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Telbivudine

 
  Generic Name: Telbivudine (tel BIV yoo deen)
 
  Brand Names: Tyzeka  
     
   
 

What is telbivudine?

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 is the most important information I should know about telbivudine?

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.

What should I discuss with my health care provider before taking telbivudine?

You should not use this medication if you are allergic to telbivudine.

If you have certain conditions, you may need a dosage adjustment or special tests to safely use this medication. Before you take telbivudine, tell your doctor if you have:

  • kidney disease;
  • other 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.

This medication may cause lactic acidosis (the build up of lactic acid in the body, which can be fatal). You may be more likely to develop lactic acidosis if you are overweight, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. It is not known whether this medication is safe to use while you are pregnant. Telbivudine may not keep you from passing hepatitis B to your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while you are taking telbivudine.

Your name may need to be listed on a pregnancy registry if you become pregnant while you are taking telbivudine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether the medication had any effect on the baby.

It is not known whether telbivudine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give telbivudine to a child younger than 16 years old without the advice of a doctor.

How should I take telbivudine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Telbivudine may be taken with or without food. Take the medicine at the same time each day.

It is important to use telbivudine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Do not stop taking this medication without talking to your doctor.

While taking telbivudine, you should remain under the care of a doctor. Your blood will need to be checked on a regular basis.

Your liver symptoms may become severe after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop taking telbivudine. Do not miss any scheduled visits.

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

Store telbivudine 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 dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a telbivudine overdose are not known.

What should I avoid while taking telbivudine?

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.

Telbivudine side effects

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.

Telbivudine Dosing Information

Usual Adult Dose for Chronic Hepatitis B:

600 mg orally once a day

Usual Pediatric Dose for Chronic Hepatitis B:

16 years or older: 600 mg orally once a day

What other drugs will affect telbivudine?

Tell your doctor about all other medications you use, especially:

  • cyclosporine (Gengraf, Neoral, Sandimmune)

  • erythromycin (E.E.S., Ery-Tab, E-Mycin);

  • penicillamine (Cuprimine, Depen);

  • zidovudine (Retrovir);

  • an antifungal antibiotic 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), clofibrate (Atromid), fenofibrate (Antara, Lofibra, TriCor), gemfibrozil (Lopid), niacin (Advicor, Niacor, Niaspan, Nicobid), simvastatin (Zocor), 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 there may be other drugs that can interact with telbivudine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about telbivudine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 03/23/2009 4:35:46 PM.;
 
 
 
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