Technivie contains a comination of ombitasvir, paritaprevir, and ritonavir. Ombitasvir, paritaprevir, and ritonavir are antiviral medicines that prevent hepatitis C virus (HCV) from multiplying in your body.

Technivie is used to treat genotype 4 chronic hepatitis C in adults without cirrhosis or with a certain type of cirrhosis (compensated cirrhosis).

Technivie is given together with another drug called ribavirin.

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

Technivie is used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Technivie.

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 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.

If you've ever had hepatitis B, using Technivie can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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

Store 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.

Usual Adult Dose for Chronic Hepatitis C:

2 tablets orally once a day (in the morning)

Recommended Regimen and Duration of Therapy:
-Genotype 4, without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ombitasvir/paritaprevir/ritonavir plus ribavirin for 12 weeks
---Therapy-naive patients without cirrhosis who cannot take or tolerate ribavirin: May consider ombitasvir/paritaprevir/ritonavir for 12 weeks

Comments:
-The manufacturer product information should be consulted for ribavirin dosing recommendations; the manufacturer product information for ribavirin should be consulted regarding dose adjustments.

Use: In combination with ribavirin, for the treatment of patients with genotype 4 chronic HCV infection without cirrhosis or with compensated cirrhosis

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 ombitasvir, paritaprevir, and ritonavir 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 this medicine is safe for you, tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• heart disease;

• HIV (human immunodeficiency virus);

• a liver transplant; or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Technivie is used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

• If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

• If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Technivie with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breast-feed while using ombitasvir, paritaprevir, and ritonavir. Ask your doctor about any risk.

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

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Call your doctor at once if you have new or worsening symptoms such as:

• confusion;

• loss of appetite, upper stomach pain;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common Technivie side effects may include:

• nausea;

• headache, mood changes;

• muscle or joint pain;

• dizziness, feeling weak or tired;

• sleep problems (insomnia); or

• itching or other skin problems.

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.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ombitasvir, paritaprevir, and ritonavir, 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.