HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIEKIRA PAK safely and effectively. See full prescribing information
for VIEKIRA PAK.
VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets), co-packaged for oral use
Initial U.S. Approval: 2014
----------------------------INDICATIONS AND USAGE---------------------------
VIEKIRA PAK with or without ribavirin is indicated for the treatment of
patients with genotype 1 chronic hepatitis C virus (HCV) infection including
those with compensated cirrhosis. VIEKIRA PAK includes ombitasvir, a
hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A
protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C
virus non-nucleoside NS5B palm polymerase inhibitor. (1)
Limitation of Use: VIEKIRA PAK is not recommended for use in patients
with decompensated liver disease. (1)
-----------------------DOSAGE AND ADMINISTRATION-----------------------
• Recommended dosage: Two ombitasvir, paritaprevir, ritonavir 12.5/75/50
mg tablets once daily (in the morning) and one dasabuvir 250 mg tablet
twice daily (morning and evening) with a meal without regard to fat or
calorie content. (2.1)
Treatment Regimen and Duration by Patient Population
Patient Population Treatment* Duration
Genotype 1a, without
cirrhosis VIEKIRA PAK + ribavirin 12 weeks
Genotype 1a, with cirrhosis VIEKIRA PAK + ribavirin 24 weeks**
Genotype 1b, without
cirrhosis VIEKIRA PAK 12 weeks
Genotype 1b, with cirrhosis VIEKIRA PAK + ribavirin 12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an
unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA PAK administered with ribavirin for 12 weeks may be
considered for some patients based on prior treatment history [See Clinical
Studies (14.3)].
• HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection,
follow the dosage recommendations in the table above. (2.1)
• Liver Transplant Recipients: In liver transplant recipients with normal
hepatic function and mild fibrosis (Metavir fibrosis score ≤2), the
recommended duration of VIEKIRA PAK with ribavirin is 24 weeks. (2.2)
----------------------DOSAGE FORMS AND STRENGTHS---------------------
Tablets:
• Ombitasvir, paritaprevir, ritonavir: 12.5/75/50 mg (3)
• Dasabuvir: 250 mg (3)
-
----------------------------CONTRAINDICATIONS-----------------------------
• If VIEKIRA PAK is administered with ribavirin, the contraindications to
ribavirin also apply to this combination regimen. (4)
• Patients with severe hepatic impairment. (4, 8.7, 12.3)
• Co-administration with drugs that are: highly dependent on CYP3A for
clearance; strong inducers of CYP3A and CYP2C8; and strong inhibitors
of CYP2C8. (4)
• Known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis,
Stevens-Johnson syndrome). (4)
----------------------WARNINGS AND PRECAUTIONS-----------------------
• ALT Elevations: Discontinue ethinyl estradiol-containing medications
prior to starting VIEKIRA PAK (alternative contraceptive methods are
recommended). Perform hepatic laboratory testing on all patients during
the first 4 weeks of treatment. For ALT elevations on VIEKIRA PAK,
monitor closely and follow recommendations in full prescribing
information. (5.1)
• Risks Associated With Ribavirin Combination Treatment: If VIEKIRA
PAK is administered with ribavirin, the warnings and precautions for
ribavirin also apply to this combination regimen. (5.2)
• Drug Interactions: The concomitant use of VIEKIRA PAK and certain
other drugs may result in known or potentially significant drug interactions,
some of which may lead to loss of therapeutic effect of VIEKIRA PAK.
(5.3)
------------------------------ADVERSE REACTIONS------------------------------
In subjects receiving VIEKIRA PAK with ribavirin, the most commonly
reported adverse reactions (greater than 10% of subjects) were fatigue, nausea,
pruritus, other skin reactions, insomnia and asthenia. In subjects receiving
VIEKIRA PAK without ribavirin, the most commonly reported adverse
reactions (greater than or equal to 5% of subjects) were nausea, pruritus 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 VIEKIRA PAK can alter the plasma concentrations of
some drugs and some drugs may alter the plasma concentrations of VIEKIRA
PAK. The potential for drug interactions must be considered before and
during treatment. Consult the full prescribing information prior to and during
treatment for potential drug interactions. (4, 5.3, 7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
