Apo-Saxagliptin: Uses, Side Effects and Dosage

What APO-SAXAGLIPTIN is used for:

APO-SAXAGLIPTIN is used to improve blood sugar levels in adult patients with type 2 diabetes, in combination with:

• metformin, or
• sulfonylurea, or
• metformin and a sulfonylurea, or
• insulin, or
• insulin and metformin.

APO-SAXAGLIPTIN is used in these patients when diet and exercise with other medications have not worked well enough to control blood sugar levels.

How APO-SAXAGLIPTIN works:

APO-SAXAGLIPTIN helps to improve blood sugar levels in response to a meal. APO-SAXAGLIPTIN also lowers blood sugar levels between meals, and helps to decrease the amount of sugar made by your body.

The ingredients in APO-SAXAGLIPTIN are:

Medicinal ingredient: saxagliptin (as saxagliptin hydrochloride)

Non-medicinal ingredients: hydroxypropyl cellulose, hydroxypropyl methylcellulose, mannitol, polyethylene glycol, red ferric oxide (5 mg), sodium hydroxide, stearic acid, tartaric acid, titanium dioxide and yellow ferric oxide (2.5 mg).

APO-SAXAGLIPTIN comes in the following dosage forms:

Tablets: 2.5 mg and 5 mg saxagliptin (as saxagliptin hydrochloride)

Do not use APO-SAXAGLIPTIN if:

• you are allergic to saxagliptin, any of the other ingredients in APO-SAXAGLIPTIN or if you are allergic to other drugs like APO-SAXAGLIPTIN;

• you have:

  • diabetic ketoacidosis (accumulation of ketones in the blood and urine),
  • diabetic pre-coma or diabetic coma,
  • type 1 diabetes.

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

• have or have had any kidney problems;
• have or have had liver problems;
• have or have had heart failure or have previously had a heart attack;
• have been told you have a reduced immune system, for example you have had an organ transplant or have been diagnosed with human immunodeficiency syndrome (HIV/AIDS);
• have or have had pancreatitis (inflammation of the pancreas);
• have or have had gallstones, alcoholism or hypertriglyceridemia (high levels of fats in your blood);
• are taking other medications to lower your blood sugar levels;

Other warnings you should know about:

Heart failure has been seen in patients treated with APO-SAXAGLIPTIN. Heart failure is when your heart is unable to pump enough blood to meet the needs of the body. You have a higher chance of having 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.

Kidney Problems: You should not take APO-SAXAGLIPTIN if you have severe kidney problems (called end-stage renal disease) and need dialysis.

Blood Sugar Levels:

• Low blood sugar (hypoglycemia) may occur more frequently in people who already take a sulfonylurea or insulin. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache, and change in mood. If you have symptoms of low blood sugar, check your blood sugar and treat if low, then call your healthcare professional.
• Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery, or trauma (stress conditions). In such cases contact your healthcare professional as your medication may need to be adjusted.

Pregnancy and breastfeeding: You should not use APO-SAXAGLIPTIN if you are pregnant, planning to become pregnant, breastfeeding or are planning to breastfeed.

Driving and using machines: If you experience fatigue, dizziness, problems concentrating or in your ability to react, do not drive or use machines until your symptoms get better.

Blood tests: You will have blood work before starting APO-SAXAGLIPTIN to assess how well your kidneys and liver are working and regular blood work to measure your blood sugar and HbA1c levels.

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 APO-SAXAGLIPTIN:

• Medicines used to treat seizures such as phenobarbital, carbamazepine, phenytoin
• Medicines used to treat bacterial or fungal infections such as rifampin and ketoconazole
• A medicine used to treat many conditions including inflammation, asthma allergies and arthritis called dexamethasone

Avoid eating grapefruit or drinking grapefruit juice while taking APO-SAXAGLIPTIN. It may affect the way the medicine works.

How to take APO-SAXAGLIPTIN:

• Take APO-SAXAGLIPTIN

  • exactly as your healthcare professional has told you. Check with them if you are not sure.

  • once daily, with or without food.

• Swallow tablets whole. Do not split or cut tablets.

Usual dose:

Adults: 5 mg, once daily.

You may need a lower dose of APO-SAXAGLIPTIN if your kidneys are not working well.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-SAXAGLIPTIN, 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 miss a dose of APO-SAXAGLIPTIN, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.

Possible side effects from using APO-SAXAGLIPTIN:

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

• upper respiratory tract infection
• urinary tract infection
• headache
• rash
• cold, nasal congestion, runny nose
• dizziness, headache or having blurred vision (signs of high blood pressure)
• pale colour, weakness, fast heartbeat
• diarrhea
• vomiting, nausea, abdominal pain
• muscle pain

Serious side effects and what to do about themSeri

od

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°C - 30°C.

Keep out of reach and sight of children and pets.

Medicines should not be disposed of down the drain or in household garbage. Ask your healthcare professional how to dispose of medicines no longer required. These measures will help to protect the environment.

If you want more information about APO-SAXAGLIPTIN:

• 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 (http://www.apotex.ca/products); or by calling 1-800-667-4708.

Date of Authorization: 2025-11-28