Saxagliptin belongs to the group of diabetes medications called DPP-4 inhibitors. It works by increasing the amount of incretin available in the body. Incretin is a hormone that is released by the intestines. It raises insulin levels when blood sugar is high and decreases the amount of sugar made by the body. Saxagliptin is used in combination with metformin, a sulfonylurea (e.g., gliclazide, glyburide), or insulin to improve blood sugar levels in adults with type 2 diabetes. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual dose of this medication is 5 mg taken by mouth once daily with or without food. Swallow the tablet whole with some fluid. Do not split the tablet.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

2.5 mg
Each pale yellow, biconvex, round, film-coated tablet, with "2.5" printed on one side and "4214" printed on the other side in blue ink, contains 2.5 mg of saxagliptin as saxagliptin hydrochloride. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: yellow iron oxide, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide; printing ink: FD&C Blue No. 2 and shellac glaze.

5 mg
Each pink, biconvex, round, film-coated tablet with "5" printed on one side and "4215" printed on the other side in blue ink, contains 5 mg of saxagliptin as saxagliptin hydrochloride. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: red iron oxide, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide; printing ink: FD&C Blue No. 2 and shellac glaze.

Do not take this medication if you:

• are allergic to saxagliptin or any ingredients of this medication
• have type 1 diabetes, diabetic pre-coma or coma, or diabetic ketoacidosis (these conditions should be treated with insulin)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• headache
• stomach upset

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blistering, red, or peeling skin
• severe joint pain
• signs of heart failure (e.g., sudden weight gain, difficulty breathing, leg swelling)
• symptoms of a urinary tract infection, e.g.:
• cloudy-looking or foul-smelling urine
• frequent urge to urinate
• pain or burning when urinating
• symptoms of an upper respiratory tract infection, e.g.:
• cough
• fever
• headache
• runny nose
• sore throat
• symptoms of low blood sugar, e.g.:
• change in mood
• change in vision
• headache
• hunger
• rapid heartbeat
• shaking
• sweating

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of a serious allergic reaction, e.g.:
• difficulty breathing
• hives
• skin rash
• swelling of the face, lips, tongue, or throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood sugar control: If your body experiences stress such as fever, trauma, infection, or surgery, you may lose control of blood glucose. Your doctor may decide to temporarily stop saxagliptin and advise you to take insulin. Talk to your doctor if you have fever, infection, or are about to undergo surgery.

Congestive heart failure (CHF): Heart failure has been reported in people taking saxagliptin. If you have CHF or heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether this medication is appropriate for you.

Galactose intolerance/glucose malabsorption: Saxagliptin is prepared with lactose. If you have lactose or galactose intolerance speak with your doctor about whether this medication is appropriate for you.

Hypoglycemia: This medication may increase the risk of hypoglycemia (low blood sugar) when taking this medication with a sulfonylurea or insulin. If you are taking saxagliptin with another medication to reduce blood sugar, your doctor may recommend a lower dose of the other medication.

If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) contact your doctor.

Immune system: If you have a weakened immune system (e.g., you have had an organ transplant or have HIV), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Saxagliptin may also cause reduced kidney function. Your doctor may recommend regular testing to check your kidney function while you are taking saxagliptin. This medication is not recommended for people with end-stage renal disease and those on dialysis.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

This medication is not recommended for people with moderately or severely reduced liver function.

Pancreatitis: Saxagliptin can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Type 1 diabetes and diabetic ketoacidosis: Saxagliptin should not be used to treat type 1 diabetes, diabetic pre-coma or coma, or diabetic ketoacidosis (increased ketones in the blood or urine).

Pregnancy: This medication is not recommended for use during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if saxagliptin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 may be more at risk of developing side effects from this medication.

There may be an interaction between saxagliptin and any of the following:

• abiraterone
• acetylsalicylic acid
• amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• apalutamide
• atypical antipsychotics (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone)
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
• bicalutamide
• carbamazepine
• carvedilol
• cobicistat
• conivaptan
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• danazol
• other diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, rosiglitazone)
• diltiazem
• dipyridamole
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• dronedarone
• elagolix
• enzalutamide
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• flibanserin
• glucagon
• grapefruit juice
• hepatitis C antivirals (e.g., daclatasvir, grazoprevir, ledipasvir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• idelalisib
• lanreotide
• luteinizing hormone-releasing hormone analogues (e.g., buserelin, goserelin, leuprolide)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mefloquine
• mifepristone
• mitotane
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• niacin
• octreotide
• pasireotide
• pegvisomant
• phenobarbital
• phenytoin
• primidone
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• rifampin
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• sirolimus
• stiripentol
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• tacrolimus
• testosterone
• tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
• verapamil
• vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.