Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir

IMPORTANT WARNING:

Elvitegravir, cobicistat, emtricitabine, and tenofovir 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. 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 to see if your HBV has worsened.

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 elvitegravir, cobicistat, emtricitabine, and tenofovir.

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

WHY is this medicine prescribed?

The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir (Genvoya, Stribilid) is used to treat human immunodeficiency virus (HIV) infection in adults and children who have not been treated with other HIV medications or to replace current medication therapy in certain people already taking HIV medications. 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 will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting 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 comes as a tablet to take by mouth. It is usually taken with food once a day. Take elvitegravir, cobicistat, emtricitabine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elvitegravir, cobicistat, emtricitabine, and tenofovir 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 help to control HIV infection but do not cure it. Continue to take elvitegravir, cobicistat, emtricitabine, and tenofovir even if you feel well. Do not stop taking elvitegravir, cobicistat, emtricitabine, and tenofovir 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,

• tell your doctor and pharmacist if you are allergic to elvitegravir, cobicistat, emtricitabine, or tenofovir, any other medications, or any of the ingredients in elvitegravir, cobicistat, emtricitabine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking any of the following medications: alfuzosin (Uroxatral); carbamazepine (Carbatrol, Epitol, Tegretol, others), cisapride (Propulsid) (not available in the U.S.); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine); lomitapide (Juxtapid); lovastatin (Altoprev); lurasidone (Latuda); midazolam (Versed) by mouth; phenobarbital; phenytoin (Dilantin, Phenytek); pimozide (Orap); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); St. John's wort; sildenafil (only Revatio, brand used for lung disease); simvastatin (Simcor, Zocor, in Vytorin); or triazolam (Halcion). Your doctor will probably tell you not to take elvitegravir, cobicistat, emtricitabine, and tenofovir if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as gentamicin; anticoagulants ('blood thinners') such as apixaban (Eliquis), betrixaban (Bevyxxa), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto), and warfarin (Coumadin, Jantoven); antifungal medications such as itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); antiviral medications such as acyclovir (Sitavig, Zovirax), cidofovir, ganciclovir (Cytovene), valacyclovir (Valtrex), and valganciclovir (Valcyte); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); atorvastatin (Lipitor, in Caduet); benzodiazepines such as clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), estazolam, flurazepam, and midazolam given intravenously (into a vein); beta blockers such as metoprolol (Lopressor, Toprol-XL, in Dutoprol) and timolol; bosentan (Tracleer); buprenorphine and naloxone (Bunavail, Suboxone); buspirone; calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Diltzac, Tiazac, others), felodipine, nicardipine (Cardene), nifedipine (Adalat CC, Afeditab CR, Procardia), and verapamil (Calan, Verelan, in Tarka); clarithromycin (Biaxin, in PrevPac); colchicine (Colcrys, Mitagare, in Col-Probenecid); dexamethasone; ethosuximide (Zarontin), hormonal contraceptives (birth control pills, patch, vaginal ring, or injectable); medications for depression such as amitriptyline, bupropion (Aplenzin, Forfivo XL, Wellbutrin, Zyban), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Brisdelle, Paxil, Pexeva), and trazodone; other medications for HIV or AIDS including cobicistat (Tybost, in Evotaz, in Prezcobix), emtricitabine (Emtriva, in Atripla, in Complera, in Truvada), lamivudine (Epivir, in Combivir, in Epzicom, in Trizivir, others), ritonavir (Norvir, in Kaletra, in Technivie), and tenofovir (Viread, in Atripla, in Complera, in Truvada); fentanyl (Actiq, Duragesic, Subsys); medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), flecainide, lidocaine (Xylocaine), mexiletine, propafenone (Rythmol), and quinidine (in Nuedexta); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); naloxone (Evzio, Narcan); oxcarbazepine (Oxtellar XR, Trileptal); perphenazine; quetiapine (Seroquel); phosphodiesterase (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, Staxyn); rifabutin (Mycobutin); rifapentine (Priftin); risperidone (Risperdal); salmeterol (Serevent, in Advair); oral or inhaled steroids such as betamethasone, budesonide (Pulmicort), ciclesonide (Alvesco, Omnaris), dexamethasone, fluticasone (Flonase, Flovent, in Advair), methylprednisolone (Medrol). mometasone (in Dulera). prednisone (Rayos), and triamcinolone; telithromycin (Ketek; no longer available in US); thioridazine; tramadol; and zolpidem (Ambien, Edluar, Intermezzo, Zolpimist). Many other medications may also interact with elvitegravir, cobicistat, emtricitabine, and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• 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.

• tell your doctor if you have or have ever had the conditions 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, plan to become pregnant, or are breastfeeding. If you become pregnant while taking elvitegravir, cobicistat, emtricitabine, and tenofovir, call your doctor right away. You should not breastfeed if you are infected with HIV or if you are taking elvitegravir, cobicistat, emtricitabine and tenofovir.

• 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, 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 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• difficulty falling asleep or staying asleep
• unusual dreams
• diarrhea
• gas
• 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:

• 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
• weakness
• dizziness
• lightheadedness
• fast or irregular heartbeat
• trouble breathing
• dark yellow or brown urine
• light-colored bowel movements
• yellowing of the skin or eyes
• feeling cold, especially in the arms or legs
• muscle pain

Elvitegravir, cobicistat, emtricitabine, and tenofovir 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 (http://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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.