Insulin glargine with lixisenatide injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of insulin glargine with lixisenatide.
Drugs List
Therapeutic Indications
Uses
Control of type-2 diabetes (NIDDM) with metformin if metformin inadequate
Indicated for the treatment of diabetes mellitus in combination with metformin, when metformin alone produces an inadequate response or in addition to another oral glucose lowering medicinal product or basal insulin.
Dosage
Dosing options vary between device strength. To avoid medication errors ensure the correct strength and number of dose steps are stated when prescribing.
Dose to be determined by the individual patient requirement.
Manufacturer recommends optimising glycaemic control via a dose adjustment based on fasting plasma glucose.
Adults
The starting dose of insulin glargine and lixisenatide should be based on previous anti-diabetic therapy as follows:
Previous treatment with oral anti-diabetic treatment (insulin naive patients)
Insulin glargine with lixisenatide 100 units/ml + 50micrograms/ml device
10 dose steps equivalent to 10 units/5micrograms.
Insulin glargine with lixisenatide 100 units/ml + 33micrograms/ml device
Not suitable.
Previous treatment with insulin glargine (100 units/ml) greater than or equal to 20 units to less than 30 units
Insulin glargine with lixisenatide 100 units/ml + 50micrograms/ml device
20 dose steps equivalent to 20 units/10micrograms.
Insulin glargine with lixisenatide 100 units/ml + 33micrograms/ml device
Not suitable.
Previous treatment with insulin glargine (100 units/ml) greater than or equal to 30 units to less than or equal to 60 units
Insulin glargine with lixisenatide 100 units/ml + 50micrograms/ml device
Not suitable.
Insulin glargine with lixisenatide 100 units/ml + 33micrograms/ml device
30 dose steps equivalent to 30 units/10micrograms.
Dose titration
In patients starting treatment using the 100units/ml + 50micrograms/ml device, the dose may be titrated to up to 40 dose steps.
For patients requiring more than 40 dose steps per day, the titration should be continued with the 100units/ml + 33micrograms/ml device.
Dose should be titrated to individual patient response. Maximum daily dose of 60 units/20micrograms equivalent to 60 dose steps using the 100units/ml + 33microgram/ml device.
Additional Dosage Information
If previous treatment include a different basal insulin, the daily dose of insulin glargine and lixisenatide should be adjusted, as follows:
For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% as the starting dose of insulin glargine with lixisenatide.
For any other basal insulin the dosing should follow recommended dosing for patients with previous therapy with insulin glargine (100 units/ml). See Dosage; Adult.
Administration
To be administered by subcutaneous injection into the abdomen, deltoid or thigh. Injection sites must be rotated within a given injection area from one injection to the next.
Contraindications
Children under 18 years
Breastfeeding
Diabetic ketoacidosis
Pregnancy
Severe renal impairment
Precautions and Warnings
Patients over 75 years
Hepatic impairment
History of pancreatitis
Renal impairment
Severe gastrointestinal disorder
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Contains metacresol
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
For single patient use only
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
Advise patient to report cutaneous amyloidosis symptoms
Advise patients to report symptoms of acute pancreatitis immediately
Antibodies to ingredient may develop
Consider dose reduction to prevent hypoglycaemia if dietary intake reduced
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Discontinue if pancreatitis is suspected
Discontinue if patient is attempting to conceive
Do not restart treatment following confirmation of pancreatitis
Pregnancy confirmed: Discontinue this medication
Dose steps may not be equivalent between strengths/brands-see product info
Removal of stress factors may necessitate dose adjustment
May affect the gastro-intestinal absorption of other drugs
Female: Ensure adequate contraception during treatment
Advise patient on fluid replacement if GI side effects occur
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patient to eat meal less than 60 minutes after each dose
Advise patient to read the leaflet in the pack
Advise patients of the warning signs of hypoglycaemia
Pregnancy and Lactation
Pregnancy
Insulin glargine and lixisenatide is contraindicated during pregnancy.
The manufacturer does not recommend using insulin glargine and lixisenatide during pregnancy. If a patient becomes pregnant during treatment or wishes to become pregnant, treatment with insulin glargine and lixisenatide should be discontinued.
Animal study data does not indicate reproductive toxicity with insulin glargine.
Animal studies have shown reproductive toxicity with lixisenatide.
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
Insulin glargine and lixisenatide is contraindicated during breastfeeding.
The manufacturer does not recommend using insulin glargine with lixisenatide during breastfeeding.
It is unknown whether insulin glargine or lixisenatide is excreted into breast milk.
Counselling
Advise patient to eat a meal less than 60 minutes after each dose.
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 product is the one they are expecting.
Use designated delivery device only.
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 if symptoms of acute pancreatitis occur, such as sudden severe abdominal pain.
Advise patient to seek medical advice if symptoms of dehydration occur.
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 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.
Ensure adequate contraception during treatment in female patients of childbearing potential.
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
Abdominal pain
Anaphylactic reaction
Angioedema
Antibody formation
Cutaneous amyloidosis
Diarrhoea
Dizziness
Dyspepsia
Fatigue
Hypoglycaemia
Injection site reactions
Lipodystrophy (injection site)
Nasopharyngitis
Nausea
Upper respiratory tract infection
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: February 2019
Reference Sources
Summary of Product Characteristics: Suliqua 100 units/ml + 30 micrograms/ml solution for injection in a pre-filled pen. Sanofi. Revised March 2020.
Summary of Product Characteristics: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen. Sanofi. Revised January 2017.
MHRA Drug Safety Update September 2020
Available at: https://www.mhra.gov.uk
Last accessed: 16 December 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.