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Ertugliflozin oral

Updated 2 Feb 2023 | SGLT 2 inhibitors


Tablets containing ertugliflozin.

Drugs List

  • ertugliflozin 15mg tablets
  • ertugliflozin 5mg tablets
  • STEGLATRO 15mg tablets
  • STEGLATRO 5mg tablets
  • Therapeutic Indications


    Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone

    Treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise.

    As monotherapy
    In patients where metformin is consider inappropriate due to contraindication or intolerance.

    Adjunctive therapy
    In addition to other treatments for diabetes.



    Monotherapy and combination with other oral antidiabetic agents or insulin:
    5mg once a day.

    In patients tolerating 5mg once a day, the dose can be increased to 15mg once a day if additional glycaemic control is required.

    Additional Dosage Information

    When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or an insulin secretagogue may be considered to reduce the risk of hypoglycaemia.

    Missed dose
    If a dose is missed, it should be taken as soon as possible, providing that two doses are not taken on the same day.


    Children under 18 years
    Diabetic ketoacidosis
    Renal impairment - creatinine clearance below 60ml/minute at baseline
    Severe hepatic impairment

    Precautions and Warnings

    Acute illness
    Major surgery
    Patients over 65 years
    Predisposition to hypotension
    Cardiovascular disorder
    Glucose-galactose malabsorption syndrome
    History of pancreatitis
    Lactose intolerance
    Renal impairment - creatinine clearance 45 - 60ml/minute
    Urinary tract infection

    Advise ability to drive/operate machinery may be affected by side effects
    Correct hypovolaemia prior to administration
    Contains lactose
    Monitor renal function before treatment and regularly during treatment
    Electrolyte & volume depletion may occur - interrupt treatment as necessary
    Hospitalised patients: Monitor blood ketones before restart treatment
    Monitor fluid and electrolyte status
    Advise patient to report genital/perineal symptoms with fever or malaise
    Advise patient to report symptoms of diabetic ketoacidosis immediately
    Discontinue SGLT2 inhibitor if Fournier's gangrene is suspected
    Increased risk of genital mycotic infection
    Increased risk of urinary tract infection
    Interrupt treatment temporarily in complicated urinary tract infections
    May affect results of some laboratory tests
    Test results for urinary glucose will be positive
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if creatinine clearance below 45ml/minute
    Interrupt therapy if acute serious illness requiring hospitalisation occurs
    Interrupt treatment in patients undergoing major surgery
    Pregnancy confirmed: Discontinue this medication
    Discontinue if diabetic ketoacidosis is suspected
    Advise patient to avoid excess of alcohol
    Advise patient on the need for adequate foot hygiene
    Advise patient on the need for adequate hydration
    Advise patient to report symptoms of volume depletion
    Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

    An increase in cases of lower limb amputation (1.2 to 1.6 fold) has been observed in clinical studies with the use of ertugliflozin. Aside from general risk factors, the risk factors for amputation are unknown as the underlying mechanism has not been established.

    Cases of diabetic ketoacidosis (DKA) have been reported in patient taking sodium-glucose co-transporter 2 (SGLT2) inhibitors. The signs and symptoms of DKA are rapid weight loss; feeling or being sick; stomach pain; fast and deep breathing; sleepiness; a sweet smell to the breath; a sweet or metallic taste in the mouth; or a different odour to urine or sweat. The risk factors for DKA include low beta cell function reserve; conditions leading to restricted food intake or severe dehydration; sudden reduction in insulin; increased insulin requirements due to acute illness; surgery and alcohol abuse.

    Restarting treatment in patients with previous DKA while on SGLT2 inhibitor is not recommended, unless another precipitating factor has been identified and resolved.

    Cases of necrotising fasciitis of the perineum (Fournier's gangrene) have been reported in patients taking SGLT2 inhibitors. This a rare but serious event that requires urgent intervention and may be preceded by genital infection or penineal abscess. Patients should be advised to report a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

    Pregnancy and Lactation


    Ertugliflozin is contraindicated during pregnancy.

    The manufacturer does not recommend the use of ertugliflozin during pregnancy.

    Animal studies have shown ertugliflozin to affect renal development and maturation.


    Ertugliflozin is contraindicated during breastfeeding.

    The manufacturer does not recommend using ertugliflozin during breastfeeding, due to developmental risk to infant's kidneys.

    There is limited published information regarding the presence of ertugliflozin in breast milk (Lactmed, 2018).

    In animal studies ertugliflozin was shown to be present in the milk of lactating rats, producing pharmacologically mediated effects in the infants.


    Advise the patient of the signs and symptoms of diabetic ketoacidosis (DKA) and to seek medical advice if they occur. The risk factors of DKA should be discussed with the patient.

    Advise patient on the need for adequate foot hygiene.

    Advise patient on the need for adequate hydration.

    Advise patient to report symptoms of volume depletion.

    Advise patient to report symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

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

    Advise patient to avoid excessive alcohol.

    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.

    Side Effects

    Blood lipid changes
    Decrease in glomerular filtration rate
    Fournier's gangrene
    Genital infections
    Increase in blood urea nitrogen
    Increase in haemoglobin
    Increased urinary frequency
    Plasma volume depletion
    Postural dizziness
    Serum creatinine increased
    Urinary tract infections
    Urinary urgency
    Vaginal candidiasis
    Vulvovaginal disorders
    Vulvovaginal itching

    Effects on Laboratory Tests

    In diabetic patients taking ertugliflozin, it is advisable not to use the 1,5-anhydroglucitol (1,5 AG) assay to monitor glycaemic control. This is because measurements of 1,5 AG are unreliable in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycaemic control.


    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: August 2021

    Reference Sources

    Summary of Product Characteristics: Steglatro 5mg and 15mg film-coated tablets. Merck Sharp and Dohme Limited. Revised January 2021.

    NICE Evidence Services Available at: Last accessed: 03 August 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Ertugliflozin Last revised: 03 December 2018
    Last accessed: 03 August 2021

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

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