This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Lixisenatide parenteral

Updated 2 Feb 2023 | GLP-1 agonists


Solution for injection containing lixisenatide

Drugs List

  • lixisenatide 10microgram/0.2ml injection solution
  • lixisenatide 10microgram/0.2ml injection solution + 20microgram/0.2ml injection solution
  • lixisenatide 20microgram/0.2ml injection solution
  • LYXUMIA 10microgram/0.2ml injection solution
  • LYXUMIA 20microgram/0.2ml injection solution
  • LYXUMIA INITIATION PACK injection solution
  • Therapeutic Indications


    Control of type-2 diabetes when combined oral therapies inadequate

    Treatment of type 2 (non insulin dependent) diabetes mellitus, when dietary management and exercise in combination with oral glucose-lowering medicinal product and/or basal insulin does not result in adequate glycaemic control.

    Lixisenatide is used in combination therapy with other oral antidiabetics and/or basal insulin.

    Not to be given in triple combination with basal insulin and a sulfonylurea.



    Initial dose: 10 micrograms of lixisenatide administered once daily for 14 days.
    Maintenance dose: 20 micrograms of lixisenatide, administered once daily starting on day 15.


    (See Dosage; Adults)

    Additional Dosage Information

    When used in combination with existing metformin therapy
    The current metformin dose can be continued unchanged.

    When used in combination with sulfonylurea or basal insulin
    A reduction in the dose of the sulfonylurea or the basal insulin may need to be considered to reduce the risk of hypoglycaemia. Blood glucose monitoring or blood glucose self-monitoring may become necessary to adjust the doses of the sulfonylurea or the basal insulin.


    For subcutaneous injection only. The injection site may be the thigh, abdomen or upper arm.

    Lixisenatide may be administered any time within a 1 hour period before a meal, preferably before the same meal every day.

    Administration before meals is essential.

    Lixisenatide and basal insulin must be administered as two separate injections.


    Children under 18 years
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe gastrointestinal disorder

    Precautions and Warnings

    Patients over 75 years
    History of pancreatitis
    Renal impairment - creatinine clearance 30-50ml/minute

    Advise patient to take precautions to avoid hypoglycaemia whilst driving
    Contains metacresol
    Do not use if contents have been frozen
    Use only if the solution is clear and colourless
    Consider glucose monitoring when given in combination
    Insulin dose adjustment: Reduce insulin dose gradually and monitor for DKA
    Advise patient to seek medical advice if symptoms of dehydration occur
    Advise patients to report symptoms of acute pancreatitis immediately
    Discontinue if pancreatitis occurs
    Pregnancy confirmed: Change patient to insulin treatment
    May affect the gastro-intestinal absorption of other drugs
    Advise patient to eat meal less than 60 minutes after each dose
    Advise patients to have glucose available in the event of hypoglycaemia
    Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

    Pregnancy and Lactation


    Lixisenatide is contraindicated in pregnancy.

    At the time of writing there is limited published information regarding the use of lixisenatide during pregnancy. Animal studies have shown reproductive toxicity. The risk to humans is unknown.

    Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at

    Insulin is the treatment of choice for both Type 1 and Type 2 diabetes during pregnancy as it provides better control of maternal blood glucose compared to oral hypoglycaemics. It is believed that human insulin and insulin analogues do not cross the placenta, however there may be endogenous carrier proteins allowing passage of insulin to the embryo during early gestation; animal insulin is believed to cross the human placenta. The foetus produces its own insulin once insulin-secreting cells in the foetal pancreas become differentiated at the end of the first trimester.

    Human insulin is considered safe to use during pregnancy and extensive experience with human insulin during pregnancy does not indicate any embryotoxic potential. Human insulin is often the first line treatment for diabetes and the benchmark used when comparing the safety of other insulins during pregnancy.

    Infants of diabetic mothers are at an increased risk of congenital abnormalities, the rate of which appears to be related to maternal glycaemic control during the first trimester. Careful control of maternal blood glucose is required throughout pregnancy. Good maternal glycaemic control during labour and birth is important in preventing adverse neonatal outcomes including neonatal hypoglycaemia and respiratory stress.

    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 ( ) or if this is unavailable at the backup site ( ).


    Lixisenatide is contraindicated in breastfeeding.

    It is unknown whether lixisenatide is excreted in breast milk, therefore a risk to the nursing infant cannot be excluded.

    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


    Advise patient of the characteristic symptom of acute pancreatitis and to seek medical advice if this symptom occurs.

    Advise patient to seek medical advice if symptoms of dehydration occur.

    Advise patient to eat a meal less than 60 minutes after each dose.

    Advise patient if a dose of lixisenatide is missed, it should be injected within the hour prior to the next meal.

    Advise patient of the warning signs of hypoglycaemia.

    Advise patients to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent hypoglycaemic episodes.

    Advise the patient that they need to inform the Driving and Vehicle Licensing Agency (DVLA) about the medication they are receiving. The Drivers' medical enquiries at the DVLA will be able to advise the patient on the legal issues surrounding the treatment of diabetes mellitus and driving.

    The DVLA can be contacted by post at the following address:

    Drivers' medical enquiries, DVLA, Swansea, SA99 1TU

    By phone on 0300 790 6806; or by fax on 0845 850 0095

    Detailed guidance on eligibility to drive, and precautions required, is available from the DVLA.

    Further information concerning diabetes and driving may be obtained from the DVLA website at:

    Side Effects

    Acute pancreatitis
    Anaphylactic reaction
    Back pain
    Cardiac arrhythmias
    Hypersensitivity reactions
    Injection site reactions
    Upper respiratory tract infection
    Viral infection


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

    Summary of Product Characteristics: Lyxumia 10 micrograms solution for injection. Sanofi. Revised April 2016.
    Summary of Product Characteristics: Lyxumia 20 micrograms solution for injection. Sanofi. Revised April 2016.
    Summary of Product Characteristics: Lyxumia Treatment Initiation Pack. Sanofi. Revised April 2016.

    MHRA Drug Safety Update June 2019
    Available at:
    Last accessed: 28 August 2019

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    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.