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Description

Tenofovir is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Tenofovir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Tenofovir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

Tenofovir is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, tenofovir is used in certain patients with the following medical condition:

• Human immunodeficiency virus (HIV) infection in combination with hepatitis B virus (HBV) infection.

This product is available in the following dosage forms:

• Tablet
• Powder

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tenofovir for the treatment of HIV infection in children younger than 2 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of tenofovir for the treatment of hepatitis B infection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tenofovir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tenofovir.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adefovir Dipivoxil
• Atazanavir
• Didanosine
• Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lopinavir
• Ritonavir
• Tipranavir

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (e.g., fracture, osteomalacia), history of or
• Kidney disease (e.g., Fanconi syndrome) or
• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe (requires dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

This medicine comes with a patient information leaflet. Read and follow the information carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

It is important to take tenofovir as part of a combination regimen. Take all of the medicines your doctor prescribed at the right time of day. This will make your medicines work better.

Keep taking tenofovir for the full time of treatment, even if you or your child begin to feel better.

You may take this medicine with or without food.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.

When your tenofovir supply runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to tenofovir and be harder to treat. Do not allow yourself to run out of this medicine.

For patients who cannot swallow the tablets, tell your doctor right away. Your doctor may want you to take the oral powder.

If you are using the oral powder:

• Measure the oral powder correctly using the dosing scoop that comes with the package. If you have any questions about this, ask your doctor or pharmacist.
• Mix the oral powder with 2 to 4 ounces of soft food (e.g., applesauce, baby food, yogurt).
• After mixing, swallow it right away to avoid bitter taste.
• Do not mix the oral powder with any liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral powder or tablets):
  • For treatment of HIV infection:
    • Adults—300 milligrams (mg) once a day.
    • Teenagers and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For chronic hepatitis B infection:
    • Adults—300 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not use this medicine if you or your child are also taking adefovir (Hepsera®), Atripla®, Complera®, or Truvada®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using tenofovir until your doctor tells you to.

Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have stomach discomfort or cramping; nausea, vomiting, or diarrhea; a decreased appetite; a general feeling of discomfort; muscle cramping or pain; unusual tiredness or weakness; trouble with breathing; or yellow skin or eyes.

Do not change your dose or stop taking this medicine, even for a short time, without talking to your doctor.

This medicine may increase your risk of having bone fractures. Ask your doctor about this if you or your child have any concerns.

When you or your child start taking HIV medicines, your immune system may get stronger. If you or your child have infections or disorders that are hidden in your body (e.g., Graves' disease, Guillain-Barre syndrome, polymyositis, pneumonia, or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Tenofovir does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not re-use or share needles with anyone. If you have any questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain
• Cough
• Fever or chills
• Shortness of breath
• Sneezing
• Sore throat
• Tightness in the chest
• Troubled breathing
• Wheezing

• Abdominal or stomach discomfort
• Decreased appetite
• Diarrhea
• Fast, shallow breathing
• General feeling of discomfort
• Muscle pain or cramping
• Nausea
• Sleepiness
• Unusual tiredness or weakness

• Agitation
• Bloating
• Bloody or cloudy urine
• Bone pain
• Coma
• Confusion
• Constipation
• Convulsions or seizures
• Darkened urine
• Decreased frequency or amount of urine
• Depression
• Difficult or painful urination
• Dizziness
• Fast heartbeat
• Fever
• Headache
• Hostility
• Increased blood pressure
• Increased thirst
• Indigestion
• Irritability
• Lethargy
• Loss of appetite
• Muscle twitching
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Stupor
• Swelling of the face, fingers, or lower legs
• Vomiting
• Weight gain
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• Hives or welts
• Itching skin
• Lack or loss of strength
• Pain
• Redness of the skin
• Skin rash

• Acid or sour stomach
• Belching
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Difficulty with moving
• Heartburn
• Joint pain
• Muscle pains or stiffness
• Passing of gas
• Redistribution or accumulation of body fat
• Sleeplessness
• Stomach pain or upset
• Swollen joints
• Trouble with sleeping
• Unable to sleep
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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