TYZEKA- telbivudine tablet, film coated 
Novartis Pharmaceuticals Corporation

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This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: December 2018
MEDICATION GUIDE
TYZEKA® (Tie-zee′-ka)
(telbivudine)
tablets
TYZEKA® (Tie-zee′-ka)
(telbivudine)
oral solution
What is the most important information I should know about TYZEKA?
TYZEKA can cause serious side effects, including:
Worsening of your hepatitis B virus (HBV) infection after discontinuation. Your HBV infection may get worse or become very serious if you stop taking TYZEKA.
  • Take your TYZEKA exactly as your healthcare provider tells you to.
  • Do not let your TYZEKA run out. Refill your medicine or talk to your healthcare provider before your TYZEKA is all gone.
  • Do not stop taking your TYZEKA without talking to your healthcare provider.

Your healthcare provider will monitor your health and do regular blood tests to check your liver if you stop taking TYZEKA. Tell your healthcare provider right away about any new or unusual symptoms that happen after you stop taking TYZEKA.


Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.


Severe liver problems. In rare cases, severe liver problems that can lead to death have happened in some people who take medicines like TYZEKA. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.


Muscle problems (myopathy). TYZEKA can cause muscle problems, including unexplained muscle pain, muscle weakness or muscle tenderness. Serious muscle problems can happen, including muscle breakdown (rhabdomyolysis). Muscle breakdown can cause kidney damage that can lead to death. Tell your healthcare provider right away if you have unexplained muscle aches, pain, tenderness, or weakness.


Nerve problems. People who take TYZEKA alone or with any type of injectable interferon product can have nerve problems such as numbness, tingling, burning sensations in the arms or legs (peripheral neuropathy), or problems walking. Call your healthcare provider right away if you have any of these symptoms. Your healthcare provider may delay or stop your treatment with TYZEKA if you have any signs or symptoms of nerve problems.

What is TYZEKA?

TYZEKA is a prescription medicine used for the treatment of long-term (chronic) infection with hepatitis B virus (HBV) in people 16 years of age and older who also have active liver damage.


TYZEKA will not cure HBV. TYZEKA may lower the amount of HBV in the body. TYZEKA may improve the condition of your liver.


TYZEKA may lower the ability of HBV to multiply and infect new liver cells.
It is not known if TYZEKA is safe and effective in children younger than age 16.

Who should not take TYZEKA?
Do not take TYZEKA if you also receive Pegasys® (peginterferon alfa-2a). Taking TYZEKA with peginterferon alfa-2a may increase your risk of nerve problems.
Before taking TYZEKA, tell your healthcare provider about all of your medical conditions, including if you:
  • have HIV-1 (human immunodeficiency virus type 1), hepatitis C or hepatitis D (delta) virus infection
  • have had a liver transplant
  • have kidney problems
  • are receiving hemodialysis
  • are pregnant or plan to become pregnant. It is not known if TYZEKA will harm your unborn baby. It is not known if TYZEKA helps prevent a pregnant mother from passing hepatitis B virus (HBV) to her baby. Tell your healthcare provider if you become pregnant during treatment with TYZEKA.
    • Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. It is not known if TYZEKA can pass into your breast milk or if it can harm your baby.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
TYZEKA may interact with other medicines, Especially tell your healthcare provider or pharmacist if you are also being treated with Pegasys® (pegylated interferon alfa-2a), or any type of injectable interferon product for chronic hepatitis B or C. See “Who should not take TYZEKA?”
TYZEKA oral solution contains salt (sodium). Tell your healthcare provider if you are on a low sodium diet.
How should I take TYZEKA?
  • See the detailed Instructions for Use for information about how to take a dose of TYZEKA oral solution. Take TYZEKA exactly as your healthcare provider tells you to.
  • Take TYZEKA 1 time each day with or without food.
  • Do not change your dose or stop taking TYZEKA without talking to your healthcare provider first.
  • Tell your healthcare provider if you have trouble swallowing tablets. TYZEKA also comes as a liquid (oral solution).
  • If you miss a dose of TYZEKA, take it as soon as you remember and then take your next dose at the regular time. If it is almost time for your next dose, skip the missed dose.
  • If you take more than your prescribed dose of TYZEKA, call your healthcare provider right away.
  • It is important to stay under your healthcare provider's care during treatment with TYZEKA. Your healthcare provider will regularly test the level of the hepatitis B virus in your blood.
What are the possible side effects of TYZEKA?
TYZEKA can cause serious side effects. See "What is the most important information I should know about TYZEKA?"
The most common side effects of TYZEKA include:
  • tiredness
  • headache
  • cough
  • diarrhea
  • stomach area (abdominal) pain
  • nausea
  • sore throat
  • joint pain
  • fever
  • skin rash
  • back pain
  • dizziness
  • muscle aches
  • upset stomach
  • trouble sleeping
  • stomach area (abdominal) swelling
  • certain abnormal blood tests
These are not all the possible side effects of TYZEKA.
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 TYZEKA?
  • Store TYZEKA tablets and TYZEKA oral solution in their original container at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze TYZEKA oral solution.
  • Use TYZEKA oral solution within 2 months after opening the bottle.
  • Keep the bottle closed tightly.
  • Throw away TYZEKA when it is outdated or no longer needed by taking TYZEKA to a community take-back disposal program, if available, or by placing TYZEKA in a closed container (such as a sealed bag) in the household trash. Remove all identifying information from the original TYZEKA container before throwing it out.
Keep TYZEKA and all medicines out of the reach of children.
General information about the safe and effective use of TYZEKA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TYZEKA for a condition for which it was not prescribed. Do not give TYZEKA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TYZEKA that is written for health professionals.
What are the ingredients in TYZEKA tablets and TYZEKA oral solution?
Active ingredient: telbivudine
Inactive ingredients in TYZEKA tablets: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc, and hypromellose.
Inactive ingredients in TYZEKA oral solution: citric acid anhydrous, benzoic acid, passion fruit flavor, sodium saccharin, sodium hydroxide, and purified water. A 600 mg dose (30 mL) of TYZEKA oral solution contains about 47 mg of sodium.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936

TYZEKA® is a registered trademark of Novartis AG.© Novartis

T2018-147
For more information call 1-877-889-9352 or go to www.TYZEKA.com.
Revised: 12/2018
Novartis Pharmaceuticals Corporation