Efavirenz/Emtricitabine/Tenofovir, 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: efavirenz/emtricitabine/tenofovir, oral; Atripla

What is this medicine used for?

This medicine is a combination of 3 medicines in each tablet. It is taken by mouth to treat HIV infection. It will not cure HIV or AIDS but may slow the progression of the disease. This medicine may be taken alone or with other 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
• Hepatitis B, hepatitis C, or other liver disease
• Kidney disease
• Mental health problems such as depression, bipolar disorder, or paranoia
• Problems with alcohol or drug abuse
• Seizures

This medicine may interact with many other medicines. This medicine may change the effect of other medicines, including the ones for HIV, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect this medicine. For this reason, it is very important to tell your healthcare providers and pharmacists all the medicines, natural remedies, or vitamins you take.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. This medicine may make hormonal birth control less effective. You should use 2 reliable birth control methods (including a barrier method, such as a diaphragm or condom) while you are taking this medicine and for 12 weeks after stopping it. Talk with your healthcare provider about effective birth control methods. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are 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. Do not let your medicine run out. The amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to this medicine and become harder to treat.

Check with your healthcare provider before using this medicine in children under age 12.

Take this medicine on an empty stomach, 30 minutes before or 2 hours after meals. Take it with a full glass of water.

If this medicine makes you dizzy or drowsy, take it at bedtime.

What if I miss a dose?

Do not 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?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: uncontrolled muscle movements, confusion, loss of balance, sudden change in behavior, thoughts of suicide.

What should I watch out for?

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.

You need to have lab tests regularly to see how this medicine affects you. You may also need bone scans or X-rays to see if the medicine is affecting your bones. Keep all appointments for tests.

This medicine may cause a severe or life-threatening condition called lactic acidosis (a buildup of acid in your blood). Contact your healthcare provider right away if you have symptoms such as:

• Feeling very weak or tired
• Unusual muscle pain
• Having trouble breathing
• Severe stomach pain with nausea and vomiting
• Feeling cold, especially in your arms or legs
• Feeling dizzy or lightheaded
• Suddenly developing a fast or irregular heartbeat

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.

You may develop a rash. This usually goes away without any change in treatment. Occasionally, the rash becomes serious. Report any rash to your healthcare provider right away.

This medicine may cause dizziness or drowsiness. These symptoms often go away as your body adjusts to the medicine. Taking this medicine at night may help to make these symptoms less bothersome. Do not drive or operate machinery unless you are fully alert.

This medicine may increase the effects of alcohol and other drugs that affect your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

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.

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

This medicine may cause nausea or vomiting. Eating several small meals a day, sucking lozenges, or chewing gum may help.

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.

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

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

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, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): Depression that does not go away; hallucinations; strange thoughts or angry behavior; thoughts of suicide; confusion; serious rash with a fever; blistering; mouth sores; red eyes; swelling; muscle pain or joint pain; feeling cold, especially in your arms or legs; decreased or increased urination; unusual thirst; pain when urinating; dark urine; yellowing of your eyes or skin; light-colored bowel movements; unexplained loss of appetite; unexplained fever; unusual tiredness or weakness; trouble breathing; severe dizziness or fainting; fast, slow, or irregular heartbeat; severe stomach pain; severe nausea or vomiting.

Other: Numbness or pain in arms or legs, indigestion, stomach pain, gas, diarrhea, nausea, trouble sleeping, dizziness, drowsiness, abnormal dreams, trouble concentrating, headache, sweating, changes in body fat, skin discoloration of the hands or feet, back pain, nervousness, runny or stuffy 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:

• Alfuzosin (Uroxatral)
• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), and quinidine
• Antibiotics such as amikacin, atovaquone (Mepron), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), tobramycin, and vancomycin (Vancocin)
• Antidepressants such as fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as caspofungin (Cancidas), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), ganciclovir (Cytovene), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), simeprevir (Olysio), valacyclovir (Valtrex), and valganciclovir (Valcyte)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as axitinib (Inlyta), bosutinib (Bosulif), doxorubicin (Doxil), enzalutamide (Xtandi), idelalisib (Zydelig), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), and repaglinide (Prandin)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Exemestane (Aromasin)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as fluticasone/salmeterol (Advair), roflumilast (Daliresp), and theophylline
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), and warfarin (Coumadin)
• Methylergonovine
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• 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 HIV medicines such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), lamivudine/zidovudine (Combivir), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), raltegravir (Isentress), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), tenofovir (Viread), tipranavir (Aptivus), and zidovudine (Retrovir)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Ranolazine (Ranexa)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

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.