Technivie (ombitasvir, paritaprevir & ritonavir) for Hepatitis C

What is Technivie (ombitasvir, paritaprevir and ritonavir), and what is it used for?

Technivie is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C virus (HCV) infection without cirrhosis or with a certain type of cirrhosis (compensated). You should also read the Medication Guide for ribavirin. Technivie can be used in people who have compensated cirrhosis. Technivie is not for people with advanced cirrhosis (decompensated). If you have cirrhosis, talk to your healthcare provider before taking Technivie. Each Technivie tablet contains the medicines ombitasvir, paritaprevir and ritonavir. It is not known if Technivie is safe and effective in children under 18 years of age.

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

WARNING

Hepatitis B virus reactivation: Before starting treatment with Technivie, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for hepatitis C virus with Technivie. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Technivie.
Severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death. If you have cirrhosis, your healthcare provider will check your liver before and during treatment with Technivie.
Increases in your liver function blood tests, especially if you use ethinyl estradiol-containing medicines (contained in certain birth control products).
You must stop using ethinyl estradiol-containing medicines before you start treatment with Technivie. See the section “Do not take Technivie if you” for a list of these medicines.
- If you use these medicines as a method of birth control, you must use another method of birth control during treatment with Technivie, and for about 2 weeks after you finish treatment with Technivie. Your healthcare provider will tell you when you may begin taking ethinyl estradiolcontaining 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 Technivie.
Your healthcare provider may tell you to stop taking Technivie if you develop signs or symptoms of liver problems.

Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with Technivie:

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
dizziness

These are not all the possible side effects of Technivie. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Technivie is ombitasvir, paritaprevir and ritonavir fixed dose combination tablets. The recommended dosage of Technivie is two tablets taken orally once daily (in the morning). Take Technivie with a meal without regard to fat or calorie content. Technivie is used in combination with ribavirin (RBV). When administered with Technivie, the recommended dosage of RBV is based on weight: 1000 mg per day for subjects less than 75 kg and 1200 mg per day for those weighing at least 75 kg, divided and administered twice-daily with 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)?

Do not take Technivie if you:

have moderate or severe liver problems
take any of the following medicines:
- alfuzosin hydrochloride
- atorvastatin
- carbamazepine
- cisapride
- colchicine in people who have certain kidney or liver problems
- dronedarone
- efavirenz
- ergot containing medicines including:
  - ergotamine
  - dihydroergotamine
  - methylergonovine
- ethinyl estradiol-containing medicines:
  - combination birth control pills or transdermal systems
  - hormonal vaginal rings
  - the hormone replacement therapy
- everolimus
- lovastatin
- lurasidone
- midazolam, when taken by mouth
- phenytoin
- phenobarbital
- pimozide
- ranolazine
- rifampin
- sildenafil citrate when taken for pulmonary artery hypertension (PAH)
- simvastatin
- sirolimus
- St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
- tacrolimus
- triazolam
have had a severe skin rash after taking ritonavir

QUESTION

Hepatitis C virus causes an infection of the ______________.
See Answer

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

Pregnancy

If Technivie is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on use in pregnancy. No adequate human data are available to establish whether or not Technivie poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of Technivie were administered separately during organogenesis and lactation.

During organogenesis, the exposures were up to 29 and 4 times (mice and rabbits, respectively; ombitasvir), 143 and 12 times (mice and rats, respectively; paritaprevir, ritonavir) exposures at the recommended clinical dose of Technivie. In rodent pre/postnatal developmental studies, maternal systemic exposures (AUC) to ombitasvir and paritaprevir were approximately 26 and 24 times, respectively, the exposure in humans at the recommended clinical dose.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Breastfeeding

It is not known whether Technivie and its metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant. Unchanged ombitasvir, paritaprevir and its hydrolysis product M13 were the predominant components observed in the milk of lactating rats, without effect on nursing pups.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technivie and any potential adverse effects on the breastfed child from Technivie or from the underlying maternal condition. If Technivie is administered with ribavirin, the nursing mother’s information for ribavirin also applies to this combination regimen.

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

How does Technivie work?

Technivie combines two direct-acting hepatitis C virus antiviral agents with distinct mechanisms of action. Ritonavir is not active against HCV. Ritonavir is a potent CYP3A inhibitor that increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure (i.e., area under the curve).

How is Techinvie supplied?

Technivie is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each child resistant daily dose pack contains two Technivie tablets. The NDC number is 0074-3082-28. Technivie is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed with “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir. Store at or below 30°C (86°F).