Interferon alfa-2a indications and usage: Difference between revisions

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==Indications And Usage==
==Indications And Usage==


===Chronic [[ hepatitis]] C===
Roferon-A is indicated for the treatment of chronic hepatitis C and hairy cell leukemia in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).


PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of patients 5 years of age and older with chronic [[ hepatitis]] C (CHC) virus infection with compensated liver disease and have not been previously treated with interferon alpha. Efficacy has been demonstrated in subjects with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and in adult subjects with clinically stable HIV disease and CD4 count greater than 100 cells/mm3.
===For Patients With Chronic Hepatitis C===
 
Pegasys in combination with Copegus 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).
Pegasys in combination with Copegus is indicated in patients with HCV genotypes other than 1, pediatric patients (5-17 years of age), or in patients with HCV genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.
 
The following points should be considered when initiating therapy with PEGASYS and COPEGUS:
 
Use of PEGASYS monotherapy is not recommended for treatment of CHC unless a patient has a contraindication to or significant intolerance to ribavirin. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies (14)].
Safety and efficacy have not been demonstrated for treatment longer than 48 weeks.
The safety and efficacy have not been established in liver or other organ transplant recipients [see Use in Specific Populations (8.7)].
 
===Chronic [[ hepatitis]] B===
 
PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic [[ hepatitis]] B infection who have compensated liver disease and evidence of viral replication and liver inflammation.<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf| url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf | publisher = |date = | accessdate = }}</ref>


Roferon-A is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older. A liver biopsy and a serum test for the presence of antibody to HCV should be performed to establish the diagnosis of chronic hepatitis C. Other causes of hepatitis, including hepatitis B, should be excluded prior to therapy with Roferon-A.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ROFERON-A (INTERFERON ALFA-2A) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4c918b02-f158-4f7c-8ecc-fd49574ec228#nlm34090-1 | publisher =  | date =  | accessdate = 9 January 2014 }}</ref>
==References==
==References==
{{Reflist}}
{{Reflist}}

Latest revision as of 14:00, 9 January 2014

Interferon alfa-2a
PEGASYS® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Indications And Usage

Roferon-A is indicated for the treatment of chronic hepatitis C and hairy cell leukemia in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).

For Patients With Chronic Hepatitis C

Roferon-A is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older. A liver biopsy and a serum test for the presence of antibody to HCV should be performed to establish the diagnosis of chronic hepatitis C. Other causes of hepatitis, including hepatitis B, should be excluded prior to therapy with Roferon-A.[1]

References

  1. ↑ "ROFERON-A (INTERFERON ALFA-2A) INJECTION, SOLUTION [ROCHE PHARMACEUTICALS]". Retrieved 9 January 2014.

Adapted from the FDA Package Insert.

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