dasabuvir, ombitasvir, paritaprevir, and ritonavir

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Pronunciation: da SAB ue vir, om BIT as vir, PAR i TAP re vir, and rye TON a vir

Brand: Viekira Pak, Viekira XR

What is the most important information I should know about this medicine?

Do not use this medicine together with ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant.

Before you start taking Viekira, you must stop using certain birth control pills or hormone replacement medicines. Ask your doctor about using non-hormonal birth control to prevent pregnancy.

If you have ever had hepatitis B, Viekira can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

What is dasabuvir, ombitasvir, paritaprevir, and ritonavir (Viekira)?

Dasabuvir, ombitasvir, paritaprevir, and ritonavir are antiviral medicines that prevent hepatitis C virus (HCV) from multiplying in your body.

Dasabuvir, ombitasvir, paritaprevir, and ritonavir (Viekira) is a combination medicine 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.

Dasabuvir, ombitasvir, paritaprevir, and ritonavir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

You should not use Viekira if you are allergic to dasabuvir, ombitasvir, paritaprevir, or ritonavir, or if:

  • you have moderate to severe liver disease; or
  • you have ever had a severe skin rash after taking ritonavir (Norvir).

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:

  • alfuzosin;
  • colchicine;
  • dronedarone;
  • efavirenz (Atripla, Sustiva);
  • lurasidone;
  • pimozide;
  • ranolazine;
  • rifampin;
  • sildenafil (Revatio), when taken for pulmonary artery hypertension (PAH);
  • St. John's wort;
  • oral midazolam (Versed), or triazolam;
  • birth control pills or patches --Lo Loestrin FE, Norinyl, Ortho Tri-Cyclen Lo, Ortho Evra, and others;
  • hormone replacement therapy such as Fem HRT;
  • a vaginal ring such as NuvaRing;
  • cholesterol-lowering medicine --gemfibrozil, lovastatin, simvastatin (Zocor, Vytorin, Simcor);
  • ergot medicine --dihydroergotamine, ergotamine, methylergonovine; or
  • seizure medicine --carbamazepine, phenytoin, phenobarbital.

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.

To make sure Viekira is safe for you, tell your doctor if you have:

  • a history of hepatitis B;
  • liver problems other than hepatitis;
  • HIV (human immunodeficiency virus); or
  • if you have received a liver transplant.

Viekira is not expected to harm an unborn baby. Tell your doctor 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 this medicine on the baby.

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 this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take this medicine?

Viekira is usually taken for 12 to 24 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with food.

Viekira XR is an extended-release form of this combination medicine to be taken once daily. Viekira XR is supplied as 3 pale yellow tablets that are taken all at once with a daily meal.

The Viekira Pak contains two different types of tablets. The pink tablet contains only ombitasvir, paritaprevir, and ritonavir. The beige tablet contains only dasabuvir.

Take 2 pink tablets plus 1 beige tablet at the same time every morning. Take 1 beige tablet at the same time every evening.

The monthly Viekira XR or Viekira Pak carton contains enough tablets for you to take this medicine for 4 weeks (28 days in a row).

You will need frequent blood tests to check your liver function.

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. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Viekira suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Viekira can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

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.

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, 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 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.

What are the possible side effects of this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • 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 side effects may include:

  • nausea;
  • itching, skin rash or redness;
  • sleep problems (insomnia); or
  • feeling weak or tired.

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.

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. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • amlodipine (Norvasc, Amturnide, Azor, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta);
  • heart rhythm medicine;
  • medicine to treat HIV or AIDS;
  • antifungal medicine --ketoconazole, voriconazole;
  • asthma or allergy medicine --Flonase, Veramyst, Flovent, Advair, Arnuity Ellipta, Serevent Diskus, and others;
  • cholesterol medication --rosuvastatin (Crestor), pravastatin (Pravachol); or
  • 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.

Where can I get more information?

Your pharmacist can provide more information about dasabuvir, ombitasvir, paritaprevir, and ritonavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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