Telbivudine

Telbivudine is a prescription medication used to treat chronic hepatitis B infection in people age 16 and older who show signs of liver damage. Telbivudine belongs to a group of drugs called nucleoside analogs. It works by decreasing the amount of virus in the body.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of telbivudine include tiredness, headaches, cough, and diarrhea.

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS & SEVERE ACUTE EXACERBATIONS OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including telbivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Telbivudine can cause serious side effects, including:

Lactic Acidosis (build-up of an acid in the blood). Lactic acidosis can occur in people who take medicines like telbivudine (a nucleoside analogue). Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis must be treated in the hospital. Women, and people who are obese, or who have taken nucleoside analogues like telbivudine for long periods of time may be at higher risk for lactic acidosis.

Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or light-headed.
• You have a fast or irregular heartbeat.

Liver problems. Serious liver problems have occurred in some people who take medicines like telbivudine. This includes liver enlargement (hepatomegaly) and fat in the liver (steatosis).

Call your healthcare provider right away if you get any of these signs of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
• You do not feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach pain.

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

Nerve problems. People who take telbivudine alone or with any type of injectable interferon product can have nerve problems such as continuing 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.

• Do not take telbivudine when you are also taking Pegasys (pegylated interferon alfa-2a) since your chance of having nerve problems may be higher and the nerve problems may be more severe.

If you take telbivudine with any type of injectable interferon product, your chance of having nerve problems may be higher and the nerve problems may be more severe. Be sure to tell your healthcare provider or pharmacist if you are also being treated with any type of injectable interferon for chronic hepatitis B or C. Check with your healthcare provider if you are not sure whether you are taking an injectable interferon product.

Worsening of your hepatitis B infection. Your hepatitis B infection may get worse or become very serious if you stop taking telbivudine.

• Take your telbivudine exactly as prescribed.
• Do not let your telbivudine run out. Refill your prescription or talk to your healthcare provider before your telbivudine is all gone.
• Do not stop taking your telbivudine without talking to your healthcare provider.

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

Telbivudine can cause serious side effects. (See "Drug Precautions").

Common side effects of telbivudine 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

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of telbivudine. Your healthcare provider or pharmacist can give you a more complete list.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Telbivudine may interact with other medicines that leave the body through the kidneys.

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. Telbivudine must not be taken with Pegasys (pegylated interferon alfa-2a). See "Telbivudine Precautions".

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.

Tell your healthcare provider if you are pregnant or planning to become pregnant. It is not known if telbivudine is safe to use during pregnancy. It is not known whether telbivudine helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if telbivudine is right for you. If you use telbivudine while you are pregnant, talk to your healthcare provider.

Tell your healthcare provider if you are breastfeeding. It is not known if telbivudine can pass into your breast milk or if it can harm your baby. Do not breastfeed if you are taking telbivudine.

Telbivudine can cause muscle problems, including unexplained muscle pain, muscle weakness or muscle tenderness. Tell your healthcare provider right away if you have unexplained muscle aches, pain, tenderness, or weakness.

Telbivudine alone or with any type of injectable interferon product can cause nerve problems such as continuing 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.

Telbivudine does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood.

• Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.