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DRUG DESCRIPTION
HEPSERAź is the tradename for adefovir dipivoxil, a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV).
The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy]-phosphinyl]-methoxy]ethyl]adenine. It has a molecular formula of C20H32N5O8P, a molecular weight of 501.48 and the following structural formula:
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Adefovir dipivoxil is a white to off-white crystalline powder with an aqueous solubility of 19 mg/mL at pH 2.0 and 0.4 mg/mL at pH 7.2. It has an octanol/aqueous phosphate buffer (pH 7) partition coefficient (log p) of 1.91.
HEPSERA (adefovir dipivoxil) tablets are for oral administration. Each tablet contains 10 mg of adefovir dipivoxil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc.
What are the possible side effects of adefovir (Hepsera)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- urinating less than usual or not at all;
- muscle pain, tenderness, or weakness (may occur several weeks or months after you start taking adefovir);
- numbness or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, and feeling...
Read All Potential Side Effects and See Pictures of Hepsera »
What are the precautions when taking adefovir dipivoxil (Hepsera)?
Before taking adefovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney problems, liver transplant, being very overweight (obese).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before...
Read All Potential Precautions of Hepsera »
Hepsera Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if this very unlikely but serious side effect occurs: change in the amount of urine.
For additional side effects see Warning section.
An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking adefovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney problems, liver transplant, being very overweight (obese).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Hepsera Patient Information Including Side Effects
Brand Names: Hepsera
Generic Name: adefovir (Pronunciation: a DEF o veer)
- What is adefovir (Hepsera)?
- What are the possible side effects of adefovir (Hepsera)?
- What is the most important information I should know about adefovir (Hepsera)?
- What should I discuss with my healthcare provider before taking adefovir (Hepsera)?
- How should I take adefovir (Hepsera)?
- What happens if I miss a dose (Hepsera)?
- What happens if I overdose (Hepsera)?
- What should I avoid while taking adefovir (Hepsera)?
- What other drugs will affect adefovir (Hepsera)?
- Where can I get more information?
What is adefovir (Hepsera)?
Adefovir is an antiviral medication. It works by preventing viral cells from multiplying in the body and infecting new liver cells.
Adefovir is used to treat chronic hepatitis B in adults. This medicine will not cure hepatitis.
Adefovir may also be used for other purposes not listed in this medication guide.
What are the possible side effects of adefovir (Hepsera)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- urinating less than usual or not at all;
- muscle pain, tenderness, or weakness (may occur several weeks or months after you start taking adefovir);
- numbness or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, and feeling light-headed or fainting; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- mild nausea, vomiting, diarrhea, gas, or stomach pain;
- mild skin rash or itching;
- weakness; or
- headache.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about adefovir (Hepsera)?
This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.
Adefovir can also cause serious kidney problems, especially if you have kidney disease or take certain medications.
Your liver symptoms may become severe after you stop taking adefovir, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop taking adefovir. Do not miss any scheduled appointments.
Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking adefovir will not prevent you from passing hepatitis B to other people. Talk with your doctor about safe methods of preventing hepatitis transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.
Tell your doctor if you have been exposed to HIV, or if you have untreated HIV or AIDS. Taking medicines to treat chronic hepatitis B can cause HIV infection to become resistant to the standard HIV and AIDS medications. You may need to be tested for HIV before you start taking adefovir.
- Hepsera