ombitasvir, paritaprevir, and ritonavir

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Pronunciation: om BIT as vir, PAR i TA pre vir, and ri TOE na vir

Brand: Technivie

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 Technivie, 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, Technivie can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

What is ombitasvir, paritaprevir, and ritonavir (Technivie)?

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

Ombitasvir, paritaprevir, and ritonavir (Technivie) is a combination medicine used to treat genotype 4 chronic hepatitis C in adults without cirrhosis or with a certain type of cirrhosis (compensated cirrhosis). This medicine is sometimes given together with another drug called ribavirin.

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 Technivie if you are allergic to ombitasvir, paritaprevir, or ritonavir, or if you have:

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

If you take Technivie 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 Technivie 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:

  • alfuzosin;
  • colchicine;
  • dronedarone;
  • efavirenz;
  • ranolazine;
  • rifampin;
  • sildenafil (Revatio), when taken for pulmonary artery hypertension (PAH);
  • St. John's wort;
  • oral midazolam (Versed), or triazolam;
  • antipsychotic medicine --lurasidone, pimozide;
  • 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, ergonovine, methylergonovine; or
  • seizure medicine --carbamazepine, phenytoin, phenobarbital.

Before you start taking Technivie, 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 Technivie and for 2 weeks after your treatment ends.

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

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

If you take Technivie with ribavirin: Avoid getting pregnant during treatment and for at least 6 months after you stop taking these medicines together. Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking ribavirin.

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

Technivie is not approved for use by anyone younger than 18 years old.

How should I take this medicine?

Before you start treatment, your doctor may perform tests to make sure you do not have conditions that would prevent you from safely using this medicine.

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

The monthly Technivie carton contains enough tablets for you to take this medicine for 4 weeks (28 days in a row). Each of the 4 weekly cartons contains 7 daily dose packs.

Take 2 tablets at the same time every morning with food.

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 this medicine suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Technivie 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 Technivie 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?

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.

Do not take extra medicine to make up the 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 Technivie 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 --upper stomach pain or swelling, confusion, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea;
  • headache, mood changes;
  • muscle or joint pain;
  • dizziness, feeling weak or tired;
  • sleep problems (insomnia); or
  • itching.

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 Technivie, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with Technivie. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Technivie, especially:

  • metformin;
  • quetiapine;
  • heart or blood pressure medicine;
  • medicine to treat HIV or AIDS;
  • narcotic pain medicine;
  • antifungal medicine --ketoconazole, voriconazole;
  • asthma or allergy medicine --including Flonase, Veramyst, Flovent, Advair, Arnuity Ellipta, Serevent Diskus, and others; or
  • medicine to prevent organ transplant rejection --cyclosporine, tacrolimus.

Many drugs can interact with Technivie, 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 Technivie. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about 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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