Cobicistat/Darunavir, Oral

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KEY POINTS

• This medicine is taken by mouth along with other medicines to treat HIV-1 infection. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• You MUST avoid taking certain other medicines while you are taking this medicine. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: protease inhibitor/CYP3A inhibitor; anti-HIV

Generic and brand names: cobicistat/darunavir, oral; Prezcobix

What is this medicine used for?

This medicine is taken by mouth along with other medicines to treat HIV-1 infection.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Hemophilia or bleeding problems
• High cholesterol or high triglycerides
• Kidney problems
• Liver disease, including hepatitis B or hepatitis C
• Problems with alcohol abuse

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines and natural remedies you take, especially antibiotics, sedatives, St. John's Wort, and medicines to treat cholesterol, prostate problems, migraines, mental disorders, or heart rhythm problems.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine.

Males: If you take avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are taking this medicine, you may be at increased risk of side effects such as low blood pressure, vision changes or priapism (prolonged and painful erections).

Hormonal birth control may be less effective while you are taking this medicine. Talk to your healthcare provider if you need birth control.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.

Do not run out of this medicine. The amount of HIV-1 in your blood may increase and become harder to treat if the medicine is stopped for even a short time.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine once a day with other medicines your healthcare provider prescribes. Take the medicine with food. Follow your healthcare provider's instructions exactly.

What if I miss a dose?

Do not miss any doses. If you do miss a dose by 12 hours or less, take your missed dose right away. Then take your next dose at your regularly scheduled time. If you miss a dose by more than 12 hours, wait and then take the next dose at your regularly scheduled time. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, pounding or irregular heartbeat, drowsiness, slurred speech, fainting, trouble walking; numbness or tingling in hands or feet; trouble urinating, vomiting, rash.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. There is no evidence that this medicine will reduce the risk of spreading HIV through sexual contact or blood contamination.

Do not give this medicine to other people, even if they have the same symptoms you have.

Your body fat may change as a result of taking this medicine. Talk with your healthcare provider about this.

This medicine may increase the total cholesterol and triglyceride levels in your blood. You will need tests to check these levels regularly. Keep all appointments for tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may develop diabetes when you take this medicine. Talk with your healthcare provider about this.

If you have diabetes: Your dosage of insulin or medicines taken by mouth for diabetes may need to be changed. If you are controlling your diabetes with diet and exercise, you may need to start taking medicine. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe nausea, vomiting, and stomach pain; severe back pain; fever; blood in the urine; unusual bruising or bleeding; unusual tiredness or weakness; severe diarrhea; yellowing of eyes or skin; dark urine; light-colored bowel movements; unexplained loss of appetite; severe skin rash, blistering, or peeling; mouth sores; red or inflamed eyes; muscle or joint aches; increased hunger, thirst, and urination; decreased urination; confusion; severe drowsiness.

Other: Mild nausea, vomiting, diarrhea, gas, or stomach cramps; abnormal dreams; tiredness; headache; mild rash.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alosetron (Lotronex)
• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, lidocaine (Lidoderm, Xylocaine), mexiletine, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), levomilnacipran (Fetzima), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clonazepam (Klonopin), ethosuximide (Zarontin), felbamate (Felbatol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Beta blockers such as bisoprolol (Zebeta), carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), and timolol
• Bladder control medicines such as darifenacin (Enablex), fesoterodine (Toviaz), solifenacin (VESIcare), and tolterodine (Detrol)
• Bromocriptine (Cycloset, Parlodel)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Calcium channel blockers such as amlodipine (Caduet, Norvasc), diltiazem (Cardizem, Cartia, Tiazac), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), cabozantinib (Cometriq), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), docetaxel (Docefrez, Taxotere), enzalutamide (Xtandi), everolimus (Afinitor, Zortress), idelalisib (Zydelig), ifosfamide (Ifex), imatinib (Gleevec), irinotecan (Camptosar), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), paclitaxel (Abraxane, Taxol), pazopanib (Votrient), regorafenib (Stivarga), sorafenib (Nexavar), sunitinib (Sutent), temsirolimus (Torisel), topotecan (Hycamtin), toremifene (Fareston), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris), dexamethasone, fluticasone (Flonase, Flovent, Veramyst), hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and prednisone (Prednisone Intensol)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as exenatide (Bydureon, Byetta), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), sitagliptin (Januvia), and tolbutamide
• Didanosine (Videx) (Take didanosine at least 1 hour before or 2 hours after you take this medicine.)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Dronabinol (Marinol)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• Flibanserin (Addyi)
• Hepatitis C medicines such as elbasvir/grazoprevir (Zepatier), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), simeprevir (Olysio), and sofosbuvir (Sovaldi)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Liraglutide (Saxenda, Victoza)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), mometasone (Asmanex, Nasonex), and salmeterol (Serevent)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dabigatran (Pradaxa), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Methylergonovine
• Midazolam (Versed)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Natural remedies such as garlic, ginkgo biloba, goldenseal, red yeast rice, and St. John's wort
• Nausea medicines such as aprepitant (Emend), ondansetron (Zofran), and promethazine
• Other HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and tipranavir (Aptivus)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Sleeping pills such as estazolam (ProSom), eszopiclone (Lunesta), suvorexant (Belsomra), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil), methamphetamine (Desoxyn), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Theophylline

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.