Ombitasvir, paritaprevir, ritonavir and dasabuvir (Oral)

Ombitasvir, paritaprevir, ritonavir, and dasabuvir 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 that your doctor checks 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 together 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 becomes pregnant. Avoid pregnancy during combination treatment with this medicine and ribavirin for 6 months after stopping treatment. If you get pregnant while using these medicines, tell your doctor right away.

Do not use the following medicines while you are using 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, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using Viekira Pak® with any of these medicines can cause very serious medical problems.

Check with your doctor right away if you feel weak or tired, have sudden 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 symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of using 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 clinician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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 Pak® 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 Pak® in the elderly.

Breast Feeding

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

Interactions with Drugs

Although certain drugs 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 physician may want to change the dose, or other precautions may be necessary. When you are using this medicine, it is especially important that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not advised. Your physician may decide not to treat you with this drug or change some of the other medicines 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 medicines are prescribed together, your physician 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 drugs may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• 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 drugs 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 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 recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how often you use this medication, 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 drug. Make sure you inform your clinician 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 severe—Should not be used in patients with this condition.

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

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

Less common

• Abdominal or stomach pain
• bloating of the abdomen or stomach
• dark urine
• light-colored stools
• nausea and vomiting
• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• itching
• joint or muscle pain
• 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
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you ways to prevent or lessen 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

• Itching skin or rash
• lack or loss of strength
• trouble sleeping

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

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

In the U.S.

• Viekira Pak

Available Dosage Forms:

• Tablet

To help clear up your infection completely, Viekira Pak® 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 Pak® 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.

Viekira Pak® contains 2 different types of tablets: the pink tablet (contains a fixed dose combination of ombitasvir, paritaprevir, ritonavir) and the beige tablet (contains dasabuvir). These tablets should be taken with or without ribavirin, as prescribed by your doctor.

Take this medicine with food.

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 (tablets):For chronic hepatitis C virus infection, with or without ribavirin: Adults—2 pink tablets once a day (taken in the morning) and 1 beige tablet two times a day (one tablet in the morning and one tablet in the evening). 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.

If it is less than 12 hours from the time your dose was scheduled, take the pink tablet as soon as you can. If you miss a dose and it is more than 12 hours from the time your dose was scheduled, skip the missed dose and take your next dose at the regular time.

If it is less than 6 hours from the time your dose was scheduled, take the beige tablet as soon as you can. If you miss a dose and it is more than 6 hours from the time your dose was scheduled, skip the missed dose and take your next dose at the regular time.

Do not take extra medicine to make up for a missed dose. Call your doctor if you have questions.

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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