Glyxambi
Glyxambi
Empagliflozin, Linagliptin
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Select product strength & quantity:

WHAT IS GLYXAMBI?

Glyxambi (empagliflozin and linagliptin) 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 GLYXAMBI WORK?

Glyxambi is a combination tablet. It contains empagliflozin, a sodium-glucose co-transporter (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Empagliflozin reduces the amount of glucose that is reabsorbed from the kidneys and so lowers blood glucose concentrations in the blood. Linagliptin prevents the breakdown of incretin hormones. Incretin hormones increase the secretion of insulin and decrease the concentration of glucagon. By inhibiting the breakdown of incretin, there is a reduction in blood glucose levels in the blood.

WHAT ARE THE INDICATIONS FOR GLYXAMBI?

Glyxambi 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 GLYXAMBI?

The dose of Glyxambi is given as a 10/5 mg combination tablet. This contains 10 mg empagliflozin and 5 mg linagliptin and is taken once daily in the morning. If this dose is well-tolerated, it can be increased to a 25/5 mg combination tablet. This contains 25 mg empagliflozin and 5 mg linagliptin and is taken once daily in the morning.

WARNINGS AND PRECAUTIONS

Pancreatitis

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

Hypotension

Glyxambi has been reported to cause a reduction in blood volume, leading to low blood pressure. This seems to be caused by empagliflozin. This occurs more commonly in patients with renal impairment, older patients, and patients with preexisting low blood pressure.

Impaired renal function

Glyxambi causes an increase in serum creatinine. This is mediated by empagliflozin. It occurs more commonly in elderly patients and those with preexisting renal dysfunction.

Hypoglycemia

Glyxambi, 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 Glyxambi.

Genital fungal infections

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

Urinary tract infections

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

Hypersensitivity

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

SPECIAL POPULATIONS

Pregnancy

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

Breastfeeding

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

Pediatrics

The safety of Glyxambi 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 Glyxambi, 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, Glyxambi should be stopped.

Hepatic impairment

Glyxambi can be safely used in patients with hepatic impairment.

CONTRAINDICATIONS

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

  • Severe renal impairment or renal failure
  • Hypersensitivity to linagliptin or empagliflozin

SIDE EFFECTS

Common side effects of Glyxambi 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
  • 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 Glyxambi. These include:

  • Diuretics
  • Insulin
  • Insulin secretagogues
  • Rifampicin

FREQUENTLY ASKED QUESTIONS

Glyxambi is manufactured as a 10/5 mg combination tablet that contains 10 mg empagliflozin and 5 mg linagliptin. It is yellow, triangular and marked with 10/5 on one side. It also comes as a 25/5 mg combination tablet that contains 25 mg empagliflozin and 5 mg linagliptin. It is pink, triangular and marked with 25/5 on one side.

The starting dose of Glyxambi is one 10/5 mg combination tablet taken once daily in the morning. If this dose is well-tolerated, it can be increased to one 25/5 mg combination tablet taken daily in the morning.

Glyxambi should be taken as instructed by your doctor. Take one tablet each day in the morning. You can take this with or without food. If you take insulin at the same time as Glyxambi, your doctor will adjust the dose of the insulin. Check your blood sugar as your doctor instructs you to. Should you be undergoing a period of physical stress due to an infection or a fever, your dose of Glyxambi may need to be adjusted. Your doctor should be consulted on these events.

Persons with severe hypersensitivity to Glyxambi constituents should not take the medication. If you have renal failure, you should not take this medication.

Should you miss a dose of Glyxambi, take your medication as soon as you remember. If you are due to take your next dose, skip the dose you have missed and return to your normal schedule. Never take two doses ofGlyxambi at the same time.

You should not use Glyxambi if you have:

  • Severe renal failure, renal dysfunction, or are on dialysis
  • An allergy to linagliptin or empagliflozin

Common side effects of Glyxambi include:

  • Nausea
  • Diarrhea
  • Lack of appetite
  • Fatigue
  • Dizziness
  • Stuffy nose
  • Runny nose
  • Sore throat
  • Infections of 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
  • 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.