TELBIVUDINE

(tel BIV yoo deen) Brand: Tyzeka

What is the most significant information I must know about telbivudine?

• Some people develop lactic acidosis while taking telbivudine. Early symptoms may get worse over time and this condition can be fatal. Get abnormal medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cool feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, quick or uneven heart course, dizziness, or feeling very weak or tired.

• Your liver symptoms may become severe after you stop taking telbivudine, even months after stopping. Your doctor may want to check your liver function for different months after you stop taking telbivudine. Visit your doctor regularly.

• Taking this medicine will not prevent you from passing hepatitis B to another people. Avoid having unprotected sex or sharing razors or toothbrushes. Conversation with your doctor about safety ways to prevent transmission during sex. Sharing drug or medication needles is never safety, even for a healthy person.

What is telbivudine?

• Telbivudine is an antiviral medicine. It works by preventing viral cells from multiplying in the body and infecting new liver cells.

• Telbivudine is used to treat chronic hepatitis B in adults. This medication will not cure hepatitis.

• Telbivudine may also be used for purposes not listed in this medicine guide.

What must I discuss with my health care provider till taking telbivudine?

• You must not take telbivudine if you are allergic to it, or if you are also using peginterferon alfa-2b (PegIntron, PegIntron Redipen, Sylatron).

• To create certain you can safely take telbivudine, speak your doctor if you have any of these another conditions:

· kidney disease;

· another types of hepatitis (C or D);

· HIV or AIDS;

· if you have received a liver transplant; or

· if any hepatitis B medications you received in the past did not work well in treating your condition.

• Some people develop a life-threatening condition called lactic acidosis while taking telbivudine. You may be more likely to develop lactic acidosis if you are overweight or have liver malady, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Conversation with your doctor about your individual risk.

• It is not known whether this medicine is safety to use while you are pregnant. Telbivudine may not hold you from passing hepatitis B to your unborn child. Speak your doctor if you are pregnant or plan to become pregnant while you are taking telbivudine.

• If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to estimate any effects of telbivudine on the baby.

• It is not known whether telbivudine passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

• Do not give telbivudine to a baby younger than 16 years old without the advice of a doctor.

How must I take telbivudine?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Telbivudine may be taken with or without food. Take the medication at the same time every day.

• Use telbivudine regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• While taking telbivudine, you must stay under the care of a doctor. Your blood will need to be checked often.

• If your condition worsens after you stop taking telbivudine, your doctor may recommend that you restart this medicine or other treatment for hepatitis B.

• Store at room temperature away from moisture and heat.

• Throw away any unused or expired telbivudine tablets in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking telbivudine?

What are the possible side effects of telbivudine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• This medicine may reason lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get abnormal medical help if you have even mild symptoms of lactic acidosis, such as:

· muscle pain or weakness;

· numb or cool feeling in your arms and legs;

· trouble breathing;

· feeling dizzy, light-headed, weary, or very weak;

· stomach pain, nausea with vomiting; or

· quick or uneven heart rate.

• Call your doctor at once if you have any another serious side effects, such as:

· muscle tenderness, or weakness (may occur different weeks or months after you start taking telbivudine);

· fever or flu symptoms and dark colored urine;

· burning, pain or tingly feeling in your arms or legs; or

· liver symptoms - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Smaller serious side effects may include:

· cough, sore throat;

· headache, weary feeling;

· dizziness;

· muscle aches;

· low fever;

· bloating, mild nausea, vomiting, diarrhea;

· itching or mild skin rash;

· joint pain, back pain; or

· sleep problems (insomnia).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect telbivudine?

• Speak your doctor about all another medications you use, especially:

· cyclosporine (Gengraf, Neoral, Sandimmune)

· erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);

· penicillamine (Cuprimine, Depen);

· zidovudine (Retrovir);

· an antifungal medicine such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend);

· anti-malaria drugs such as chloroquine (Aralen), hydroxychloroquine (Plaquenil, Quineprox);

· cholesterol-lowering medicines such as atorvastatin (Lipitor, Caduet), clofibrate (Atromid), fenofibrate (Antara, Lofibra, TriCor), gemfibrozil (Lopid), niacin (Advicor, Niacor, Niaspan, Nicobid), simvastatin (Zocor, Simcor, Vytorin), and others;

· an interferon such as Actimmune, Alferon N, Avonex, Betaseron, Infergen, Intron A, Rebetron, Rebif, Roferon-A, or peginterferon alfa-2a (Pegasys); or

· steroids (prednisone and others).

• This list is not complete and another drugs may interact with telbivudine. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about telbivudine.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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