Onglyza

The active ingredient in Onglyza is saxagliptin. The mechanism of action of saxagliptin is that it inhibits the enzyme dipeptidyl peptidase 4 (DPP-4), which is responsible for the breakdown of incretin hormones. The use of saxagliptin results in an increase in incretin hormones, which stimulate insulin release and decrease glucagon production. The effects of saxagliptin will help lower blood glucose levels and help with glycemic control.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-approved product Labeling, Instructions for Use, and Medication Guide, before using Onglyza. However, the following is a synopsis of the general guidelines for the use of Onglyza:

• Onglyza is typically taken by mouth once daily. You can take it with or without food.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses in one day.
• Onglyza tablets are film-coated. Do not crush, chew, or split the tablets.

The most common side effects of Onglyza seen in clinical trials as compared to placebo include:

• Upper respiratory tract infections.
• Urinary tract infections.
• Headache.
• Hypoglycemia may occur more frequently in people who already take sulfonylurea or insulin. If you have symptoms of low blood sugar (e.g., shaking, sweating, fast heartbeat, hunger), check your blood sugar and treat it appropriately if low.

Some individuals may experience serious side effects while using Onglyza. These adverse reactions may require immediate medical attention or hospitalization. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of pancreatitis.
• Serious allergic reaction. This includes swelling of the face, shortness of breath, skin rashes, angioedema, and hives.
• Heart failure. Symptoms of heart failure include shortness of breath, swollen ankles, and a rapid increase in weight gain.
• Bullous pemphigoid (blistering of the skin).
• Arthralgia (severe joint pain).

These are not all of the possible side effects of Onglyza. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Onglyza, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• An allergic reaction to other DPP-4 inhibitors.
• Pancreatitis (inflammation of the pancreas).
• Kidney problems.
• Liver problems.
• Heart disease.
• Immunodeficiency disorders.
• Pregnant.
• Breastfeeding.

Do not take Onglyza if:

• You are allergic to any of the ingredients in the formulation of Onglyza.
• You have diabetic ketoacidosis, diabetic pre-coma, or diabetic coma.
• You have Type 1 diabetes. This medication is meant only for Type 2 diabetes.

Onglyza starts to work within a few hours, and it lasts for 24 hours. However, it may take up to several months before you see the full effects of this medication.

When Onglyza is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ketoconazole.
• Clarithromycin.
• Phenytoin.
• Rifampin.

Onglyza is available in the following dosage forms and strengths: 2.5 mg and 5 mg tablets. The usual recommended dose is 2.5 mg or 5 mg once daily.

Store Onglyza at room temperature and keep it out of reach of children and pets.

AstraZeneca produces Onglyza.

The brand name Onglyza has been discontinued. However, there are generic versions available.

Do not stop taking Onglyza without talking to your healthcare professional. Your blood sugar levels may increase if you abruptly stop taking Onglyza.

There are currently no clinical studies of Onglyza in pregnant women, therefore, the manufacturer does not recommend Onglyza in pregnant women. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Onglyza is secreted in human breastmilk, therefore, the manufacturer does not recommend Onglyza in lactating women. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.