Insulin glargine subcutaneous
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of insulin glargine.
Patients and professionals should be aware that the 300units/ml strength is higher than that of other existing insulin products available in the UK.
Drugs List
Therapeutic Indications
Uses
Diabetes mellitus
Treatment of Type 1 diabetes mellitus.
In patients with Type 1 diabetes mellitus, it must be used in combination with a short acting insulin to cover mealtime insulin requirements.
In patients with Type 2 diabetes mellitus, it may be used together with other antidiabetic medicinal products.
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 lifestyle.
Adults
To be administered once daily at any time of day, but at the same time each day, according to individual requirements.
Children
To be administered once daily at any time of day, but at the same time each day, according to individual requirements.
300units/ml devices are not licensed to be used in children under the age of 6.
Additional Dosage Information
Switching between 100units/ml and 300units/ml preparations
Preparations are not bioequivalent and therefore are not directly interchangeable.
From 100units/ml to 300units/ml: Switch on a unit-to-unit basis. A higher dose (approximately 10 to 18%) may be needed to achieve appropriate ranges for plasma glucose levels.
From 300units/ml to 100units/ml: Reduce the dose by approximately by 20%.
Switching from twice daily basal insulin to once daily insulin glargine
To lower the risk of nocturnal or early morning hypoglycaemia reduce the daily dose of basal insulin by 20% to 30% during the first weeks of treatment.
An increase in mealtime insulin may be required to compensate. After this period, adjust the regime according to individual requirements.
Administration
For subcutaneous injection only into the abdominal wall, the deltoid or thigh. Injection sites must be rotated within a given injection area from one injection to the next.
Contraindications
Children under 2 years
Hypoglycaemia
Precautions and Warnings
Children aged 2 to 6 years
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Insulin requirements may be diminished by renal or hepatic impairment
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Not all available products are licensed for all age groups
Contains metacresol
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
Record name and batch number of administered product
Rotate injection sites within a given area to avoid lipodystrophy
Solution must not be drawn from cartridge or pre-filled pen into a syringe
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
Consider dose reduction to prevent hypoglycaemia if dietary intake reduced
Increased risk of early morning hypoglycaemia
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Dose steps may not be equivalent between strengths/brands-see product info
Insulin requirements may be reduced in the elderly
Removal of stress factors may necessitate dose adjustment
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 patients of the warning signs of hypoglycaemia
Advise patients on adequate dietary control
Transfer from animal insulin may alter usual hypoglycaemia warning symptoms
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (rapid acting insulin, intermediate acting insulin, long acting insulin etc) species (human insulin analogue, animal), and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change of dose.
If normal or decreased values of glycated haemoglobin occur, consider the possibility of recurrent, unrecognised episodes of hypoglycaemia.
Some products contain magnets which may interfere with functions of an implantable electronic medical device, such as a pacemaker.
Pregnancy and Lactation
Pregnancy
Use insulin glargine with caution during pregnancy.
The manufacturer suggests using insulin glargine in pregnancy if clinically necessary.
Data indicate no adverse effects of insulin glargine on pregnancy and no specific toxicity to the foetus/newborn.
Older forms of insulin (human or porcine origin) are considered safe during pregnancy and insulin glargine may be classified similarly (Briggs, 2015).
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 glargine with caution during breastfeeding.
Manufacturers state that the presence of insulin glargine in human breast milk is unknown.
Insulin glargine is digested into amino acids in the gastrointestinal tract, therefore no metabolic effects of ingested insulin glargine are expected.
Breastfeeding women may require adjustments in insulin dose and diet.
Counselling
Each cartridge/pre-filled pen must be used by one patient only, even if the needle is changed, to prevent the possible transmission of disease.
Advise patient to always use a new needle. The re-use of insulin pen needles increases the risk blocked needles which can cause over or underdosing.
Patients should be shown the container to confirm the version of insulin is the one they are expecting.
Use designated delivery device only.
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.
Advise female patients to consult their GP if pregnancy is suspected or planned.
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.
Patient should be advised that injection sites should be rotated within the same area to minimise the risk of developing lipodystrophy.
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 reaction
Angioedema
Bronchospasm
Cutaneous amyloidosis
Dysgeusia
Hypoglycaemia
Hypotension
Insulin antibodies
Lipodystrophy (injection site)
Lipohypertrophy
Local reaction at injection site
Myalgia
Oedema
Rash
Refraction anomalies
Retinopathy
Shock
Sodium retention
Urticaria
Visual impairment (irreversible)
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 Full Review Date: March 2020
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: Abasaglar 100 units/mL solution for injection in cartridge. Eli Lilly and Company Limited. Revised January 2020.
Summary of Product Characteristics: Abasaglar 100 units/mL solution for injection in pre-filled pen. Eli Lilly and Company Limited. Revised July 2020.
Summary of Product Characteristics: Lantus 100 units/ml solution for injection in a vial. Sanofi-Aventis. Revised August 2020.
Summary of Product Characteristics: Lantus 100 units/ml solution for injection in SoloStar pre-filled pen. Sanofi-Aventis. Revised August 2020.
Summary of Product Characteristics: Lantus 100 units/ml solution for injection in a cartridge. Sanofi-Aventis. Revised August 2020.
Summary of Product Characteristics: Semglee 100 units/ml solution for injection in pre-filled pen. Mylan. Revised January 2020.
Summary of Product Characteristics: Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen. Sanofi. Revised August 2020.
Summary of Product Characteristics: Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen. Sanofi. Revised August 2020.
MHRA Drug Safety Update September 2020
Available at: https://www.mhra.gov.uk
Last accessed: 16 December 2020
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 19 March 2020
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: 20 January 2020
Last accessed: 19 March 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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