Emtricitabine/Rilpivirine/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: emtricitabine/rilpivirine/tenofovir disoproxil fumarate, oral; Complera; emtricitabine/rilpivirine/tenofovir alafenamide, oral; Odefsey

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 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
• Depression or thoughts of suicide
• Kidney disease
• Liver disease such as hepatitis B or hepatitis C
• Long QT syndrome (problems with electrical activity in the heart muscle)

Tell your healthcare providers and pharmacists all the medicines, natural remedies, or vitamins you take. 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. Other medicines, including herbal products, may affect this medicine. You should not take any other HIV medicines while you take this medicine. You should also not take this medicine if you also take Hepsera to treat hepatitis B.

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 without your healthcare provider's approval.

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 run out of this medicine. The amount of virus in your blood may increase if you stop the medicine, even for a short time. The virus may become harder to treat.

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

You must take this medicine with food. A protein drink does not replace a meal.

What if I miss a dose?

If you miss a dose, and it is more than 12 hours until the next scheduled dose, take it with a meal as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and use the next one as directed. Do not use double doses. 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 have not been reported.

What should I watch out for?

This medicine may cause severe liver problems. Call your healthcare provider right away if you have:

• Yellowing of your skin or eyes
• Dark urine
• Light-colored bowel movements
• Loss of appetite for several days or longer
• Nausea
• Stomach pain

You may need urine and blood 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. You may also need blood tests after you stop taking this medicine. 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
• Feeling cold, especially in your arms or legs
• Stomach pain with nausea and vomiting
• Feeling dizzy or lightheaded
• Suddenly developing a fast or irregular heartbeat

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.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

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 supplements.

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.

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 dizziness or drowsiness. 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.): Decreased urination, pain when urinating, dark urine, light-colored bowel movements, yellowing of your eyes or skin, red eyes; unexplained fever, muscle or joint pain; unusual tiredness or weakness; severe dizziness or fainting; fast or irregular heartbeat; trouble breathing; severe stomach or back pain; feeling cold, especially in your arms or legs; severe nausea or vomiting; tingling or numbness; depression or thoughts of suicide, unusual mood changes; severe skin redness, blisters, or peeling; rash with a fever; mouth sores.

Other: Nausea, vomiting, diarrhea, gas, stomach pain, changes in body fat, headache, mild rash, dizziness, trouble sleeping, abnormal dreams, mild tiredness, runny nose, freckles, joint or muscle pain.

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)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 4 hours after you take this medicine.)
• Antibiotics such as amikacin, bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), tobramycin, and vancomycin (Vancocin)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), ganciclovir (Cytovene), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), valacyclovir (Valtrex), and valganciclovir (Valcyte)
• Apomorphine (Apokyn)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone acetate (Zytiga), arsenic trioxide (Trisenox), bortezomib (Velcade), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), degarelix (Firmagon), enzalutamide (Xtandi), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and pravastatin (Pravachol)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• 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 block or prevent stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) (Take these at least 12 hours before or 4 hours after you take Complera.)
• Medicines to block or prevent stomach acid such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and vilanterol (Breo Ellipta)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), and ondansetron (Zofran)
• 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), acyclovir (Zovirax), adefovir (Hepsera), atazanavir (Reyataz), cidofovir (Vistide), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), ganciclovir (Cytovene), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), valacyclovir (Valtrex), valganciclovir (Valcyte), and zidovudine/lamivudine (Combivir)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• St. John’s wort
• Tetrabenazine (Xenazine)

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

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.