Kombiglyze
(Onglyza [saxagliptin] plus Metformin)
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What is Kombiglyze?
Kombiglyze XR contains a combination of metformin and saxagliptin. Metformin and saxagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Saxagliptin works by regulating the levels of insulin your body produces after eating.

Kombiglyze is not for:
  • people with type 1 diabetes.
  • people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take KOMBIGLYZE.
  • people who have kidney problems.
  • are allergic to metformin, saxagliptin, or any of the ingredients in KOMBIGLYZE.
Symptoms of a serious allergic reaction to KOMBIGLYZE may include:
swelling of your face, lips, throat, and other areas on your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) skin rash, itching, flaking, or peeling.
If you have these symptoms, stop taking KOMBIGLYZE and contact your healthcare provider right away.

How should I take Kombiglyze?
Take exactly as your healthcare provider tells you.
  • Should be taken with meals to help lessen an upset stomachside effect.
  • Swallow whole. Do not crush, cut, or chew this medication.
  • Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE.


What are the possible side Effects of Kombiglyze: Allergic (hypersensitivity) reactions, such as:
  • swelling of your face, lips, throat, and other areas on your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) skin rash, itching, flaking, or peeling If you have these symptoms, stop taking KOMBIGLYZE and contact your healthcare provider right away.
  • Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include:
  • shaking
  • sweating
  • rapid heartbeat
  • change in vision
  • hunger
  • headache
  • change in mood

Common side effects include:
  • upper respiratory tract infection
  • stuffy or runny nose and sore throat
  • urinary tract infection
  • headache
  • diarrhea
  • nausea and vomiting
Taking KOMBIGLYZE XR with meals can help lessen the common stomach side effects of metformin. If you have unexplained stomach problems, tell your healthcare provider. Stomach problems that start later during treatment may be a sign of something more serious.
Stop using this medicine and call your doctor at once if you have a serious side effect such as: swelling, rapid weight gain; or severe pain in your upper stomach spreading to your back, nausea and vomiting, and fast heart rate.

How should I store KOMBIGLYZE?
Store between 68°F and 77°F (20°C and 25°C).

What are the ingredients?
Active ingredients: saxagliptin and metformin hydrochloride. Inactive ingredients in each tablet: carboxymethylcellulose sodium, hypromellose 2208, and magnesium stearate.

The 5 mg/500 mg tablet also contains: microcrystalline cellulose and hypromellose 2910. Tablet film coat contains: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and iron oxides.