Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir disoproxil fumarate (DF)

IMPORTANT WARNING:

Elvitegravir, cobicistat, emtricitabine, and tenofovir 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 elvitegravir, cobicistat, emtricitabine, and tenofovir DF. If you have HBV and you take elvitegravir, cobicistat, 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. Your doctor will order certain tests before and during your treatment.

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

WHY is this medicine prescribed?

The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir DF is used to treat human immunodeficiency virus (HIV) infection. The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir is in a class of medications called antivirals. Elvitegravir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood. Cobicistat helps to keep elvitegravir in the body longer so that the medication will have a greater effect.

Although the combination of elvitegravir, cobicistat, 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 elvitegravir, cobicistat, emtricitabine, and tenofovir DF comes as a tablet to take by mouth. Take with food once a day. Take elvitegravir, cobicistat, emtricitabine, and tenofovir DF at around the same time every day.

Take elvitegravir, cobicistat, 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.

Elvitegravir, cobicistat, emtricitabine, and tenofovir DF help to control HIV infection but do not cure it. Continue to take elvitegravir, cobicistat, emtricitabine, and tenofovir DF even if you feel well. Do not stop taking elvitegravir, cobicistat, emtricitabine, 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 elvitegravir, cobicistat, 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 elvitegravir, cobicistat, emtricitabine, and tenofovir DF. Other medications may cause dosing changes or extra monitoring when taken with elvitegravir, cobicistat, emtricitabine, and tenofovir DF. Make sure you have discussed any medications you are currently taking or plan to take before starting elvitegravir, cobicistat, emtricitabine, and tenofovir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking elvitegravir, cobicistat, emtricitabine, and tenofovir, please get the advice of your doctor or pharmacist.

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

• if you are taking antacids containing aluminum, magnesium, or calcium (Maalox^®, Mylanta^®, others), take them 2 hours before or 2 hours after elvitegravir, cobicistat, emtricitabine, and tenofovir DF.

• tell your doctor if you have or have ever had the condition mentioned in the IMPORTANT WARNING section, bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, 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 patients 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 elvitegravir, cobicistat, emtricitabine, and tenofovir, call your doctor right away.

• 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 elvitegravir, cobicistat, emtricitabine, and tenofovir DF.

• 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 during your treatment with elvitegravir, cobicistat, emtricitabine, 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 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?

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

• nausea
• diarrhea

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:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness; difficulty swallowing or breathing
• decreased urination
• pain in the arms, hands, feet, or legs
• pain in upper right part of your stomach, loss of appetite, flu-like symptoms, nausea, vomiting, extreme tiredness, unusual bleeding or bruising, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes
• weakness, dizziness, lightheadedness, fast or irregular heartbeat, trouble breathing, feeling cold, especially in the arms or legs, muscle pain

Elvitegravir, cobicistat, 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 elvitegravir, cobicistat, 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.