PEGASYS

PEGASYS® (peginterferon alfa-2a) is a prescription medication that is: -used with other hepatitis C medicines to treat adults with chronic (lasting a long time) hepatitis C and certain types of liver problems -used with a hepatitis C medicine called ribavirin to treat adults and children 5 years and older with chronic hepatitis C and certain types of liver problems -used alone to treat chronic hepatitis C only if you are not able to take other hepatitis C medicines -not recommended to be used alone or with a hepatitis C medicine called ribavirin without additional hepatitis C medicines if you have taken an alpha interferon -not recommended to treat chronic hepatitis C if you have had a solid organ transplant -used to treat adults with chronic hepatitis B virus who show signs that the virus is damaging the liver.

- PEGASYS therapy may cause patients to develop mood or behavioral problems - Some people who take PEGASYS alone or in combination with ribavirin may get heart problems - Stroke or symptoms of a stroke. - Some people taking PEGASYS develop new or worsening autoimmune problems - Some people who take PEGASYS may get an infection. The most common, but less serious, side effects of PEGASYS include: flu-like symptoms, tiredness and weakness, stomach problems, loss of appetite, skin reactions, hair thinning, trouble sleeping.

PEGASYS, peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon (approximate molecular weight [MW] 20,000 daltons) with a single branched bis-monomethoxy polyethylene glycol (PEG) chain (approximate MW 40,000 daltons). The PEG moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli. PEGASYS is a sterile, preservative-free, colorless to light yellow injectable solution administered subcutaneously. Each vial of 180 mcg/mL peginterferon alfa-2a (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.05 mg), benzyl alcohol (10 mg), polysorbate 80 (0.05 mg), sodium acetate trihydrate (2.62 mg), and sodium chloride (8 mg) at pH 6 ± 0.5. Each prefilled syringe of 180 mcg/0.5 mL peginterferon alfa-2a (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5. Each Autoinjector containing 180 mcg/0.5 mL peginteferon alfa-2a (expressed as the amount of interferon alfa-2a), also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5. Each Autoinjector containing 135 mcg/0.5 mL peginteferon alfa-2a (expressed as the amount of interferon alfa-2a), also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5. Because the autoinjectors are designed to deliver the full content, autoinjectors should only be used for patients who need the full dose (180 or 135 mcg). If the required dose is not available in an autoinjector, prefilled syringes, or vials should be used to administer the required dose. The autoinjector is for subcutaneous administration only.