Viekira Pak

Viekira Pak is a prescription medication used to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Viekira Pak contains three antiviral agents - ombitasvir, paritaprevir, and dasabuvir - that work together to inhibit the growth of HCV. It also contains ritonavir, which is used to increase blood levels of paritaprevir. The Viekira Pak contains combination tablets containing ombitasvir, paritaprevir, and ritonavir, and single-ingredient tablets containing dasabuvir.

The usual dosage of the Viekira Pak is 2 combination tablets containing ombitasvir, paritaprevir, and ritonavir once daily in the morning, and 1 dasabuvir tablet twice daily in the morning and evening. Take Viekira Pak with a meal. Viekira Pak may be administered with ribavirin.

Common side effects of Viekira Pak include feeling tired, itching, feeling weak or lacking energy, nausea, and trouble sleeping.

Viekira Pak is used to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• AbbVie Inc.

Serious side effects have been reported with Viekira Pak. See the “Viekira Pak Precautions” section.

Common side effects of Viekira Pak include:

• feeling tired
• itching
• feeling weak or lacking energy
• nausea
• trouble sleeping

This is not a complete list of Viekira Pak side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antiarrhythmics, including amiodarone (Cordarone, Pacerone)bepridil (Vascor), disopyramide (Norpace), flecainide (Tambocor), systemic lidocaine (Xylocaine), mexiletine (Mexitil), propafenone (Rythmol), and quinidine
• Antifungals, including ketoconazole (Nizoral) and voriconazole (Vfend)
• Calcium channel blockers, including amlodipine (Norvasc)
• Corticosteroids, including fluticasone (Flonase, Veramyst)
• Diuretics, including furosemide (Lasix)
• Antiviral agents, including atazanavir (Reyataz, in Evotaz), darunavir (Prezista, in Prezcobix), lopinavir (Aluvia, in Kaletra), and rilpivirine (Edurant, in Complera)
• Cholesterol-reducing medications, including rosuvastatin (Crestor) and pravastatin (Pravachol)
• Immunosuppressants, including cyclosporine (Sandimmune, Neoral, Restasis, Gengraf) and tacrolimus (Protopic, Hecoria, Prograf)
• Salmeterol (Serevent)
• Buprenorphine/naloxone (Suboxone)
• Omeprazole (Prilosec)
• Alprazolam (Xanax)
• Ethinyl estradiol (in combined oral contraceptives, contraceptive vaginal rings, and contraceptive patches) 
• Warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of Viekira Pak drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Viekira Pak including the following:

• Changes in liver function (especially if you use ethinyl estradiol-containing medicines (such as some birth control products). Tell your healthcare provider right away if you have some or all of the following symptoms of changes in liver function:
  • fatigue
  • lack or appetite
  • weakness
  • vomiting
  • nausea
  • yellowing of the skin or eyes (jaundice)
  • discolored feces

You must stop using ethinyl estradiol-containing medicines before you start taking Viekira Pak. If you use these medicines as a method of birth control, it is recommended you use another method of birth control during treatment with Viekira Pak, and for about 2 weeks after you finish your treatment with Viekira Pak. Your healthcare provider will tell you when you may begin taking ethinyl estradiol-containing medicines.

Your healthcare provider should do blood tests to check your liver function during the first 4 weeks and then as needed, during treatment with Viekira Pak.

• Viekira Pak can cause serious liver injury mostly in patients with underlying advanced liver disease. Tell your healthcare provider right away if you develop:
  • fatigue
  • weakness 
  • loss of appetite
  • nausea and vomiting
  • yellow eyes or skin
  • light-colored stools

Do not take Viekira Pak if you:

• are allergic to any of the medications or ingredients in Viekira Pak
• have severe liver dysfunction
• have had a severe reaction to ritonavir
• are taking drugs that are metabolized by or affect the activity of certain liver enzymes

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Viekira Pak, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Viekira Pak, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any of the medications or ingredients in Viekira Pak
• if you have a history of hepatitis B infection
• have HIV infection
• have liver problems
• have had a liver transplant
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Viekira Pak falls into category B. There are no well-done studies that have been done in humans with Viekira Pak. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vikekira Pak crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Viekira Pak.

Take Viekira Pak exactly as prescribed.

The Viekira Pak contains combination tablets containing ombitasvir, paritaprevir, and ritonavir, and single-ingredient tablets containing dasabuvir. Take Viekira Pak with a meal. Viekira Pak may be administered with ribavirin.

If you miss a dose of the combination tablets containing ombitasvir, paritaprevir, and ritonavir, you may take the missed dose within 12 hours. If you miss a dose of the dasabuvir tablets, you may take the missed dose within 6 hours. If more than the allotted time has passed, do not take the missed dose. Take the next dose at the usual time. Do not take 2 doses of Viekira Pak at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have

The recommended dosing of Viekira Pak is 2 ombitasvir/paritaprevir/ritonavir 12.5 mg/75 mg/50 mg tablets once daily in the morning and 1 dasabuvir 250 mg tablet twice daily in the morning and evening.

If you take too much Viekira Pak, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Viekira Pak is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Viekira Pak below 86°F (30°C).
• Keep this and all medications out of the reach of children.

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C