Ertugliflozin oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing ertugliflozin.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Adults
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.
Contraindications
Children under 18 years
Breastfeeding
Diabetic ketoacidosis
Galactosaemia
Pregnancy
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
Alcoholism
Cardiovascular disorder
Dehydration
Glucose-galactose malabsorption syndrome
History of pancreatitis
Hypotension
Hypovolaemia
Lactose intolerance
Polycythaemia
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
Pregnancy
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.
Lactation
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.
Counselling
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 Gov.uk website.
Side Effects
Balanitis
Blood lipid changes
Decrease in glomerular filtration rate
Dehydration
Dysuria
Fournier's gangrene
Genital infections
Hypoglycaemia
Hypotension
Increase in blood urea nitrogen
Increase in haemoglobin
Increased urinary frequency
Ketoacidosis
Nocturia
Plasma volume depletion
Pollakiuria
Polydipsia
Postural dizziness
Serum creatinine increased
Thirst
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.
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: 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: www.nice.org.uk Last accessed: 03 August 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ertugliflozin Last revised: 03 December 2018
Last accessed: 03 August 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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