Kazano

Kazano is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. It is a combination of two prescription medications, alogliptin and metformin.

Alogliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by stopping the DPP-4 enzyme from removing a hormone that is responsible for telling your body to release insulin after you eat. This allows insulin to be released, which lowers blood sugar. Metformin belongs to a group of drugs called biguanides. It decreases blood sugar levels by decreasing the amount of glucose made by the liver, decreasing the amount of glucose absorbed in the intestines from the food that is eaten, and helping the body to respond to insulin.

Kazano comes in tablet form and is usually taken twice daily, with food. Do not break or cut Kazano tablets before swallowing.

Some of the common side effects of Kazano include stuffy or runny nose and sore throat, headache, and cold-like symptoms, and diarrhea.

Kazano is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Kazano can cause serious side effects. See "Kazano Precautions"

The most common side effects of Kazano include:

• cold-like symptoms (upper respiratory tract infection)
• stuffy or runny nose and sore throat
• diarrhea
• increase in blood pressure
• headache
• back pain
• urinary tract infection

Taking Kazano with food can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment may be a sign of something more serious.

• shaking or feeling jittery
• sweating
• fast heartbeat
• change in vision
• hunger
• headache
• change in mood
• confusion
• dizziness

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix)
• estrogens
• insulins or other medicines for diabetes
• isoniazid (INH, Nydrazid)
• morpine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of Kazano drug interactions. Ask your doctor or pharmacist for more information.

Kazano can cause serious side effects, including:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance for getting lactic acidosis with Kazano if you:

• have kidney problems. People whose kidneys are not working properly should not take Kazano.
• have liver problems
• have congestive heart failure that requires treatment with medicines
• drink a lot of alcohol (very often or short-term “binge” drinking)
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents
• have surgery
• have a heart attack, severe infection, or stroke

Inflammation of the pancreas (pancreatitis). Alogliptin, one of the medicines in Kazano, may cause pancreatitis which may be severe. Certain medical conditions make you more likely to get pancreatitis.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kazano there are no specific foods that you must exclude from your diet when receiving Kazano.

Before receiving Kazano, tell your doctor if you:

• have or have had inflammation of your pancreas (pancreatitis)
• have kidney or liver problems
• have heart problems, including congestive heart failure
• are older than 80 years, you should not take Kazano unless your kidneys have been checked and they are normal
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking
• have other medical conditions
• are pregnant or plan to become pregnant. It is not known if Kazano will harm your unborn baby. Talk with your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known whether Kazano passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking Kazano.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. This medication falls into category B. It is not known if Kazano will harm your unborn baby. Talk with your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Kazano passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking Kazano.

Take Kazano exactly as your doctor tells you to take it.

• Take Kazano 2 times each day.
• Take Kazano with food to lower your chances of having an upset stomach.
• Do not break or cut Kazano tablets before swallowing.
• Your doctor may need to change your dose of Kazano to control your blood glucose. Do not change your dose unless told to do so by your doctor.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular schedule. Do not take 2 doses of Kazano at the same time.
• If you take too much Kazano, call your doctor or go to the nearest hospital emergency room right away.
• If your body is under stress, such as from fever, infection, accident, or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
• Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.

Your doctor may do certain blood tests before you start Kazano and during treatment as needed. Your doctor may ask you to stop taking Kazano based on the results of your blood tests due to how well your kidneys are working. 

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

The dose your doctor recommends will depend on several factors including:

• the medications you are currently taking
• other medical conditions you have
• how well Kazano works for you
• how well you tolerate the medication (side effects)

The maximum recommended daily dose is 25 mg alogliptin and 2000 mg metformin.

If you take too much Kazano, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Kazano at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the container of Kazano tightly closed.
• Keep Kazano and all medicines out of the reach of children.

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
• The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. 
• If acidosis is suspected, Kazano should be discontinued and the patient hospitalized immediately.