ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate. Severe acute exacerbations of hepatitis have been reported in patients infected with hepatitis B virus (HBV) who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Closely monitor hepatic function in these patients for several months following the discontinuation of emtricitabine and resume anti-HBV therapy if warranted .
Nucleotide Reverse Transcriptase Inhibitor
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:
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:
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.
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 children younger than 12 years of age and weighing less than 35 kilograms (kg). Safety and efficacy have not been established.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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.
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:
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.
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. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.
You may take this medicine with or without food.
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:
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.
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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the bottle tightly closed. Use the medicine dispensed only in its original container.
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 and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also taking adefovir, Atripla®, Complera®, Hepsera®, Stribild®, 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 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 broken bones (fractures). Ask your doctor about this if you or your child have any concerns.
This medicine may increase the risk of injury to the kidneys. To reduce this risk, be sure to follow up with all blood tests your doctor may order, and avoid other medications that may injure the kidneys such as certain other antiviral medicines or NSAID pain medicines.
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 (eg, Graves' disease, Guillain-Barré syndrome, polymyositis, pneumonia, 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 acquired from or 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 or equipment 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.
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:
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:
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.