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Last Updated : 3/5/2018

General Information on Ertugliflozin

Generic Name : Ertugliflozin

Pronunciation : ER-too-gli-FLOE-zin

Latest prescription information about Ertugliflozin. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Antidiabetics

Trade Names/Brand Names of Ertugliflozin

Steglatro

Overview of Ertugliflozin

Ertugliflozin tablet for oral use has been approved by the US FDA in December 2017 for treating type 2 diabetes mellitus in adult patients.

Why is Ertugliflozin Prescribed? (Indications)

Ertugliflozin tablet is a sodium glucose co-transporter 2 (SGLT2) inhibitor which is prescribed for adult patients with type 2 diabetes as an adjunct therapy to diet control and exercise with a focus to improve glycemic control.
It is prescribed either as a monotherapy or in combination with metformin or sitagliptin.  

When should Ertugliflozin not to be taken? (Contraindications)

Ertugliflozin should not be used in patients with-

Allergy to ertugliflozin
Type 1 diabetes mellitus
Diabetic ketoacidosis
Severe kidney disorder in patients with an estimated glomerular filtration rate (eGFR) of 60 mL/minute/1.73 m2 or less, end-stage renal disease or patients undergoing dialysis
Volume depleted or severely dehydrated patients
Pregnancy, especially in the second and third trimesters, and breastfeeding
Children below 18 years of age

What is the dosage of Ertugliflozin?

The recommended initial dose of ertugliflozin tablets is 5 mg to be taken once a day.
The dose of ertugliflozin can be increased to 15 mg once daily to achieve adequate glycemic control.

How should Ertugliflozin be taken?

Ertugliflozin tablet should be taken by mouth once daily in the morning either with or without food.

What are the warnings and precautions for Ertugliflozin?

Ertugliflozin can lead to severe or life-threatening ketoacidosis especially in patients at risk e.g. those with acute fever, pancreatic disorder or alcohol abuse. The level of ketones in the urine should regularly be monitored even if the blood sugar is normal.
Patients should be monitored for the signs and symptoms of volume depletion or low blood pressure during ertugliflozin therapy.

Abnormalities of kidney function tests like increased serum creatinine levels or decreased glomerular filtration rate may occur during ertugliflozin therapy. Patients should be monitored for kidney function before and after initiating ertugliflozin therapy.
Ertugliflozin can increase the risk of developing urinary tract infections (UTI) such as urosepsis or pyelonephritis (kidney infection). Patients should be monitored for the signs and symptoms of UTI and should be treated appropriately.

Patients should be monitored for the signs and symptoms of pain, tenderness, ulcers or sores of the lower limbs, and bone infections such as osteomyelitis. Ertugliflozin therapy should be discontinued in such cases to avoid the risk of limb amputation.
Increase in genital fungal or bladder infections have been observed in patients on ertugliflozin therapy. It is necessary to monitor to detect early and treat with appropriately. Patients who are uncircumcised or who have a history of genital fungal or bladder infections could be at a particularly higher risk.

Patients who have high cholesterol levels should be monitored for the rise in the level of low-density lipoproteins and treated accordingly.

What are the side effects of Ertugliflozin?

  Common: Frequent urination, low blood sugar level, genital fungal infections
  Gastrointestinal: Nausea, pain in the stomach, vomiting
  Cardiovascular: Low blood volume, low blood pressure, faster heartbeat, increased LDL-cholesterol level in blood
  Nervous system: Confusion, dizziness, headache, irritability, weakness
  Respiratory: Difficulty in breathing, nasopharyngitis
  Kidney: Urinary tract infections (pyelonephritis, urosepsis or bladder infections), pain or burning sensation while passing urine, blood in urine, reduced kidney function
  Others: Foot ulcers or sores, fever, pain or tenderness in the lower limbs, pain in the back, reduced weight, increased thirst

Some of the side effects mentioned above could be due to ketoacidosis.

What are the other precautions for Ertugliflozin?

Ertugliflozin may increase urinary glucose excretion. This could result in positive test results for urinary glucose even in patients with adequate blood glucose control.
Patients should be advised to not to stand up suddenly from sitting or lying position to prevent from falling due to the risk of orthostatic hypotension.
Avoid alcohol consumption as it may cause fluctuations in blood sugar levels. Do not change the dose of ertugliflozin or diet plan without the approval of the treating physician.
Do not take extra tablets to make up the missed dose.

What are the Drug Interactions of Ertugliflozin?

Ertugliflozin increases the risk of causing low blood sugar level when used with insulin or insulin secretagogues, therefore, the low dose of insulin should be prescribed when taken in combination with ertugliflozin to reduce the risk of hypoglycemia.

Gatifloxacin should not be used along with ertugliflozin as it may interfere with the therapeutic activity of ertugliflozin.

What are the storage conditions for Ertugliflozin?

Store the tablets in the original container in a dry place at a room temperature of about 20C and 25C.
Protect from excess heat and moisture.
Keep away from the reach of children.

Last Updated : 3/5/2018
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