Saxagliptin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes in adults. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: DPP-4 inhibitor; antidiabetic

Generic and brand names: saxagliptin, oral; Onglyza

What is this medicine used for?

This medicine is taken by mouth to treat type 2 diabetes in adults when diet alone has not worked. It should not be used to treat type 1 diabetes or diabetic ketoacidosis. This medicine may be used alone or along with other diabetes medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetic ketoacidosis
• Gallstones
• Heart failure, heart attack, or other heart problems
• Kidney problems
• Pancreatitis (inflammation of your pancreas)
• Problems with alcohol abuse or if you regularly drink alcohol

Tell your healthcare provider if you get sick or injured, or if you are scheduled to have surgery. Your medicine dose may need to be adjusted.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Do not cut or split the tablets. Swallow the tablets whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Follow the diet and exercise program prescribed by your healthcare provider.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

This medicine is not likely to cause hypoglycemia (low blood sugar). However, low blood sugar can also happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or glucose gel (available in drug stores) is another quick way to treat hypoglycemia. If you have low blood sugar often, contact your healthcare provider to find out if you need a dosage adjustment.

This medicine may cause joint pain. Tell your healthcare provider if you have severe joint pain.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); increased urination or pain while urinating; severe stomach pain or stomach pain that won't go away or radiates to your back; severe and constant joint pain; severe vomiting; fever; severe skin redness, itching, peeling, or swelling; unexplained tiredness or weakness; trouble breathing or shortness of breath (especially when lying down); swelling in legs, hands, or feet, or any unexplained swelling; unusually fast weight gain.

Other: Stomach cramps, diarrhea, headache, stuffy or runny nose, sore throat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Androgen hormones such as danazol, methyltestosterone (Android, Testred), and testosterone (Androderm, AndroGel, Axiron, Testim)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone) and quinidine
• Antibiotics such as chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), sertraline (Zoloft), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), and mitotane (Lysodren)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid)
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diuretics (water pills) such as amiloride, furosemide (Lasix), hydrochlorothiazide (Microzide), and triamterene (Dyrenium)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Natural remedies such as aloe, bilberry, bitter melon, chromium, fenugreek, garcinia, garlic, ginger, ginseng, gotu kola, gymnema, St. John's wort, and stinging nettle
• Nefazodone
• Other diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), insulin, and tolbutamide
• Pegvisomant (Somavert)
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.