Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate

IMPORTANT WARNING:

Efavirenz, emtricitabine, and tenofovir disoproxil fumarate (DF) should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with efavirenz, emtricitabine, and tenofovir DF. If you have HBV and you take efavirenz, emtricitabine, and tenofovir, your condition may suddenly worsen when you stop taking this medication. Your doctor will examine you and order lab tests regularly for several months after you stop taking this medication.

Keep all appointments with your doctor and the laboratory.

Talk to your doctor about the risks of taking efavirenz, emtricitabine, and tenofovir DF.

WHY is this medicine prescribed?

The combination of efavirenz, emtricitabine, and tenofovir DF is used to treat human immunodeficiency virus (HIV) infection. Efavirenz is in a class of medications non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine and tenofovir are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the body.

Although efavirenz, emtricitabine, and tenofovir DF will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of efavirenz, emtricitabine, and tenofovir DF comes as a tablet to take by mouth. It is usually taken once a day with water on an empty stomach (at least 1 hour before or 2 hours after a meal). Take efavirenz, emtricitabine, and tenofovir DF at around the same time every day. Taking efavirenz emtricitabine, and tenofovir DF at bedtime may make certain side effects less bothersome.

Take efavirenz, emtricitabine, and tenofovir DF exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take efavirenz, emtricitabine, and tenofovir DF even if you feel well. Do not stop taking efavirenz, emtricitabine, and tenofovir DF without talking to your doctor. If you stop taking efavirenz, emtricitabine, and tenofovir DF even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking efavirenz, emtricitabine, and tenofovir DF,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with efavirenz, emtricitabine, and tenofovir DF. Other medications may cause dosing changes or extra monitoring when taken with efavirenz, emtricitabine, and tenofovir DF. Make sure you have discussed any medications you are currently taking or plan to take before starting efavirenz, emtricitabine, and tenofovir DF with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking efavirenz, emtricitabine, and tenofovir DF, please get the advice of your doctor or pharmacist.

• the following herbal product may interact with efavirenz, emtricitabine, and tenofovir DF: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking efavirenz, emtricitabine, tenofovir. Do not start this medication while taking efavirenz, emtricitabine, tenofovir DF without discussing with your healthcare provider.

• tell your doctor if you currently or have a prolonged QT interval (rare heart problem that may cause irregular heartbeat, fainting, or sudden death), or low levels of potassium or magnesium in your blood, ever drunk large amounts of alcohol, used street drugs, or over-used prescription medications. Also tell your doctor if you have or have ever had the condition mentioned in the IMPORTANT WARNING section, depression or other mental illness, bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, seizures, or liver or kidney disease.

• you should know that efavirenz, emtricitabine, and tenofovir DF may make you drowsy, dizzy, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking efavirenz, emtricitabine, and tenofovir DF. Alcohol can make the side effects from efavirenz, emtricitabine, and tenofovir DF worse.

• tell your doctor if you are pregnant, or plan to become pregnant. You should not become pregnant during your treatment and for 12 weeks after your final dose. If you can become pregnant, you will have to have a negative pregnancy test before you begin taking this medication and use effective birth control during your treatment. Efavirenz, emtricitabine, and tenofovir DF may interfere with the action of hormonal contraceptives (birth control pills, patches, rings, implants, or injections), so you should not use these as your only method of birth control during your treatment. You must use a barrier method of birth control (device that blocks sperm from entering the uterus such as a condom or a diaphragm) along with any other method of birth control you have chosen. Ask your doctor to help you choose a method of birth control that will work for you. If you become pregnant while taking efavirenz, emtricitabine, and tenofovir DF, call your doctor immediately.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking efavirenz, emtricitabine, and tenofovir DF.

• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with efavirenz, emtricitabine, and tenofovir DF be sure to tell your doctor.

• you should know that efavirenz, emtricitabine, and tenofovir DF may cause changes in your thoughts, behavior, or mental health. Call your doctor immediately if you develop any of the following symptoms while you are taking efavirenz: depression, thinking about killing yourself or planning or trying to do so, angry or aggressive behavior, hallucinations (seeing things or hearing voices that do not exist), strange thoughts, or loss of touch with reality. Be sure your family knows which symptoms may be serious so that they can call your doctor if you are unable to seek treatment on your own.

• you should know that efavirenz may cause potentially serious nervous system problems, including encephalopathy (a serious and potentially fatal disorder of the brain) months or years after you first take efavirenz, emtricitabine, and tenofovir. Call your doctor right away if you experience problems with balance and coordination, confusion, memory problems, and other difficulties caused by abnormal brain function, at any time during your treatment with efavirenz, emtricitabine, and tenofovir.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Efavirenz, emtricitabine, and tenofovir DF may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• difficulty falling asleep or staying asleep
• feeling agitated, worried, or nervous
• unusual dreams
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• decreased urination or urinating large amounts, increased thirst
• ongoing or worsening bone pain; bone fractures; pain in the in the arms, hands, feet, or legs
• muscle pain or weakness
• rash; peeling, blistering, or shedding skin; swelling of the face, throat, tongue, lips, eyes, legs, ankles, or feet; difficulty swallowing or breathing; hoarseness;
• numbness, burning, or tingling in the hands, arms, feet, or legs
• seizures
• nausea; vomiting; extreme tiredness; flu-like symptoms; yellowing of skin or eyes; light-colored bowel movements; dark yellow or brown urine; loss of appetite; pain in upper right part of stomach; or unusual bleeding or bruising
• weakness; muscle pain; shortness of breath or fast breathing; stomach pain with nausea and vomiting; cold or blue hands and feet; feeling dizzy or lightheaded; or fast or irregular heartbeat

Efavirenz, emtricitabine, and tenofovir DF may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of efavirenz, emtricitabine, and tenofovir DF on hand. Do not wait until you run out of medication to refill your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.