Hepsera is an antiviral medicine used to treat adults with chronic infections with active hepatitis B virus who have: 

• active hepatitis B virus in their blood 
• high levels of liver enzymes in their blood 
• liver damage that is seen on a liver biopsy

Who should not take Hepsera?

Do not take Hepsera if you are allergic to any of the ingredients in Hepsera.

Special Warnings with Hepsera:

• Hepsera can cause a worse or very serious hepatitis in some people when they stop taking Hepsera. This usually happens within 12 weeks after stopping. You will need to have regular blood tests to check for liver function and hepatitis B virus levels if you stop taking Hepsera. 
• Hepsera can cause liver enlargement and damage to the liver. Some of the warning signs of liver damage can be yellowing of the skin or eyes, dark urine, light-colored stools, nausea, lower stomach pain, or loss of interest in eating for several days. 
• Hepsera may cause kidney damage. This usually happens in people that already have a kidney problem, but it can happen to anyone taking Hepsera. 
• If you get or have HIV that isn't being treated with medicines, Hepsera may increase the chances your HIV infection cannot be helped with usual HIV medicines. You should get an HIV test before you start taking Hepsera and anytime after that when there is a chance you were exposed to HIV. 
• Hepsera can cause a serious condition called lactic acidosis (build up of lactic acid in the body). Lactic acidosis is a medical emergency and must be treated in the hospital. Some of the warning signs of lactic acidosis can be weakness, tiredness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold feelings in your arms or legs, dizziness, or irregular heartbeat. 

General Precautions with Hepsera:

• It is very important to take Hepsera exactly as prescribed by your health care provider for the entire time that you are being treated. It is especially important not to stop taking Hepsera without first talking to your health care provider or else your liver disease may get worse. 
• Since Hepsera does not stop you from passing hepatitis B to others, it is important to avoid activities that can spread hepatitis B virus. This includes: 
  • do not share needles of any kind 
  • do not share razors, toothbrushes, or other items that may carry blood or bodily fluids 
  • do not have unprotected sex, and always practice “safe sex” by using condoms and dental dams 

What should I tell my health care provider?

Tell your health care provider if: 

• you are trying to become pregnant, are already pregnant, or are breast-feeding. If you take Hepsera and you are pregnant, talk with your health care provider about how you can be on the Hepsera pregnancy registry. 
• you have kidney problems now or had them before. Your dose and schedule of Hepsera may be reduced. Blood test will be done regularly to see how your kidneys are working. 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Hepsera works, especially medicines that affect how your kidneys work. 

What are some possible side effects of Hepsera? (This is NOT a complete list of side effects reported with Hepsera. Your health care provider can discuss with you a more complete list of side effects.)  

In addition to the serious side effects listed above, the most common side effects of Hepsera are: 

• weakness 
• headache 
• stomach pain 
• nausea 

For more detailed information about Hepsera, ask your health care provider and pharmacist.

Posted  1/9/03