Description

WHAT IS STEGLUJAN?

STEGLUJAN is a tablet that is taken orally in patients with type 2 diabetes mellitus to improve their blood sugar control. It is used in conjunction with diet and exercise.

HOW DOES STEGLUJAN WORK?

STEGLUJAN is a combination tablet. It contains ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Ertugliflozin reduces the amount of glucose that is reabsorbed from the kidneys and so lowers blood glucose concentrations in the blood. Sitagliptin prevents the breakdown of incretin hormones. Incretin hormones increase the secretion of insulin and decrease the concentration of glucagon. Inhibition of incretin breakdown reduces blood glucose levels in the blood.

WHAT ARE THE INDICATIONS FOR STEGLUJAN?

STEGLUJAN is indicated for the management of patients with type 2 diabetes mellitus. It is used in combination with diet and exercise to improve blood glucose concentrations.

WHAT IS THE DOSE OF STEGLUJAN?

The dose of STEGLUJAN is given as a 5/100 mg combination tablet. This contains 5 mg ertugliflozin and 100 mg sitagliptin and is taken once daily in the morning. If this dose is well-tolerated, it can be increased to a 15/100 mg combination tablet. This contains 15 mg ertugliflozin and 100 mg sitagliptin and is taken once daily in the morning.

WARNINGS AND PRECAUTIONS

Pancreatitis

STEGLUJAN has been reported to cause acute pancreatitis. This seems to be caused by sitagliptin. Patients should be carefully monitored for this complication. If pancreatitis is diagnosed, STEGLUJAN should be stopped immediately.

Hypotension

STEGLUJAN has been reported to cause a reduction in blood volume, leading to low blood pressure. This seems to be caused by ertugliflozin. It occurs more commonly in patients with renal impairment, older patients, and patients with preexisting low blood pressure. Therefore, ensure that any underlying volume deficit is replaced in the patients before starting STEGLUJAN.

Ketoacidosis

Ketoacidosis is a condition of increased ketones in the blood or urine. This may happen in patients taking STEGLUJAN who have type 1 or type 2 diabetes. This condition is life-threatening and may need to be managed in a hospital. Ketoacidosis can happen even if you have normal blood sugar.

Impaired renal function

STEGLUJAN causes an increase in serum creatinine. This is mediated by ertugliflozin. It occurs more commonly in elderly patients and those with preexisting renal dysfunction. There have been reports of patients developing acute renal failure linked to taking sitagliptin. Some of these patients progress to needing dialysis. Ensure renal function is monitored.

Hypoglycemia

STEGLUJAN, when used together with insulin or drugs that stimulate the secretion of insulin, can cause low blood sugar (hypoglycemia). A lower dose of insulin or insulin secretion stimulators should be used when used in combination with STEGLUJAN.

Genital fungal infections

STEGLUJAN increases the risk of developing fungal infections on the genitals.

Urinary tract infections

STEGLUJAN increases the risk of developing infections in the urinary tract.

Lower limb amputation

STEGLUJAN may increase the risk of having an amputation of the lower limb. Monitor patients for infections of the lower limb or ulcers of the lower limbs. If these occur, make sure to stop STEGLUJAN.

Hypersensitivity

There have been reports of severe hypersensitivity reactions in patients taking STEGLUJAN. These generally occur within three months of starting treatment.

SPECIAL POPULATIONS

Pregnancy

STEGLUJAN has not been studied well in pregnant women. Evidence suggests that STEGLUJAN does not affect the fetus. Its use in pregnancy should only be considered if the benefits outweigh the potential fetal risk.

Breastfeeding

STEGLUJAN is excreted in breast milk. Only use STEGLUJAN if the benefits to the mother outweigh the possible risk to the infant.

Pediatrics

The safety of STEGLUJAN in pediatric patients under the age of 18 has not been established.

Elderly

When used in patients 75 years or older, there is an increased incidence of osmotic diuresis. This increases the risk of hypotension and renal failure.

Renal impairment

In patients taking STEGLUJAN, renal function should be checked on a regular basis. It should not be started in patients with a renal function less than 45 ml/min/1.73 m². If renal function deteriorates below with level, STEGLUJAN should be stopped. It should not be started in any patient in end-stage renal disease or in patients on dialysis.

Hepatic impairment

STEGLUJAN can be safely used in patients with hepatic impairment.

CONTRAINDICATIONS

Patients with any of the following should not be put on STEGLUJAN therapy:

• Severe renal impairment or renal failure or patients on dialysis
• Hypersensitivity to sitagliptin or ertugliflozin

SIDE EFFECTS

Common side effects of STEGLUJAN include:

• Nausea
• Diarrhea
• Lack of appetite
• Fatigue
• Dizziness
• Stuffy nose
• Runny nose
• Sore throat
• Infections in the upper respiratory tract

Less common side effects include:

• Urinary tract infections
• Fungal infections on the genitals
• Hypoglycemia
  • Headache
  • Drowsiness
  • Weakness
  • Confusion
  • Irritability
  • Hunger
  • Sweating
  • Feeling jittery
• Low blood pressure
• Problems with your kidneys
• Increased levels of cholesterol in your blood
• Acute pancreatitis
• Ketoacidosis
• Hypersensitivity reactions
  • Swelling of your body, in particular your face or throat.
  • Difficulty swallowing
  • Difficulty breathing
  • Skin rash and raised red areas

If any of these side effects are noticed, a doctor should be consulted urgently.

DRUG INTERACTIONS

Certain drugs may interact with STEGLUJAN. These include:

• Diuretics
• Insulin
• Insulin secretagogues
• Rifampicin