Drugs List

Therapeutic Indications

Uses

Diabetes mellitus

Insulin aspart is a fast acting insulin that is usually given 3 or 4 times a day immediately before a meal or carbohydrate containing snack. It may be used in combination with intermediate or long-acting insulins.

Administration

Subcutaneous injection:
Insulin aspart is usually injected into the abdominal wall, thighs, buttocks or upper arms.

Injection sites should be rotated within the same region from one injection to the next.

The faster action of insulin aspart compared to soluble human insulin is maintained regardless of injection site, however changing the region of injection site may cause variation in absorption.

Continuous subcutaneous insulin infusion:
It may be given by continuous subcutaneous infusion using a portable infusion device. Insulin aspart should not be mixed with any other insulin in an infusion pump.

Intravenous infusion:
Insulin aspart may be given by continuous intravenous infusion after dilution. An insulin aspart vial should be used.

Contraindications

Children under 1 year
Hypoglycaemia

Precautions and Warnings

Elderly
Breastfeeding
Delayed food absorption
Hepatic impairment
Pregnancy
Renal impairment

Insulin requirements may be diminished by renal or hepatic impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
Do not use if contents have been frozen
Dose should be administered just before or after food
For single patient use only
Record name and batch number of administered product
Rotate injection sites within a given area to avoid lipodystrophy
Use designated delivery device only
Use only if the solution is clear and colourless
Hypoglycaemic symptoms may be masked or altered in long duration diabetes
Hypoglycaemic symptoms may be masked/altered in intensified insulin therapy
Monitor blood or urinary glucose
Advise patient to report cutaneous amyloidosis symptoms
Antibodies to ingredient may develop
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Consider dose adjustment during illness or diet/physical activity changes
Insulin requirements may be reduced in the elderly
Insulin requirements may increase during illness,puberty or emotional upset
Transfer from other brands of insulin may involve dosage adjustment
Pregnancy & breastfeeding: Insulin requirements may vary
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patient to contact doctor if travel between time zones is planned
Advise patients of the warning signs of hypoglycaemia
Advise patients on adequate dietary control
Advise patients to have glucose available in the event of hypoglycaemia

Insulin resistance frequently occurs in patients with lipid disorders, hypertension and ischaemic heart disease. More than 200 units of insulin daily are usually required in patients with insulin resistance. Greatly increased insulin requirements may be due to factors including antibody formation, infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress.

Insulin aspart should be administered in immediate relation to a meal. The fast onset of action should therefore be considered in patients with concurrent diseases or medication where a delayed absorption of food might be expected.

In patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

Pregnancy and Lactation

Pregnancy

Use insulin aspart with caution during pregnancy.

The manufacturer recommends intensified blood glucose control and monitoring in pregnant women with diabetes. Insulin requirements are usually decreased during the first trimester and increased during the second and third trimesters.

Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3.

Lactation

Use insulin aspart with caution during breastfeeding.

The manufacturer advises that there are no restriction on the use of insulin aspart during breastfeeding, but a dose adjustment may be required.

Insulin is a natural component of breast milk and insulin treatment of breastfeeding mothers should represent no risk to the infant. Insulin in breast milk is digested by the infant's gut and is thought to contribute to intestinal maturation and decrease the risk of contracting type 1 diabetes in breastfed infants (LactMed, 2021).

Proper insulin levels are required for lactation. Good glycaemic control decreases the delay in establishment of lactation that is observed in diabetic mothers as well as enhancing maternal serum and milk prolactin concentrations.

Side Effects

Allergic skin reactions
Anaphylactic reaction
Bruising at injection site
Cutaneous amyloidosis
Dermatitis
Eczema
Facial oedema
Generalised oedema
Hypersensitivity reactions
Hypoglycaemia
Inflammation (injection site)
Injection site reactions
Lipodystrophy (injection site)
Peripheral neuropathy
Pruritus
Rash
Refraction anomalies
Skin eruption
Urticaria
Worsening of diabetic retinopathy (temporary)

Presentation

Solution for injection containing 100 units/ml of insulin aspart.

Some of these products have been produced by recombinant DNA technology using S. cerevisiae.

Some of these products have been produced by recombinant DNA technology using Escherichia coli.

Drugs List

Therapeutic Indications

Uses

Diabetes mellitus

Insulin aspart is a fast acting insulin that is usually given 3 or 4 times a day immediately before a meal or carbohydrate containing snack. It may be used in combination with intermediate or long-acting insulins.

Dosage

The desired blood glucose levels, the insulin preparations to be used and the insulin dosage (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.

Insulin aspart may be administered in various ways depending on the formulation used. It may be given in combination with an intermediate or long acting insulin given at least once a day, administered by continuous subcutaneous insulin infusion (CSII) in pump systems or be administered intravenously by healthcare professionals.

When administered by a CSII pump system, insulin aspart will cover both the bolus and basal insulin requirements.

Adults

Children

Additional Dosage Information

Administration

Subcutaneous injection:
Insulin aspart is usually injected into the abdominal wall, thighs, buttocks or upper arms.

Injection sites should be rotated within the same region from one injection to the next.

The faster action of insulin aspart compared to soluble human insulin is maintained regardless of injection site, however changing the region of injection site may cause variation in absorption.

Continuous subcutaneous insulin infusion:
It may be given by continuous subcutaneous infusion using a portable infusion device. Insulin aspart should not be mixed with any other insulin in an infusion pump.

Intravenous infusion:
Insulin aspart may be given by continuous intravenous infusion after dilution. An insulin aspart vial should be used.

Contraindications

Children under 1 year
Hypoglycaemia

Precautions and Warnings

Elderly
Breastfeeding
Delayed food absorption
Hepatic impairment
Pregnancy
Renal impairment

Insulin requirements may be diminished by renal or hepatic impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
Do not use if contents have been frozen
Dose should be administered just before or after food
For single patient use only
Record name and batch number of administered product
Rotate injection sites within a given area to avoid lipodystrophy
Use designated delivery device only
Use only if the solution is clear and colourless
Hypoglycaemic symptoms may be masked or altered in long duration diabetes
Hypoglycaemic symptoms may be masked/altered in intensified insulin therapy
Monitor blood or urinary glucose
Advise patient to report cutaneous amyloidosis symptoms
Antibodies to ingredient may develop
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Consider dose adjustment during illness or diet/physical activity changes
Insulin requirements may be reduced in the elderly
Insulin requirements may increase during illness,puberty or emotional upset
Transfer from other brands of insulin may involve dosage adjustment
Pregnancy & breastfeeding: Insulin requirements may vary
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patient to contact doctor if travel between time zones is planned
Advise patients of the warning signs of hypoglycaemia
Advise patients on adequate dietary control
Advise patients to have glucose available in the event of hypoglycaemia

Insulin resistance frequently occurs in patients with lipid disorders, hypertension and ischaemic heart disease. More than 200 units of insulin daily are usually required in patients with insulin resistance. Greatly increased insulin requirements may be due to factors including antibody formation, infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress.

Insulin aspart should be administered in immediate relation to a meal. The fast onset of action should therefore be considered in patients with concurrent diseases or medication where a delayed absorption of food might be expected.

In patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

Pregnancy and Lactation

Pregnancy

Use insulin aspart with caution during pregnancy.

The manufacturer recommends intensified blood glucose control and monitoring in pregnant women with diabetes. Insulin requirements are usually decreased during the first trimester and increased during the second and third trimesters.

Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3.

Lactation

Use insulin aspart with caution during breastfeeding.

The manufacturer advises that there are no restriction on the use of insulin aspart during breastfeeding, but a dose adjustment may be required.

Insulin is a natural component of breast milk and insulin treatment of breastfeeding mothers should represent no risk to the infant. Insulin in breast milk is digested by the infant's gut and is thought to contribute to intestinal maturation and decrease the risk of contracting type 1 diabetes in breastfed infants (LactMed, 2021).

Proper insulin levels are required for lactation. Good glycaemic control decreases the delay in establishment of lactation that is observed in diabetic mothers as well as enhancing maternal serum and milk prolactin concentrations.

Counselling

Patients should be shown the container to confirm the version of insulin is the one they are expecting.

When given as a meal related treatment, insulin aspart should be administered immediately before the start of a meal. If necessary it can be given soon after a meal.

Advise patients of the warning signs of hypoglycaemia.

Patients should be aware that emotional upset or concurrent illness, especially infection and fever, will usually increase insulin requirements.

Patients whose blood glucose is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.

Patients should carry glucose tablets or other suitable form of sugar with them to take in the event of hypoglycaemia and should be advised of the warning signs that they may experience.

Advise patient that alcohol may alter hypoglycaemic effect of insulin.

Advise patient that changes in regular physical activity may require dose adjustment.

Patients administering by continuous subcutaneous insulin infusion must have an alternative insulin delivery method available in case of pump system failure.

Patient should be advised that injection sites should be rotated within the same area to minimise the risk of developing lipodystrophy.

Advise patient to seek medical advice regarding dosage if they are intending to travel between different time zones.

Advise female patients to consult their GP if pregnancy is suspected or planned.

Advise patients that their ability to drive or operate machinery may be impaired.

Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing Gov.uk website.

Advise patient to report cutaneous amyloidosis symptoms.

Side Effects

Allergic skin reactions
Anaphylactic reaction
Bruising at injection site
Cutaneous amyloidosis
Dermatitis
Eczema
Facial oedema
Generalised oedema
Hypersensitivity reactions
Hypoglycaemia
Inflammation (injection site)
Injection site reactions
Lipodystrophy (injection site)
Peripheral neuropathy
Pruritus
Rash
Refraction anomalies
Skin eruption
Urticaria
Worsening of diabetic retinopathy (temporary)

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 review date: November 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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: Fiasp 100 units/mL solution for injection. Novo Nordisk Limited. Revised July 2019.

Summary of Product Characteristics: NovoRapid 100 units/ml in a vial, NovoRapid Penfill 100 units/ml, NovoRapid FlexPen 100 units/ml, NovoRapid FlexTouch 100 units/ml, NovoRapid PumpCart 100 units/ml. Novo Nordisk Ltd. Revised April 2018.

Summary of Product Characteristics: Trurapi 100 units/ml solution for injection in cartridge, Trurapi 100 unit/ml solution for injection in pre-filled pen. Sanofi. Revised April 2021.

Summary of Product Characteristics: Trurapi 100 unit/ml solution for injection in vial. Sanofi. Revised September 2021.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Insulin. Last revised: 19 July 2021
Last accessed: 25 August 2021