Pronunciation:

em-trye-SYE-ta-been, ten-OF-oh-vir al-a-FEN-a-mide

Brand Names:

• Descovy

Dosage Forms:

• Tablet

Warnings:

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who 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 with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine/tenofovir alafenamide. If appropriate, initiation of antihepatitis B therapy may be warranted. Emtricitabine/tenofovir alafenamide used for HIV-1 pre-exposure prophylaxis must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of FTC during use. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine/tenofovir alafenamide for HIV-1 pre-exposure prophylaxis if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

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 is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. Your doctor may do tests to make sure you are negative from HIV-1 infection before taking this medicine for HIV-1 PrEP.

This medicine does not cure HIV infection or 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 problems that usually result from AIDS or HIV disease. It 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 disease.

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:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of emtricitabine and tenofovir alafenamide combination in children weighing less than 14 kilograms (kg) and in children weighing less than 35 kg who are also given other medicines (eg, ritonavir, cobicistat) to treat HIV infection and in children weighing less than 35 kg to prevent getting HIV infection. Safety and efficacy have not been established.

Older adults—

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.

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.

Other 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

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
• Adagrasib
• Amikacin
• Amikacin Liposome
• Amiodarone
• Amtolmetin Guacil
• Apalutamide
• Asciminib
• Aspirin
• Berotralstat
• Bromfenac
• Bufexamac
• Cabotegravir
• Capmatinib
• Capreomycin
• Carvedilol
• Celecoxib
• Choline Salicylate
• Cidofovir
• Clarithromycin
• Clonazepam
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Darolutamide
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Dronedarone
• Droxicam
• Eltrombopag
• Enasidenib
• Encorafenib
• Erythromycin
• Eslicarbazepine Acetate
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ganciclovir
• Gentamicin
• Horsetail
• Ibuprofen
• Indomethacin
• Itraconazole
• Kanamycin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Leflunomide
• Leniolisib
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Midostaurin
• Momelotinib
• Morniflumate
• Nabumetone
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Orlistat
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Parecoxib
• Paromomycin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Plazomicin
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Ranolazine
• Rifabutin
• Rifapentine
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Spectinomycin
• Streptomycin
• Sulindac
• Tacrolimus
• Tafamidis
• Telaprevir
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tipranavir
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Valacyclovir
• Valdecoxib
• Valganciclovir
• Vemurafenib
• Verapamil

Other interactions—

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 failure, 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.

• Kidney disease, severe or requiring hemodialysis—Use is not recommended in patients with these conditions.

• Unknown or positive HIV-1 status (for Pre-Exposure Prophylaxis)—Do not use 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.

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.

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 at least 35 kilograms (kg) and with creatinine clearance greater than or equal to 30 mL per minute—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 25 mg of tenofovir alafenamide.
    • Adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis—One tablet once a day on days of hemodialysis. Each tablet contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
    • Children 14 to less than 35 kg—Dose is based on body weight and must be determined by your doctor.
      • Children weighing 25 to less than 35 kg—One tablet once a day. Each tablet contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
      • Children weighing 14 to less than 25 kg—One tablet once a day. Each tablet contains 120 mg of emtricitabine and 15 mg of tenofovir alafenamide.
    • Children weighing less than 14 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 and with creatinine clearance greater than or equal to 30 mL per minute—One tablet once a day. Each tablet contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
    • Adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis—One tablet once a day on days of hemodialysis. Each tablet contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
    • 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 its original bottle 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. 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. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, 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, decreased appetite, fever, headache, itching, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

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, including pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves disease, polymyositis, 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 keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone..

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

• 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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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

Chest pain or tightness

confusion

cough

fever or chills

increase in bone pain

irregular heartbeat

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

sneezing

stomach pain

trouble breathing

weakness or heaviness of the legs

Incidence not known

Agitation

bloody urine

change in consciousness

dark urine

decreased appetite

decreased frequency or amount of urine

depression

diarrhea

fast, shallow breathing

general feeling of discomfort

headache

hostility

increased thirst

irritability

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

loss of consciousness

lower back or side pain

muscle pain, twitching, or cramping

seizures

sleepiness

stomach discomfort

swelling of the face, fingers, or lower legs

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

upper right abdominal or stomach pain

vomiting

weight gain

yellow eyes and skin

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.