Viekira XR

Viekira XR 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 XR 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 usual dosage of Viekira XR is 3 tablets by mouth once daily, with a meal.

Swallow tablets whole. Do not split, crush, or chew tablets.

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

Viekira XR 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.

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

Common side effects of Viekira XR include:

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

This is not a complete list of Viekira XR 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:

• alfuzosin hydrochloride (Uroxatral)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, TEGRETOL-XR)
• colchicine (Colcrys) in patients who have certain kidney or liver problems
• dronedarone (Multaq)
• efavirenz (Atripla, Sustiva)
• medications to help prevent organ rejection such as tacrolimus (Prograf), cyclosporine (Gengraf, Neoral, Sandimmune)
• ergot containing medicines including:
  • ergotamine tartrate (Cafergot, Ergomar, Ergostat, Medihaler, Migergot, Wigraine, Wigrettes)
  • dihydroergotamine mesylate (D.H.E. 45, Migranal)
  • methylergonovine (Ergotrate, Methergine)
• ethinyl estradiol-containing medicines:
  • combination birth control pills or patches, such as Lo Loestrin FE, Norinyl, Ortho Tri-Cyclen Lo, Ortho Evra
  • hormonal vaginal rings such as NuvaRing
  • the hormone replacement therapy medicine, Fem HRT
• cisapride
• gemfibrozil (Lopid)
• statins such as lovastatin (Advicor, Altoprev, Mevacor) and simvastatin (Vytorin)
• lurasidone (Latuda)
• midazolam, when taken by mouth
• phenytoin (Dilantin, Phenytek)
• phenobarbital (Luminal)
• pimozide (Orap)
• ranolazine (Ranexa)
• rifampin
• sildenafil citrate
• St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
• Triazolam (Halcion)
• 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 XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Viekira XR 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. Your doctor will order blood tests to check your liver function during the first 4 weeks and then as needed, during treatment with this medication. 
  • 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 XR. 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 XR, and for about 2 weeks after you finish your treatment with Viekira XR. 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 XR.

• Viekira XR 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 XR 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 XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Viekira XR, 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 XR
• if you have a history of hepatitis B infection
• have had a severe skin rash after taking ritonavir (Norvir)
• have HIV infection
• have liver problems other than hepatitis C infection
• have had a liver transplant
• drink alcohol
• can not swallow pills
• 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.

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

It is not known if this medication will harm your unborn baby. When taking this medication in combination with ribavirin you should also read the medication information for ribavirin for important pregnancy information.

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

It is not known if Vikekira XR 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 XR.

Take Viekira XR exactly as prescribed.

Viekira XR contains ombitasvir, paritaprevir, and ritonavir, and dasabuvir.

Viekira XR may be administered with ribavirin.

This medication is available as an extended-release tablet and is taken once a day, with a meal. 

Swallow Viekira XR tablets whole. Do not split, crush, or chew the tablets.

Do not drink alcohol within 4 hours of taking Viekira XR.

• Do not change your dose.
• Do not stop taking VIEKIRA XR without first talking with your healthcare provider.

It is important that you do not miss or skip doses of Viekira XR during treatment.

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

Viekira XR is a 4-drug fixed-dose combination, extended-release tablet containing 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir.

The recommended dosage of Viekira XR is three tablets taken orally once daily with a meal. 

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

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

• Store Viekira XR 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.