Kazano contains a combination of alogliptin and metformin. Alogliptin and metformin 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. Alogliptin works by regulating the levels of insulin your body produces after eating.

Kazano is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Kazano is not for treating type 1 diabetes.

You should not use Kazano if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Alogliptin can cause pancreatitis. Stop using Kazano and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and loss of appetite.

Before taking this medicine

You should not use Kazano if you are allergic to alogliptin or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• kidney disease;

• heart disease;

• liver disease;

• pancreatitis;

• gallstones; or

• alcoholism.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Kazano. Be sure your caregivers know ahead of time that you are using this medicine.

Follow your doctor's instructions about using Kazano if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using Kazano. Ask your doctor about any risk.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

This medicine is not approved for use by anyone younger than 18 years old.

Take Kazano exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Kazano with meals.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Kazano is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your doctor may have you take extra vitamin B12 while you are taking Kazano. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Kazano for Diabetes Type 2:

Individualize the initial dose based on patients current regimen

Initial dose: alogliptin 12.5 mg-metformin 500 mg OR alogliptin 12.5 mg-metformin 1000 mg orally twice a day
Maintenance dose: Adjust dose based on efficacy and tolerability
Maximum dose: alogliptin 25 mg-metformin 2000 mg per day

Comments:
-When used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or the insulin secretagogue may be required to minimize the risk of hypoglycemia.
-Metformin dose should be gradually titrated and taken with food to reduce the gastrointestinal side effects.

Use: As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with Kazano is appropriate.

You should not use Kazano if you are allergic to alogliptin or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• kidney disease;

• heart disease;

• liver disease;

• pancreatitis;

• gallstones; or

• alcoholism.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Kazano. Be sure your caregivers know ahead of time that you are using this medicine.

Follow your doctor's instructions about using Kazano if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using Kazano. Ask your doctor about any risk.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

This medicine is not approved for use by anyone younger than 18 years old.

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking Kazano and call your doctor right away if you have symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;

• feeling cold;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, vomiting; or

• slow or irregular heart rate.

Call your doctor at once if you have:

• severe or ongoing pain in your joints;

• pain or burning when you urinate;

• liver problems - nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or

• symptoms of heart failure - shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Kazano side effects may include:

• diarrhea, upset stomach;

• increased blood pressure (severe headache, blurred vision, pounding in your neck or ears);

• back pain, headache; or

• cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with alogliptin and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.