Emtricitabine and tenofovir (Oral)

Generic name: emtricitabine and tenofovir [ em-trye-SYE-ta-been, ten-OF-oh-vir-dye-soe-PROX-il-FUE-ma-rate ]
Brand name: Truvada
Drug class: Antiviral combinations

Medically reviewed by Drugs.com. Last updated on Oct 11, 2024.

Oral route(Tablet)

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 .

Uses for emtricitabine and tenofovir

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 and children 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 emtricitabine and tenofovir

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 emtricitabine and tenofovir combination in children weighing less than 17 kilograms (kg) to treat HIV infection and in children weighing less than 35 kg to prevent HIV infection. 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 emtricitabine and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

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.

Interactions with Medicines

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.

Aceclofenac
Acemetacin
Acyclovir
Amikacin
Amikacin Liposome
Amtolmetin Guacil
Aspirin
Atazanavir
Bromfenac
Bufexamac
Cabotegravir
Capreomycin
Celecoxib
Choline Salicylate
Cidofovir
Clonixin
Dexibuprofen
Dexketoprofen
Diclofenac
Didanosine
Diflunisal
Dipyrone
Droxicam
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Flurbiprofen
Ganciclovir
Gentamicin
Horsetail
Ibuprofen
Indomethacin
Itraconazole
Kanamycin
Ketoprofen
Ketorolac
Ledipasvir
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Morniflumate
Nabumetone
Naproxen
Neomycin
Nepafenac
Netilmicin
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Orlistat
Oxaprozin
Oxyphenbutazone
Parecoxib
Paromomycin
Phenylbutazone
Piketoprofen
Piroxicam
Plazomicin
Pranoprofen
Proglumetacin
Propyphenazone
Proquazone
Rofecoxib
Salicylic Acid
Salsalate
Sodium Salicylate
Spectinomycin
Streptomycin
Sulindac
Tacrolimus
Tenoxicam
Tiaprofenic Acid
Tobramycin
Tolfenamic Acid
Tolmetin
Valacyclovir
Valdecoxib
Valganciclovir

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.

Darunavir
Lopinavir
Nirmatrelvir
Ritonavir
Tipranavir

Interactions with Food/Tobacco/Alcohol

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.

Proper use of emtricitabine and tenofovir

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.

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 form (tablets):
- For treatment of HIV infection:
  - Adults and children weighing 35 kilograms (kg) or more—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—The dose is based on body weight and must be determined by your doctor:
    - Weighing 28 to less than 35 kg—One tablet once a day. Each tablet contains 167 mg of emtricitabine and 250 mg of tenofovir.
    - Weighing 22 to less than 28 kg—One tablet once a day. Each tablet contains 133 mg of emtricitabine and 200 mg of tenofovir.
    - Weighing 17 to less than 22 kg—One tablet once a day. Each tablet contains 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 and children weighing 35 kilograms (kg) or more—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 300 mg of tenofovir.
  - Children weighing less than 35 kg—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

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 emtricitabine and tenofovir

It is very important that your doctor check your or your child's progress 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 using this medicine.

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 stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, general feeling of discomfort, muscle pain or cramping, nausea, 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. You should also be tested for hepatitis B before starting treatment with this medicine.

This medicine may cause kidney problems. Avoid using other medicines that may injure the kidneys, including 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 using 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.

If you are using this medicine for Pre-exposure prophylaxis:

You should be confirmed that you are HIV-negative before you start using this medicine and you must stay HIV-negative to keep taking this medicine.
You and your partner should be tested regularly (for at least once every 3 months) for HIV-1. You should also be tested regularly for other sexually transmitted infections, 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.

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.

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 emtricitabine and tenofovir

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:

More common

Blisters under the skin
body aches or pain
chills
difficulty in breathing
ear congestion
fever
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 or stuffy 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

Agitation
bloating
bloody or cloudy urine
bone pain
change in how much or how often you urinate
confusion
constipation
cough
dark urine
decreased awareness or responsiveness
difficult or painful urination
difficulty in swallowing
fast heartbeat
fast, shallow breathing
general feeling of discomfort
increased thirst
indigestion
irritability
itching skin, hives, welts
loss of appetite
loss of consciousness
lower back or side pain
muscle pain, cramp, or 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
seizures
severe sleepiness
stomach pain
sudden decrease in the amount of urine
swelling of the face, fingers, hands, lower legs, or ankles
tightness in the chest
unusual drowsiness, dullness, or feeling of sluggishness
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:

More common