Viekira XR (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 during regular visits to ensure this medicine is working properly. Blood tests may be required to monitor for unwanted effects.

Using this medicine along with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using them when his sexual partner is pregnant. Avoid getting pregnant 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 for 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 lead to very serious medical issues.

Contact your doctor immediately if you feel weak or tired, experience confusion, have 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 problem.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Additionally 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 risk when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this drug while breastfeeding.

Interactions with Medicines

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

Using this drug with any of the following drugs is not advised. Your physician may decide not to treat you with this medicine 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 medicines is normally not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how often 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 risk of certain adverse effects, but using both drugs may be the best treatment for you. If both drugs are prescribed together, your physician 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 medications 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 medicines may additionally 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 typically not recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately 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. Also, your health care professional may 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 or 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.

• What are the new drugs for the treatment of hepatitis C?
• What's the difference between Viekira Pak and Viekira XR?