Drugs List

Therapeutic Indications

Uses

Vitamin D deficiency

Administration

To be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

Contraindications

Hypercalcaemia
Metastatic calcification
Pregnancy

Precautions and Warnings

Tissue calcification
Arteriosclerosis
Breastfeeding
Hereditary fructose intolerance
Nephrolithiasis
Sarcoidosis
Valvular heart disease

Renal failure increases risk of hypercalcaemia
Advise patient dizziness may affect ability to drive or operate machinery
Overdose potential.Prescriber- state dose in micrograms(not mls)+frequency
Injection contains propylene glycol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations may contain alcohol
Some products contain sesame oil
Some products may contain arachis (peanut) oil
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor parathyroid hormone levels
Monitor plasma calcium
Monitor serum alkaline phosphatase levels periodically
Monitor serum phosphate levels
Discontinue if hypercalcaemia occurs
Female: Ensure adequate contraception during treatment

Serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses.

In patients with chronic renal failure prolonged hypercalcaemia may aggravate the decline of renal function.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone as well as radiographic and histological investigations.

Use with caution in patients being treated with cardiac glycosides as hypercalcaemia may lead to arrhythmias in these patients.

Interrupt therapy if hypercalcaemia occurs until plasma levels return to normal (in approximately 1 week). Therapy with alfacalcidol may be restarted at half the previous dose with monitoring of calcium.

Early symptoms of hypercalcaemia are muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea and vomiting , constipation, polyuria, sweating, headache, polydipsia, hypertensionand somnolence.

Pregnancy and Lactation

Pregnancy

Alfacalcidol is contraindicated in pregnancy.

Animal studies have shown reproductive toxicity at high doses. As such, alfacalcidol is not recommended during pregnancy and in women of child-bearing potential not using contraception.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Alfacalcidol should be used with caution in breastfeeding.

Safety has not been established. It is likely that increased amounts of 1,25-dihydroxyvitamin D will be found in breast milk and may influence the calcium metabolism of breast fed infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal discomfort
Abdominal pain
Asthenia
Calcinosis (injection site)
Confusion
Constipation
Diarrhoea
Dizziness
Fatigue
Headache
Hypercalcaemia
Hypercalciuria
Hyperphosphataemia
Malaise
Myalgia
Nausea
Nephrocalcinosis
Nephrolithiasis
Pruritus
Rash
Renal impairment
Urticaria
Vomiting

Presentation

Solution for injection containing alfacalcidol.

Drugs List

Therapeutic Indications

Uses

Vitamin D deficiency

Dosage

Adults

Elderly

Children

Neonates

Patients with Renal Impairment

Additional Dosage Information

Administration

To be administered intravenously as a bolus over approximately 30 seconds. Shake the ampoule for a minimum of 5 seconds before use.

Contraindications

Hypercalcaemia
Metastatic calcification
Pregnancy

Precautions and Warnings

Tissue calcification
Arteriosclerosis
Breastfeeding
Hereditary fructose intolerance
Nephrolithiasis
Sarcoidosis
Valvular heart disease

Renal failure increases risk of hypercalcaemia
Advise patient dizziness may affect ability to drive or operate machinery
Overdose potential.Prescriber- state dose in micrograms(not mls)+frequency
Injection contains propylene glycol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations may contain alcohol
Some products contain sesame oil
Some products may contain arachis (peanut) oil
Breastfeeding: Hypercalcaemia of infant possible if mother taking vitamin D
Monitor parathyroid hormone levels
Monitor plasma calcium
Monitor serum alkaline phosphatase levels periodically
Monitor serum phosphate levels
Discontinue if hypercalcaemia occurs
Female: Ensure adequate contraception during treatment

Serum calcium and serum phosphate should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses.

In patients with chronic renal failure prolonged hypercalcaemia may aggravate the decline of renal function.

Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone as well as radiographic and histological investigations.

Use with caution in patients being treated with cardiac glycosides as hypercalcaemia may lead to arrhythmias in these patients.

Interrupt therapy if hypercalcaemia occurs until plasma levels return to normal (in approximately 1 week). Therapy with alfacalcidol may be restarted at half the previous dose with monitoring of calcium.

Early symptoms of hypercalcaemia are muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea and vomiting , constipation, polyuria, sweating, headache, polydipsia, hypertensionand somnolence.

Pregnancy and Lactation

Pregnancy

Alfacalcidol is contraindicated in pregnancy.

Animal studies have shown reproductive toxicity at high doses. As such, alfacalcidol is not recommended during pregnancy and in women of child-bearing potential not using contraception.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Alfacalcidol should be used with caution in breastfeeding.

Safety has not been established. It is likely that increased amounts of 1,25-dihydroxyvitamin D will be found in breast milk and may influence the calcium metabolism of breast fed infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal discomfort
Abdominal pain
Asthenia
Calcinosis (injection site)
Confusion
Constipation
Diarrhoea
Dizziness
Fatigue
Headache
Hypercalcaemia
Hypercalciuria
Hyperphosphataemia
Malaise
Myalgia
Nausea
Nephrocalcinosis
Nephrolithiasis
Pruritus
Rash
Renal impairment
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2017

Reference Sources

Summary of Product Characteristics: One-Alpha Injection. Leo Laboratories Ltd. Revised March 2017.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 17 August 2017