Telbivudine (By mouth)

Introduction

Telbivudine (tel-BIV-ue-deen)

Treats chronic hepatitis B infection.

Brand Name(s)

Tyzeka

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• The oral liquid contains sodium. Ask your doctor for advice if you are on a low sodium diet.
• This medicine works best if there is a constant amount in the blood. Take this medicine at the same time each day and do not miss any doses.
• Contact your doctor or pharmacist when your supply of this medicine is running low. Do not allow yourself to run out of this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Throw away any unused oral liquid 60 days after you open the bottle. Unused or outdated medicine should not be put directly in the trash can. Place it in a closed container first, such as a sealed bag, then into the household trash. You may also take it to a community take-back program.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use any interferon injection product.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, runny or stuffy nose, and body aches
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Trouble breathing
• Unexplained muscle aches, pain, tenderness, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have kidney disease, myopathy, or peripheral neuropathy.
• Lactic acidosis (too much acid in the blood) and liver toxicity are rare but serious reactions to this medicine. These are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: stomach pain; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle pain or cramping; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.
• Do not stop taking this medicine without checking with your doctor. Hepatitis B infection may become worse when this medicine is stopped. Your doctor will continue to check your liver after you stop taking this medicine.
• Some patients who have used this medicine had unexplained muscle aches, pain, tenderness, or weakness. Call your doctor right away if you notice any of these symptoms.
• This medicine is not a cure for the hepatitis B virus, but it may lower the amount of virus in your body.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine will not keep you from giving the hepatitis B virus to others. Practice safe sex, even if your partner also has hepatitis B. Do not share needles and personal items, such as toothbrushes or razor blades, that can have blood or body fluids on them.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.