Ombitasvir/Paritaprevir/Ritonavir, Oral

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KEY POINTS

• This medicine, along with ribavirin, is taken by mouth to treat hepatitis C. 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 may cause life-threatening problems if you take this medicine with certain other medicines. 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: NS5A inhibitor/NS3/4A protease inhibitor/CYP3A inhibitor; hepatitis C treatment

Generic and brand names: ombitasvir/paritaprevir/ritonavir, oral; Technivie

What is this medicine used for?

This medicine is taken by mouth to treat chronic hepatitis C infection. It is taken along with ribavirin.

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
• Any other liver disease or a liver transplant
• HIV/AIDS

Many medicines should NOT be taken while you are taking this medicine. Do not start or stop any medicine or supplement unless you check with your healthcare provider or pharmacist.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, are breast-feeding, or plan to breast-feed. It is not known if this medicine can harm an unborn baby. If you are using birth control, talk with your healthcare provider about safe and effective forms of birth control. Some forms of hormonal birth control should not be taken during treatment with this medicine and for 2 weeks after you stop taking this medicine due to increased risk of serious side effects. It is not known if this medicine passes into your breast milk. Do not breast-feed while taking this medicine without your healthcare provider's approval.

Important: When taking this medicine along with ribavirin, you must avoid pregnancy. You should also read the ribavirin Medication Guide for important pregnancy information.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take all medicines exactly as your healthcare provider prescribes. Do not take more medicine or take it more often than directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.

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

Take this medicine with food in the morning.

What if I miss a dose?

If you miss a dose, take it with a meal as soon as you remember unless it is within 12 hours of 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?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

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

This medicine does not cure hepatitis C or keep you from spreading it to other people. Do not share needles, toothbrushes, or razor blades with others. Talk with your healthcare provider about this.

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 if you have 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; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Dark urine; light-colored bowel movements; yellowing of your skin or eyes; unusual loss of appetite; severe nausea or vomiting; pale skin; unusual tiredness or weakness; shortness of breath; severe stomach pain; any skin redness, peeling, or blisters.

Other: Mild tiredness, mild nausea, trouble sleeping, itching.

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), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Anagrelide (Agrylin)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, diazepam (Valium), lorazepam (Ativan), midazolam (Versed), 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 atovaquone (Mepron), azithromycin (Zithromax, Zmax), 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), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), protriptyline, trazodone, trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ribavirin (Copegus, Rebetol, Ribasphere, Virazole) and simeprevir (Olysio)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), and sotalol (Betapace, Sorine)
• Bladder control medicines such as darifenacin (Enablex), solifenacin (VESIcare), and tolterodine (Detrol)
• Bromocriptine (Cycloset, Parlodel)
• 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), nicardipine (Cardene), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), arsenic trioxide (Trisenox), 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), tamoxifen, temsirolimus (Torisel), topotecan (Hycamtin), toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Cisapride
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)
• Dapsone
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Diabetes medicines such as glipizide/metformin (Metaglip), glyburide (Glynase), linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), rosiglitazone/metformin (Avandamet), saxagliptin (Onglyza), sitagliptin (Januvia), and sitagliptin/metformin (Janumet)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Furosemide (Lasix)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tipranavir (Aptivus), and zidovudine (Retrovir)
• 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)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), lansoprazole (Prevacid), and omeprazole (Prilosec)
• Medicines to treat breathing or lung problems such as budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), 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), clopidogrel (Plavix), 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
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), and sumatriptan (Alsuma, Imitrex, Sumavel)
• Muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Naloxegol (Movantik)
• Natural remedies such as garlic, ginger, ginkgo biloba, red yeast rice, and St. John's wort
• Nausea medicines such as aprepitant (Emend), ondansetron (Zofran), and promethazine
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), 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 eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil), methamphetamine (Desoxyn), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Theophylline

Do not drink alcohol while you are taking this medicine. Talk with your healthcare provider about this.

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.