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 should I discuss with my healthcare 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:
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kidney disease;
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other types of hepatitis (C or D);
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HIV or AIDS;
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if you have received a liver transplant; or
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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 of telbivudine?
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.
Where can I get more information about telbivudine?
Your pharmacist has information about telbivudine written for health professionals that you may read.
What are the possible side effects of telbivudine?
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;
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feeling dizzy, light-headed, tired, or very weak;
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stomach pain, nausea with vomiting; or
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fast or uneven heart rate.
Call your doctor at once if you have any of these serious side effects:
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muscle tenderness, or weakness (may occur several weeks or
months after you start taking telbivudine);
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fever or flu symptoms and dark colored urine;
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burning, pain or tingly feeling in your arms or legs; or
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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:
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cough, sore throat;
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headache, tired feeling;
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dizziness;
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muscle aches;
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low fever;
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bloating, mild nausea, vomiting, diarrhea;
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itching or mild skin rash;
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joint pain, back pain; or
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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. You may report side effects to FDA at 1-800-FDA-1088.
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 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.
What other drugs will affect telbivudine?
Tell your doctor about all other medications you use, especially:
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cyclosporine (Gengraf, Neoral, Sandimmune)
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erythromycin (E.E.S., Ery-Tab, E-Mycin);
-
penicillamine (Cuprimine, Depen);
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zidovudine (Retrovir);
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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;
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an interferon such as Actimmune, Alferon N, Avonex,
Betaseron, Infergen, Intron A, Rebetron, Rebif, Roferon-A, or peginterferon alfa-2a (Pegasys); or
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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.
What happens if I have an overdose of telbivudine?
