Dasabuvir, ombitasvir, paritaprevir, and ritonavir (Oral)

Dasabuvir, ombitasvir, paritaprevir, and ritonavir combination is used with or without ribavirin to treat chronic hepatitis C infection, including patients with compensated cirrhosis.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine along with ribavirin while you are pregnant can harm your unborn baby. These medicines may also lead to birth defects if the father is using them when his partner is pregnant. Avoid pregnancy during treatment with this medicine and ribavirin and for 6 months after stopping treatment. If you become pregnant while using these medicines, inform your doctor immediately.

Do not use the following medicines while taking this medicine: alfuzosin (Uroxatral®), apalutamide (Erleada™), cisapride (Propulsid®), colchicine (Colcrys®), dronedarone (Multaq®), efavirenz (Sustiva®), ethinyl estradiol (Norinyl®, Ortho Evra®), everolimus (Afinitor®), gemfibrozil (Lopid®), lomitapide (Juxtapid®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), sirolimus (Rapamune®), St. John's wort, tacrolimus (Prograf®), triazolam (Halcion®), certain medicines to lower cholesterol (such as atorvastatin, lovastatin, simvastatin, Mevacor®, Zocor®), medicines to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Tegretol®), or ergot medicines (such as dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using Viekira XR™ with any of these medicines can cause very serious medical problems.

Contact your doctor immediately if you feel weak or tired, have confusion, experience pain or tenderness in the upper stomach, have pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines as well as herbal or vitamin supplements.

In deciding to use a medication, the risks of using the medication must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Viekira XR™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of Viekira XR™ in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to using this drug while breastfeeding.

Interactions with Drugs

Although certain drugs should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially critical that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medications is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medications you take.

• Abiraterone Acetate
• Alfuzosin
• Amiodarone
• Apalutamide
• Astemizole
• Atorvastatin
• Bepridil
• Carbamazepine
• Cisapride
• Colchicine
• Conivaptan
• Crizotinib
• Dihydroergotamine
• Dronedarone
• Efavirenz
• Elbasvir
• Eletriptan
• Eliglustat
• Encainide
• Enzalutamide
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Estetrol
• Ethinyl Estradiol
• Etravirine
• Everolimus
• Finerenone
• Flecainide
• Flibanserin
• Fluconazole
• Fosphenytoin
• Gemfibrozil
• Gepirone
• Grazoprevir
• Isavuconazonium Sulfate
• Ivabradine
• Ivacaftor
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Methylergonovine
• Methysergide
• Midazolam
• Mitotane
• Naloxegol
• Nelfinavir
• Nevirapine
• Nimodipine
• Pacritinib
• Phenobarbital
• Phenytoin
• Pimozide
• Piperaquine
• Primidone
• Propafenone
• Quinidine
• Ranolazine
• Rifampin
• Rifapentine
• Riociguat
• Romidepsin
• Sildenafil
• Silodosin
• Simvastatin
• Sirolimus
• Sparfloxacin
• St John's Wort
• Tacrolimus
• Terfenadine
• Thioridazine
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin
• Voriconazole
• Ziprasidone

Using this medicine with any of the following medications is usually not recommended, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Alfentanil
• Alprazolam
• Amiodarone
• Amisulpride
• Amlodipine
• Amphetamine
• Amprenavir
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Atazanavir
• Atogepant
• Atovaquone
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Bedaquiline
• Benzhydrocodone
• Benzphetamine
• Bepridil
• Berotralstat
• Betamethasone
• Betrixaban
• Boceprevir
• Bosentan
• Bosutinib
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Cabazitaxel
• Cabotegravir
• Cabozantinib
• Calcifediol
• Cariprazine
• Ceritinib
• Chloroquine
• Ciclesonide
• Cilostazol
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Conivaptan
• Copanlisib
• Cyclophosphamide
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darunavir
• Dasatinib
• Deferasirox
• Deflazacort
• Degarelix
• Delamanid
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dienogest
• Digoxin
• Dihydrocodeine
• Disopyramide
• Docetaxel
• Dofetilide
• Dolutegravir
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Duvelisib
• Elacestrant
• Elagolix
• Elexacaftor
• Eluxadoline
• Encorafenib
• Entrectinib
• Erlotinib
• Erythromycin
• Escitalopram
• Estradiol
• Eszopiclone
• Ethynodiol
• Etonogestrel
• Etrasimod
• Etravirine
• Fedratinib
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluticasone
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Furosemide
• Fusidic Acid
• Futibatinib
• Garlic
• Gestodene
• Gilteritinib
• Glasdegib
• Glecaprevir
• Gonadorelin
• Goserelin
• Hemin
• Histrelin
• Hydrocodone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Ifosfamide
• Iloperidone
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Itraconazole
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lacosamide
• Lapatinib
• Larotrectinib
• Lefamulin
• Leflunomide
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levonorgestrel
• Lidocaine
• Lisdexamfetamine
• Lofexidine
• Lopinavir
• Lorlatinib
• Lumateperone
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Mavacamten
• Medroxyprogesterone
• Mestranol
• Metformin
• Methadone
• Methamphetamine
• Methotrexate
• Methylenedioxymethamphetamine
• Methylprednisolone
• Metronidazole
• Mexiletine
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mobocertinib
• Mometasone
• Montelukast
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Olaparib
• Omaveloxolone
• Omeprazole
• Ondansetron
• Orlistat
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Palovarotene
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Pibrentasvir
• Pimavanserin
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Ponatinib
• Ponesimod
• Posaconazole
• Pralsetinib
• Pravastatin
• Prednisone
• Propafenone
• Quercetin
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Reboxetine
• Regorafenib
• Relugolix
• Retapamulin
• Ribociclib
• Rifabutin
• Rilpivirine
• Rimegepant
• Ritlecitinib
• Rivaroxaban
• Rosuvastatin
• Ruxolitinib
• Salmeterol
• Segesterone
• Selpercatinib
• Selumetinib
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sirolimus Protein-Bound
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Temsirolimus
• Tenofovir Alafenamide
• Teriflunomide
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tocilizumab
• Topotecan
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Triamcinolone
• Triclabendazole
• Triptorelin
• Upadacitinib
• Valbenazine
• Valproic Acid
• Vamorolone
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Vortioxetine
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuclopenthixol
• Zuranolone

Using this medication with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Acenocoumarol
• Amitriptyline
• Amprenavir
• Cerivastatin
• Clonazepam
• Dalfopristin
• Delavirdine
• Desipramine
• Didanosine
• Dutasteride
• Fosamprenavir
• Imipramine
• Indinavir
• Lamotrigine
• Levothyroxine
• Meperidine
• Mexiletine
• Nefazodone
• Prasugrel
• Quinupristin
• Risperidone
• Tenofovir Disoproxil Fumarate
• Theophylline
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Hepatitis B, history of—Use with caution. May cause this condition to become active again.

• HIV infection—Use with caution. May make this condition worse.

• Liver disease, moderate to serious—Should not be used in patients with this condition.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cough
• dark-colored urine
• diarrhea
• general feeling of tiredness or weakness
• headache
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nausea
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain, continuing
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• hives or welts, or skin rash
• increased sensitivity of the skin to sunlight
• lack or loss of strength
• redness or other discoloration of the skin
• severe sunburn
• swelling
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Viekira XR

Pharmacologic Class: Hepatitis C Virus NS5A Inhibitor

To help clear up your infection completely, Viekira XR™ may or may not be taken together with ribavirin, for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, Viekira XR™ must be used on a regular schedule.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet whole. Do not crush, break, or chew it. Take this medicine with food.

Do not drink alcohol within 4 hours of taking Viekira XR™.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):For chronic hepatitis C virus infection, with or without ribavirin: Adults—3 tablets taken once a day. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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