Komboglyze: Uses, Side Effects and Dosage

Serious warnings and precautions box

KOMBOGLYZE contains metformin and it can cause a rare but serious side effect called lactic acidosis. Lactic acidosis can cause death and must be treated in the hospital. Alcohol may increase the risk of developing lactic acidosis. Do not drink a lot of alcohol while taking KOMBOGLYZE.

What KOMBOGLYZE is used for:

KOMBOGLYZE is used along with diet and exercise to improve blood sugar levels in adults with type 2 diabetes.

KOMBOGLYZE can be used in patients:

• whose diabetes is not controlled on:

  • metformin alone
  • metformin and sulfonylurea alone
  • metformin and insulin alone

• who are already treated with:

  • saxagliptin and metformin
  • saxagliptin, metformin and sulfonylurea
  • saxagliptin, metformin and insulin

How KOMBOGLYZE works:

KOMBOGLYZE contains two drugs.

Saxagliptin: helps to improve blood sugar levels after a meal. Saxagliptin also lowers blood sugar levels between meals and helps to decrease the amount of sugar made by your body.

Metformin: helps to lower the amount of sugar made by the liver, lowers the amount of sugar your intestines absorb and improves insulin sensitivity

The ingredients in KOMBOGLYZE are:

Medicinal ingredients: saxagliptin (as saxagliptin hydrochloride) and metformin hydrochloride.

Non-medicinal ingredients: magnesium stearate, polyethylene glycol 3350, polyvinyl alcohol, povidone, talc, titanium dioxide, and red iron oxide (2.5 mg/500 mg strength) or a combination of red and yellow iron oxides (2.5 mg/850 mg strength) or yellow iron oxide (2.5 mg/1000 mg strength).

KOMBOGLYZE comes in the following dosage form:

Tablets:

• 2.5 mg saxagliptin (as saxagliptin hydrochloride) / 500 mg metformin hydrochloride
• 2.5 mg saxagliptin (as saxagliptin hydrochloride) / 850 mg metformin hydrochloride
• 2.5 mg saxagliptin (as saxagliptin hydrochloride) / 1000 mg metformin hydrochloride

Do not use KOMBOGLYZE if:

• you have uncontrolled and/or insulin-dependent type 1 diabetes;
• you have a build-up of acid in your body. This is known as metabolic acidosis;
• you have or have had a condition called metabolic acidosis (including diabetic ketoacidosis, or lactic acidosis – too much acid in the blood);
• you have or have had a liver or kidney problem;
• you have heart failure or abrupt failure of blood circulation. This is known as cardiovascular collapse;
• you have heart and lungs that do not function properly. This is known as cardiorespiratory insufficiency, a disease state that can cause hypoxemia (low oxygen in the blood);
• you drink alcohol very often or drink a lot of alcohol in a short time. This is known as binge drinking;
• you are stressed, have severe infections, are experiencing trauma;
• you are about to undergo surgery or during the recovery time after your surgery;
• you suffer from severe dehydration (have lost a lot of water from your body) or shock;

• you are breastfeeding;

• you are pregnant or planning to become pregnant;
• you are going to have an exam or other tests such as an X-ray or scan with injectable dyes or contrast agents used. Talk to your healthcare professional about when to stop KOMBOGLYZE and when to start again;
• you are allergic to saxagliptin, other drugs like saxagliptin, metformin or any of the ingredients in KOMBOGLYZE.

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

• have any of the following conditions:

  • low vitamin B₁₂ levels;
  • have or have had pancreas problems such as inflammation of the pancreas (pancreatitis);
  • are weak or malnourished;
  • problems with your adrenal or pituitary glands (adrenal or pituitary insufficiency).
• are taking any of the medications listed in the drug interactions section (see The following may interact with KOMBOGLYZE)

• have risk factors for lactic acidosis, such as if you:

  • have metabolic acidosis (such as diabetic ketoacidosis);
  • have kidney problems;
  • have liver problems;
  • have congestive heart failure that requires treatment with medicines;
  • have a heart attack, severe infection, or stroke;
  • drink a lot of alcohol (very often or short-term “binge” drinking);
  • are dehydrated. Dehydration can also happen when you sweat a lot with activity or exercise and don’t drink enough fluids. Tell your healthcare professional if this happens.
  • have certain X-ray tests with injectable dyes or contrast agents used;
  • have surgery;
  • are 80 years of age or older and have not been assessed for kidney function.
  • have or think you have certain mitochondrial diseases, specifically Mitochondrial Encephalomyopathy with Lactic acidosis, and Stroke-like episodes (MELAS) syndrome and Maternally Inherited Diabetes and Deafness (MIDD) (diseases that are passed down at birth affecting mitochondria). For these patients, taking KOMBOGLYZE increases the risk for lactic acidosis and can lead to worsening of the mitochondrial disease.

Other warnings you should know about:

Vitamin B₁₂ levels

KOMBOGLYZE can cause your vitamin B₁₂ levels to be low. This can cause peripheral neuropathy (nerve damage) or anemia (low red blood cells). Surgery Tell your healthcare professional if you are going to have a surgery or had major surgery. Your healthcare professional may stop your KOMBOGLYZE treatment before and after certain types of surgery. Check-ups and testing

You will have regular visits with your healthcare professional before and during treatment with KOMBOGLYZE to monitor your health. They may check:

• the condition of your heart;
• your blood sugar levels;
• that your kidneys are working properly;
• the amount of red blood cells in your blood;
• ketone levels in your blood or urine. Ketones are a type of chemical that your liver produces when it breaks down fats for energy;
• your blood levels of vitamin B_12.

Driving and using machines Do not drive or use machines until you know how the medicine affects you. Do not drive or operate machines if you develop hypoglycemia (low blood sugar levels). Serious skin reactions KOMBOGLYZE can cause serious skin reactions called Stevens-Johnson syndrome and bullous pemphigoid. See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.

Heart problems Heart failure has been seen in patients treated with KOMBOGLYZE. Heart failure is when your heart is unable to pump enough blood to meet the needs of the body. You are at greater risk of heart failure if you have or have had:

• heart or blood vessel disease including heart failure and heart attack;
• kidney disease;
• several risk factors of getting heart disease.

Worsening of existing mitochondrial disease such as MELAS syndrome and MIDD

Tell your healthcare professional if you experience symptoms such as seizures, reduction in mental abilities (memory lapses, difficulty concentrating, trouble finding words or following conversations, poor judgement or decision-making), difficulty with body movements, muscle pain or weakness, pain, numbness, migraine or deafness after starting KOMBOGLYZE. These may be signs that your existing medical condition is getting worse.

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 KOMBOGLYZE:

• Other diabetes drugs such as glyburide;
• Furosemide;
• Cationic drugs (such as amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin);
• Rifampin, an antibiotic used to treat bacterial infections such as tuberculosis;
• Phenprocoumon and other drugs used to prevent blood clots and thin the blood;

• Other drugs that tend to produce hyperglycemia (high blood sugar) and may lead to a loss of blood sugar control. Examples include:

  • A group of medicines known as calcium channel blockers, used to treat heart problems such as: nifedipine, amlodipine, felodipine, verapamil, diltiazem
  • Bronchodilators (known as beta-2-agonists): medicines that make breathing easier, used to treat asthma like salbutamol or formoterol;
  • Thiazide and other diuretics (used to lower extra fluid in your body);
  • Phenytoin, used to treat epilepsy;
  • Nicotinic acid, used to prevent and treat low niacin;
  • Isoniazid, used to treat tuberculosis;
  • Corticosteroids (anti-inflammatory drugs);
  • Phenothiazines, used to treat mental and emotional disorders;
  • Thyroid drugs such as levothyroxine;
  • Female hormones like estrogens or estrogens plus progestogen;
  • Oral birth control pills;
  • Sympathomimetics, used to stimulate the sympathetic nervous system;
  • Medicines used to lower blood pressure, like diltiazem;
  • Medicines for asthma;
• ACE inhibitor drugs (may lower blood glucose).

How to take KOMBOGLYZE:

• Take KOMBOGLYZE exactly as your healthcare professional tells you. Check with your healthcare professional if you are not sure.
• Take with meals to reduce your chance of having an upset stomach.

Usual dose:

Your healthcare professional will decide the best dose that is right for you.

Overdose:

If you think you, or a person you are caring for, have taken too much KOMBOGLYZE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.

Possible side effects from using KOMBOGLYZE:

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

• abdominal bloating
• changes in taste or a metallic taste
• diarrhea
• fatigue
• gas
• headache
• loss of appetite
• low vitamin B₁₂ (vitamin B₁₂ deficiency)
• nausea
• rash
• upper respiratory tract infection
• upset stomach
• urinary tract infection
• vomiting

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, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15 to 25°C).

Keep out of reach and sight of children.

If you want more information about KOMBOGLYZE:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.astrazeneca.ca; or by calling 1-800-668-6000.
• The Patient Medication Information is current at the time of printing. The most up-to-date version can be found at www.astrazeneca.ca.

Date of Authorization: 2026-04-01

KOMBOGLYZE^® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.