HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full prescribing information for TECHNIVIE.
TECHNIVIE (ombitasvir, paritaprevir and ritonavir) tablets, for oral use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
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Indications and Usage, Removed-Limitations of Use (1) |
10/2015 |
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Dosage and Administration, Testing Prior to Initiation of TECHNIVIE (2.1) |
10/2015 |
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Dosage and Administration, Recommended Dosage in Adults (2.2) |
10/2015 |
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Dosage and Administration, Dosage in Patients with Hepatic Impairment (2.3) |
10/2015 |
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Contraindications (4) |
5/2016 |
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Warnings and Precautions (5.1) |
10/2015 |
INDICATIONS AND USAGE
TECHNIVIE is a fixed-dose combination of ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor and is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis. (1)
DOSAGE AND ADMINISTRATION
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Testing Prior to Initiation: Assess baseline hepatic laboratory and clinical parameters. (2.1)
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Recommended dosage: Two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. TECHNIVIE is recommended to be used in combination with ribavirin. (2.2)
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Patient Population |
Treatment |
Duration |
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Genotype 4 without cirrhosis |
TECHNIVIE + ribavirin* |
12 weeks |
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*TECHNIVIE administered without ribavirin for 12 weeks may be considered for treatment-naïve patients who cannot take or tolerate ribavirin [see Microbiology (12.4) and Clinical Studies (14)]. |
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir. (3)
CONTRAINDICATIONS
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The contraindications to ribavirin also apply to this combination regimen. (4)
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Patients with moderate to severe hepatic impairment. (4, 5.1, 8.6, 12.3)
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Co-administration with drugs that are: highly dependent on CYP3A for clearance; moderate and strong inducers of CYP3A. (4)
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Known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
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Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Discontinue treatment in patients who develop evidence of hepatic decompensation. (5.1)
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ALT Elevations: Discontinue ethinyl estradiol-containing medications prior to starting TECHNIVIE (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment. For ALT elevations on TECHNIVIE, monitor closely and follow recommendations in full prescribing information. (5.2)
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Risks Associated With Ribavirin Combination Treatment: The warnings and precautions for ribavirin also apply to this combination regimen. (5.3)
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Drug Interactions: The concomitant use of TECHNIVIE and certain other drugs may result in known or potentially
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence greater than 10% of subjects, all grades) observed with treatment with ombitasvir, paritaprevir and ritonavir with ribavirin for 12 weeks were asthenia, fatigue, nausea and insomnia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of TECHNIVIE can alter the plasma concentrations of some drugs and some drugs may alter the plasma concentrations of TECHNIVIE. The potential for drug-drug interactions must be considered before and during treatment. Consult the full prescribing information prior to and during treatment for potential drug interactions. (4, 5.4, 7, 12.3
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to Initiation of TECHNIVIE
Prior to initiation of TECHNIVIE, assess baseline hepatic laboratory and clinical parameters[see Contraindications (4) and Warnings and Precautions (5.1 and 5.2)].
2.2 Recommended Dosage in Adults
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 [see Clinical Pharmacology (12.3)].
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. For ribavirin dosage modifications, refer to the ribavirin prescribing information.
Table 1 shows the recommended TECHNIVIE treatment regimen and duration for HCV genotype 4 patients without cirrhosis.
2.3 Dosage in Patients with Hepatic Impairment
TECHNIVIE is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C)[see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
TECHNIVIE is a pink-colored, film-coated, oblong, biconvex-shaped tablet debossed “AV1” on one side. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
4 CONTRAINDICATIONS
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The contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
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TECHNIVIE is contraindicated:
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In patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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With drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
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With drugs that are moderate or strong inducers of CYP3A and may lead to reduced efficacy of TECHNIVIE.
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In patients with known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome).
Table 2 lists drugs that are contraindicated with TECHNIVIE [see Drug Interactions (7)].
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