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Saxagliptin with dapagliflozin oral


Tablets containing saxagliptin and dapagliflozin.

Drugs List

  • QTERN 5mg+10mg tablets
  • saxagliptin 5mg and dapagliflozin 10mg tablets
  • Therapeutic Indications


    Oral combination treatment of type 2 diabetes

    Treatment of adults with type 2 diabetes mellitus:
    To improve glycaemic control when metformin and/or sulfonylurea with saxagliptin or dapagliflozin do not provide adequate glycaemic control.
    When already being treated with saxagliptin and dapagliflozin as separate tablets.



    One tablet (5 mg saxagliptin and 10 mg dapagliflozin) once daily.

    Additional Dosage Information

    When used in combination with a sulfonylurea, a reduction in the dose of the sulfonylurea may be required to minimise the risk of hypoglycaemia.

    Missed dose
    More than 12 hours until next dose
    The missed tablet should be taken and the next scheduled dose should be taken at the usual time.

    Less than 12 hours until the next dose
    The missed tablet should be skipped and the next dose taken at the usual time.


    Children under 18 years
    Patients over 75 years at initiation
    Renal impairment - glomerular filtration rate below 60ml/minute at baseline
    Severe hepatic impairment

    Precautions and Warnings

    Immunosuppressed transplant recipients
    Major surgery
    Patients over 65 years
    Predisposition to hypotension
    Cardiovascular disorder
    Glucose-galactose malabsorption syndrome
    History of cardiac failure
    History of pancreatitis
    Immunodeficiency syndromes
    Lactose intolerance
    Moderate hepatic impairment
    Renal impairment - glomerular filtration rate 45-60ml/minute
    Urinary tract infection

    Advise patient dizziness may affect ability to drive or operate machinery
    Correct hypovolaemia prior to administration
    Exclude volume depletion before commencing treatment
    Contains lactose
    Monitor renal function prior to initiating treatment
    Electrolyte & volume depletion may occur - interrupt treatment as necessary
    Hospitalised patients: Monitor blood ketones before restart treatment
    Monitor fluid and electrolyte status
    Monitor renal function 2-4 times a year in renal impairment
    Monitor renal function annually in patients with normal renal function
    Monitor renal function if concomitant drugs that impair renal function
    Monitor skin changes
    Advise patient to report genital/perineal symptoms with fever or malaise
    Advise patient to report new or worsening signs of cardiac failure
    Advise patient to report symptoms of diabetic ketoacidosis immediately
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patients to report symptoms of acute pancreatitis immediately
    Discontinue if pemphigus-type reactions develop
    Discontinue SGLT2 inhibitor if Fournier's gangrene is suspected
    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 glomerular filtration rate below 45ml/minute
    Discontinue if pancreatitis occurs
    Discontinue if severe hypersensitivity reactions occur
    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 not to take St John's wort concurrently
    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

    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.

    Clinical trials suggest there is an increased risk of lower limb amputation in patients treated with canagliflozin. An increased risk of amputation has not yet been seen in studies of dapagliflozin. However, the increased risk of amputation cannot be excluded and caution should be advised in patients receiving dapagliflozin.

    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.

    Cases of bullous pemphigoid requiring hospitalisation have been reported with saxagliptin use. If bullous pemphigoid is suspected or development of blisters or erosions occur, discontinue treatment and referral to a dermatologist should be considered.

    Pregnancy and Lactation


    Saxagliptin with dapagliflozin is contraindicated in pregnancy.
    The manufacturer does not recommend the use of this product during pregnancy.
    No data is available regarding the use of saxagliptin during pregnancy. Reproductive toxicity at high doses has been demonstrated in animal studies. The potential risk for humans is unknown.
    No data is available from the use of dapagliflozin in pregnant women. Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters for human pregnancy.
    Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at


    Saxagliptin with dapagliflozin is contraindicated in breastfeeding.
    The manufacturer states that the product should not be used during breastfeeding.
    It is unknown whether saxagliptin is excreted in human breast milk. Animal studies have shown excretion of saxagliptin and/or metabolite in milk, and therefore, a risk to the nursing infant cannot be excluded.
    It is unknown whether dapagliflozin and/or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data from animal studies have shown excretion of dapagliflozin and/or its metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring. A risk to the newborns/infants cannot be excluded.


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

    Advise patients that they should not self-medicate with St John's Wort during treatment as the hypoglycaemic effect of saxagliptin may be reduced.

    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 to report symptoms of volume depletion.

    Advise patient to report new or worsening signs of cardiac failure.

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

    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

    Abdominal pain
    Anaphylactic shock
    Back pain
    Bullous pemphigoid
    Dry mouth
    Erectile dysfunction
    Fournier's gangrene
    Fungal infection
    Genital infections
    Genital pruritus
    Hypersensitivity reactions
    Increase in blood urea or creatinine
    Increase in haematocrit
    Increased serum inorganic phosphate
    Peripheral oedema
    Plasma volume depletion
    Renal impairment
    Upper respiratory tract infection
    Urinary tract infections
    Vulvovaginal infections
    Vulvovaginal irritation
    Vulvovaginal itching
    Weight loss

    Effects on Laboratory Tests

    In diabetic patients taking dapagliflozin, 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 (dapagliflozin). 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: June 2019

    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: Qtern 5 mg/10 mg film-coated tablets. AstraZeneca UK Ltd. Revised March 2020.

    NICE Evidence Services Available at: Last accessed: 12 June 2019

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