About Steglatro (Ertugliflozin)
What is STEGLATRO?1
STEGLATRO is the sodium-glucose co-transporter-2 (SGLT-2) inhibitor available from MSD.
Steglatro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
- In addition to other medicinal products for the treatment of diabetes.
How does STEGLATRO work?
Mechanism of action
SGLT-2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. STEGLATRO is a potent selective and reversible inhibitor of SGLT-2. By inhibiting SGLT-2, STEGLATRO reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.1
What is STEGLUJAN?2
STEGLUJAN 5 mg/100 mg film-coated tablets
Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
STEGLUJAN 15 mg/100 mg film-coated tablets.
Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
STEGLUJAN is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
- when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.
- in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Please consult the full SPC for contraindications, warnings and precautions against the use of Steglatro and Steglujan.
- Steglatro/Steglujan should not be used in patients with type 1 diabetes.
- Volume depletion: Symptomatic hypotension may occur upon initiation of therapy, particularly in patients with impaired renal function. Assess volume status prior to initiation. Consider temporary interruption of therapy if volume depletion occurs.
- Diabetic ketoacidosis: Use with caution in patients at risk of DKA. If DKA is suspected or diagnosed, discontinue Steglatro/Steglujan. Interrupt therapy in patients hospitalised for major surgical procedures or acute serious medical illness. Monitor these patients’ ketone levels (preferably in blood). Steglatro/Steglujan may be restarted when ketone levels are normalised, and patient is stabilised.
- Hypoglycaemia: When Steglatro/Steglujan is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia.
- Renal impairment: Assessment of renal function is recommended prior to initiation of Steglatro and Steglujan and periodically thereafter. Initiation of these medicinal products are not recommended for patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2 or CrCl less than 45 mL/min. Steglatro should be discontinued when eGFR is persistently less than 30 mL/min/1.73 m2 or CrCl is persistently less than 30 mL/min. Steglujan should be discontinued when eGFR is persistently less than 45 mL/min/1.73 m2 or CrCl is persistently less than 45 mL/min. Steglatro/Steglujan should not be used in patients with severe renal impairment, with end-stage renal disease (ESRD), or receiving dialysis.
- Lower limb amputations: Before initiating ertugliflozin, consider factors in the patient history that may increase the risk for amputation. In a long-term cardiovascular outcomes study of ertugliflozin added to existing therapy in patients with type 2 diabetes and with a history of established cardiovascular disease, the occurrence of non-traumatic lower limb amputations was reported with event rates of 4.7, 5.7 and 6.0 events per 1,000 patient-years in the placebo, ertugliflozin 5mg and ertugliflozin 15mg arms, respectively.
- For Steglujan only: Acute pancreatitis: Use of dipeptidyl peptidase-4 (DPP‑4) inhibitors has been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, Steglujan and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Steglujan should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
Please consult the full SPC for contraindications, warnings and precautions against the use of Steglatro/Steglujan.
- Steglatro Summary of Product Characteristics,
Date of revision of text: November 2021.
- Steglujan of Product Characteristics,
Date of revision of text: November 2021.