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Insulin degludec with liraglutide subcutaneous


Injections of insulin degludec with liraglutide.

Drugs List

  • insulin degludec with liraglutide 100unit+3.6mg/ml solution for injection 3ml pre-filled pen
  • XULTOPHY 100unit+3.6mg/ml solution for injection 3ml pre-filled pen
  • Therapeutic Indications


    Diabetes mellitus Type 2 where oral therapy inadequate

    Treatment of adults with uncontrolled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise, in addition to other oral antidiabetic treatment.


    To be administered once daily at any time of day, but at the same time each day, according to individual requirements.


    Add-on to oral glucose lowering medicinal products
    Starting dose: 10 dose steps (10 units of insulin degludec and 0.36 mg of liraglutide) daily.
    Maximum dose: 50 dose steps daily.

    Transfer from GLP-1 receptor agonist or from basal insulin
    Starting dose: 16 dose steps (16 units of insulin degludec and 0.6 mg of liraglutide) daily.
    Maximum dose: 50 dose steps daily.

    If transferring from a long acting GLP-1 receptor agonist prolonged action should be taken into consideration. Insulin degludec with liraglutide should be initiated when the next dose of long acting GLP-1 receptor agonist would have been taken.


    Subcutaneous injection only.

    Administer in the thigh, upper arm or abdominal wall.


    Children under 18 years
    End stage renal disease
    Inflammatory bowel disease
    New York Heart Association class IV failure
    Severe hepatic impairment

    Precautions and Warnings

    History of thyroid disorder
    Mild hepatic impairment
    Mild renal impairment

    Not suitable for treatment of diabetic ketoacidosis
    Advise patient to take precautions to avoid hypoglycaemia whilst driving
    Consider sulfonylurea dose reduction if added to sulfonylurea therapy
    Change in injection site area may necessitate dose adjustment
    Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
    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
    Monitor closely during and after transfer from insulin or GLP-1 agonist
    Monitor dosage closely in presence of renal or hepatic impairment
    Advise patient to report cutaneous amyloidosis symptoms
    Advise patients to report symptoms of acute pancreatitis immediately
    Antibodies to ingredient may develop
    Compensatory response to hypoglycaemia may be impaired
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if pancreatitis is suspected
    Do not restart treatment following confirmation of pancreatitis
    Consider dosage modification if diet or exercise levels are changed
    Consider dose adjustment during illness or diet/physical activity changes
    Advise patient on fluid replacement if GI side effects occur
    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 to have glucose available in the event of hypoglycaemia

    Pregnancy and Lactation


    Insulin degludec with liraglutide is contraindicated during pregnancy.

    The manufacturer recommends discontinuing insulin degludec with liraglutide if a patient becomes pregnant or wishes to become pregnant.

    Animal studies regarding embryotoxicity and teratogenicity have not shown any differences between insulin degludec and human insulin. However, animal studies have shown reproductive toxicity effects when using liraglutide. Human data is limited and as such a potential risk cannot be ruled out.

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


    Insulin degludec with liraglutide is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking insulin degludec with liraglutide. The presence of insulin degludec with liraglutide in human breast milk is unknown.


    Patients who forget a dose are advised to take it upon discovery and then resume their usual-once daily dosing schedule. A minimum of 8 hours between injections should always be ensured.

    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.

    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.

    Advise patients to report symptoms of acute pancreatitis (e.g. severe abdominal pain) immediately.

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

    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 website.

    Advise patient to report cutaneous amyloidosis symptoms.

    Side Effects

    Abdominal distension
    Abdominal pain
    Abnormal hunger
    Allergic reaction
    Anaphylactic reaction
    Cold sweat
    Concentration difficulties
    Cool pale skin
    Cutaneous amyloidosis
    Decreased appetite
    Elevated amylase levels
    Elevated serum lipase
    Facial swelling
    Gastroesophageal reflux disease
    Hypersensitivity reactions
    Increased heart rate
    Injection site reactions
    Insulin antibodies
    Lipodystrophy (injection site)
    Necrotising pancreatitis
    Peripheral oedema
    Visual disturbances
    Worsening of diabetic retinopathy (temporary)


    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: June 2019

    Reference Sources

    Summary of Product Characteristics: Xultophy 100 units/ml + 3.6 mg/ml solution for injection in a pre-filled pen. Novo Nordisk Ltd. Revised September 2018.

    MHRA Drug Safety Update September 2020
    Available at:
    Last accessed: 16 December 2020

    NICE Evidence Services Available at: Last accessed: 04 June 2019

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