Emtricitabine and tenofovir alafenamide (Oral route)
em-trye-SYE-ta-been, ten-OF-oh-vir al-a-FEN-a-mide
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs. Emtricitabine/tenofovir alafenamide is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of emtricitabine/tenofovir alafenamide. Hepatic function should be monitored closely in these patients. If appropriate, initiation of antihepatitis B therapy may be warranted .
Nucleoside Reverse Transcriptase Inhibitor
Uses of This Medicine:
Emtricitabine and tenofovir alafenamide 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 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 alafenamide combination in children younger than 12 years or those 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 emtricitabine and tenofovir alafenamide combination in the elderly.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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.
- St John's Wort
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
- Fanconi syndrome (kidney disease), history of or
- Hepatitis B infection, history of or
- Kidney disease, history of or
- Liver disease, history of or
- Osteomalacia (soft bones), history of or
- Osteoporosis (weak or brittle bones), history of Use with caution. May make these conditions worse.
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.
Keep taking this medicine for the full time of treatment, even if you 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.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take the medicine with or without food. Swallow the tablet whole. Do not crush, break, or chew it.
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 12 years and older weighing 35 kilograms (kg) or more One tablet once per day.
- Children younger than 12 years or weighing less than 35 kg 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 your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause a rare, but serious, unwanted effect called lactic acidosis (too much acid in the blood). Call your doctor right away if you have abdominal or stomach discomfort, a decreased appetite, diarrhea, fast and shallow breathing, a general feeling of discomfort, muscle pain or cramping, nausea, shortness of breath, sleepiness, or unusual tiredness or weakness.
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 may cause you to have extra body fat. Tell your doctor if you 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 your legs, arms, or face.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you 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.
This medicine may cause your bones to get weak and brittle. This could increase your risk for broken bones (fractures). Ask your doctor about this if you have any concerns.
This medicine will 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 share needles or equipment with anyone or use dirty needles. 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 (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach discomfort
- bloody urine
- bone pain
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- fast, shallow breathing
- general feeling of discomfort
- increased thirst
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain or cramping
- nausea and vomiting
- shortness of breath
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- weight gain
- yellow eyes and skin
- Incidence not known
- Weight gain around your neck, upper back, breast, or waist
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: 9/15/2016