Generic Name: telbivudine (tel-BIV-ue-deen)
Brand Name: Tyzeka
Lactic acidosis (high blood lactic acid levels) has occurred with similar medicines. This has sometimes been fatal. The risk may be greater if you are a woman, are very overweight, or have a history of liver problems. It may also be increased in patients who have taken similar medicines for a prolonged period of time. Check with your doctor at once if you feel very weak, tired, dizzy, light-headed, or unusually cold (especially in the arms or legs). Check with your doctor at once if you develop unusual muscle pain or tenderness, fast or difficult breathing, fast or irregular heartbeat, severe or unusual drowsiness, sluggishness, or stomach pain with nausea and vomiting.
Severe and sometimes fatal liver problems have occurred with the use of similar medicines. Check with your doctor at once if you develop nausea, stomach pain, persistent loss of appetite, dark urine, pale stools, or yellowing of the eyes or skin.
Worsening of hepatitis B infection has occurred in patients who have stopped treatment, including treatment with telbivudine. Do not stop taking telbivudine without checking with your doctor. If you need to stop taking it, your liver function will be monitored for at least several months after you stop treatment.
Telbivudine is used for:
Treating chronic hepatitis B infection in certain patients.
Telbivudine is a nucleoside analog reverse transcriptase inhibitor. It works by blocking the growth of the hepatitis B virus (HBV).
Do NOT use telbivudine if:
- you are allergic to any ingredient in telbivudine
- you have an enlarged liver or high levels of lactic acid in the blood
- you are taking peginterferon alfa-2a
Contact your doctor or health care provider right away if any of these apply to you.
Before using telbivudine:
Some medical conditions may interact with telbivudine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have another type of hepatitis, HIV, or kidney problems, or if you are receiving dialysis
- if you have received a liver transplant
- if you have a history of muscle problems or nerve problems
- if you are very overweight or have a history of liver problems other than hepatitis B
Some MEDICINES MAY INTERACT with telbivudine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Peginterferon alfa-2a or other interferons because the risk and severity of nerve problems (eg, peripheral neuropathy) may be increased
- Certain azole antifungals, chloroquine, corticosteroids (eg, prednisone), erythromycin, fibric acids (eg, fenofibrate), HMG-CoA reductase inhibitors (eg, simvastatin), hydroxychloroquine, niacin, penicillamine, or zidovudine because the risk of muscle problems may be increased
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidneys
This may not be a complete list of all interactions that may occur. Ask your health care provider if telbivudine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use telbivudine:
Use telbivudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Telbivudine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get telbivudine refilled.
- Take telbivudine by mouth with or without food.
- If you have difficulty swallowing telbivudine, tell your doctor. There may be another form of telbivudine you can take.
- Take telbivudine on a regular schedule to get the most benefit from it. Taking telbivudine at the same time each day will help you remember to take it.
- Continue to take telbivudine even if you feel well. Do not miss any doses.
- If you miss a dose of telbivudine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Contact your health care provider if you are not sure what to do.
Ask your health care provider any questions you may have about how to use telbivudine.
Important safety information:
- Telbivudine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use telbivudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose, use for longer than prescribed, or stop taking telbivudine without checking with your doctor.
- Telbivudine is not a cure for HBV infection. Remain under the care of your doctor.
- Telbivudine does not stop the spread of HBV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HBV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can.
- Lab tests, including liver function, kidney function, and HBV blood, may be performed while you use telbivudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use telbivudine with caution in the ELDERLY; they may be more sensitive to its effects.
- Telbivudine should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using telbivudine while you are pregnant. It is not known if telbivudine is found in breast milk. Do not breast-feed while taking telbivudine.
Possible side effects of telbivudine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cough; diarrhea; dizziness; headache; joint pain; mild sore throat; mild stomach pain or upset; nausea; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased coordination or trouble walking; decreased urination; fast or irregular heartbeat; fever or persistent sore throat; loss of appetite; numbness, tingling, or burning in the arms or legs; pale stools; severe or persistent dizziness or light-headedness; severe or persistent tiredness or weakness; severe or unusual drowsiness; severe or unusual nausea or vomiting; severe, persistent, or unusual stomach pain; sluggishness; stomach swelling; trouble breathing or shortness of breath; unusual cold feeling, especially in the arms or legs; unusual or severe muscle pain, ache, tenderness, or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of telbivudine:
Store telbivudine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep telbivudine out of the reach of children and away from pets.
- If you have any questions about telbivudine, please talk with your doctor, pharmacist, or other health care provider.
- Telbivudine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take telbivudine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about telbivudine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to telbivudine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using telbivudine.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.