Back HCV Treatment PegIntron Label Updated to Include Use with New Direct-Acting HCV Agents

PegIntron Label Updated to Include Use with New Direct-Acting HCV Agents

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The U.S. Food and Drug Administration (FDA) last week announced revisions to the product label for pegylated interferon alfa-2b (brand name PegIntron) to incorporate information about its use with the recently approved hepatitis C virus (HCV) protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek), as well as use by people with psychiatric conditions.

The update reflects the latest standard of care, indicating that people with HCV genotype should use a protease inhibitor along with pegylated interferon and ribavirin unless there are specific reasons not to do so.

Below is an edited excerpt from the FDA press release describing the changes. The full announcement is available on the FDA website.

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 updated 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...

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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.

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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.

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.

12/27/11

Source

R Klein and K Struble, U.S. Food and Drug Administration. Important Updates to PegIntron Labeling. FDA Hepatitis Update. December 23, 2011.