Emtricitabine/Tenofovir Alafenamide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This medicine may also cause severe or life-threatening liver problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: emtricitabine/tenofovir alafenamide, oral; Descovy

What is this medicine used for?

This medicine is taken by mouth to treat HIV infection and slow the progression of the disease. It will not cure HIV or AIDS. It is used with other antiretroviral medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bone problems such as osteoporosis
• Liver disease such as hepatitis B
• Kidney disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon.

Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

Check with your healthcare provider before using this medicine in children under age 12 or who weigh less than 77 pounds.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is time for your next dose (the next day). Do not double the dose the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You need to have urine and blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause new or worse kidney problems, including kidney failure. Talk with your healthcare provider about this.

You may need bone scans or X-rays to see if the medicine is affecting your bones. Your healthcare provider may prescribe calcium and vitamin D supplements while you are taking this medicine. Follow your healthcare provider's instructions about exercise, diet, and taking vitamin supplements.

Lactic acidosis is a rare but serious complication that can happen with use of this medicine. This condition is caused by a buildup of lactic acid in the blood. The symptoms of lactic acidosis are:

• Feeling very tired or weak
• Unusual muscle pain
• Trouble breathing
• Feeling cold, especially in hands or feet
• Stomach pain with nausea and vomiting
• Feeling dizzy or lightheaded
• Fast or irregular heartbeat

This medicine is not approved for treatment of hepatitis B and may cause flare-ups of hepatitis B. Your healthcare provider may test you for hepatitis B. If you are also infected with hepatitis B, you need blood tests and checkups for several months after you stop taking this medicine.

This medicine may cause severe or life-threatening liver problems. Contact your healthcare provider right away if you have yellowing of your skin or eyes, dark urine, light-colored bowel movements, and loss of appetite.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

Alcohol may increase the risk of side effects of this medicine. Do not drink alcohol without your healthcare provider's approval.

This medicine does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

Your body fat may change. Your legs and arms may be thin but your chest, belly, back and face may have more fat. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast, slow, or irregular heartbeat; decreased urination; pain when urinating; dark urine, yellowing of your eyes or skin; light-colored bowel movements; unexplained fever; muscle or joint pain; unusual muscle weakness, severe dizziness or fainting; unusual tiredness or weakness; trouble breathing; feeling cold; severe nausea or vomiting; severe stomach or back pain; tingling or numbness; enlarged lymph nodes in your neck or groin; depression or other mood changes.

Other: Mild nausea or vomiting, diarrhea, gas, mild stomach pain, loss of appetite, weight loss, changes in body fat, headache, mild rash, mild dizziness, trouble sleeping, abnormal dreams, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as amikacin, azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), tobramycin, and vancomycin (Vancocin)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Cancer medicines such as abiraterone (Zytiga), bosutinib (Bosulif), cisplatin, crizotinib (Xalkori), enzalutamide (Xtandi), ibrutinib (Imbruvica), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and simvastatin (Zocor)
• Diabetes medicines such as alogliptin/metformin (Kazano), canagliflozin (Invokana), canagliflozin/metformin (Invokamet), dapagliflozin/metformin (Xigduo), glipizide/metformin (Metaglip), linagliptin/metformin (Jentadueto), metformin (Fortamet, Glucophage, Riomet), pioglitazone/metformin (Actoplus Met), rosiglitazone/metformin (Avandamet), saxagliptin/metformin (Kombiglyze), and sitagliptin/metformin (Janumet)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), quinidine, and verapamil (Calan, Covera, Verelan)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other antiviral medicines such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), acyclovir (Zovirax), adefovir (Hepsera), atazanavir (Reyataz), cidofovir (Vistide), darunavir (Prezista), delavirdine (Rescriptor), didanosine (Videx), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera), etravirine (Intelence), fosamprenavir (Lexiva), ganciclovir (Cytovene), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), nelfinavir (Viracept), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), Ombitasvir/paritaprevir/ritonavir (Technivie), ritonavir (Norvir), saquinavir (Invirase), simeprevir (Olysio), stavudine (Zerit), tenofovir (Viread), tipranavir (Aptivus), valacyclovir (Valtrex), valganciclovir (Valcyte), and zidovudine/lamivudine (Combivir)
• Probenecid
• Rivaroxaban (Xarelto)
• St. John’s wort
• Suvorexant (Belsomra)
• Tolvaptan (Samsca)
• Trospium

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.