Emtricitabine and tenofovir (Oral)

Emtricitabine and tenofovir disoproxil fumarate combination is used along with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that leads to acquired immune deficiency syndrome (AIDS). This medicine is also used as part of a complete prevention strategy (Pre-exposure prophylaxis) to lower 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 reducing the amount of HIV in the blood and helps the immune system. This may help delay some of the health issues that usually come from AIDS or HIV disease. It will not prevent you from spreading HIV to other people.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for side effects. You should stay under a doctor's care 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 can include 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. Contact your doctor immediately if you or your child experience stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, a 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. Contact your doctor immediately 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 treating hepatitis B virus infection. Patients who are infected with both HBV and HIV and take emtricitabine and tenofovir combination need close medical follow-up for several months after stopping treatment to ensure their hepatitis B infection does not worsen. You should also be tested for hepatitis B before starting this medicine.

This medicine may cause kidney problems. Avoid using other medicines that may harm 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 strengthen when you start using HIV medicines. Inform your doctor right away if you or your child notice any changes in health. Sometimes the immune system may begin to fight infections that were previously hidden in the 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 must be confirmed as HIV-negative before starting this medicine, and you must stay HIV-negative to continue taking it.
• You and your partner should be tested regularly (at least once every 3 months) for HIV-1. You should also be tested regularly for other sexually transmitted infections, including syphilis or gonorrhea.
• Contact your doctor immediately if you have a fever, headache, joint or muscle pain, a rash, night sweats, or swollen lymph nodes.

This medicine does not reduce the risk of transmitting HIV to others through sexual contact or 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 questions about this, contact your doctor.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or packaging carefully.

Pediatric

There have not been appropriate studies on how emtricitabine and tenofovir combination affects children weighing less than 17 kilograms (kg) when treating HIV infection and children weighing less than 35 kg when preventing HIV infection. Safety and effectiveness have not been confirmed.

Geriatric

Studies conducted so far have not shown specific problems in older adults that would limit the usefulness of emtricitabine and tenofovir combination. However, older patients are more likely to have liver or kidney issues related to aging, which may require caution and adjustments in dosage for those taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are based on 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 necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both 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 increase the risk of specific side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Darunavir
• Lopinavir
• Nirmatrelvir
• Ritonavir
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtimes or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare provider the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you use this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Bone fracture, history of or
• Kidney disease (e.g., acute renal failure, Fanconi syndrome), history of or
• Liver disease (e.g., hepatitis B infection), history of or
• Osteomalacia (soft bones), history of or
• Osteoporosis (weak or brittle bones), history of—Use with caution. May worsen these conditions.

• 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.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Depression
• diarrhea
• nausea

Less common

• Anxiety
• back pain
• belching
• difficulty in moving
• heartburn
• joint pain or swelling
• lack or loss of strength
• pain
• passing of gas
• stomach upset
• sweating
• trouble sleeping
• vomiting
• weight loss

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.

In the U.S.

• Truvada

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

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.