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Nesina

"The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochlor"...

Nesina

PATIENT INFORMATION

MEDICATION GUIDE

NESINA
(nes-see'-na)
(alogliptin) Tablets

Read this Medication Guide carefully before you start taking NESINA 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 NESINA, ask your doctor or pharmacist.

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

Serious side effects can happen to people taking NESINA, including inflammation of the pancreas (pancreatitis) which may be severe.

Certain medical conditions make you more likely to get pancreatitis.

Before you start taking NESINA:

Tell your doctor if you have ever had:

Stop taking NESINA 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.

What is NESINA?

  • NESINA is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
  • NESINA is unlikely by itself to cause your blood sugar to be lowered to a dangerous level (hypoglycemia). However, hypoglycemia may still occur with NESINA.
  • NESINA is not for people with type 1 diabetes.
  • NESINA is not for people with diabetic ketoacidosis (increased ketones in blood or urine).

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

Who should not take NESINA?

Do not take NESINA if you:

  • Are allergic to any ingredients in NESINA or have had a serious allergic (hypersensitivity) reaction to NESINA. See the end of this Medication Guide for a complete list of the ingredients in NESINA.
  • Symptoms of a serious allergic reaction to NESINA 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 any of these symptoms, stop taking NESINA 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 NESINA?

Before you take NESINA, tell your doctor if you:

  • have or have had inflammation of your pancreas (pancreatitis)
  • have kidney or liver problems
  • have other medical conditions
  • are pregnant or plan to become pregnant. It is not known if NESINA can 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 breast-feeding or plan to breast-feed. It is not known whether NESINA passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking NESINA.

Tell your doctor about all the medicines you take, including prescription and nonprescription 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.

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

How should I take NESINA?

  • Take NESINA exactly as your doctor tells you to take it.
  • Take NESINA 1 time each day with or without food.
  • 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 time. Do not take 2 doses of NESINA at the same time.
  • If you take too much NESINA, 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 NESINA and during treatment as needed. Your doctor may change your dose of NESINA 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.

What are the possible side effects of NESINA?

NESINA can cause serious side effects, including:

See “What is the most important information I should know about NESINA?”

  • 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 NESINA and contact your doctor right away.

  • Liver problems. Call your doctor right away if you have unexplained symptoms, such as:
    • nausea or vomiting
    • stomach pain
    • unusual or unexplained tiredness
    • loss of appetite
    • dark urine
    • yellowing of your skin or the whites of your eyes
  • Low blood sugar (hypoglycemia). If you take NESINA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take NESINA. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar include:
  • shaking or feeling jittery
    • fast heartbeat
    • sweating
    • change in vision
    • hunger
    • confusion
    • headache
    • dizziness
    • change in mood

The most common side effects of NESINA include:

  • stuffy or runny nose and sore throat
  • headache
  • cold-like symptoms (upper respiratory tract infection)

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 NESINA. 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 NESINA?

Store NESINA at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of NESINA

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not take NESINA for a condition for which it was not prescribed. Do not give NESINA 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 NESINA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about NESINA that is written for health professionals.

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

What are the ingredients in NESINA?

Active ingredient: alogliptin

Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film-coating contains the following inactive ingredients: hypromellose, titanium dioxide, ferric oxide (red or yellow), and polyethylene glycol, and is marked with gray F1 printing ink.

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

Last reviewed on RxList: 2/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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