Telbivudine (patient information)

IMPORTANT WARNING:

Telbivudine can cause serious or life-threatening damage to the liver and a condition called lactic acidosis (a build-up of an acid in the blood).Tell your doctor if you drink or have ever drunk large amounts of alcohol, if you use or have ever used injectable street drugs, and if you have or have ever had cirrhosis (scarring) of the liver or any liver disease other than hepatitis B. Tell your doctor and pharmacist if you are taking or have taken the following medications: acetaminophen (Tylenol, others);cholesterol-lowering medications (statins); iron products; isoniazid (INH, Nydrazid); medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);methotrexate (Rheumatrex);niacin (nicotinic acid);or rifampin (Rifadin, Rimactane). If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes; dark-colored urine; light-colored bowel movements; difficulty breathing; stomach pain; or swelling; nausea; vomiting;unusual muscle pain; loss of appetite for at least several days; lack of energy; extreme weakness or tiredness; feeling cold, especially in the arms or legs; dizziness or lightheadedness; or fast or irregular heartbeat.

Do not stop taking telbivudine without talking to your doctor. When you stop taking telbivudine your hepatitis may get worse. This is most likely to happen during the first several months after you stop taking telbivudine. Be careful not to miss doses or run out of telbivudine. Refill your prescription at least 5 days before you expect that you will need the new supply of medication. If you experience any of the following symptoms after you stop taking telbivudine, call your doctor immediately: extreme tiredness, weakness, nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark-colored urine, or light-colored bowel movements.

Keep all appointments with your doctor and the laboratory before, during, and after your treatment with telbivudine. Your doctor will order certain tests to check your body's response to telbivudine during this time.

Talk to your doctor about the risks of taking telbivudine.

Why is this medication prescribed

Telbivudine is used for chronic (long term) hepatitis B infection (swelling of the liver caused by a virus) in people who may also show signs of liver damage. Telbivudine is in a class of medications called nucleoside analogues. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Telbivudine does not cure hepatitis B and may not prevent complications of chronic hepatitis B, such as cirrhosis of the liver or liver cancer. Telbivudine does not prevent the spread of hepatitis B to other people through sexual contact, sharing needles, or contact with blood.

How should this medicine be used

Telbivudine comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take telbivudine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take telbivudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking telbivudine:

• tell your doctor and pharmacist if you are allergic to telbivudine or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: chloroquine (Aralen);erythromycin (E.E.S., E-Mycin, Erythrocin); fenofibrate (Antara, Lofibra, Triglide); gemfibrozil (Lopid); hydroxychloroquine (Plaquenil); medications to prevent rejection of a transplanted organ, such as cyclosporine (Neoral, Sandimmune) or tacrolimus (Prograf); medications to treat fungal infections such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone; (Deltasone), penicillamine (Cuprimine); probenecid; or zidovudine (AZT, Retrovir, in Combivir, in Trizivir). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had a liver transplant (surgery to replace a diseased liver), or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking telbivudine, call your doctor. Do not breastfeed while you are taking telbivudine.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking telbivudine.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Telbivudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• back pain
• joint pain
• difficulty falling asleep or staying asleep
• itching
• rash

Severe side effects

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• muscle aches, pain, weakness, or tenderness

Telbivudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Tyzeka®