VIEKIRA XR- dasabuvir and ombitasvir and paritaprevir and ritonavir kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825), DASABUVIR SODIUM MONOHYDRATE (UNII: OG6D40M62L) (DASABUVIR - UNII:DE54EQW8T1), PARITAPREVIR DIHYDRATE (UNII: HRQ5901O78) (PARITAPREVIR - UNII:OU2YM37K86), OMBITASVIR HEMINONAHYDRATE (UNII: EQE3I70J3W) (OMBITASVIR - UNII:2302768XJ8)

Disponible desde:

AbbVie Inc.

Designación común internacional (DCI):

RITONAVIR

Composición:

RITONAVIR 33.33 mg

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

VIEKIRA XR is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2) and Clinical Studies (14)] : - genotype 1b infection without cirrhosis or with compensated cirrhosis - genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. - If VIEKIRA XR is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin. - VIEKIRA XR is contraindicated: In patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] . 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 [see Drug Interactions (7) and Clinical Pharmac

Resumen del producto:

VIEKIRA XR 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 three tablets. The NDC number is 0074-0063-28. Dasabuvir, ombitasvir, paritaprevir, and ritonavir 200 mg/8.33 mg/50 mg/33.33 mg tablets are pale yellow-colored, film-coated, oblong shaped, debossed with “3QD” on one side. Store at or below 30°C (86°F).

Estado de Autorización:

New Drug Application

Información para el usuario

AbbVie Inc.
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MEDICATION GUIDE
VIEKIRA XR (vee-KEE-rah-XR)
(dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release
tablets
for oral use
Important: When taking VIEKIRA XR in combination with ribavirin, you
should also read the Medication
Guide that comes with ribavirin.
What is the most important information I should know about VIEKIRA XR?
VIEKIRA XR can cause serious side effects, including:
•
Hepatitis B virus reactivation: Before starting treatment with VIEKIRA
XR, 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 VIEKIRA XR. 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 VIEKIRA
XR.
•
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 VIEKIRA XR.
•
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
VIEKIRA XR. See the section “Do not take VIEKIRA XR 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 VIEKIRA XR, and for about 2 weeks after
you finish treatment
with VIEKIRA XR. Your healthcare provider will tell you when you may
begin taking
ethinyl estradiol-containing medicines.
•
Your healthcare provider should do blood tests to check your l

Ficha técnica

VIEKIRA XR- DASABUVIR AND OMBITASVIR AND PARITAPREVIR AND RITONAVIR
ABBVIE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIEKIRA XR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIEKIRA XR.
VIEKIRA XR (DASABUVIR, OMBITASVIR, PARITAPREVIR, AND RITONAVIR)
EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED
WITH HCV
AND HBV
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATITIS B VIRUS (HBV) REACTIVATION HAS BEEN REPORTED, IN SOME CASES
RESULTING IN FULMINANT HEPATITIS,
HEPATIC FAILURE, AND DEATH. (5.1)
RECENT MAJOR CHANGES
Contraindications (4)
12/2019
INDICATIONS AND USAGE
VIEKIRA XR includes dasabuvir, a hepatitis C virus non-nucleoside NS5B
palm polymerase inhibitor, ombitasvir, a
hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus
NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor
and is indicated for the treatment of adult patients with chronic
hepatitis C virus (HCV):
genotype 1b infection without cirrhosis or with compensated cirrhosis
genotype 1a infection without cirrhosis or with compensated cirrhosis
for use in combination with ribavirin. (1)
DOSAGE AND ADMINISTRATION
Testing Prior to the Initiation of Therapy:
Test all patients for HBV infection by measuring HBsAg and anti-HBc.
(2.1)
Assess for laboratory and clinical evidence of hepatic decompensation.
(2.1)
Recommended dosage: Three tablets taken once daily. VIEKIRA XR must be
taken with a meal because administration
under fasting conditions may result in reduced virologic response and
possible development of resistance. (2.2)
TREATMENT REGIMEN AND DURATION BY PATIENT POPULATION
PATIENT POPULATION
T REATMENT*
DURATIO N
GENOTYPE 1A,
WITHOUT CIRRHOSIS
VIEKIRA XR + ribavirin
12 weeks
GENOTYPE 1A,
WITH COMPENSATED CIRRHOSIS
VIEKIRA XR + ribavirin
24 weeks**
GENOTYPE 1B,
WITH OR WITHOUT COMPENSATED CIRRHOSIS
VIEKIRA XR
12 weeks
*Note: Follow