Technivie (ombitasvir, paritaprevir and ritonavir)

Technivie is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic hepatitis C virus (HCV) infection. It is effective for those without cirrhosis or with compensated cirrhosis. If you have advanced cirrhosis, do not take Technivie without consulting your healthcare provider. Each Technivie tablet contains ombitasvir, paritaprevir, and ritonavir. Technivie’s safety and effectiveness in children under 18 years of age have not been established.

What are the side effects of Technivie (ombitasvir, paritaprevir and ritonavir)?

WARNING

• Hepatitis B virus reactivation: Before starting treatment, your healthcare provider will test for hepatitis B virus infection. Reactivation of the virus may lead to serious liver problems. Close monitoring is done for those at risk during and after treatment.
• Severe liver problems: Especially in individuals with certain types of cirrhosis, Technivie may cause severe liver problems that could lead to liver failure or death. Regular liver checks are necessary for those with cirrhosis.
• Increases in liver function blood tests: Particularly when using ethinyl estradiol-containing medicines.
• Stop using ethinyl estradiol-containing medicines before starting Technivie. Use alternative birth control during treatment and for two weeks after treatment completion. Your healthcare provider will advise when ethinyl estradiol-containing medicines can be resumed.

Contact your healthcare provider immediately if you experience or if your symptoms worsen during Technivie treatment:

• tiredness
• weakness
• loss of appetite
• nausea and vomiting
• yellowing of your skin or eyes
• color changes in your stools
• confusion
• swelling of the stomach area

Common side effects of Technivie when used with ribavirin include feeling weak, tiredness, headache, change in mood, itching, nausea, sleep problems, trouble breathing, muscle or joint pain, skin reactions, and dizziness. This list does not include all possible side effects. Consult your doctor for medical advice. Report side effects to the FDA at 1-800-FDA-1088.

What is the dosage for Technivie (ombitasvir, paritaprevir and ritonavir)?

Take two Technivie tablets orally once daily with a meal, regardless of fat or calorie content. Technivie is used in combination with ribavirin. The recommended dosage of ribavirin is based on body weight: 1000 mg per day for individuals weighing less than 75 kg and 1200 mg per day for those weighing at least 75 kg, with divided doses administered daily alongside food.

Technivie is contraindicated in patients with moderate to severe hepatic impairment (Child Pugh B and C).

What drugs interact with Technivie (ombitasvir, paritaprevir and ritonavir)?

Avoid taking Technivie if you:

• have moderate or severe liver problems
• take any of the following medicines: alfuzosin hydrochloride, atorvastatin, carbamazepine, cisapride, colchicine in people with certain kidney or liver problems, dronedarone, efavirenz, ergot-containing medicines (ergotamine, dihydroergotamine, methylergonovine), combination birth control pills or transdermal systems, hormonal vaginal rings, or hormone replacement therapy.

Is Technivie (ombitasvir, paritaprevir and ritonavir) safe to use while pregnant or breastfeeding?

Pregnancy

If Technivie is administered with ribavirin, it is contraindicated in pregnant women and in men whose female partners are pregnant. Animal studies show no adverse developmental effects, but there is insufficient human data. The background risk of major birth defects and miscarriage in the indicated population is unknown.

Breastfeeding

The presence of Technivie and its metabolites in human breast milk, its effects on milk production, and its impact on breastfed infants are unknown. Studies on lactating rats did not show any effects on nursing pups. The benefits of breastfeeding should be considered alongside the mother’s need for Technivie and any potential adverse effects on the breastfed child.

What else should I know about Technivie (ombitasvir, paritaprevir, and ritonavir)?

How does Technivie work?

Technivie combines two direct-acting antiviral agents against hepatitis C virus. Ritonavir enhances the effects of paritaprevir by inhibiting CYP3A. Ritonavir itself is not active against HCV.

How is Technivie supplied?

Technivie is supplied in a monthly carton for a 28-day therapy duration. Each monthly carton contains four weekly cartons, and each weekly carton contains seven daily dose packs. Each child-resistant daily dose pack contains two pink-colored, film-coated, oblong, biconvex-shaped Technivie tablets debossed with "AV1." Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir, and 50 mg ritonavir. Store Technivie at or below 30°C (86°F).

Summary

Technivie is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.