Darunavir, Cobicistat, Emtricitabine, and Tenofovir

IMPORTANT WARNING:

Darunavir, 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 and during your treatment with darunavir, cobicistat, emtricitabine, and tenofovir. If you have HBV and you take darunavir, 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 darunavir, cobicistat, emtricitabine, and tenofovir.

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

WHY is this medicine prescribed?

The combination of darunavir, cobicistat, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults and children weighing at least 88 pounds (40 kg) 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 darunavir, cobicistat, emtricitabine, and tenofovir is in a class of medications called antivirals. Darunavir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood. Cobicistat helps to keep darunavir in the body longer so that the medication will have a greater effect. Although the combination of darunavir, 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 life-style 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 darunavir, cobicistat, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken with food once a day. Take darunavir, 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 darunavir, 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.

If you have trouble swallowing the tablets, you can split them into two pieces with a tablet-cutter. Take the split tablets right after cutting them. Do not save them for future use.

The combination of darunavir, cobicistat, emtricitabine, and tenofovir helps to control HIV infection but does not cure it. Continue to take darunavir, cobicistat, emtricitabine, and tenofovir even if you feel well. Do not stop taking darunavir, 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 darunavir, cobicistat, emtricitabine, and tenofovir,

• tell your doctor and pharmacist if you are allergic to darunavir, cobicistat, emtricitabine, and tenofovir, any other medications, sulfa medications, or any of the other ingredients in darunavir, 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.); colchicine (Colcyrs, Mitigare) in people with kidney or liver disease; dronedarone (Multaq); elbasvir and grazoprevir (Zepatier); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine); ivabradine (Corlanor); lomitapide (Juxtapid); lovastatin (Altoprev); lurasidone (Latuda); midazolam by mouth; naloxegol (Movantik); phenobarbital; phenytoin (Dilantin, Phenytek); pimozide (Orap); ranolazine (Ranexa); 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 darunavir, 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; antifungal medications such as isavuconazonium (Cresemba), itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); antiviral medications such as acyclovir (Sitavig, Zovirax), cidofovir, ganciclovir (Cytovene, Valcyte), valacyclovir (Valtrex), and valganciclovir (Valcyte); antibiotics such as clarithromycin (Biaxin, in PrevPac), erythromycin (E.E.S, Eryc, Ery-Tab), and telithromycin (no longer available in U.S., Ketek); apixaban (Eliquis); artemether and lumefantrine (Coartem); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); benzodiazepines such as clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, midazolam given intravenously (into a vein), and zolpidem (Ambien, Zolpmist); beta blockers such as arvedilol (Coreg), metoprolol (Lopressor, Toprol-XL, in Dutoprol), and timolol; bosentan (Tracleer); buprenorphine (Belbuca, Buprenex, others); buprenorphine and naloxone (Bunavail, Suboxone); buspirone; calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Diltzac, Tiazac, others), felodipine, nifedipine (Adalat CC, Afeditab CR, Procardia), and verapamil (Calan, Verelan, in Tarka); carvedilol (Coreg); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol), pitavastatin (Livalo), pravastatin (Pravachol), and rosuvastatin (Crestor); dasatinib (Sprycel); medications for depression such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Brisdelle, Paxil, Pexeva), sertraline (Zoloft), and trazodone; digoxin (Lanoxin); eslicarbazepine (Aptiom); everolimus (Afinitor, Zortress); fentanyl (Duragesic, Subsys); fesoterodine (Toviaz); irinotecan (Camptosar); medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), 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); methadone (Methadose); nilotinib (Tasigna); oral contraceptives ('birth control pills'); oxcarbazepine (Trileptal); oxycodone (Xtampza, in Percodan); perphenazine; quetiapine (Seroquel); phosphodiesterase (PDE5) inhibitors such as avanafil (Stendra), avanafil (Stendra);sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, Staxyn); rifabutin (Mycobutin); rifapentine (Priftin); risperidone (Risperdal); rivaroxaban (Xarelto); salmeterol (Serevent, in Advair); simeprevir (Olysio; no longer available in US); solifenacin (Vesicare); oral or inhaled steroids such as betamethasone, budesonide (Pulmicort), ciclesonide (Alvesco, Omnaris, Zetonna) dexamethasone, fluticasone (Flonase, Flovent, in Advair), methylprednisolone, mometasone (Asmanex, in Dulera), and triamcinolone; thioridazine; ticagrelor (Brilinta); tramadol (Conzip, Ultram); vinblastine; vincristine; and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with darunavir, 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.

• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, 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); diabetes; hemophilia (a disease in which the blood does not clot normally); or liver or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking darunavir, cobicistat, emtricitabine, and tenofovir, call your doctor.

• tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking darunavir, cobicistat, emtricitabine, and tenofovir.

• 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. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms during your treatment with darunavir, 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. 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?

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

• diarrhea
• headache
• stomach discomfort
• gas

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:

• dark yellow or brown urine; light-colored bowel movements; loss of appetite; nausea; vomiting; right upper stomach-area pain; or yellow skin or eyes
• increased or decreased urination
• weakness; muscle pain; shortness of breath or fast breathing; stomach pain with nausea and vomiting; cold or blue hands and feet; dizziness, lightheadedness; or fast or abnormal heartbeat
• sore throat; fever; chills; cough; and other signs of infection
• severe rash or rash with one or more of the following: fever, muscle or joint aches, red or swollen eyes, blisters or peeling skin, mouth sores, or swelling of face or neck

Darunavir, 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). Do not remove the desiccant (drying agent) pouches from the container.

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?

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

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