Details for: AA-ADEFOVIR
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02420333 | AA-ADEFOVIR | ADEFOVIR DIPIVOXIL | 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- AA-ADEFOVIR is used to treat adults with continuing (chronic) infection with active hepatitis B virus
What it does
- AA-ADEFOVIR binds to viral DNA to interfere with replication of the virus and helps lower the amount of hepatitis B virus in your body.
- AA-ADEFOVIR will not cure your chronic hepatitis B.
- AA-ADEFOVIR may help lower the amount of hepatitis B virus in your body.
- It is not known how long AA-ADEFOVIR may help your hepatitis.
- Sometimes viruses change in your body and medications no longer work. This is called drug resistance.
- It is not known if AA-ADEFOVIR will reduce your chances of getting liver cancer or liver damage (cirrhosis) from chronic hepatitis B.
- AA-ADEFOVIR does not stop you from spreading hepatitis B to others by sex or sharing needles. It is important to practice safe sex and not to share needles.
When it should not be used
Together with your doctor, you need to decide whether AA-ADEFOVIR is right for you.
- Do not take AA-ADEFOVIR if you are allergic to any of the ingredients in AA-ADEFOVIR (see What the nonmedicinal ingredients are).
- Do not take AA-ADEFOVIR if you are HIV positive.
- Do not take AA-ADEFOVIR if you are pregnant or breastfeeding.
- AA-ADEFOVIR has not been studied in adults over the age of 65 or in persons under 18 years of age.
- Do not take AA-ADEFOVIR if you are also taking VIREAD® (tenofovir disoproxil fumarate), TRUVADA® (emtricitabine/tenofovir disoproxil fumarate), ATRIPLA® (efavirenz/emtricitabine/ tenofovir disoproxil fumarate), or COMPLERA™ (rilpivirine/ emtricitabine/tenofovir disoproxil fumarate).
What the medicinal ingredient is
Adefovir dipivoxil
What the non-medicinal ingredients are
Lactose monohydrate, starch, croscarmellose sodium, magnesium stearate, talc
What dosage form it comes in
10 mg tablets
Warnings and precautions
Serious Warnings and Precautions
- Talk to your doctor before you stop taking AA-ADEFOVIR. Some people who take AA-ADEFOVIR get a very serious hepatitis when they stop taking AA-ADEFOVIR. This usually happens within 12 weeks after you stop AA-ADEFOVIR. You will need to have regular blood tests to check for liver function and hepatitis B virus levels if you stop taking AA-ADEFOVIR.
- AA-ADEFOVIR may cause kidney problems. This can happen to anyone that uses AA-ADEFOVIR, especially people who already have kidney problems. Your doctor may ask you to have blood tests to check for kidney function while you are taking AA-ADEFOVIR. Since kidney problems often do not cause symptoms and are often only detected with blood tests, it is important to have all of your blood tests as instructed by your doctor.
- If you get or have HIV infection (the virus that causes AIDS), and you don’t know it, or if your HIV is not being treated while you are taking AA-ADEFOVIR, AA-ADEFOVIR may increase the chances of you developing resistance to HIV infection, as AA-ADEFOVIR may have some anti-HIV activity. You should talk to your doctor to find out if you should have an HIV test before you start taking AA-ADEFOVIR and whenever there is a chance that you were exposed to HIV.
- Some people who have taken nucleotide analog medications like AA-ADEFOVIR, either alone or in combination with other anti-retroviral drugs, have developed a serious condition called lactic acidosis (buildup of acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. (See Serious Side Effects, How Often They Happen and What To Do About Them section for symptoms). Some people who have taken medications like AA-ADEFOVIR, have developed serious liver problems called hepatoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). (See Serious Side Effects, How Often They Happen and What To Do About Them section for symptoms). You may be more likely to get lactic acidosis or serious liver problems if you are very overweight (obese) or have been taking nucleotide analog medicines, like AA-ADEFOVIR, for a long time.
Before starting AA-ADEFOVIR and to get the best possible treatment, be sure to tell your doctor if you:
- You know that you are pregnant or suspect that you may be pregnant, so that you can discuss the risk and benefit of taking AA-ADEFOVIR. It is not known if AA-ADEFOVIR can harm your unborn child.
- You are breastfeeding.
- You have kidney problems now or had them before.
- You are taking other medications that affect how your kidneys work.
- You think you may have HIV (the virus that causes AIDS).
Interactions with this medication
Tell your doctor about all the medications you take. Some medications may affect how AA-ADEFOVIR (adefovir dipivoxil) works, especially medications that affect how your kidneys work. Do not take any other medications while you are taking AA-ADEFOVIR, until you have checked with your doctor.
Proper use of this medication
Usual Dose
- The usual adult dose is one AA-ADEFOVIR 10 mg tablet orally (by mouth) once a day.
- Your doctor may prescribe a different dosing schedule if you have problems with your kidneys.
- AA-ADEFOVIR may be taken with or without food.
- Do not stop taking AA-ADEFOVIR without consulting your doctor.
Overdose
For management of a suspected drug overdose, or in case of an actual overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
- If you miss your regular time for taking your dose, but then remember it during that same day, take your missed dose immediately.
- Then, take your next dose at the regularly scheduled time the following day.
- Do not take two doses of AA-ADEFOVIR at once to make up for missing a dose.
- If you are not sure what to do if you miss taking your medication check with your doctor or pharmacist for further instructions.
Side effects and what to do about them
The most common side effects of AA-ADEFOVIR are:
weakness, headache, stomach pain, nausea, diarrhea,
flatulence (intestinal gas) and indigestion.
The most common side effects of AA-ADEFOVIR in patients
with chronic hepatitis B having a liver transplant are:
weakness, stomach pain, headache, nausea, vomiting,
diarrhea, rash and itching. Some patients also had undesirable
effects on their kidneys, including kidney failure and damage to
kidney cells.
Other possible side effects may include: muscle pain, muscle
weakness, bone pain and softening of the bone (which may
contribute to fractures) which are associated with kidney
problems, and inflammation of the pancreas.
These are not all the possible side effects of AA-ADEFOVIR.
Your doctor, nurse or pharmacist can discuss with you a more
complete list of possible side effects with AA-ADEFOVIR. You
should report any new or continuing symptoms to your doctor,
nurse or pharmacist.
| Symptom / effect | Stop taking drug and seek immediate and emergency medical attention | |
|---|---|---|
| Rare (approximately 1 in 1,000 patients) | Symptoms: | |
| You feel very weak or tired. | ✔ | |
| You have unusual (not normal) muscle pain. | ✔ | |
| You have stomach pain with nausea and vomiting. | ✔ | |
| You feel cold especially in your arms and legs. | ✔ | |
| You feel dizzy or lightheaded. | ✔ | |
| You have fast or irregular heartbeat. | ✔ | |
| Effect: Lactose acidosis | ||
| Very Rare (approximately 1 in 10,000 patients) | Symptoms: | |
| 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. | ✔ | |
| Effect: Severe liver problems called hepatotoxicity with liver enlargement (hepatomegaly) and fat in the liver (steatosis) | ||
Lactic acidosis is a medical emergency and must be treated in
the hospital. You may be more likely to get lactic acidosis or
serious liver problems if you are very overweight (obese) or
have been taking nucleotide analog medicines, like AA-ADEFOVIR, for a long time.
This is not a complete list of side effects. For any
unexpected effects while taking AA-ADEFOVIR, contact
your doctor or pharmacist.
How to store
AA-ADEFOVIR tablets should be stored in original container at controlled room temperature, 15°C to 25°C in a tightly closed container. Protect from moisture.
Reporting side effects
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at http://www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the
adverse reaction reporting guidelines are available on the
MedEffect™ Canada Web site at
http://www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about AA-ADEFOVIR:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website https://www.aapharma.ca/en/, or by calling 1-877-998-9097.
This leaflet was prepared by AA Pharma Inc.
Last revised: April 1, 2021