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PEGASYS(peginterferon alfa-2a) injection
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PEGASYS safely and effectively. See full prescribing information for PEGASYS.
PEGASYS® (peginterferon alfa-2a) injection, for subcutaneous use
Initial U.S. Approval: 2002
WARNING: RISK OF SERIOUS DISORDERS
See full prescribing information for complete boxed warning.
Risk of Serious Disorders
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May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders (5)
RECENT MAJOR CHANGES
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Boxed Warning |
9/2014 |
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Indications and Usage (1) |
9/2014 |
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Dosage and Administration (2) |
9/2014 |
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Contraindications (4) |
9/2014 |
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Warnings and Precautions |
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Pregnancy: Use with Ribavirin (5.1) |
9/2014 |
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Impact on Growth in Pediatric Patients (5.15) |
3/2015 |
INDICATIONS AND USAGE
PEGASYS is an antiviral indicated for:
Treatment of Chronic Hepatitis C (CHC) as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs in patients 5 years of age and older with compensated liver disease (1.1)
PEGASYS monotherapy is indicated for:
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CHC only if patient has contraindication to or significant intolerance to other HCV antiviral drugs (1.1)
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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 (1.2)
DOSAGE AND ADMINISTRATION
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PEGASYS is administered by subcutaneous injection (2)
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In adult patients with CHC or chronic hepatitis B (CHB), PEGASYS is dosed as 180 mcg per week and the duration of treatment depends on indication, genotype, and whether it is administered with other HCV antiviral drugs (2.2, 2.4)
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In pediatric patients with CHC, PEGASYS is dosed as 180 mcg/1.73 m2 × BSA per week, in combination with ribavirin, and the duration of treatment depends on genotype (2.3)
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Dosage modification is recommended in patients experiencing certain laboratory abnormalities, adverse reactions or renal impairment (2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
Injection (all presentations below are single-dose):
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180 mcg/mL in a Vial (3)
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180 mcg/0.5 mL in a Prefilled Syringe (3)
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180 mcg/0.5 mL in an Autoinjector (3)
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135 mcg/0.5 mL in an Autoinjector (3)
CONTRAINDICATIONS
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Autoimmune hepatitis (4)
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Hepatic decompensation in patients with cirrhosis (4)
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Use in neonates/infants (4)
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Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction and anaphylaxis to alpha interferons or any component of the product (4)
Additional contraindications for use with other HCV antiviral drugs:
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When used in combination with other HCV antiviral drugs, all contraindications also apply to Pegasys combination therapy (4)
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Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant (4, 8.1)
WARNINGS AND PRECAUTIONS
Use with Ribavirin
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Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy, use 2 forms of effective contraception, and have monthly pregnancy tests (5.1)
PEGASYS Clinically Significant Adverse Reactions or Risks
Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:
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Neuropsychiatric reactions (5.2)
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Cardiovascular disorders (5.3)
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Bone marrow suppression (5.4)
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Autoimmune and endocrine disorders (including thyroid disorders; hyperglycemia) (5.5, 5.6)
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Ophthalmologic disorders (5.7)
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Cerebrovascular disorders (5.8)
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Hepatic decompensation in cirrhotic patients. Exacerbation of hepatitis during hepatitis B treatment (5.9)
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Pulmonary disorders (5.10)
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Infections (bacterial, viral, fungal) (5.11)
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Colitis and pancreatitis (5.12, 5.13)
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Hypersensitivity and serious skin reactions including Stevens-Johnson syndrome (5.14)
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Growth impairment with combination therapy in pediatric patients (5.15)
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Peripheral neuropathy when used in combination with telbivudine (5.16)
ADVERSE REACTIONS
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The most common adverse reactions (incidence greater than 40%) are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1)
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The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly (7.2)
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Methadone: monitor for signs and symptoms of methadone toxicity (7.3)
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Nucleoside analogues: closely monitor for toxicities. Reduce or discontinue the dose of PEGASYS or ribavirin or both should the events worsen (7.4)
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Zidovudine: monitor for worsening neutropenia and/or anemia with PEGASYS and/or ribavirin (7.4)
USE IN SPECIFIC POPULATIONS
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Pediatric patients: Safety and efficacy in pediatric patients less than 5 years old have not been established (8.4)
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Geriatric patients: Neuropsychiatric, cardiac, and systemic (flu-like) adverse reactions may be more severe (8.5)
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Patients with hepatic impairment: Clinical status and hepatic function should be closely monitored and treatment should be immediately discontinued if decompensation occurs (8.6)
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Patients with renal impairment: PEGASYS dose should be reduced in patients with creatinine clearance less than 30 mL/min (2.5, 8.7)
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Chronic Hepatitis B: Safety and efficacy have not been established in hepatitis B patients coinfected with HCV or HIV (8.9)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Chronic Hepatitis C
PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease. For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS in combination with ribavirin is indicated for treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease. PEGASYS monotherapy is only indicated for the treatment of patients with CHC with compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.
Limitations of Use:
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PEGASYS alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa.
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PEGASYS is not recommended for treatment of patients with CHC who have had solid organ transplantation [see Use in Specific Populations (8.8)].
1.2 Chronic Hepatitis B (CHB)
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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Overview
Administer PEGASYS by subcutaneous injection once weekly in the abdomen or thigh for the treatment of:
For treatment of CHC, use PEGASYS in combination with other HCV antiviral drugs. For information about the recommended dosage and administration and the safe and effective use of these other HCV antiviral drugs, refer to their prescribing information. PEGASYS monotherapy is only indicated in the treatment of CHC if there are contraindications to or significant intolerance to other HCV antiviral drugs.
For dosage modifications in patients with CHC or CHB:
For important administration instructions for all the PEGASYS injection presentations (i.e., vial, prefilled syringe, autoinjector) see Dosage and Administration (2.6).
2.2 Adult Patients with Chronic Hepatitis C
Dosage in Adults with CHC without HIV Coinfection
Table 1 displays the recommended dosage and duration of PEGASYS and other HCV antiviral drugs in adults with CHC (without HIV coinfection) based on HCV genotype.
For treatment of HCV genotype 1 with PEGASYS in combination with ribavirin or alone, discontinuation of treatment is recommended if at least a 2 log10 reduction from baseline in HCV RNA has not been demonstrated by 12 weeks of therapy or if undetectable HCV RNA has not been achieved after 24 weeks of therapy [see Clinical Studies (14)]. Refer to the prescribing information for specific HCV antiviral drugs used in combination with PEGASYS for information on stopping therapy based on treatment response.
Immediately discontinue PEGASYS for hepatic decompensation (Child-Pugh score greater than 6 [class B and C]).
If PEGASYS monotherapy is used for treatment of CHC, the recommended PEGASYS dosage is 180 mcg via subcutaneous injection in thigh or abdomen once weekly for 48 weeks.
Dosage in Adults with CHC with HIV Coinfection
The recommended PEGASYS dosage in adults with CHC and HIV coinfection is 180 mcg subcutaneously once weekly in the thigh or abdomen. If PEGASYS is used in combination with other antiviral drugs, refer to the prescribing information of the other HCV antiviral drugs for the recommended dosage of the other HCV antiviral drugs and duration of the entire treatment regimen (including PEGASYS). If PEGASYS and ribavirin are used without other HCV antiviral drugs, the recommended duration of therapy is 48 weeks (regardless of HCV genotype).
2.3 Pediatric Patients with CHC
PEGASYS is administered as 180 mcg/1.73 m2 × BSA subcutaneously once weekly, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for pediatric patients with HCV genotype 2 or 3 is 24 weeks and for other HCV genotypes is 48 weeks. Patients who initiate treatment prior to their 18th birthday should maintain the recommended pediatric dosage (not the adult dosage) through the completion of therapy. Refer to the prescribing information of ribavirin for the recommended dosage and duration.
2.4 Adults with Chronic Hepatitis B (CHB)
The recommended PEGASYS dosage in adults with CHB is 180 mcg subcutaneously once weekly in the thigh or abdomen for 48 weeks.
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