Early Success with PEGASYS® (Peginterferon alfa-2a)

PEGASYS® (Peginterferon alfa-2a) for Injection

Long term and short term success begins here

Because we know that the best treatment plan goes beyond medication.

Only PEGASYS offers convenient dosing in a prefilled syringe (PFS), which may help reduce patient error

Pegasys PFS (actual size)

Complex treatment regimens are predictive of poor adherence to medication^1-3
PEGASYS offers precise, fixed dosing and requires no calculations
No need to reconstitute or mix solution
No need to dial adjustments

One standard dose makes prescribing easy

180 mcg qw dose regardless of genotype, weight, or indication

Guide to PEGASYS Prefilled Syringes

Pegasys Prefilled Syringes

Convenience right from the start

The PEGASYS Prefilled Syringes Convenience Pack contains everything a patient needs to inject PEGASYS

4 syringes filled with PEGASYS
4 needles (27 gauge, ½ inch long) with needle guards for added safety
Alcohol swabs

In a recent 9-center study including physicians and 103 patients allocated to therapy with the PEGASYS PFS or PEG-Intron Redipen^®:

PEGASYS PFS was found to be user friendly by more patients

91% (51/56) PEGASYS PFS vs 66% (31/47) Redipen^‡4

PEGASYS PFS had fewer problems reported by providers and patients

Problems with patient self-administration as assessed by physicians:^‡4

13% (7/56) PEGASYS PFS vs 43% (20/47) Redipen

Problems with self-administration as reported by patients:^‡4

4% (2/53) PEGASYS PFS vs 19% (8/42) Redipen

In a large independent study, treatment with PEGASYS was a positive predictor
of SVR

A retrospective, observational, cohort study of US veterans (N=5944) demonstrated that positive predictors of response to treatment of hepatitis C included⁵

Low viral load
Elevated ALT quotient
Treatment with PEGASYS

*Patients in clinical studies including genotypes 1-4 had a better than 50% chance of achieving SVR.
Response to treatment may vary based on genotype and individual factors.
^†Early success—when patients are taught and are able to self-administer the product correctly at the
beginning.
^‡Study participants were given questionnaires concerned with the following aspects of administration:
recording time requirements for patient education and drug administration, as well as documenting handling
difficulties encountered with both formulations.

Redipen is a registered trademark of Schering Corporation.

References:

Osterberg L et al. Adherence to medication. N Engl J Med. 2005;353(5):487-497.
Ammassari A et al. Correlates and predictors of adherence to highly active antiretroviral therapy: overview of published literature. J Acquir Immune Defic Syndr. 2002;31(suppl 3):S123-S127.
Stone VE et al. Antiretroviral regimen complexity, self-reported adherence, and HIV patients’ understanding of their regimens: survey of women in the HER study. J Acquir Immune Defic Syndr. 2001;28(2):124-131.
Janisch HD et al. Economic evaluation of standard-therapy (ST) for chronic hepatitis C (CHC) with peginterferon alfa-2a (40KD) plus ribavirin versus pegylated interferon alfa-2b (12KD) plus ribavirin: ready-to-use syringe (SYR) versus injector (INJ) (SPRINT). Presented at: 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 11-15, 2005; San Francisco, CA.
Backus LI et al. Predictors of response of U.S. veterans to treatment for the hepatitis C virus. Hepatology. 2007;46(1):37-47.

See Patient Self-Administration Video

See Patient Self-Administration Instructions for Prefilled Syringes

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INDICATIONS

PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

Boxed WARNINGS and additional IMPORTANT SAFETY INFORMATION

Alpha interferons, including PEGASYS^® (Peginterferon alfa-2a), 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 therapy.

Use with Ribavirin. Ribavirin, including COPEGUS^®, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal.

PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

AVOIDING PREGNANCY

COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.

WARNINGS

Serious adverse events in hepatitis B and hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema), and peripheral neuropathy (in combination with telbivudine).

Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include dehydration, hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, infections (bacterial, viral and fungal), and serous retinal detachment, and pure red cell aplasia.

MOST COMMON ADVERSE EVENTS

The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection-site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%). In clinical trials of 48-week treatment duration, the adverse event profile of PEGASYS in chronic hepatitis B was similar to that seen in chronic hepatitis C PEGASYS monotherapy use, except for exacerbations of hepatitis. The most common adverse events reported for PEGASYS, observed in clinical studies, were pyrexia (54%), headache (27%), myalgia (26%), fatigue (24%), alopecia (18%) and anorexia (16%).

WARNINGS SPECIFIC TO HEPATITIS C PATIENTS

Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients’ clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score >6) is observed. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.

WARNINGS SPECIFIC TO HEPATITIS B PATIENTS

Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. PEGASYS dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of PEGASYS dose or are accompanied by increased bilirubin or evidence of hepatic decompensation, PEGASYS should be immediately discontinued.

Please see full Prescribing Information, including Boxed WARNINGS for additional Important
Safety Information.

Success† with Pegasys right from the start

Only PEGASYS offers convenient dosing in a prefilled syringe (PFS), which may help reduce patient error

Guide to PEGASYS Prefilled Syringes

Success^† with Pegasys right from the start