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Brand Names: Tyzeka

Generic Name: telbivudine (Pronunciation: tel BIV yoo deen)

• What is telbivudine (Tyzeka)?
• What are the possible side effects of telbivudine (Tyzeka)?
• What is the most important information I should know about telbivudine (Tyzeka)?
• What should I discuss with my health care provider before taking telbivudine (Tyzeka)?
• How should I take telbivudine (Tyzeka)?
• What happens if I miss a dose (Tyzeka)?
• What happens if I overdose (Tyzeka)?
• What should I avoid while taking telbivudine (Tyzeka)?
• What other drugs will affect telbivudine (Tyzeka)?
• Where can I get more information?

What is telbivudine (Tyzeka)?

Telbivudine is an antiviral medication. 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 medicine will not cure hepatitis.

Telbivudine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of telbivudine (Tyzeka)?

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

This medication may cause 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 emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• muscle pain or weakness;
• numb or cold feeling in your arms and legs;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• fast or uneven heart rate.

Call your doctor at once if you have any of these serious side effects:

• muscle tenderness, or weakness (may occur several 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 - pain in your upper stomach with low fever, loss of appetite, dark urine, clay-colored stools, and/or jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• cough, sore throat;
• headache, tired 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 report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about telbivudine (Tyzeka)?

Some people have developed a life-threatening condition called lactic acidosis while taking telbivudine. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking telbivudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing hepatitis B to other people. Talk with your doctor about safe methods of preventing hepatitis transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.