Onglyza (Saxagliptin): What is it used for, How does it work, What are the side effects?

What is Onglyza used for?

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

  • metformin,
  • sulfonylurea,
  • metformin and a sulfonylurea or
  • insulin (with or without metformin)

when diet and exercise and metformin, sulfonylurea, metformin and a sulfonylurea or insulin (with or without metformin) alone have failed to adequately control blood sugar levels.

How does Onglyza work?

ONGLYZA belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). ONGLYZA helps to improve blood sugar levels in response to a meal. ONGLYZA also lowers blood sugar levels between meals, and helps to decrease the amount of sugar made by your body.

What is Type 2 Diabetes?

Insulin is a hormone that helps control the level of sugar (glucose) in your blood. Type 2 diabetes is a condition in which your body does not make enough insulin and/or the insulin that your body produces does not work as well as it should. When this happens, glucose can build up in the blood. This can lead to serious problems.

Who should not take Onglyza?

  • Do not take ONGLYZA if you are allergic to any of the ingredients in ONGLYZA or if you are allergic to the other drugs belonging to DPP-4 class.
  • Do not take ONGLYZA if you have diabetic ketoacidosis (accumulation of ketones in the blood and urine), diabetic pre-coma or diabetic coma.
  • Do not take ONGLYZA if you have Type 1 diabetes.

What are the ingredients in Onglyza?

ONGLYZA contains saxagliptin (as saxagliptin hydrochloride) the active ingredient.

nonmedicinal ingredients: ONGLYZA tablets contain the following nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides. The printing ink contains FD&C Blue #2 and shellac glaze.

What strength tablets is Onglyza available in?

ONGLYZA is supplied in 2.5 mg and 5 mg saxagliptin (as saxagliptin hydrochloride) tablets.

Warnings and Precautions for Onglyza?

BEFORE you use ONGLYZA talk to your doctor or pharmacist if:

  • you have had an allergic reaction to other DPP-4 inhibitors
  • you have or have had any kidney problems
  • you have or have had liver problems
  • you have or have had heart failure
  • you have been told you have a reduced immune system [e.g. you have had organ transplantation or have been diagnosed with human immunodeficiency syndrome (HIV/AIDS)]
  • you are pregnant or planning to become pregnant
  • you are breast-feeding or plan to breast-feed
  • you have or have had pancreas problems such as inflammation of the pancreas (pancreatitis)

Heart Failure has been seen in patients treated with ONGLYZA. 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

Symptoms of heart failure include one or more of the following: tiredness, swollen ankles, a fast increase in weight and increased shortness of breath especially when lying down. This is serious. You must talk to your physician immediately or go to the hospital if this happens to you.

ONGLYZA should not be used in patients with end-stage renal disease (ESRD) who require dialysis.

Lactose monohydrate is a nonmedicinal ingredient in ONGLYZA. Do not take ONGLYZA if a doctor has told you that you have one of the following hereditary diseases: galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

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.

What is the usual dose of Onglyza?

The usual recommended adult dose is 5 mg once daily, taken with or without food. You may need a lower dose of ONGLYZA if your kidneys are not working well. ONGLYZA tablets must not be split or cut.

What to do if you overdose on Onglyza?

Warning: If you think you, or a person you are caring for, have taken too much ONGLYZA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What to do if you miss a dose of Onglyza?

If you miss a dose of ONGLYZA, 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.

What are the side effects of Onglyza? What to do about them?

The common side effects of ONGLYZA include: upper respiratory tract infection, urinary tract infection and headache. Hypoglycemia may occur more frequently in people who already take a sulfonylurea or insulin. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache, and change in mood. Tell your physician or pharmacist if you develop any unusual side effects, or if any of the above side effects do not go away or get worse.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/EffectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Pancreatitis (inflammation of the pancreas): prolonged severe abdominal pain which may be accompanied by vomiting 
Severe disabling joint pain  
Very rare
Allergic (hypersensitivity) reactions: rash, hives, swelling of the face, lips, and throat that may cause difficulty in breathing or swallowing 
Bullous pemphigoid (serious skin reaction): blistering of the skin, redness, peeling skin  
Rhabdomyolysis (breakdown of damaged muscle): muscle spasms, weakness, red-brown (tea-coloured) urine  
Heart failure (a weakness of the heart): tiredness, swollen ankles, increasing shortness of breath especially when lying down and a fast increase in weight  

This is not a complete list of side effects. For any unexpected effects while taking ONGLYZA, contact your doctor or pharmacist.

How to Store Onglyza?

Store at room temperature (15-30°C). Keep ONGLYZA well out of reach of children and pets. Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reference: FDA Monograph

Disclaimer: We have made every effort to ensure that all information is factually correct and up to date, however this article is not comprehensive and does not contain all relevant information about the topic. IT should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should consult your doctor or pharmacist before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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