Aa
PegIntron information.
Haven't read it completely yet but it's information and just another shout out that if you deal with depression or other related issues, take your time when it comes to tx. Maybe the fda has noticed that some people who deal with depression have a more pronounced tx outcome than previously thought. Like I said, I not did read it all yet, just the quick once over. Yep, tx and 6 month follow-up period, bigger warning than before, I think. Anyone?
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Date: Dec, Tue 20 2011 16:50 -0500 (EST)
Subject: FDA Hepatitis Update - Intron A (Interferon alfa-2b) product labeling changes
On December 20, 2011, the Food and Drug Administration approved changes to the Intron A (Interferon alfa-2b) product labeling to more accurately reflect recommendations for initiating and monitoring alpha interferon treatment in patients with histories of psychiatric and substance use disorders.
Specifically the following changes were made:
WARNING AND PRECAUTION
Neuropsychiatric Disorders
DEPRESSION AND SUICIDAL BEHAVIOR INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HOMICIDAL IDEATION, AND AGGRESSIVE BEHAVIOR SOMETIMES DIRECTED TOWARDS OTHERS, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALPHA INTERFERONS, INCLUDING INTRON A THERAPY.
If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period.
INTRON A should be used with caution in patients with a history of psychiatric disorders. INTRON A therapy should be discontinued for any patient developing severe psychiatric disorder during treatment. Obtundation and coma have also been observed in some patients, usually elderly, treated at higher doses. While these effects are usually rapidly reversible upon discontinuation of therapy, full resolution of symptoms has taken up to 3 weeks in a few severe episodes. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with INTRON A be discontinued and the patient followed, with psychiatric intervention as appropriate. Narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until the adverse effects have resolved. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% vs 1%) during treatment and off-therapy follow-up. Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of INTRON A.
Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Intron A is a product of Schering Corp.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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Date: Dec, Tue 20 2011 16:50 -0500 (EST)
Subject: FDA Hepatitis Update - Intron A (Interferon alfa-2b) product labeling changes
On December 20, 2011, the Food and Drug Administration approved changes to the Intron A (Interferon alfa-2b) product labeling to more accurately reflect recommendations for initiating and monitoring alpha interferon treatment in patients with histories of psychiatric and substance use disorders.
Specifically the following changes were made:
WARNING AND PRECAUTION
Neuropsychiatric Disorders
DEPRESSION AND SUICIDAL BEHAVIOR INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HOMICIDAL IDEATION, AND AGGRESSIVE BEHAVIOR SOMETIMES DIRECTED TOWARDS OTHERS, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALPHA INTERFERONS, INCLUDING INTRON A THERAPY.
If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period.
INTRON A should be used with caution in patients with a history of psychiatric disorders. INTRON A therapy should be discontinued for any patient developing severe psychiatric disorder during treatment. Obtundation and coma have also been observed in some patients, usually elderly, treated at higher doses. While these effects are usually rapidly reversible upon discontinuation of therapy, full resolution of symptoms has taken up to 3 weeks in a few severe episodes. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with INTRON A be discontinued and the patient followed, with psychiatric intervention as appropriate. Narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until the adverse effects have resolved. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% vs 1%) during treatment and off-therapy follow-up. Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of INTRON A.
Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Intron A is a product of Schering Corp.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
While an eye exam was a must to be in the boceprevir trial a psych exam was not. And i believe they try to use only the most experienced doctors possible. Theres alot of work getting approved for a trial in a teaching hospital.
I think it is responsible and wise to refer a patient for a psych evaluation prior to treatment. Think of it like a baseline eye exam. Personally I don't want to take psych drugs during TX and for years afterward. That is yet another reason I am trying to get into a trial for a treatment that doesn't require them if I can. However, if I was going to take IFN and Ribavirin and needed such drugs I would much rather a specialist was prescribing them and monitoring my condition. I would imagine that since psychosis would be a treatment stopper, some patients would try to hide it too. I have noticed that the more experienced and sophisticated doctors are with HCV treatment, e.g. Researchers and professors the more likely they are to recommended a psych evaluation and to explore starting people on medication prior to treatment.
To quote one of my specialists Interferon blocks neurotransmitters. Did it ever! "Combo" treatment reduced my working memory to almost nothing by around the 4th week. I could barely work at all except to do a few routine tasks with documented procedure step one do this, step two do that.
I was stunned to see that these drugs are approved for children with GT 2 or 3. I suppose they think that 6 months exposure is worht the risks. What on earth would that do to a developing brain?
To quote one of my specialists Interferon blocks neurotransmitters. Did it ever! "Combo" treatment reduced my working memory to almost nothing by around the 4th week. I could barely work at all except to do a few routine tasks with documented procedure step one do this, step two do that.
I was stunned to see that these drugs are approved for children with GT 2 or 3. I suppose they think that 6 months exposure is worht the risks. What on earth would that do to a developing brain?
I think some doctors refer their patients for a psych. eval prior to treatment and some do not. My doctor does refer patients to a psychiatrist for an evaluation prior to treatment. My doctor is cautious and want all of the bases covered. She also does weekly lab work and weekly office visits for the first 3 months.
"PegIntron in combination with REBETOL is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age),"
Hmmm, something tells me if its ok to give to a 3 year old then i don't think we should worry to much.
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" guess that's the reason why ny hep c hepatologist makes sure his patients are evaluted prior to tx,"
Mine never did and i really doubt they would a 3 year old.
Hmmm, something tells me if its ok to give to a 3 year old then i don't think we should worry to much.
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" guess that's the reason why ny hep c hepatologist makes sure his patients are evaluted prior to tx,"
Mine never did and i really doubt they would a 3 year old.
Following is some of the older product labeling for PegIntron and Pegasys. Although not as specific, it contain much of the same information and is readily available to the patient and the doctor. This information label was given to me by my GI to read and discuss regarding issues related to anger and depression and the potential for needing an AD sometime during trt.
I would hope all doctors discuss this prior to trt, but this may not be the case. I'm also curious what "psychological evaluations" are being done. Are they done by the treating GI or Hepatologist with some informal questions, or referred out for a full blown psychological evaluation.
Earlier product labeling:
"The FDA requires the manufacturers of ribavirin and peginterferon to label these products with strong warnings. Read the product information before taking any medication, especially the following:
Alpha interferons, including PegIntron and Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients
with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping Pegasys."
From Pegasys website:
"5.2 Neuropsychiatric
Life-threatening or fatal neuropsychiatric reactions may manifest in all patients receiving therapy with PEGASYS and include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose. These reactions may occur in patients with and without previous psychiatric illness. PEGASYS should be used with extreme caution in all patients who report a history of depression. Neuropsychiatric adverse events observed with alpha interferon treatment include aggressive behavior, psychoses, hallucinations, bipolar disorders, and mania. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Patients should be advised to report any sign or symptom of depression or suicidal ideation to their prescribing physicians. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted [see Adverse Reactions (6.1) and Dosage and Administration (2.5)]."
I would hope all doctors discuss this prior to trt, but this may not be the case. I'm also curious what "psychological evaluations" are being done. Are they done by the treating GI or Hepatologist with some informal questions, or referred out for a full blown psychological evaluation.
Earlier product labeling:
"The FDA requires the manufacturers of ribavirin and peginterferon to label these products with strong warnings. Read the product information before taking any medication, especially the following:
Alpha interferons, including PegIntron and Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients
with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping Pegasys."
From Pegasys website:
"5.2 Neuropsychiatric
Life-threatening or fatal neuropsychiatric reactions may manifest in all patients receiving therapy with PEGASYS and include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose. These reactions may occur in patients with and without previous psychiatric illness. PEGASYS should be used with extreme caution in all patients who report a history of depression. Neuropsychiatric adverse events observed with alpha interferon treatment include aggressive behavior, psychoses, hallucinations, bipolar disorders, and mania. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Patients should be advised to report any sign or symptom of depression or suicidal ideation to their prescribing physicians. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted [see Adverse Reactions (6.1) and Dosage and Administration (2.5)]."
That is my understanding evaluation I guess for depression ? I guess he wants to make sure his patients are mentally stable to endure tx and sx that come from it. I am glad he is looking out for me , doesn't bother me .Maybe he had patients in the past who didn't divulge their mh issues and then had serious prblems, not sure .I will find out next week .
Do you mean all his patients see a psychiatrist before treatment? Wondering what you mean by "evaluated".
I think everyone is asked about their history with respect to MH issues. That seems sufficient to me.
I think everyone is asked about their history with respect to MH issues. That seems sufficient to me.
I guess that's the reason why ny hep c hepatologist makes sure his patients are evaluted prior to tx, I am a normal stable person never suffered from depression or anger issues ( I have had my bad days) like all people do but nothing serious to be dealt with professionally , nevertheless, they are powerful drugs, hopefully I too will not hav any issues , I NEED TO WORK while tx I would be fired if I had those outbursts.
Yuk, staying positive !
Yuk, staying positive !
I took shot #20 last Friday. So far, I've had no MH issues apart from not caring about much. But that seems to be related to my exhaustion...
Not everyone experiences every side effect and certainly not in the extreme.
Not everyone experiences every side effect and certainly not in the extreme.
I think if one reads the side effects to many/most meds they can be scary. It is better to list all side effects, especially serious side effects, so people are aware of them. I think that even if one has a history of depression the person can treat as long as the person is not unstable mentally to begin with and the depression is being managed well. So if a person is being managed well on ADs then that person should be able to treat, The main thing is to be aware of the possible side effects and deal with them immediately if they appear. Also, I think most people with a history of depression are started on ADs before they even start triple med treatment. I was already on ADs before starting treatment and I have been fine, absolutely no depression and absolutely no rage or anger or abnormal behavior or thoughts.
The HepC drugs are very powerful but if you are otherwise healthy and you do not have a problem with depression, bi-polar or any of those types of issues then you should be fine. My suggestion to all is to learn, meaning study HepC and the drugs for a few months before you start. That way, you will know exactly all the warnings and side effects possible. once you start that's it and you're in for the duration.
More...
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Date: Dec, Fri 23 2011 12:19 -0500 (EST)
Subject: FDA Hepatitis Update - Important updates to PegIntron labeling
On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the product labeling.
The Indication and Usage section was update as follows:
PegIntron®, as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C in patients with compensated liver disease.
PegIntron in combination with REBETOL (ribavirin) and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients (18 years of age and older) with HCV genotype 1 infection (see the Package Insert of the specific HCV NS3/4A protease inhibitor for further information).
PegIntron in combination with REBETOL is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.
The Dosage and Administration section, PegIntron Combination Therapy and Discontinuation of Dosing subsections were updated as follows:
DOSAGE AND ADMINISTRATION
2.1 PegIntron Combination Therapy
Adults
The recommended dose of PegIntron is 1.5 mcg/kg/week. The volume of PegIntron to be injected depends on the strength of PegIntron and patient’s body weight (see Table 1).
should be taken with food. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen and administration of the protease inhibitor in combination with PegIntron and ribavirin.
Duration of Treatment – Treatment with PegIntron/REBETOL of Interferon Alpha-naïve Patients
The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.
Duration of Treatment – Retreatment with PegIntron/REBETOL of Prior Treatment Failures
For patients with genotype 1 infection, PegIntron and REBETOL without an HCV NS3/4A protease inhibitor should only be used if there are contraindications, significant intolerance or other clinical factors that would not warrant use of an HCV NS3/4A protease inhibitor. The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at Week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered
2.4 Discontinuation of Dosing
Adults
See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding discontinuation of dosing based on treatment futility.
In HCV genotype 1, interferon-alfa-naïve patients receiving PegIntron, alone or in combination with REBETOL, discontinuation of therapy is recommended if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24, are highly unlikely to achieve SVR and discontinuation of therapy is recommended.
Warning and Precaution section was revised as follows:
Neuropsychiatric Events
Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.
PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms.
If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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Date: Dec, Fri 23 2011 12:19 -0500 (EST)
Subject: FDA Hepatitis Update - Important updates to PegIntron labeling
On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the product labeling.
The Indication and Usage section was update as follows:
PegIntron®, as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C in patients with compensated liver disease.
PegIntron in combination with REBETOL (ribavirin) and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients (18 years of age and older) with HCV genotype 1 infection (see the Package Insert of the specific HCV NS3/4A protease inhibitor for further information).
PegIntron in combination with REBETOL is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.
The Dosage and Administration section, PegIntron Combination Therapy and Discontinuation of Dosing subsections were updated as follows:
DOSAGE AND ADMINISTRATION
2.1 PegIntron Combination Therapy
Adults
The recommended dose of PegIntron is 1.5 mcg/kg/week. The volume of PegIntron to be injected depends on the strength of PegIntron and patient’s body weight (see Table 1).
should be taken with food. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen and administration of the protease inhibitor in combination with PegIntron and ribavirin.
Duration of Treatment – Treatment with PegIntron/REBETOL of Interferon Alpha-naïve Patients
The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.
Duration of Treatment – Retreatment with PegIntron/REBETOL of Prior Treatment Failures
For patients with genotype 1 infection, PegIntron and REBETOL without an HCV NS3/4A protease inhibitor should only be used if there are contraindications, significant intolerance or other clinical factors that would not warrant use of an HCV NS3/4A protease inhibitor. The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at Week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered
2.4 Discontinuation of Dosing
Adults
See the Package Insert of the specific HCV NS3/4A protease inhibitor for information regarding discontinuation of dosing based on treatment futility.
In HCV genotype 1, interferon-alfa-naïve patients receiving PegIntron, alone or in combination with REBETOL, discontinuation of therapy is recommended if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24, are highly unlikely to achieve SVR and discontinuation of therapy is recommended.
Warning and Precaution section was revised as follows:
Neuropsychiatric Events
Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.
PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms.
If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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