Glyxambi: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is GLYXAMBI used for?

GLYXAMBI is used with metformin along with diet and exercise, to improve blood sugar levels in adults with type 2 diabetes. GLYXAMBI can be used:

• in patients who are not controlled with metformin and JARDIANCE (empagliflozin), or
• in patients who are not controlled with metformin and TRAJENTA (linagliptin), or
• in patients currently taking metformin and JARDIANCE (empagliflozin), and TRAJENTA (linagliptin) as separate tablets.

How does GLYXAMBI work?

GLYXAMBI contains two medicines: empagliflozin and linagliptin.

Empagliflozin belongs to a class of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It removes excess sugar from the body through the urine.

Linagliptin belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors. It helps to improve insulin levels in the body when blood sugar levels are high, especially after a meal.

Linagliptin also helps to decrease the amount of sugar made by the body.

What are the ingredients in GLYXAMBI?

Medicinal ingredients: empagliflozin and linagliptin.

Non-medicinal ingredients: copovidone, corn starch, crospovidone, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

GLYXAMBI comes in the following dosage forms:

Tablets containing:

• 10 mg empagliflozin and 5 mg linagliptin, or
• 25 mg empagliflozin and 5 mg linagliptin.

Do not use GLYXAMBI if you:

• are allergic to any of the ingredients in GLYXAMBI including empagliflozin (or any other SGLT2 inhibitor) and linagliptin (or any other DPP-4 inhibitor);
• have severe kidney problems or are on dialysis;
• have severe liver disease;
• have DKA or a history of DKA;
• have type 1 diabetes;
• are experiencing loss of fluids from the body due to vomiting, diarrhea or dehydration;

• are pregnant or are planning on becoming pregnant;

• are breastfeeding or are planning to breastfeed; or
• are under 18 years of age.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GLYXAMBI. Talk about any health conditions or problems you may have, including if you:

• have an increased chance of developing DKA (increased levels of ketones in your blood or urine, seen in tests), including if you:

  • o are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
  • o are on a very low carbohydrate diet;
  • o have been fasting for a while;
  • o are eating less, or there is a change in your diet;
  • o drink a lot of alcohol;
  • o have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
  • o are going to have surgery and after surgery;
  • o are hospitalized for major surgery, serious infection, or serious medical illnesses;
  • o have an acute illness;
  • o have sudden reductions in insulin dose;
  • o have a history of DKA.
• have kidney problems;
• have liver problems;
• have heart failure or heart disease;
• are at high risk for stroke (e.g., due to heart rhythm problems, history of mini-strokes etc.);
• have low blood pressure;
• are taking a medicine for high blood pressure or taking a water pill (used to remove excess water from the body);
• are taking insulin. Taking GLYXAMBI with insulin can increase the risk of having low blood sugar (hypoglycemia). GLYXAMBI is not approved for use with insulin;
• are taking other medicines to lower your blood sugar. Taking GLYXAMBI with these medicines can increase the risk of having low blood sugar (hypoglycemia);
• have been told by a doctor that you have a reduced immune system. For example, if you have had organ transplantation or if you have HIV/AIDS;
• have a history of yeast infection of the vagina or penis. GLYXAMBI increases your chance of getting a yeast infection. This is more likely if you have had an infection in the past;
• have or have had inflammation of your pancreas (pancreatitis);
• have a history of urinary tract infections or problems with urination;
• have any skin problems;
• are 65 years of age or older. If you are older than 75 years of age, the use of GLYXAMBI is not recommended.

Other warnings you should know about:

Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery or trauma (stress conditions). In such cases, contact your doctor as your medication may need to be adjusted.

GLYXAMBI may cause necrotizing fasciitis of the perineum (area between and around the anus and genitals). This is a rare, but serious and potentially life-threatening infection that can affect both men and women with diabetes taking SGLT2 inhibitors. It is also known as Fournier’s gangrene and requires urgent treatment. If you experience tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if you also have a fever or are feeling unwell, contact your doctor right away. These may be signs of Fournier’s gangrene.

GLYXAMBI may cause dizziness or light-headedness. Do not drive or use machines until you know how the medicine affects you.

If you are going to have a surgery and after your surgery, or if you are hospitalized for a serious infection, a serious medical illness, or a major surgery, your doctor may stop your GLYXAMBI. Talk to your doctor about when to stop taking GLYXAMBI and when to start it again. Your doctor will check for ketones in your blood or urine.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with GLYXAMBI:

• some medicines, including insulin, that are used to treat diabetes;
• medicines used to treat seizures such as phenobarbital, carbamazepine and phenytoin may require that your doctor monitor control of your blood sugar levels more closely;
• rifampin (used to treat bacterial infections), dexamethasone (a steroid), may require that your doctor monitor control of your blood sugar levels more closely;
• medicines to lower your blood pressure;
• diuretics, known as water pills, such as furosemide. They are used to remove excess water from the body;
• an herbal medicine called St. John’s Wort, which may reduce the effect of GLYXAMBI.
• lithium, because GLYXAMBI can lower the amount of lithium in your blood.

How to take GLYXAMBI:

Follow the directions given to you by your doctor.

Take GLYXAMBI:

• once a day;
• at any time of the day, at about the same time each day;
• by mouth;
• with or without food.

Swallow whole. Do NOT cut or divide tablets.

Usual dose:

GLYXAMBI comes in two strengths: 10 mg/5 mg tablets and 25 mg/5 mg tablets. Your doctor will tell you which strength of GLYXAMBI to start with. GLYXAMBI should be taken as one tablet once a day.

Overdose:

Missed Dose:

• If it is 12 hours or more until your next dose, take GLYXAMBI as soon as you remember. Then take your next dose at the usual time.
• If it is less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.

What are possible side effects from using GLYXAMBI?

These are not all the possible side effects you may have when taking GLYXAMBI. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• cough (with or without phlegm);
• stuffy or runny nose;
• sore throat;
• mouth ulcers;
• diarrhea;
• nausea and vomiting;
• abdominal pain;
• constipation;
• weight loss;
• headache/dizziness;
• back pain;
• muscle pain;
• feeling weak;
• tremor;
• passing more urine than usual or needing to pass urine more often;
• strain or pain when urinating;
• itchiness;
• rash.

If any of the above affect you severely, tell your doctor or pharmacist.

GLYXAMBI can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check kidney function, liver function, blood fat levels and amount of red blood cells in your blood (hematocrit).

Diabetic ketoacidosis (DKA) is a serious, life-threatening medical condition that may lead to death. DKA can occur with normal or high blood glucose levels. DKA has happened in people who have type 1 diabetes or type 2 diabetes, or in people with diabetes who were sick or who had surgery, during treatment with GLYXAMBI. DKA requires immediate treatment in a hospital. DKA can happen with GLYXAMBI even if your blood sugar is at normal or near normal levels. Stop taking GLYXAMBI immediately and get immediate medical help if you have any of the symptoms described in the table below under DKA, even if your blood glucose levels are normal.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at 15-30°C.

Keep out of reach and sight of children.

If you want more information about GLYXAMBI:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp), the manufacturer’s website (https://www.boehringer-ingelheim.ca), or by calling the manufacturer, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, extension 84633.

Last revised: APR 04, 2023

Boehringer Ingelheim (Canada) Ltd.

Burlington, ON, Canada L7L 5H4

Co-promoted with:

Eli Lilly Canada Inc.

Box 73, Toronto, ON, Canada M5X 1B1