Emtricitabine and tenofovir (Oral route)
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Emtricitabine/tenofovir disoproxil fumarate is 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 disoproxil fumarate combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. 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 who are at high risk.
This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and helps the immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people.
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 weighing less than 17 kilograms. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine and tenofovir combination in the elderly. 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 fracture, history of or
- Kidney disease (eg, acute renal failure, Fanconi syndrome), history of or
- Liver disease (eg, hepatitis B infection), history of or
- Osteomalacia (soft bones), history of or
- Osteoporosis (weak or brittle bones), 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 use more of it, do not use it more often, and do not use 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.
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 can be taken with or without food. Swallow the tablet whole. Do not crush, break, or chew it.
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 and children 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 weighing 17 kg to less than 35 kg and who are able to swallow a whole tablet—One tablet once a day. Your doctor will determine your dose based on body weight. Each tablet contains 167 mg of emtricitabine and 250 mg of tenofovir, 133 mg of emtricitabine and 200 mg of tenofovir, or 100 mg of emtricitabine and 150 mg of tenofovir.
- Children weighing less than 17 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.
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 medicine in the original bottle that you were given at the pharmacy and keep it tightly closed.
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®) and medicines containing similar drugs, including Atripla®, Complera®, Descovy®, Emtriva®, Genvoya®, Odefsey®, Stribild®, Vemlidy®, or Viread®. Do not use this medicine if you are also using medicines containing lamivudine (eg, Combivir®, Dutrebis®, Epivir®, Epivir-HBV®, Epzicom®, Triumeq®, 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 may cause rare, but serious, liver problems. This is more common in patients with a history of hepatitis B infection or those who already have liver disease. Check with your doctor right away if you have clay-colored stools, dark urine, a decreased appetite, a fever, a headache, itching, nausea and vomiting, a skin rash, stomach pain or tenderness, swelling of the feet or lower legs, 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.
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 (including Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.
This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone. 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 regularly for other sexually transmitted disease, including 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:
- More common
- Blisters under the skin
- body aches or pain
- difficulty in breathing
- ear and nasal congestion
- fever and chills
- loss of voice
- pain or tenderness around the eyes and cheekbones
- rash with flat lesions or small raised lesions on the skin
- redness of the skin
- runny nose
- sore throat
- spots on your skin resembling a blister or pimple
- unusual tiredness or weakness
- Less common
- 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
- stabbing pain
- weakness in the hands or feet
- Incidence not known
- bloody or cloudy urine
- bone pain
- change in how much or how often you urinate
- darkened urine
- difficult or painful urination
- difficulty in swallowing
- fast heartbeat
- fast, shallow breathing
- general feeling of discomfort
- increased blood pressure
- increased thirst
- itching skin, hives, welts
- 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
- stomach pain
- sudden decrease in the amount of urine
- swelling of the face, fingers, hands, lower legs, or ankles
- tightness in the chest
- yellow eyes or skin
- More common
- Less common
- Acidic or sour stomach
- back pain
- difficulty in moving
- joint pain
- lack or loss of strength
- passing of gas
- stomach upset
- stuffy nose
- swollen joints
- trouble sleeping
- weight loss
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: 7/4/2017