Generic Name: Telbivudine
Lactic acidosis (high blood lactic acid levels) has occurred with similar medicines. This has sometimes been fatal. Check with your doctor at once if you feel very weak, tired, dizzy, lightheaded, or unusually cold (especially in the arms or legs). Check with your doctor at once if you develop unusual muscle pain, trouble breathing, fast or irregular heartbeat, or stomach pain with nausea and vomiting.
Severe and sometimes fatal liver problems have occurred with use of similar medicines. Check with your doctor at once if you develop nausea, unusual stomach pain, 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 Tyzeka . Do not stop taking Tyzeka 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.
Tyzeka is used for:
Treating chronic hepatitis B infection in certain patients.
Tyzeka is a nucleoside analog reverse transcriptase inhibitor. It works by blocking the growth of the hepatitis B virus (HBV).
Do NOT use Tyzeka if:
- you are allergic to any ingredient in Tyzeka
- you have an enlarged liver, abnormal liver function tests, or high levels of lactic acid in the blood
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tyzeka :
Some medical conditions may interact with Tyzeka . 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 an organ transplant (eg, liver transplant)
- if you have a history of muscle problems or nerve problems
- if you are also taking interferon alfa-2a
Some MEDICINES MAY INTERACT with Tyzeka . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Pegylated interferon alfa-2a or other interferons because the risk and severity of nerve problems (eg, peripheral neuropathy) 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 Tyzeka 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 Tyzeka :
Use Tyzeka as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tyzeka comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tyzeka refilled.
- Take Tyzeka by mouth with or without food.
- Take Tyzeka on a regular schedule to get the most benefit from it. Taking Tyzeka at the same time each day will help you remember to take it.
- Continue to take Tyzeka even if you feel well. Do not miss any doses.
- If you miss a dose of Tyzeka , 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.
Ask your health care provider any questions you may have about how to use Tyzeka .
Important safety information:
- Tyzeka may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tyzeka 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 or use for longer than prescribed without checking with your doctor.
- Do not suddenly stop taking Tyzeka . Your HBV infection may become worse.
- Tyzeka is not a cure for HBV infection. Remain under the care of your doctor.
- Tyzeka 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.
- Tyzeka may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tyzeka .
- Lab tests, including liver function, kidney function, and HBV blood tests, may be performed while you use Tyzeka . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Tyzeka with caution in the ELDERLY; they may be more sensitive to its effects.
- Tyzeka should not be used 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 Tyzeka while you are pregnant. It is not known if Tyzeka is found in breast milk. Do not breast-feed while taking Tyzeka .
Possible side effects of Tyzeka :
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:
Back pain; cough; diarrhea; dizziness; headache; joint pain; mild stomach pain or upset; tiredness; trouble sleeping.
Seek medical attention right away if any of these SEVERE side effects occur:
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; fainting; 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 lightheadedness; severe or persistent nausea or vomiting; severe or persistent tiredness or weakness; severe, persistent, or unusual stomach pain; stomach swelling; unusual cold feeling, especially in the arms or legs; unusual 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Tyzeka :
Store Tyzeka at 77 degrees F (25 degrees C) in the original container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tyzeka out of the reach of children and away from pets.
- If you have any questions about Tyzeka , please talk with your doctor, pharmacist, or other health care provider.
- Tyzeka 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.
This information is a summary only. It does not contain all information about Tyzeka . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Tyzeka Prescribing Information (FDA)
- Tyzeka Advanced Consumer (Micromedex) - Includes Dosage Information
- Tyzeka Consumer Overview
- Telbivudine Professional Patient Advice (Wolters Kluwer)