Ombitasvir, paritaprevir, and ritonavir (Oral)

Ombitasvir, paritaprevir, and ritonavir combination is used along with ribavirin to treat chronic hepatitis C infection without 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 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 partner becomes pregnant. Avoid pregnancy during treatment and for 6 months after stopping treatment with Technivie™ and ribavirin. If you become 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®), 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 (e.g., carbamazepine, phenobarbital, phenytoin, Tegretol®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using Technivie™ with any of these medicines can cause very serious medical problems.

Check with your doctor right away 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 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 medication, the risks of taking the drug must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medications. 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 Technivie™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Technivie™ have not been performed in the geriatric population, geriatric-specific issues are not expected to limit the usefulness of Technivie™ 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 risks before using this medicine while breastfeeding.

Interactions with Medicines

Although certain medications 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 using this medicine, it is especially critical that your healthcare professional know if you are taking 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 medicine with any of the following medicines is not advised. Your doctor may decide not to treat you with this drug or change some of the other medications you take.

• 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
• Everolimus
• Finerenone
• Flecainide
• Flibanserin
• Fluconazole
• Fosphenytoin
• Gepirone
• Grazoprevir
• Isavuconazonium Sulfate
• Ivabradine
• Ivacaftor
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Methylergonovine
• Methysergide
• Midazolam
• Mitotane
• Naloxegol
• Nelfinavir
• 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 drug with any of the following medicines is usually not advised, 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
• 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
• 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
• 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
• 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
• 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
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Temsirolimus
• Tenofovir Alafenamide
• 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 medicine with any of the following drugs may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your doctor 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 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 drugs may also 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 medicine, 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 doctor if you have any other medical problems, especially:

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

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

Along with its needed effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, you may need medical attention.

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

Less common

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• dizziness
• fever
• headache
• itching or rash
• loss of appetite
• nausea
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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, or scaly skin
• increased sensitivity of the skin to sunlight
• lack or loss of strength
• redness or other discoloration of the skin
• severe sunburn
• skin rash, encrusted, scaly, and oozing
• 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.

• Technivie

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Hepatitis C Virus NS5A Inhibitor

To help clear up your infection completely, take Technivie™ 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, Technivie™ 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.

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 without cirrhosis, with ribavirin: Adults—2 tablets once a day (taken in the morning) for 12 weeks. 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 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.

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 are the ingredient drugs in Technivie?