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Onglyza (saxagliptin) is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.
Onglyza is for people with type 2 diabetes. It is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.
Onglyza may also be used for purposes not listed in this medication guide.
You should not use Onglyza if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Onglyza is not for treating type 1 diabetes.
Before you take Onglyza, tell your doctor if you have kidney disease or if you are on dialysis.
Onglyza is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
You should not use Onglyza if you have ever had a severe allergic reaction to saxagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
To make sure you can safely take Onglyza, tell your doctor if you have:
kidney disease (or if you are on dialysis);
heart disease;
pancreatitis;
gallstones;
high triglycerides (a type of fat in the blood); or
a history of alcoholism.
Follow your doctor's instructions about using Onglyza if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.
It is not known whether saxagliptin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
Onglyza is not approved for use by anyone younger than 18 years old.
Take Onglyza exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take this medicine with or without food. Follow your doctor's instructions.
Do not crush, chew, or break a Onglyza tablet. Swallow it whole.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.
If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.
Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.
Your doctor may want you to stop taking Onglyza for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.
Onglyza is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat
Take the missed dose as soon as you remember (be sure to take the medicine with food if your doctor has instructed you to). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Get emergency medical help if you have any signs of an allergic reaction to Onglyza: hives, a purple or red skin rash that spreads and causes blistering and peeling; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking Onglyza and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.
Call your doctor at once if you have:
severe or ongoing pain in your joints;
pain or burning when you urinate; or
heart problems - shortness of breath (even while lying down), feeling weak or tired, rapid weight gain, swelling (especially in your feet, legs, or midsection.
Common Onglyza side effects may include:
runny or stuffy nose, sore throat, cough; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other drugs may increase or decrease the effects of Onglyza on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Onglyza only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Onglyza (www.drugs.com/onglyza.html).
Note: This document contains side effect information about saxagliptin. Some of the dosage forms listed on this page may not apply to the brand name Onglyza.
Common side effects of Onglyza include: hypoglycemia. See below for a comprehensive list of adverse effects.
Applies to saxagliptin: oral tablet
Along with its needed effects, saxagliptin (the active ingredient contained in Onglyza) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking saxagliptin:
More common
Incidence not known
Some side effects of saxagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Applies to saxagliptin: oral tablet
Commonly reported adverse reactions include respiratory tract infection, urinary tract infection, and headache. Peripheral edema was more commonly reported in patients treated with the combination saxagliptin (the active ingredient contained in Onglyza) and thiazolidinedione.
Very common (10% or more): Hypoglycemia
Uncommon (0.1% to 1%): Dyslipidemia, hypertriglyceridemia
Common (1% to 10%): Hypertension, peripheral edema
Frequency not reported: Heart failure
Hospitalization for heart failure occurred more frequently in patients receiving this drug compared with placebo in a cardiovascular outcomes trial that enrolled patients with established, or multiple risk factors for atherosclerotic cardiovascular disease (3.5% vs 2.8%). Additionally, in the time to first event analysis, the risk of hospitalization was higher compared to placebo (Hazard Ratio 1.27; 95% confidence interval 1.07 to 1.51).
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Angioedema
In a cardiovascular outcomes trial that enrolled patients with established, or multiple risk factors for atherosclerotic cardiovascular disease, acute pancreatitis was confirmed in 0.2% (17 of 8240) patients receiving this drug compared with 0.1% (9 of 8173) of the placebo-treated patients. Preexisting risk factor were identified in 88% and 100% of the drug treated patients and placebo patients, respectively.
Common (1% to 10%): Gastroenteritis, vomiting, nausea, dyspepsia, gastritis, flatulence
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Abdominal pain
Postmarketing reports: Acute pancreatitis
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Erectile dysfunction (with metformin)
Common (1% to 10%): Blood creatine phosphokinase increased, anemia, decreased in absolute lymphocyte count (dose related)
Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (the active ingredient contained in Onglyza) (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).
Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): Arthralgia
Common (1% to 10%): Headache, dizziness
Common (1% to 10%): Fatigue
Common (1% to 10%): Anxiety, depression
Common (1% to 10%): Upper respiratory tract infection, sinusitis, nasopharyngitis, bronchitis
Uncommon (0.1% to 1%): Hypersensitivity reactions
Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock
Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Onglyza (www.drugs.com/onglyza.html).
August 5, 2020
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