Title: FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie
Informationabout FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
The U.S. Food and Drug Administration (FDA)
is warning that hepatitis C treatments Viekira Pak and Technivie can cause
serious liver injury mostly in patients with underlying advanced liver disease.
As a result, new information about this safety risk was added to the Viekira
Pak and Technivie labels.
In addition,
FDA approved changes to the DOSAGE AND ADMINSTRATION, CONTRAINDICATIONS AND
WARNINGS AND PRECAUTIONS sections of the Viekira Pak and Technivie labeling and
to the respective patient package insert with information on postmarketing
reports of hepatic decompensation and hepatic failure including liver
transplantation or death among patients with cirrhosis.
The specific
changes to the each label are summarized below.
Major
revisions to the Viekira Pak (ombitasvir,
paritaprevir, and ritonavir tablets; dasabuvir tablets), co-packaged for oral
use label include:
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to Initiation of VIEKIRA PAK
Prior to initiation of VIEKIRA PAK, assess for laboratory
and clinical evidence of hepatic decompensation
2.4 Hepatic Impairment
VIEKIRA PAK is
contraindicated in patients with moderate to severe hepatic impairment
(Child-Pugh B and C)
4
CONTRAINDICATIONS
VIEKIRA PAK
is contraindicated in patients with moderate to severe hepatic impairment
(Child-Pugh B and C) due to risk of potential toxicity.
Additionally,
colchicine was added to the list of contraindicated drugs due to potential for
serious and/or life-threatening reactions in patients with renal and/or hepatic
impairment.
5 WARNINGS AND
PRECAUTIONS
5.1 Risk of
Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Hepatic
decompensation and hepatic failure, including liver transplantation or fatal
outcomes, have been reported postmarketing in patients treated with VIEKIRA
PAK. Most patients with these severe outcomes had evidence of advanced
cirrhosis prior to initiating therapy with VIEKIRA PAK. Reported cases
typically occurred within one to four weeks of initiating therapy and were
characterized by the acute onset of rising direct serum bilirubin levels
without ALT elevations in association with clinical signs and symptoms of
hepatic decompensation. Because these events are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
VIEKIRA PAK
is contraindicated in patients with moderate to severe hepatic impairment
(Child-Pugh B and C).
For patients
with cirrhosis:
Monitor for clinical signs and
symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy,
variceal hemorrhage).
Hepatic laboratory testing including
direct bilirubin levels should be performed at baseline and during the first 4
weeks of starting treatment and as clinically indicated.
Discontinue VIEKIRA PAK in patients
who develop evidence of hepatic decompensation.
6 ADVERSE
REACTIONS
6.2
Post-Marketing Adverse Reactions
The following
adverse reactions have been identified during post approval use of VIEKIRA
PAK.Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
No dosage
adjustment of VIEKIRA PAK is required in patients with mild hepatic impairment
(Child-Pugh A). VIEKIRA PAK is contraindicated in patients with moderate to
severe (Child-Pugh B and C) hepatic impairment
Major
revisions to the Technivie (ombitasvir, paritaprevir and ritonavir) tablet
label include:
This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
