The brand name of the drug is Onglyza. The active ingredient is saxagliptin, presented as saxagliptin hydrochloride dihydrate, which is a DPP-4 enzyme inhibitor. It is available in film-coated tablets for oral use, with dosage strengths of 2.5 mg and 5 mg saxagliptin. Key inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and titanium dioxide. The medication is intended to function by inhibiting the DPP-4 enzyme, though therapeutic use is implied but not explicitly stated.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not cut, crush, or chew this medication. Take your dose at the same time each day. Do not take more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe joint pain
• Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Headache
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetic ketoacidosis
• Heart disease
• Heart failure
• Kidney disease
• Pancreatitis
• Previous swelling of the tongue, face, or lips with trouble breathing, trouble swallowing, hoarseness, or tightening of the throat
• Type 1 diabetes
• An unusual or allergic reaction to saxagliptin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Alcohol
• Certain antibiotics, such as clarithromycin or telithromycin
• Certain antivirals for HIV, such as atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir
• Certain medications for fungal infections, such as itraconazole or ketoconazole
• Insulin
• Sulfonylureas, such as glimepiride, glipizide, glyburide

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you might need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.