Emtricitabine, Rilpivirine, and Tenofovir disoproxil fumarate

IMPORTANT WARNING:

Emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, and tenofovir DF. If you have HBV and you take emtricitabine, rilpivirine, and tenofovir DF, your condition may suddenly worsen when you stop taking emtricitabine, rilpivirine, and tenofovir DF. Your doctor will examine you and order lab tests regularly for several months after you stop taking emtricitabine, rilpivirine, and tenofovir DF.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body's response to emtricitabine, rilpivirine, and tenofovir DF.

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

WHY is this medicine prescribed?

The combination of emtricitabine, rilpivirine, and tenofovir DF is used to treat HIV. Emtricitabine, rilpivirine, and tenofovir DF are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body.

Although emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, and tenofovir DF comes as a tablet to take by mouth. It is usually taken with a meal (not just a protein drink) once a day. Take emtricitabine, rilpivirine, and tenofovir DF at around the same time every day.

Take emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, and tenofovir DF even if you feel well. Do not stop taking emtricitabine, rilpivirine, and tenofovir DF without talking to your doctor.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, and tenofovir DF. Other medications may cause dosing changes or extra monitoring when taken with emtricitabine, rilpivirine, and tenofovir DF. Make sure you have discussed any medications you are currently taking or plan to take before starting emtricitabine, rilpivirine, and tenofovir DF with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking emtricitabine, rilpivirine, and tenofovir DF, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with emtricitabine, rilpivirine, and tenofovir DF: nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil^®, Motrin^®) and naproxen (Aleve^®, Naprosyn^®) and St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking emtricitabine, rilpivirine, and tenofovir DF. Do not start these medications while taking emtricitabine, rilpivirine, and tenofovir DF without discussing with your healthcare provider.

• if you are taking antacids containing calcium, magnesium, or aluminum (Maalox^®, Mylanta^®, Tums^®, others), take the antacid 2 hours before or at least 4 hours after you take emtricitabine, rilpivirine, and tenofovir DF.

• if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet^®), famotidine (Pepcid^®, in Duexis^®), nizatidine (Axid^®), or ranitidine (Zantac^®), take it at least 12 hours before or at least 4 hours after emtricitabine, rilpivirine, and tenofovir DF.

• tell your doctor if you have or have ever had the conditions 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, or any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in people with weak immune systems), or liver or kidney disease.

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking emtricitabine, rilpivirine, and tenofovir DF, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking emtricitabine, rilpivirine, and tenofovir DF.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIVmay be passed to your baby in your breast milk. Talk to your doctor about the risks ofbreastfeeding your baby if you are taking lamivudine.

• you should know that emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, and tenofovir DF: new or worsening depression; feeling sad, hopeless, anxious, or restless; or thinking about killing yourself or planning or trying to do so.

• 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. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at any time during your treatment with emtricitabine, rilpivirine, and tenofovir DF, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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

Take the missed dose as soon as you remember it with food. However, if it has been more than 12 hours since your last 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?

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

• difficulty falling asleep or staying asleep
• unusual dreams
• change in skin color
• pain, burning or tingling in the hands or feet
• headache
• diarrhea
• mild rash

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

• ongoing or worsening bone pain
• decreased urination
• weakness, muscle pain, dizziness, lightheadedness, fast or irregular heartbeat, difficulty breathing, feeling cold, especially in the arms or legs
• nausea, vomiting, loss of appetite, extreme tiredness, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes, pain in upper right part of stomach, flu-like symptoms, unusual bleeding or bruising

If you develop a severe rash with any of the following symptoms, stop taking emtricitabine, rilpivirine, and tenofovir DF and call your doctor immediately or get emergency medical treatment:

• swollen face, lips, mouth, tongue or throat; difficulty swallowing or breathing; mouth sores or blisters on your body; pink and swollen eyes; fever; dark urine; pain on the right-side of stomach area; yellowing of the skin or eyes

Emtricitabine, rilpivirine, 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 emtricitabine, rilpivirine, 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.