Hepsera

Hepsera is a prescription medication used to treat chronic infections of hepatitis B virus in people over 12 years old. Hepsera belongs to a group of drugs called nucleotide analogs, which help decrease the amount of hepatitis B virus in the body.

This medication comes in tablet form and is usually taken once a day, with or without food.

Common side effects include weakness, headache, and nausea. 

Hepsera is a prescription medicine used to treat patients at least 12 years of age with continuing (chronic) infections with active hepatitis B virus. 

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function

The recommended dose of Hepsera (adefovir) is 10 mg, once daily.

WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS

Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including Hepsera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis B therapy may be warranted.

In patients at risk of or having underlying renal dysfunction, chronic administration of Hepsera may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment.

HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with Hepsera, that may have activity against HIV.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

1.  Some people who stop taking Hepsera get a very serious form of 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.

• 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), Complera (emtricitabine plus rilpivirine 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 fumarate), Videx (didanosine), Viread (tenofovir disoproxil fumarate), Zerit (stavudine), and Ziagen (abacavir)] for a long time.

• Do not take Hepsera if you are allergic to any of the ingredients in Hepsera. The active ingredient in Hepsera is adefovir dipivoxil.
• Do not take Hepsera if you are already taking Atripla, Complera, Stribild, Truvada, or Viread.

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• weakness
• headache
• stomach pain
• nausea
• intestinal gas
• diarrhea
• indigestion
• changes in the way the kidneys work

Additional side effects in liver transplant patients with chronic hepatitis B are vomiting, rash and itching. Some patients with liver transplants also had undesirable effects on their kidneys, including failure of the kidneys.

These are not all of the possible side effects of Hepsera. For more information, ask your doctor or pharmacist.

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

Do not take Hepsera if you are already taking Atripla, Complera, Stribild, Truvada, or Viread.

Some medicines may affect how Hepsera works, especially medicines that affect how your kidneys work. Hepsera can affect how your other medicines work. Your dose of Hepsera and the other medicines may be changed. Do not take any other medicines while you are taking Hepsera, unless your doctor has told you it is okay.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding. It is not known if Hepsera can pass into your milk and if it can harm your baby. You will need to choose either to breast feed or take Hepsera, but not both.