Cobicistat, Oral

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KEY POINTS

• This medicine is taken by mouth 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.
• This medicine interacts with many other medicines, including prescription and non-prescription medicines, and herbal supplements, causing serious or life-threatening side effects. 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: CYP3A inhibitor

Generic and brand names: cobicistat, oral; Tybost

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
• Liver or kidney disease

Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with this medicine. This medicine interacts with many other medicines, including prescription and non-prescription medicines, and herbal supplements, causing serious or life-threatening side effects. You MUST avoid taking certain other medicines while you are taking this medicine. Important: Tell your healthcare provider about any new medicines you might take even for only a short time. Do not stop or change the dose of any medicine without checking with your healthcare provider.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

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. Do not run out of this medicine. When your supply runs low, get more from your healthcare provider or pharmacy. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.

Check with your healthcare provider before using this medicine in children under 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, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. 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 have not been reported.

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.

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.

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

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; unexplained fever; blood in the urine; severe lower back pain; severe diarrhea; decreased urinating; yellowing of eyes or skin; dark urine; light-colored bowel movements; severe skin rash, blistering, or peeling; severe muscle pain.

Other: Tiredness, mild nausea, vomiting, diarrhea, trouble sleeping, abnormal dreams, headache.

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)
• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• 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, propafenone (Rythmol), and quinidine
• Antibiotics such as bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), 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), and primidone (Mysoline)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), and timolol
• Bladder control medicines such as darifenacin (Enablex), solifenacin (VESIcare), and tolterodine (Detrol)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as afatinib (Gilotrif), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), cabozantinib (Cometriq), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), docetaxel (Docefrez, Taxotere), enzalutamide (Xtandi), 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), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• 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/quinidine (Nuedexta)
• Diabetes medicines such as linagliptin (Tradjenta), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Dronabinol (Marinol)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Everolimus (Afinitor, Zortress)
• 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)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) (Take cobicistat at the same time as these medicines or at least 10 hours after you take these medicines.)
• Medicines to block or prevent stomach acid such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix) (Take cobicistat at least 12 hours after these medicines.)
• Medicines to treat breathing or lung problems such as fluticasone/salmeterol (Advair) 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)
• Natural remedies such as ginkgo biloba, goldenseal, red yeast rice, and St. John's wort
• Nausea medicines such as aprepitant (Emend) and ondansetron (Zofran)
• Other HIV medicines such as atazanavir (Reyataz), 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)
• Quinine
• Ranolazine (Ranexa)
• Sleeping pills such as estazolam (ProSom), eszopiclone (Lunesta), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• 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 tablets in original container at room temperature. Keep the container tightly closed. If stored outside of original container, throw away any unused medicine after 2 weeks. Protect from moisture or high humidity.

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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.