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: |
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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. | |
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. |
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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. |
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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. |
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Before taking TYZEKA, tell your healthcare provider about all of your medical conditions, including if you: | |
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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. |
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How should I take TYZEKA? | |
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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?" |
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The most common side effects of TYZEKA include: | |
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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. |
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How should I store TYZEKA? | |
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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 |
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TYZEKA® is a registered trademark of Novartis AG.© Novartis |
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T2018-147 |
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For more information call 1-877-889-9352 or go to www.TYZEKA.com. |