Efavirenz, 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: efavirenz, oral; Sustiva

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
• Heart disease
• Hepatitis B or hepatitis C
• High cholesterol or high triglycerides
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Mental health problems such as depression, bipolar disorder, or paranoia
• Problems with drug or alcohol abuse
• Seizures

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: 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 interfere with the effectiveness of hormonal birth control such as pills, implants, shots, patches, or vaginal rings. Use at least two effective forms of birth control, including a reliable barrier method, while you are taking this medicine and for 12 weeks after stopping it. Ask your healthcare provider about effective methods of birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving 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 3 months.

This medicine comes in tablets and capsules. Take this medicine on an empty stomach, preferably at bedtime. Swallow the tablets or capsules whole with water. Do not break, crush, or chew the tablets.

If you are unable to swallow the tablets or capsules, talk with your healthcare provider or pharmacist.

What if I miss a dose?

Do not miss any doses. If you do miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, 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?

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: confusion, loss of balance, sudden change in behavior, thoughts of suicide.

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.

When taken with this medicine, alcohol and other drugs may make you dizzier and drowsier than usual. Discuss this with your healthcare provider. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may cause dizziness, trouble concentrating, depression, 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. Contact your healthcare provider about any side effects that continue or get worse, especially if you have severe depression or thought of suicide.

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.): Depression that does not go away; suicidal thoughts; unusual thoughts or behavior; unusual mood changes; hallucinations; serious rash with a fever; blistering; mouth sores; red eyes; swelling; muscle pain or joint pain; extreme weakness; severe nausea or vomiting; loss of appetite; dark urine; light-colored bowel movements; yellowing of the skin or eyes; seizures; severe dizziness or drowsiness; irregular heartbeat; chest pain.

Other: Indigestion, stomach pain, gas, diarrhea, nausea, vomiting, tiredness, trouble sleeping, dizziness, drowsiness, abnormal dreams, trouble concentrating, headaches.

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:

• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), diazepam (Valium), midazolam (Versed), and oxazepam
• 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 azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), tedizolid (Sivextro), 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 caspofungin (Cancidas), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), 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)
• Apomorphine (Apokyn)
• Atovaquone (Mepron) and atovaquone/proguanil (Malarone)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), and timolol
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• 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), arsenic trioxide (Trisenox), 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)
• Colchicine (Colcrys)
• Dapsone
• Dexamethasone
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), linagliptin (Tradjenta), nateglinide (Starlix), repaglinide (Prandin), and saxagliptin (Onglyza)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Fingolimod (Gilenya)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), 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), and saquinavir (Invirase)
• 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)
• Ivacaftor (Kalydeco)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Maraviroc (Selzentry)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• 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)
• 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), 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 dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro) and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Praziquantel (Biltricide)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Ribavirin (Copegus, Rebetol, Ribasphere, Virazole)
• Roflumilast (Daliresp)
• Ruxolitinib (Jakafi)
• Simeprevir (Olysio)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil), benzphetamine (Regimex), methamphetamine (Desoxyn), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Tofacitinib (Xeljanz)

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.