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FDA UPDATE – VIEKIRA PAK & TECHNIVIE SAFETY WARNING & LABEL CHANGE

Hepatitis C Blog Posted on October 23, 2015 by Alan FranciscusDecember 1, 2015

Hepatitis List Serve

Information about 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.
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:
  • 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.
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:
The updated label will be available at drugs@fda or dailymed.
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

Hepatitis List Serve

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Tagged FDA product label update label, FDA Warning, TECHNIE, Viekira Pak

FDA UPDATE – VIEKIRA PAK & TECHNIVIE SAFETY WARNING & LABEL CHANGE

Hepatitis C Blog Posted on October 23, 2015 by Alan FranciscusDecember 13, 2015

Hepatitis List Serve

Information about 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.
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:
  • 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.
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:
The updated label will be available at drugs@fda or dailymed.
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

Hepatitis List Serve

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Tagged FDA product label update label, FDA Warning, TECHNIE, Viekira Pak

FDA Issues Pediatric Warning for Copegus

Hepatitis C Blog Posted on September 10, 2015 by Alan FranciscusDecember 1, 2015

Copegus (ribavirin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

August 2015

WARNINGS AND PRECAUTIONS

Impact on Growth in Pediatric Patients
  • During
    combination therapy for up to 48 weeks with PEGASYS plus ribavirin,
    growth inhibition was observed in pediatric subjects 5 to 17 years of
    age. Decreases in weight for age z-score and height for age z-score up
    to 48 weeks of therapy compared with baseline were observed. At 2 years
    post-treatment, 16% of pediatric subjects were more than 15 percentiles
    below their baseline weight curve and 11% were more than 15 percentiles
    below their baseline height curve. The available longer term data on
    subjects who were followed up to 6 years post-treatment are too limited
    to determine the risk of reduced adult height in some patients

ADVERSE REACTIONS

Growth Inhibition in Pediatric Subjects
  • Pediatric
    subjects treated with PEGASYS plus ribavirin combination therapy showed
    a delay in weight and height increases with up to 48 weeks of therapy
    compared with baseline. Both weight for age and height for age z-scores
    as well as the percentiles of the normative population for subject
    weight and height decreased during treatment. At the end of 2 years
    follow-up after treatment, most subjects had returned to baseline
    normative curve percentiles for weight (64th mean percentile at
    baseline, 60th mean percentile at 2 years post-treatment) and height
    (54th mean percentile at baseline, 56th mean percentile at 2 years
    post-treatment). At the end of treatment, 43% (23 of 53) of subjects
    experienced a weight percentile decrease of more than 15 percentiles,
    and 25% (13 of 53) experienced a height percentile decrease of more than
    15 percentiles on the normative growth curves. At 2 years
    post-treatment, 16% (6 of 38) of subjects were more than 15 percentiles
    below their baseline weight curve and 11% (4 of 38) were more than 15
    percentiles below their baseline height curve. Thirty-eight of the 114
    subjects enrolled in the long-term follow-up study, extending up to 6
    years posttreatment. For most subjects, post-treatment recovery in
    growth at 2 years post-treatment was maintained to 6 years
    post-treatment.

Source:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218877.htm

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Tagged Copegus, FDA Warning, pediatric use, ribavirin

FDA Issues Pediatric Warning for Copegus

Hepatitis C Blog Posted on September 10, 2015 by Alan FranciscusDecember 13, 2015

Copegus (ribavirin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

August 2015

WARNINGS AND PRECAUTIONS

Impact on Growth in Pediatric Patients
  • During combination therapy for up to 48 weeks with PEGASYS plus ribavirin, growth inhibition was observed in pediatric subjects 5 to 17 years of age. Decreases in weight for age z-score and height for age z-score up to 48 weeks of therapy compared with baseline were observed. At 2 years post-treatment, 16% of pediatric subjects were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve. The available longer term data on subjects who were followed up to 6 years post-treatment are too limited to determine the risk of reduced adult height in some patients

ADVERSE REACTIONS

Growth Inhibition in Pediatric Subjects
  • Pediatric subjects treated with PEGASYS plus ribavirin combination therapy showed a delay in weight and height increases with up to 48 weeks of therapy compared with baseline. Both weight for age and height for age z-scores as well as the percentiles of the normative population for subject weight and height decreased during treatment. At the end of 2 years follow-up after treatment, most subjects had returned to baseline normative curve percentiles for weight (64th mean percentile at baseline, 60th mean percentile at 2 years post-treatment) and height (54th mean percentile at baseline, 56th mean percentile at 2 years post-treatment). At the end of treatment, 43% (23 of 53) of subjects experienced a weight percentile decrease of more than 15 percentiles, and 25% (13 of 53) experienced a height percentile decrease of more than 15 percentiles on the normative growth curves. At 2 years post-treatment, 16% (6 of 38) of subjects were more than 15 percentiles below their baseline weight curve and 11% (4 of 38) were more than 15 percentiles below their baseline height curve. Thirty-eight of the 114 subjects enrolled in the long-term follow-up study, extending up to 6 years posttreatment. For most subjects, post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.

Source:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218877.htm

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Tagged Copegus, FDA Warning, pediatric use, ribavirin

FDA Safety Alert: NSAIDS

Hepatitis C Blog Posted on August 6, 2015 by Alan FranciscusDecember 1, 2015

The Food and Drug Administration (FDA) has issued a
communication strengthening an existing warning label that non-aspirin
nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a
heart attack or stroke. This includes prescribed and over-the-counter
non-aspirin NSAID labels.

Many people with hepatitis C
suffer from extrahepatic conditions of hepatitis C and may take NSAIDs
or medications that contain NSAIDs.
In a related story it was found
there was an increased risk of intracranial bleeding when taking
non-steroidal anti-inflammatory drugs (NSAIDs)—ibuprofen and
aspirin—during the first 30 days of taking a new prescription of an
anti-depressant.  This was more common in men than in women.  (BMJ.
Published online July 14, 2015.)
Read this FDA communication
carefully. Talk with your medical provider about what you should take,
how often and what are the alternatives that are safe to take.

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

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Tagged FDA Warning, NSAIDS

FDA Safety Alert: NSAIDS

Hepatitis C Blog Posted on August 6, 2015 by Alan FranciscusDecember 13, 2015

The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. This includes prescribed and over-the-counter non-aspirin NSAID labels.

Many people with hepatitis C suffer from extrahepatic conditions of hepatitis C and may take NSAIDs or medications that contain NSAIDs.
In a related story it was found there was an increased risk of intracranial bleeding when taking non-steroidal anti-inflammatory drugs (NSAIDs)—ibuprofen and aspirin—during the first 30 days of taking a new prescription of an anti-depressant.  This was more common in men than in women.  (BMJ. Published online July 14, 2015.)
Read this FDA communication carefully. Talk with your medical provider about what you should take, how often and what are the alternatives that are safe to take.

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

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Tagged FDA Warning, NSAIDS

FDA Safety Alert: NSAIDS

Hepatitis C Blog Posted on July 13, 2015 by Alan FranciscusDecember 1, 2015
The Food and Drug Administration (FDA) has issued a
communication strengthening an existing warning
label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase
the chance of a heart attack or stroke. 
This includes prescribed and over-the-counter non-aspirin NSAID medications.
Many people with hepatitis C suffer from extrahepatic
conditions of hepatitis C and may take NSAIDs or medications that contain
NSAIDs.   Read this FDA communication FDA carefully. Talk
with your medical provider about what you should take, how often and what are
the alternatives that are safe to take.

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

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Tagged FDA Warning, heart attack risk, NSAIDS, stroke risk

FDA Safety Alert: NSAIDS

Hepatitis C Blog Posted on July 13, 2015 by Alan FranciscusDecember 13, 2015
The Food and Drug Administration (FDA) has issued a communication strengthening an existing warning label that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.  This includes prescribed and over-the-counter non-aspirin NSAID medications.
Many people with hepatitis C suffer from extrahepatic conditions of hepatitis C and may take NSAIDs or medications that contain NSAIDs.   Read this FDA communication FDA carefully. Talk with your medical provider about what you should take, how often and what are the alternatives that are safe to take.

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

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Facebooktwitter
Tagged FDA Warning, heart attack risk, NSAIDS, stroke risk

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