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Precautions and Warnings With Telbivudine

If you have HIV or have had a liver transplant, telbivudine may not be the best choice for treating your hepatitis B infection. To help ensure this medication is right for you, make sure your healthcare provider knows about any allergies you have and all medications you are taking before starting treatment with telbivudine. Other warnings and precautions also apply to women who are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking telbivudine (Tyzeka®) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, other than hepatitis B
  • Had a liver transplant
  • Human immunodeficiency virus (HIV)
  • Hepatitis C or hepatitis D
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Telbivudine Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • In rare cases, telbivudine can cause a life-threatening condition known as lactic acidosis, which is an accumulation of acid in the blood. Women, people who are obese, and people who take the medicine for long periods of time may have a higher risk for lactic acidosis. Contact your healthcare provider if you get symptoms of this problem, which may include:
    • Feeling tired or weak
    • Unusual muscle pain
    • Difficulty breathing
    • Abdominal (stomach) pain with nausea and vomiting
    • Feeling cold
    • Cold or blue hands and feet
    • Dizziness or lightheadedness
    • A fast or irregular heartbeat.
  • Telbivudine can cause serious liver problems, including an enlarged liver (hepatomegaly) and fat in the liver (steatosis). Let your healthcare provider know if you get signs of liver problems, such as:
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Dark urine
    • Light-colored stools
    • Tiredness or fatigue
    • Pain in the upper-right area of the abdomen (stomach)
    • Loss of appetite for several days.
  • In some people, stopping telbivudine may cause their hepatitis B infection to get worse. Therefore, your healthcare provider will monitor you closely for several months after you stop treatment.
  • There have been reports of muscle problems (myopathy) in people taking telbivudine, including a serious muscle problem known as rhabdomyolysis. This condition results from a breakdown of muscle fiber, and can lead to kidney damage. Tell your healthcare provider right away if you have symptoms of myopathy, including unexplained muscle aches, pain, tenderness, or weakness.
  • This medicine may cause nerve problems. Taking telbivudine with interferon medicines may increase the risk for nerve problems (see Drug Interactions With Telbivudine). Contact your healthcare provider right away if you develop any numbness, tingling, or burning sensations of the arms or legs during telbivudine treatment.
  • Telbivudine has not been studied in people who have had a liver transplant, or people with human immunodeficiency virus (HIV), hepatitis C, or hepatitis D. It has also not been studied in people who are African American or Hispanic. This does not mean the medication cannot be used in such individuals. However, because of the lack of adequate studies, it is unknown whether these individuals will respond to the medicine in the same way.
  • Telbivudine is considered a pregnancy Category B medication, which means it is generally considered safe for use during pregnancy (see Tyzeka and Pregnancy).
  • It is unknown if telbivudine passes through human breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Tyzeka and Breastfeeding).

Telbivudine Drug Information

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