Viekira Pak is a multipill, antiviral containing a combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir. These four drugs are antiviral medicines that prevent hepatitis C virus (HCV) cells from multiplying in your body.
Viekira Pak is used to treat genotype 1 chronic hepatitis C in adults, including people with a certain type of cirrhosis. This medicine is sometimes given together with another drug called ribavirin.
Viekira Pak may also be used for purposes not listed in this medication guide.
Important information
Do not use Viekira Pak together with ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.
Before taking this medicine
You should not use Viekira if you are allergic to dasabuvir, ombitasvir, paritaprevir, or ritonavir, or:
If you take Viekira with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.
Some medicines can interact with Viekira and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:
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alfuzosin;
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efavirenz;
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pimozide;
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rifampin;
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sildenafil (Revatio), when taken for pulmonary artery hypertension (PAH);
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St. John"s wort;
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oral midazolam (Versed), or triazolam;
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birth control pills or patches - Lo Loestrin FE, Norinyl, Ortho Tri-Cyclen Lo, Ortho Evra, and others;
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hormone replacement therapy such as Fem HRT;
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a vaginal ring such as NuvaRing;
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cholesterol-lowering medicine - gemfibrozil, lovastatin, simvastatin (Zocor, Vytorin, Simcor);
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ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine; or
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seizure medicine - carbamazepine, phenytoin, phenobarbital.
To make sure Viekira is safe for you, tell your doctor if you have:
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liver problems other than hepatitis C;
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HIV (human immunodeficiency virus); or
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if you have received a liver transplant.
Before you start taking Viekira, you must stop using medicine that contains ethinyl estradiol. This includes certain birth control pills or hormone replacement medicines. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Viekira and for 2 weeks after your treatment ends.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of dasabuvir, ombitasvir, paritaprevir, and ritonavir on the baby.
Viekira Pak is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
However, if you also take ribavirin, you may need to have a negative pregnancy test before your treatment starts. Ribavirin is known to cause birth defects or death in an unborn baby.
While you are taking Viekira with ribavirin: Use birth control to prevent pregnancy whether you are a man or a woman. Ribavirin use by either parent may cause birth defects. Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.
It is not known whether dasabuvir, ombitasvir, paritaprevir, and ritonavir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Viekira Pak is not approved for use by anyone younger than 18 years old.
How should I take this medicine?
Viekira Pak is usually taken for 12 to 24 weeks, depending on your condition. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
The Viekira Pak contains two different types of tablets. The pink tablet contains ombitasvir, paritaprevir, and ritonavir. The beige tablet contains only dasabuvir.
The monthly Viekira Pak carton contains enough tablets for you to take this medicine for 4 weeks (28 days in a row). Each of the 4 weekly cartons in the Viekira Pak contains 7 daily dose packs.
Take this medicine with food as follows:
You will need frequent blood tests to check your liver function while using Viekira Pak.
Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Do not stop using any of your hepatitis C medicines without your doctor"s advice. Do not change your doses or medication schedule without first asking your doctor. Every person with chronic hepatitis C should remain under the care of a doctor.
Store the Viekira Pak at room temperature away from moisture and heat. Do not remove the tablets from a daily dose package until you are ready to take the medicine.
Viekira Pak dosing information
Usual Adult Dose of Viekira Pak, for Chronic Hepatitis C:
Dasabuvir: 250 mg (1 tablet) orally twice a day (morning and evening)
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Ombitasvir/paritaprevir/ritonavir fixed-dose combination tablet: 2 tablets orally once a day (in the morning)
Recommended Regimen and Duration of Therapy:
Therapy-naive or interferon-experienced patients, including those with HCV/HIV-1 coinfection:
-Genotype 1a, without cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 12 weeks
-Genotype 1a, with cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 24 weeks (12 weeks may be considered for some patients based on prior treatment history)
-Genotype 1b, without cirrhosis: Dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks
-Genotype 1b, with cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 12 weeks
Liver transplant recipients with normal liver function and mild fibrosis (Metavir fibrosis score 2 or lower): Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 24 weeks, regardless of HCV genotype 1 subtype
Comments:
-The dosing recommendations for genotype 1a should be followed for patients with unknown genotype 1 subtype or with mixed genotype 1 infection.
-The manufacturer product information should be consulted for ribavirin dosing recommendations (if applicable), regarding dosing of concomitant HIV-1 antiviral drugs in HCV/HIV-1 coinfected patients, and regarding use with calcineurin inhibitors in liver transplant recipients.
Use: With or without ribavirin, for the treatment of patients with genotype 1 chronic HCV infection including those with compensated cirrhosis
What happens if I miss a dose?
If you miss a dose of the pink tablets, take the missed dose with a meal as soon as you remember. If you are more than 12 hours late in taking your medicine, skip the missed dose and take your next dose at the usual time with a meal.
If you forget to take the beige tablet, take it with a meal as soon as you remember. If you are more than 6 hours late in taking the beige tablet, skip the missed dose and take your next dose at the usual time with a meal.
Do not take extra medicine to make up a missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking this medicine?
Taking Viekira Pak will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Viekira Pak side effects
Get emergency medical help if you have signs of an allergic reaction to Viekira Pak: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Viekira Pak side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect this medicine?
When you start or stop taking Viekira, your doctor may need to adjust the doses of any other medicines you take on a regular basis.
Many drugs can interact with Viekira. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Viekira Pak, especially:
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amlodipine (Norvasc, Amturnide, Azor, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta);
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heart rhythm medicine;
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medicine to treat HIV or AIDS;
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antifungal medicine - ketoconazole, voriconazole;
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asthma or allergy medicine - including Flonase, Veramyst, Flovent, Advair, Arnuity Ellipta, Serevent Diskus, and others;
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cholesterol medication - rosuvastatin (Crestor), pravastatin (Pravachol); or
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medicine to prevent organ transplant rejection - cyclosporine, tacrolimus.
Many drugs can interact with Viekira, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Viekira Pak. Give a list of all your medicines to any healthcare provider who treats you.
