on withdrawal.
In severe cases of hypercalcaemia general supportive measures should be undertaken: Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices, assess electrocardiographic abnormalities, especially in patients using digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about One-Alpha 2 microgram/ml injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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