Drugs List

Therapeutic Indications

Uses

Acute bone loss due to sudden immobilisation: Prophylaxis
Hypercalcaemia due to malignant disease
Paget's disease of bone

Administration

For subcutaneous, intramuscular injection or intravenous infusion. Allow solution to reach room temperature prior to use.

Contraindications

Neonates under 1 month
Hypocalcaemia

Precautions and Warnings

Children 1 month to 18 years
Breastfeeding
Cardiac failure
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Children under 18: Treatment to be initiated/supervised by a specialist
If nausea occurs patient should take dose at bedtime or after an antiemetic
Monitor bone growth in children
Monitor serum calcium levels regularly from starting treatment
Perform skin test on patients at risk of hypersensitivity to ingredients
Antibodies to ingredient may develop
Increased risk of cancer with long term use
Maintain treatment at the lowest effective dose
Limit use to short periods only in children under 18 years

Studies have shown that calcitonin is associated with a significant increase in the risk of cancer. Patients in these studies were treated with oral or intra-nasal formulations, however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations.

Skin reactions should be differentiated from generalised/local flushing which are common, non allergic effects of calcitonin.

Pregnancy and Lactation

Pregnancy

Calcitonin should be used with caution during pregnancy and only when considered essential.

At the time of writing there is insufficient information available to assess the effects of calcitonin on the foetus. Rabbits given higher than normal doses of calcitonin showed a reduction in the foetal birth weight, possibly due to metabolic effects on the mother (Briggs 2015). Calcitonin (salmon) does not cross the placenta, however, marked increase in the foetal serum concentration of calcitonin greater than that of the mother have been observed at term. The significance of this observation is unknown (Briggs 2015). The manufacturer recommends that calcitonin (salmon) should be used only when considered essential by the physician in pregnant women but also states that animal data indicate that calcitonin (salmon) is devoid of teratogenic or embryotoxic potential.

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

Use with caution during breastfeeding.

At the time of writing, there are no studies reporting the use of calcitonin during breastfeeding. It is not known whether calcitonin is excreted in breast milk although it would not be expected due to its high molecular weight (Briggs 2015). Calcitonin (salmon) has been shown to inhibit lactation in animals (Briggs, 2015) though it is unknown whether this effect would also be expected in humans. Calcitonin should be used with caution during breast feeding. The manufacturer recommends that its use should be avoided in breastfeeding mothers.

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 pain
Allergic reaction
Anaphylaxis
Antibody formation
Arthralgia
Bronchospasm
Cough
Decrease in plasma calcium
Diarrhoea
Dizziness
Dysgeusia
Fatigue
Flushing
Headache
Hypersensitivity reactions
Hypertension
Influenza-like syndrome
Local reaction at injection site
Malignancies
Musculoskeletal pain
Nausea
Oedema
Polyuria
Pruritus
Rash
Throat swelling
Tongue swelling
Tremor
Visual disturbances
Vomiting

Presentation

Solution for injection or infusion containing calcitonin (salmon)

Drugs List

Therapeutic Indications

Uses

Acute bone loss due to sudden immobilisation: Prophylaxis
Hypercalcaemia due to malignant disease
Paget's disease of bone

Dosage

Dose may be administered at bedtime or following an antiemetic to reduce the incidence of nausea and vomiting which may occur, especially at the initiation of therapy.

Adults

Children

Administration

For subcutaneous, intramuscular injection or intravenous infusion. Allow solution to reach room temperature prior to use.

Contraindications

Neonates under 1 month
Hypocalcaemia

Precautions and Warnings

Children 1 month to 18 years
Breastfeeding
Cardiac failure
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Children under 18: Treatment to be initiated/supervised by a specialist
If nausea occurs patient should take dose at bedtime or after an antiemetic
Monitor bone growth in children
Monitor serum calcium levels regularly from starting treatment
Perform skin test on patients at risk of hypersensitivity to ingredients
Antibodies to ingredient may develop
Increased risk of cancer with long term use
Maintain treatment at the lowest effective dose
Limit use to short periods only in children under 18 years

Studies have shown that calcitonin is associated with a significant increase in the risk of cancer. Patients in these studies were treated with oral or intra-nasal formulations, however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations.

Skin reactions should be differentiated from generalised/local flushing which are common, non allergic effects of calcitonin.

Pregnancy and Lactation

Pregnancy

Calcitonin should be used with caution during pregnancy and only when considered essential.

At the time of writing there is insufficient information available to assess the effects of calcitonin on the foetus. Rabbits given higher than normal doses of calcitonin showed a reduction in the foetal birth weight, possibly due to metabolic effects on the mother (Briggs 2015). Calcitonin (salmon) does not cross the placenta, however, marked increase in the foetal serum concentration of calcitonin greater than that of the mother have been observed at term. The significance of this observation is unknown (Briggs 2015). The manufacturer recommends that calcitonin (salmon) should be used only when considered essential by the physician in pregnant women but also states that animal data indicate that calcitonin (salmon) is devoid of teratogenic or embryotoxic potential.

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

Use with caution during breastfeeding.

At the time of writing, there are no studies reporting the use of calcitonin during breastfeeding. It is not known whether calcitonin is excreted in breast milk although it would not be expected due to its high molecular weight (Briggs 2015). Calcitonin (salmon) has been shown to inhibit lactation in animals (Briggs, 2015) though it is unknown whether this effect would also be expected in humans. Calcitonin should be used with caution during breast feeding. The manufacturer recommends that its use should be avoided in breastfeeding mothers.

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

Counselling

Advise patients dose may be administered at bedtime or following an antiemetic to reduce the incidence of nausea and vomiting which may occur, especially at the initiation of therapy.

Patients must be warned that fatigue, visual disturbances and transient dizziness may occur, in which case they should not drive or use machines.

Side Effects

Abdominal pain
Allergic reaction
Anaphylaxis
Antibody formation
Arthralgia
Bronchospasm
Cough
Decrease in plasma calcium
Diarrhoea
Dizziness
Dysgeusia
Fatigue
Flushing
Headache
Hypersensitivity reactions
Hypertension
Influenza-like syndrome
Local reaction at injection site
Malignancies
Musculoskeletal pain
Nausea
Oedema
Polyuria
Pruritus
Rash
Throat swelling
Tongue swelling
Tremor
Visual disturbances
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: March 2017

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Calcitonin 50 IU/ml solution for injection and infusion. Essential Pharma Ltd. Revised September 2016.
Summary of Product Characteristics: Calcitonin 100 IU/ml solution for injection and infusion. Essential Pharma Ltd. Revised September 2016.
Summary of Product Characteristics: Calcitonin 400 IU/2ml solution for injection and infusion. Essential Pharma Ltd. Revised October 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017