Tenofovir disproxil fumarate

IMPORTANT WARNING:

If you have hepatitis B virus infection (HBV; an ongoing liver infection) and you take tenofovir disproxil fumarate (DF), your condition may suddenly worsen when you stop taking this medication. Be careful not to miss doses or run out of tenofovir DF. Your doctor may test you to see if you have HBV before you begin your treatment with tenofovir DF. Your doctor will examine you and order lab tests regularly for several months after you stop taking this medication. Tell your doctor if you experience any new or unusual symptoms after you stop taking tenofovir DF.

Keep all appointments with your doctor and the laboratory.

Talk to your doctor about the risks of taking tenofovir DF.

WHY is this medicine prescribed?

Tenofovir disoproxil fumarate (DF) is used to treat HIV infection. Tenofovir DF is also used to treat chronic (long term) hepatitis B virus infection (HBV). Tenofovir DF is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood.

Although tenofovir DF will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people.

Tenofovir will not cure hepatitis B and may not prevent complications of chronic hepatitis B. Tenofovir also may not prevent the spread of hepatitis B to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Tenofovir DF comes as a tablet and as an oral powder to take by mouth. Take the tablet with or without food once daily. Take the powder mixed with soft food once daily. Take tenofovir DF at around the same time(s) every day.

Take tenofovir DF exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tenofovir DF oral powder must be added to 2 to 4 ounces of soft food such as applesauce, baby food, or yogurt. Stir the mixture with a spoon until well mixed. Consume the mixture right away to avoid a bitter taste. Do not mix tenofovir DF oral powder with liquid.

Continue to take tenofovir DF even if you feel well. Do not stop taking tenofovir DF without talking to your doctor. If you stop taking tenofovir DF even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking tenofovir DF,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking tenofovir DF. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription and herbal products may interact with tenofovir DF: nonsteroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen (Advil^®, Motrin^®, others) and naproxen (Aleve^®) and St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medications before you start taking tenofovir DF. Do not start these medications whiletaking tenofovir DF without discussing with your healthcare provider.

• tell your doctor if you have or have ever had bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, liver disease (other than hepatitis B), or kidney disease.

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking tenofovir DF, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed.

  if you are taking this medication to treat HIV, some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking tenofovir DF.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms during your treatment with tenofovir, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Tenofovir DF may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• rash, itching
• diarrhea
• nausea, vomiting
• headache
• depression
• weakness
• abdominal pain
• difficulty falling asleep or staying asleep
• dizziness
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• decreased urination
• swelling of feet and ankles
• ongoing or worsening bone pain
• weakness, tiredness, unusual muscle pain, stomach pain with nausea and vomiting, dizziness or lightheadedness, fast or irregular heartbeat, shortness of breath or fast breathing, cold or blue-colored hands and feet
• extreme tiredness, weakness, nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark-colored urine, light-colored bowel movements, pain in upper right part of your stomach

Tenofovir DF may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of tenofovir DF on hand. Do not wait until you run out of medication to refill your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.