Ombitasvir, paritaprevir, ritonavir and dasabuvir (oral route)

Brand Name

US Brand Name

Viekira Pak

Description

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.

This product is available in the following dosage forms:

Tablet

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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 Pak® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Viekira Pak® in the elderly.

Breastfeeding

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 before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines 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 taking this medicine, it is especially important 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 recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfuzosin
Alprazolam
Amiodarone
Apalutamide
Astemizole
Atorvastatin
Bepridil
Carbamazepine
Cisapride
Colchicine
Conivaptan
Crizotinib
Dihydroergotamine
Dronedarone
Efavirenz
Elagolix
Elbasvir
Eletriptan
Eliglustat
Encainide
Enzalutamide
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Estetrol
Ethinyl Estradiol
Etonogestrel
Etravirine
Everolimus
Finerenone
Flecainide
Flibanserin
Fluconazole
Fosphenytoin
Gemfibrozil
Gepirone
Grazoprevir
Isavuconazonium Sulfate
Ivabradine

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

Abametapir
Acalabrutinib
Adagrasib
Ado-Trastuzumab Emtansine
Afatinib
Alfentanil
Alpelisib
Alprazolam
Amiodarone
Amisulpride
Amlodipine
Amphetamine
Amprenavir
Anagrelide
Apixaban
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asciminib
Atazanavir
Atidarsagene Autotemcel
Atogepant
Atovaquone
Avacopan
Avanafil
Avapritinib
Axitinib
Bedaquiline
Benzhydrocodone
Benzphetamine
Bepridil
Betamethasone
Betrixaban
Bictegravir
Boceprevir
Bosentan
Bosutinib

Using this medicine with any of the following medicines may cause an increased risk 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 often you use one or both of the medicines.

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

Other Interactions

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 medicines 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 medicine with any of the following is usually not recommended, 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

Proper Use

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure 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 it when his sexual partner becomes pregnant. Avoid pregnancy during combination treatment with this medicine and ribavirin for 6 months of stopping treatment. If a pregnancy occurs while you are 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®), medicine 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 are weak or tired, have onset of confusion, have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow 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.

Side Effects

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:

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 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

Itching skin or rash
lack or loss of strength
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.

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