Information about FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
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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.
Please refer to the FDA Drug Safety Communication for specific details [http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm]
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:
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.
Hepatobiliary Disorders: Hepatic decompensation, hepatic failure
8 USE IN SPECIFIC POPULATIONS
8.6 Hepatic Impairment
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:
Richard Klein
Office of Health and Constituent Affairs Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs Food and Drug Administration
For more information about the Hepatitis Liaison Program visit the FDA Patient Network
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