HEPSERA

(Adefovir Dipivoxil)

10mg Tablet

ACTION

Hepsera is an antiviral medicine. It helps stop hepatitis B virus (HBV) from multiplying by blocking HBV DNA polymerase, an enzyme that is necessary for the replication of the virus in the body.

Hepsera has been shown to help reduce the amount of HBV in the body to low levels. After 48 weeks of treatment in some studies, Hepsera helped stop liver damage from getting worse and helped improve the damage that was already there. Some patients taking Hepsera reached the point where their bodies' natural defenses could keep the virus from actively multiplying.

INDICATIONS

Hepsera^® (adefovir dipivoxil) is a medicine used to treat chronic infection with hepatitis B virus (HBV) in adults.

Hepsera does not cure chronic hepatitis B, and it does not reduce the risk of spreading hepatitis B to others.

PRECAUTION:

1. Some people who stop taking Hepsera get a very serious hepatitis. 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.
2. Hepsera may cause a severe kidney problem called nephrotoxicity. It usually happens in people that already have a kidney problem, but it can happen to anyone that uses Hepsera. You will need to have regular blood tests to check for kidney function while you are taking Hepsera.
3. Some people who have taken medicines like Hepsera that are called nucleoside or nucleotide analogs have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor right away if you get any of the following signs of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You have a fast or irregular heartbeat.

Some people who have taken medicines like Hepsera have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your doctor right away if you get any of the following signs of liver problems.

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
• You don't feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach pain.

You may be more likely to get lactic acidosis or serious liver problems if you are very overweight (obese) or have been taking nucleoside analog medicines [Atripla^™ (efavirenz plus emtricitabine plus tenofovir disoproxil fumarate), Combivir^® (zidovudine plus lamivudine), Emtriva^® (emtricitabine), Epivir^® Epivir-HBV^® (lamivudine), Epzicom^™ (abacavir plus lamivudine), Hivid^® (zalcitabine), Retrovir^® (zidovudine), Trizivir^® (zidovudine plus lamivudine plus abacavir), Truvada^® (emtricitabine plus tenofovir disoproxil), Videx^® (didanosine), Viread^® (tenofovir disoproxil fumarate), Zerit^® (stavudine) and Ziagen^® (abacavir)] for a long time.
4. 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. This can happen if you get or have HIV and don't know it, or if your HIV is not being treated while you are taking Hepsera. You should get an HIV test before you start taking Hepsera and any time after that when there's a chance you were exposed to HIV.

5. Hepsera does not reduce the risk of spreading hepatitis B to others.

DOSAGE AND ADMINISTRATION

Hepsera^® (adefovir dipivoxil) is provided as a 10 mg tablet that you take once a day by mouth. Hepsera can be taken with or without food. If you have or develop kidney problems, your doctor may tell you to take the pill on a different schedule.

SIDE EFFECTS

The most common side effects observed were weakness, headache, stomach pain and nausea.

Hepsera also can cause the following serious side effects: very serious hepatitis if you stop taking it, a severe kidney problem called nephrotoxicity, lactic acidosis (buildup of acid in the blood) and liver problems.

The most common side effects in patients with liver transplants and chronic hepatitis B were weakness, headache, stomach pain and itching. Some patients with liver transplants also had changes in the way their kidneys worked. If you notice any side effects while taking Hepsera, talk to your healthcare provider about what to do.

DRUG RESISTANCE

Drug resistance is a primary concern of healthcare professionals around the world. Any virus can develop drug resistance, and may even develop resistance to more than one drug. Resistance occurs when a virus changes in such a way that it is able to survive and multiply in the presence of drugs that were designed to control it. Resistance to antiviral drugs presents an obstacle to providing effective long-term treatment of viral diseases, such as chronic hepatitis B.

In clinical trials, Hepsera^® (adefovir dipivoxil) has demonstrated a favorable resistance profile. At year 1, the resistance rate was 0% in all patient types studied compared to similar drugs. Resistance development through 5 years has been slow. Hepsera was found to work in people who had hepatitis B virus that was resistant to the currently approved chronic hepatitis B treatment, lamivudine. The cumulative rate of resistance in patients receiving Hepsera as a single therapy were: 0% at year 1, 3% at year 2, 11% at year 3 and 19% at year 4, and 30% at year 5.

Please see full Prescribing Information for Hepsera at following link:

LINK: www.Hepsera.com