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Frequently Asked Questions about Hepsera® (adefovir dipivoxil)
What is the most important information I should know about Hepsera?
What is Hepsera?
How does Hepsera work?
Who should not take Hepsera?
How should I take Hepsera?
Does Hepsera reduce the risk of passing hepatitis B to others?
Does Hepsera cure hepatitis B infection?
What should I tell my doctor before taking Hepsera?
What should I avoid while taking Hepsera?
What are the possible side effects of Hepsera?
What are the ingredients of Hepsera?
How do I store Hepsera?
Where can I learn more about Hepsera?
Q: What is the most important information I should know about Hepsera?
A: 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.
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.
Some people who have taken medicines like Hepsera that are called nucleoside or nucleotide analogs have developed a serious condition called lactic acidosis (buildup 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 arm 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.
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.
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Q: What is Hepsera?
A: Hepsera is a medicine used to treat adults with continuing (chronic) infections with active hepatitis B virus. Hepsera has not been studied in adults over the age of 65 or in children.
- Hepsera will not cure your chronic hepatitis B.
- Hepsera may help lower the amount of hepatitis B virus in your body.
- Hepsera may lower the ability of the virus to multiply and infect new liver cells.
- We do not know if Hepsera will reduce your chances of getting liver cancer or liver damage (cirrhosis) from chronic hepatitis B.
- We do not know how long Hepsera may help your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.
- Hepsera does not stop you from spreading hepatitis B to others by sex or sharing needles. So practice safe sex and needle use.
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Q: How does Hepsera work?
A: Hepsera helps block hepatitis B virus (HBV) DNA polymerase, an enzyme needed in the replication of the virus in the body.
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Q: Who should not take Hepsera?
A: Do not take Hepsera if you are allergic to any of the ingredients in Hepsera. The active ingredient in Hepsera is adefovir dipivoxil. Click here for a complete list of all the ingredients in Hepsera.
Tell your doctor if:
- You are pregnant. We do not know if Hepsera can harm your unborn child. You and your doctor will need to decide if Hepsera is right for you. If you take Hepsera and you are pregnant talk to your doctor about how you can be on the Hepsera pregnancy registry.
- You are breast-feeding. We do not know if Hepsera can pass through your milk and if it can harm your baby. You will need to choose either to breast feed or take Hepsera, but not both.
- You have kidney problems now or had them before. Your dose and schedule of Hepsera may be reduced. Blood tests will need to be done regularly to see how your kidneys are working.
Tell your doctor 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. 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.
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Q: How should I take Hepsera?
A:
- It is very important that you do not miss a dose of Hepsera.
- Your doctor will tell you how much Hepsera to take.
- Your doctor will tell you when and how often to take Hepsera.
- Take Hepsera the same time each day. If you forget to take Hepsera, take it as soon as you remember that day. Do not take more than 1 dose of Hepsera in a day. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.
- Do not change your dose of Hepsera or stop Hepsera without talking to your doctor. Your hepatitis may get worse if you change doses or stop.
- You may take Hepsera with or without food.
- When your Hepsera supply gets low, call your doctor or pharmacy for a refill. Do not run out of Hepsera.
- If you take too much Hepsera, call your local poison control center or emergency room right away.
Some patients get worse or very serious hepatitis B symptoms when they stop taking Hepsera. We don't know how long you should use Hepsera. You and your doctor will need to decide when it is best for you to stop taking Hepsera. After you stop taking Hepsera, your doctor will still need to check your health and take blood tests to check your liver for a few months.
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Q: Does Hepsera reduce the risk of passing hepatitis B to others?
A: Hepsera does not reduce the risk of passing hepatitis B virus to others. It is important that people who are chronically infected with hepatitis B be aware that hepatitis B is highly contagious and that there are certain activities that may put other people at risk of infection.
Ways people can become infected with hepatitis B:
- Unprotected sexual contact
- Sharing needles, including hypodermic needles, tattoo needles and body-piercing needles
- Contact with contaminated bodily fluids, or items that have been exposed to bodily fluids, without proper protection
- Perinatally from mother to child
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Q: Does Hepsera cure hepatitis B infection?
A: Hepsera will not cure your chronic hepatitis B. Hepsera may lower the amount of hepatitis B in your body and may lower the ability of the virus to multiply and infect new cells. Currently, there is no known cure for chronic infection with hepatitis B.
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Q: What should I tell my doctor before taking Hepsera?
A: Before taking Hepsera, be sure to discuss any medications and/or supplements (including herbal) that you are taking. If you are pregnant or planning to become pregnant: the effects of Hepsera on pregnant women and their unborn babies are unknown. If you are breast-feeding: do not breast-feed if you are taking Hepsera. If you have kidney problems: your dose and schedule of Hepsera may be reduced.
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Q: What should I avoid while taking Hepsera?
A: Avoid doing things that can spread hepatitis B since Hepsera doesn't stop you from passing the infection to others.
- Do not share needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
- Do not have any kind of sex without protection. Practice "safe sex" using condoms and dental dams.
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Q: What are the possible side effects of Hepsera?
A: Hepsera can cause the following serious side effects: (see, "What is the most important information I should know about Hepsera?")
- A very serious hepatitis if you stop taking it
- A severe kidney problem called nephrotoxicity
- Increase your chance of developing a form of HIV that cannot be treated with usual HIV medicines
- Lactic acidosis and liver problems
The most common side effects of Hepsera are weakness, headache, stomach pain and nausea. The most common side effects in patients with liver transplants and chronic hepatitis B are weakness, headache, stomach pain, and itching. Some patients with liver transplants also had changes in the way their kidneys worked.
These are not all of the possible side effects of Hepsera. For more information, ask your doctor or pharmacist.
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Q: What are the ingredients of Hepsera?
A: Active Ingredient: Adefovir dipivoxil
Inactive Ingredients: pregelatinized starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate
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Q: How do I store Hepsera?
A: Keep Hepsera and all other medications out of the reach of children. Hepsera Tablets should be stored at room temperature and should be stored in their original container.
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Q: Where can I learn more about Hepsera?
A: Talk to your healthcare provider to learn more about Hepsera and how the drug may help you.
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Learn how you can save on your Hepsera refills. Click here to order a FREE Starter Kit from the Your Liver, Your Health support program.
Patients should be aware of
Important Safety Information about Hepsera and may read additional product information for patients.
It is important that you discuss your treatment options and any questions that you may have with your healthcare provider.
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