Etravirine, Oral

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KEY POINTS

• This medicine is taken by mouth along with other medicines to treat HIV infection. Take it exactly as directed.
• Keep all appointments for blood tests to see how this medicine affects you.
• You may develop a rash that could become serious. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse. This medicine may cause other unwanted side effects.
• Taking this medicine with certain other medicines may be life-threatening. 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: non-nucleoside reverse transcriptase inhibitor; antiretroviral; anti-HIV

Generic and brand names: etravirine, oral; Intelence

What is this medicine used for?

This medicine is taken by mouth along with other medicines to treat HIV infection. This medicine must be taken with other anti-HIV medicines to keep from developing resistant strains of HIV.

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?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease
• Hepatitis B or hepatitis C
• High cholesterol or high triglycerides

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take.

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 change your dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. Do not run out of this medicine. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.

Take this medicine with other medicines your healthcare provider prescribes. Follow your healthcare provider's instructions exactly.

Check with your healthcare provider before using this medicine in children under age 6 years.

Do NOT take this medicine on an empty stomach. Take this medicine after a meal. Do not break, crush, or chew the tablets. Swallow them whole with water.

If you are unable to swallow the tablets, add one dose of this medicine to at least 4 ounces (or one-half cup) of water. Do NOT put the tablets in other liquids such as grapefruit juice or warm or carbonated drinks. Stir well until the water looks milky. Drink the mixture right away. Rinse the cup or glass with some more water then swallow the rinse.

What if I miss a dose?

Do not miss any doses. If you miss a dose and it is within 6 hours of the time you usually take it, take the dose following a meal as soon as possible. If you miss a dose and it is more than 6 hours after the time you usually take it, then skip the missed dose and take the next one as directed. Do not take 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?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. There is no evidence that this medicine will reduce the risk of spreading HIV through sexual contact or blood contamination.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

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, especially if it lasts for more than 2 days.

Your body fat may change as a result of taking this medicine. Your legs and arms may be thin but your chest, belly, back, and neck may have more fat. Discuss this with your healthcare provider.

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 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 about 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.): Severe rash or a rash along with fever, blistering, red eyes, sores in your mouth, swelling, muscle or joint aches, extreme muscle pain or weakness, severe nausea or vomiting, loss of appetite, dark urine, light-colored bowel movements, yellowing of the skin or eyes; numbness or tingling in hands or feet; chest pain or irregular heartbeat; confusion; memory problems; trouble urinating; seizures.

Other: nausea, vomiting, diarrhea, tiredness, trouble sleeping, nervousness.

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 products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), flecainide, mexiletine, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), maprotiline, mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify) and brexpiprazole (Rexulti)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), and timolol
• Bosentan (Tracleer)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), cabozantinib (Cometriq), crizotinib (Xalkori), dabrafenib (Tafinlar), docetaxel (Docefrez, Taxotere), enzalutamide (Xtandi), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), pazopanib (Votrient), pomalidomide (Pomalyst), ponatinib (Iclusig), regorafenib (Stivarga), romidepsin (Istodax), sorafenib (Nexavar), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), and simvastatin (Zocor)
• Dapsone
• Dexamethasone
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), linagliptin (Tradjenta), nateglinide (Starlix), and repaglinide (Prandin)
• Diazepam (Valium)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• 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)
• Interferon medicines such as interferon alfa-2b (Intron-A), interferon alfa-n3 (Alferon N), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), peginterferon alfa-2a (Pegasys), peginterferon alfa-2b (Sylatron), and peginterferon beta-1a (Plegridy)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Maraviroc (Selzentry)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as sildenafil (Revatio) and tadalafil (Adcirca)
• Methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pimozide (Orap)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Ribavirin (Copegus, Rebetol, Ribasphere, Virazole)
• Ruxolitinib (Jakafi)
• St. John’s wort

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.