Emtricitabine and tenofovir (Oral route)
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine/tenofovir; monitor hepatic function upon discontinuation of therapy. Emtricitabine/tenofovir disoproxil fumarate used for a PrEP indication is only for HIV-negative individuals; status confirmed immediately prior to initiating and periodically during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate for a PrEP indication following undetected acute HIV-1 infection .
Nucleoside Reverse Transcriptase Inhibitor
Uses of This Medicine:
Emtricitabine and tenofovir combination is used with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is also used as part of a complete prevention strategy (Pre-Exposure prophylaxis) to reduce the risk of getting HIV infection in adults that are at high risk.
Emtricitabine and tenofovir combination will not cure or prevent HIV infection or the symptoms of AIDS. It helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine and tenofovir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 emtricitabine and tenofovir combination in children younger than 12 years of age and weighing less than 35 kilograms. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of emtricitabine and tenofovir combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving emtricitabine and tenofovir combination.
|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:
- Bone problems (eg, fracture, osteopenia), history of or
- Kidney disease (including Fanconi syndrome), history of or
- Liver disease (especially hepatitis B infection), history of—Use with caution. May make these conditions worse.
- Kidney disease, severe or requiring hemodialysis or
- Unknown or positive HIV-1 status (for Pre-Exposure prophylaxis)—Should not be used in patients with these conditions.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
This medicine can be taken with or without food.
Keep using this medicine for the full time of treatment, even if you or your child begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.
Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
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 form (tablets):
- For treatment of HIV infection:
- Adults, teenagers, and children 12 years of age and older and weighing 35 kilograms (kg) or over—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 300 mg of tenofovir.
- Children younger than 12 years of age and weighing less than 35 kg—Use and dose must be determined by your doctor.
- For prevention of HIV infection (Pre-exposure prophylaxis):
- Adults—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 300 mg of tenofovir.
- Children—Use and dose must be determined by your doctor.
- For treatment of HIV infection:
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.
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.
Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.
Precautions While Using This Medicine:
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. You should remain under the care of a doctor while taking this medicine.
You should not use this medicine if you or your child are also taking adefovir (Hepsera®), Atripla®, Complera®, Emtriva®, Stribild®, or Viread®. Do not use this medicine if you are also using medicines containing lamivudine (eg, Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Trizivir®). Tell your doctor right away if you or your child are using any of these medicines. Do not start using emtricitabine and tenofovir combination until your doctor tells you to.
Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes 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. Check with your doctor right away if you or your child have abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, general feeling of discomfort, muscle pain or cramping, nausea, shortness of breath, sleepiness, unusual tiredness or weakness, or yellow eyes or skin.
This medicine is not for the treatment of hepatitis B virus infection. Patients infected with both HBV and HIV who take emtricitabine and tenofovir combination need close medical follow-up for several months after stopping treatment to make sure their hepatitis B infection does not get worse.
This medicine may cause kidney problems. Avoid using other medicines that may injure the kidneys, such as multiple or high-dose NSAID pain medications or certain other antiviral medications.
This medicine may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you or your child have any concerns.
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.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
Emtricitabine and tenofovir combination does not decrease the risk of transmitting the 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 share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.
If you are using this medicine for Pre-Exposure prophylaxis:
- You should be confirmed that you are HIV-negative before you start taking this medicine.
- You and your partner should be tested regularly (for at least 3 months) for HIV-1. You should also be tested for other sexually transmitted disease, such as syphilis or gonorrhea.
- Check with your doctor right away if you have a fever, headache, joint or muscle pain, a rash, night sweats, or swollen lymph nodes.
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 of This Medicine:
- Less common
- Blisters under the skin
- rash with flat lesions or small raised lesions on the skin
- redness of the skin
- skin rash, itching skin, hives or welts
- spots on your skin resembling a blister or pimple
- Blindness or vision changes
- burning of the face or mouth
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
- chest pain
- clumsiness or unsteadiness
- sensation of pins and needles
- sore throat
- stabbing pain
- weakness in the hands or feet
- Incidence not known
- Abdominal or stomach discomfort
- bloody or cloudy urine
- bone pain
- convulsions or seizures
- darkened urine
- decreased appetite
- decreased frequency or amount of urine
- difficult or labored breathing
- difficult or painful urination
- difficulty with swallowing
- fast heartbeat
- fast, shallow breathing
- general feeling of discomfort
- increase in the amount of urine
- increased blood pressure
- increased thirst
- loss of appetite
- lower back or side pain
- muscle pain or cramping
- muscle twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- sudden decrease in the amount of urine
- swelling of the face, fingers, hands, lower legs, or ankles
- tightness in the chest
- trouble breathing
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
- Less common
- Lack or loss of strength
- passing of gas
- weight loss
- Acid or sour stomach
- back pain
- difficulty with moving
- feeling sad or empty
- increased cough
- joint pain
- loss of interest or pleasure
- muscle aching or cramping
- muscle pain or stiffness
- runny nose
- stomach upset
- stuffy nose
- swollen joints
- trouble concentrating
- trouble sleeping
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.
Last Updated: 11/4/2014