KAZANO- alogliptin and metformin hydrochloride tablet, film coated 
Takeda Pharmaceuticals America, Inc.

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MEDICATION GUIDE

KAZANO (Kah-ZAHN-oh)
(alogliptin and metformin HCl)
tablets

Read this Medication Guide carefully before you start taking KAZANO and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about KAZANO, ask your doctor or pharmacist.

What is the most important information I should know about KAZANO?

KAZANO can cause serious side effects, including:

1.
Lactic Acidosis. Metformin, one of the medicines in KAZANO, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

Most people who have had lactic acidosis with metformin have other things that, combined with metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with KAZANO if you:

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems listed above. You doctor may decide to stop KAZANO for a while if you have any of these things.

KAZANO can have other serious side effects. See "What are the possible side effects of KAZANO?"

2.
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.

Before you start taking KAZANO:

Tell your doctor if you have ever had:

  • pancreatitis
  • kidney problems
  • liver problems

Stop taking KAZANO and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

3.
Heart failure:

Before you start taking KAZANO:

Tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.

Contact your healthcare provider right away if you have any of the following symptoms:

  • increasing shortness of breath or trouble breathing especially when lying down
  • an unusually fast increase in weight
  • swelling of feet, ankles, or legs

These may be symptoms of heart failure.

What is KAZANO?

It is not known if KAZANO is safe and effective in children under the age of 18.

Who should not take KAZANO?

Do not take KAZANO if you:

Symptoms of a serious allergic reaction to KAZANO may include:

  • swelling of your face, lips, throat and other areas on your skin
  • raised, red areas on your skin (hives)
  • difficulty with swallowing or breathing
  • skin rash, itching, flaking or peeling

If you have any of these symptoms, stop taking KAZANO and contact your doctor or go to the nearest hospital emergency room right away.

What should I tell my doctor before and during treatment with KAZANO?

Before you take KAZANO, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist before you start any new medicine.

KAZANO may affect the way other medicines work, and other medicines may affect how KAZANO works. Contact your doctor before you start or stop other types of medicines.

How should I take KAZANO?

What are the possible side effects of KAZANO?

KAZANO can cause serious side effects, including:

  • swelling of your face, lips, throat and other areas on your skin
  • raised, red areas on your skin (hives)
  • difficulty swallowing or breathing
  • skin rash, itching, flaking or peeling
If you have these symptoms, stop taking KAZANO and contact your doctor right away.
  • nausea or vomiting
  • loss of appetite
  • stomach pain
  • dark urine
  • unusual or unexplained tiredness
  • yellowing of your skin or the whites of your eyes
  • shaking or feeling jittery
  • sweating
  • fast heartbeat
  • change in vision
  • hunger
  • headache
  • change in mood
  • confusion
  • dizziness

The most common side effects of KAZANO include:

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

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.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of KAZANO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store KAZANO?

Keep KAZANO and all medicines out of the reach of children.

General information about the safe and effective use of KAZANO

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not take KAZANO for a condition for which it was not prescribed. Do not give KAZANO to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about KAZANO. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about KAZANO that is written for health professionals.

For more information go to www.kazano.com or call 1-877-TAKEDA-7 (1-877-825-3327).

What are the ingredients in KAZANO?

Active ingredients: alogliptin and metformin hydrochloride

Inactive ingredients: mannitol, microcrystalline cellulose, povidone, crospovidone and magnesium stearate; the tablets are film-coated with hypromellose 2910, talc, titanium dioxide and ferric oxide yellow.

Distributed by Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. KAZANO and NESINA are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and are used under license by Takeda Pharmaceuticals America, Inc.

©2013 - 2017 Takeda Pharmaceuticals America, Inc.

ALM143 R11

This Medication Guide has been approved by the U.S. Food and Drug Administration.
2/2017

Revised: 6/2019
Takeda Pharmaceuticals America, Inc.