The peg moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Each vial of 1 ml solution contains 180 micrograms peginterferon alfa2a. It is not known whether interferon alfa 2a passes into breast milk. Pegasys peginterferon alfa2a, 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.
Nov 08, 2019 pegasys peginterferon alfa2a injection is a sterile, preservativefree, colorless to slightly yellowish solution administered subcutaneously. Interferon alfa, when used in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. Interferon alfa2a is produced biosynthetically using recombinant dna technology and is the product of a cloned human leukocyte interferon gene. List of drug approvals by the medicines control council in south africa containing interferon alfa 2a on. How is this medicine peginterferon alfa2a best taken. Interferon alfa2a south africa drug approvals medicines. Peginterferon alfa 2a, also known as pegylated interferon alfa 2a, is a covalent conjugate of recombinant alfa 2a interferon with a single branched bismonomethoxy polyethylene glycol peg chain. Interferon alfa2b side effects, dosage, interactions. Peginterferon alfa2b is also approved to treat chronic hepatitis c. Pegasys is often used together with another medication called ribavirin copegus, rebetol, ribapak, ribasphere, ribatab.
Pegasys in combination with ribavirin is indicated for the treatment of chc in treatment. Interferon alfa 2b is commonly prescribed in a kit with ribavirin. Comparison of peginterferon alfa2a and alfa2b for treatment. Compared to other interferon alfa subtypes, interferons alfa 2a and 2b both have a deletion at position 44 in the amino acid sequence. Use peginterferon alfa2a as ordered by your doctor.
Peginterferon alfa2b pegintron treatment hepatitis c. This means that it is not known whether interferon alfa 2a will be harmful to an unborn baby. Pediatric patients treated with peginfalfa2a plus ribavirin showed a delay in weight and height increases. Interferon alfa2b is commonly prescribed in a kit with ribavirin. It is not known if peginterferon can cure hepatitis c virus infections permanently eliminate the virus from your body. A total of 16,349 patients were recorded in the japanese interferon database. Asia, suggesting that viral hepatitis is a major driver of significant morbidity in low.
Pegasys, peginterferon alfa2a, is indicated for the treatment of adults with chronic hepatitis c who have compensated liver disease and have not been previously treated with interferon alfa. Pegasys 90mcg solution for injection in prefilled syringe. Compared to other interferon alfa subtypes, interferons alfa2a and 2b both have a deletion at position 44 in the amino acid sequence. Food and drug administration fda for the treatment of chronic hepatitis b virus infection and chronic hepatitis c virus infection. Interferon alfa 2a is in the fda pregnancy category c. In study 6 n526, subjects received either roferona 6 miu three times a week for 12 weeks followed by 3 miu three times a week for 36 weeks or pegasys 180 mcg once weekly. Interferon alfa2a is produced using recombinant dna technology in which a cloned human leukocyte interferon gene is inserted into and expressed in escherichia coli. It is not known whether interferon alfa2a passes into breast milk. It is given by injection under the skin side effects are common. Peginterferon alfa2a is used to treat chronic hepatitis b or. It is used as adjuvant therapy in patients who have had surgery to remove cancer that has spread to the lymph nodes. Peginterferon alfa 2a may cause or worsen the following conditions, which may be serious or cause death. It is a manmade form of a natural substance called interferon. Genetic variants in ifnl3 are associated with increased response higher sustained virological response rate to.
Peginterferon alfa 2a works by helping the immune system fight the hepatitis b and c virus, and by making it harder for the virus to reproduce within the body. Pegasys 90mcg solution for injection in prefilled syringe summary. Peg interferon alpha pegifn 2a and 2b, or pegifn alpha, in combination with ribavirin, is used to treat hepatitis c virus hcv infection. Excipient information presented when available limited, particularly for generics. In study 5 n630, subjects received either roferona interferon alfa 2a 3 miu three times a week, pegasys 5 mcg once weekly or pegasys 180 mcg once weekly. Interferon alfa2a article about interferon alfa2a by the. Pegasys, peginterferon alfa2a, is a covalent conjugate of recombinant alfa2a interferon approximate molecular weight mw 20,000 daltons with a single branched bismonomethoxy polyethylene glycol peg chain approximate mw 40,000 daltons. Pegasys injection contains the active ingredient peginterferon alfa 2a, which is a type of medicine called an immunomodulator. Pegylated interferonalfa2a induces complete hematologic. After application of the exclusion criteria, 12,706 patients 3,578 1,710 males, 1,868 females on pegifn alfa2a. Single use syringe peginterferon alfa 2a pegasys photo. Interferons alfa2a and 2b differ at amino acid position 23.
It is used to treat chronic hepatitis b and chronic hepatitis c, which are diseases of the liver. Side effects of pegasys peginterferon alfa2a, warnings. Peginterferon alfa2a is made from human proteins that help the body fight viral infections. Pegylated interferonalfa2a induces complete hematologic and. Interferon alfa2a is fda approved to treat people who have hairy cell leukemia and philadelphia chromosome positive chronic myeloid leukemia who are minimally pretreated within 1 year of diagnosis. The subject will be randomized into one of two study regimens, either pegylated interferon alfa2a pegasys or aspirin and hydroxyurea also called hydroxycarbamide. This use is approved for the sylatron brand of peginterferon alfa2b. Interferon alfa2a article about interferon alfa2a by. Dailymed pegasys peginterferon alfa2a injection, solution. Peginterferon alfa2a, is a covalent conjugate of recombinant alfa2a interferon approximate molecular weight mw 20,000 daltons with a single branched bismonomethoxy polyethylene glycol peg chain approximate mw 40,000 daltons.
Pegasys peginterferon alfa 2a is made from human proteins that help the body fight viral infections used to treat chronic hepatitis b or c. In some cases, health care professionals may use the trade names intron a, roferona or other names such as ifnalpha and alpha interferon when referring to the generic drug name interferon alfa. Pegasys peginterferon alfa2a information for patients genentech. Interferon is a protein that modifies the response of the bodys immune system to help fight infections and severe diseases. For information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys. Peginterferon alfa2b wikimili, the best wikipedia reader. Pegylated interferon alfa 2a, sold under the brand name pegasys among others, is medication used to treat hepatitis c and hepatitis b. Nov 09, 2018 interferon alfa 2b is made from human proteins. The apparent clearance of peginterferon alfa2a was similar between subjects with esrd and subjects with normal renal function. Interferon alfa2a definition of interferon alfa2a by.
The biologic activity of peginterferonalfa2b derives from its interferon alfa2b moiety, which impacts both adaptive and innate immune responses against hepatitis c virus. The biologic activity of peginterferon alfa 2b derives from its interferon alfa 2b moiety, which impacts both adaptive and innate immune responses against hepatitis c virus. They may include headache, feeling tired, depression. The strength indicates the quantity of the interferon alfa 2a moiety of peginterferon alfa2a without consideration of the pegylation. Peginterferon alfa 2a is also used to treat chronic hepatitis b infection. Despite a lower exposure to peginterferon alfa2a with the 5 mcg dose, subjects with esrd had a high rate of adverse events and discontinuations of pegasys in the trial. The first study is designed to provide clinical data on the use of victrelis boceprevir, an oral hcv ns34a protease inhibitor, in combination with mericitabine ro5024048, roches investigational oral hcv ns5b nucleoside polymerase inhibitor, pegasys pegylated interferon alfa 2a and copegus ribavirin, in adult patients with chronic hcv genotype 1 infection who had a null response to. The active substance, peginterferon alfa2a, is a covalent conjugate of the protein. Pegasys peginterferon alfa2a is made from human proteins that help the body fight viral infections used to treat chronic hepatitis b or c. Pediatric patients treated with peginf alfa 2a plus ribavirin showed a delay in weight and height increases. Peginterferon alfa2a wikimili, the free encyclopedia. This use is approved for the sylatron brand of peginterferon alfa 2b.
For hepatitis c it is typically used together with ribavirin and cure rates are between 24 and 92%. Roche pharmaceuticals, basel, switzerland was given by subcutaneous injection at a dose of 180. Interferon alfa2b definition of interferon alfa2b by. Peginterferon alfa2a peg in ter feer on al fa too aye brand name. Peginterferon alfa2a, injection, single use prefilled. It is sometimes called consensus interferon because it is a combination of interferon alfa 2a roferona or pegasys in the pegylated form and interferon alfa2b intron a or pegintron in the pegylated form.
Drug approvals by the medicines control council in south africa containing interferon alfa2a. Peginterferon alfa2a, also known as pegylated interferon alfa2a, is a covalent conjugate of recombinant alfa2a interferon with a single branched bismonomethoxy polyethylene glycol peg chain. After application of the exclusion criteria, 12,706 patients 3,578 1,710 males, 1,868 females on pegifn alfa 2a. The study subject will be followed for their condition for about 5 years. Pegasys, peginterferon alfa 2a, is a covalent conjugate of recombinant alfa 2a interferon approximate molecular weight mw 20,000 daltons with a single branched bismonomethoxy polyethylene glycol peg chain approximate mw 40,000 daltons.
Indication pegasys peginterferon alfa2a, 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. The pbac accepted the submissions nomination of lamivudine as the main comparator. It was developed at biogen, and ultimately marketed by scheringplough under the trade name introna. Andrew karpenko, university of washington figure 3. Interferon alpha is the generic name for the trade name drugs intron a, roferona. This means that it is not known whether interferon alfa2a will be harmful to an unborn baby. The subject will be randomized into one of two study regimens, either pegylated interferon alfa 2a pegasys or aspirin and hydroxyurea also called hydroxycarbamide. Injection, interferon, alfa2a, recombinant, 3 million units drugs administered other than oral method, chemotherapy drugs j92 is a valid 2020 hcpcs code for injection, interferon, alfa2a, recombinant, 3 million units or just interferon alfa2a inj for short, used in immunosuppressive drugs. The subject must be newly diagnosed or already receiving treatment for either pv or et.
Side effects of pegasys peginterferon alfa2a, warnings, uses. Dec 14, 2010 the study subject will be followed for their condition for about 5 years. The active substance, peginterferon alfa2a, is a covalent conjugate of the protein interferon alfa 2a produced by recombinant dna technology in escherichia coli with bismonomethoxy polyethylene glycol. Interferon alfa2b is an antiviral or antineoplastic drug. Peginterferon alfa2a pegasys, hoffmannla roche 180 mcg as vial or. Drugs administered other than oral method, chemotherapy drugs j92 is a valid 2020 hcpcs code for injection, interferon, alfa2a, recombinant, 3 million units or just interferon alfa2a inj for short, used in immunosuppressive drugs j92 has been in effect since 01012019. Pegasys, innpeginterferon alfa2a european medicines agency. Interferons alfa 2a and 2b differ at amino acid position 23. Interferon alfa2a is produced using recombinant dna technologyin which a cloned human leukocyte interferon gene is inserted into and expressed in escherichia coli. This medication reduces the amount of hepatitis c virus in the body and helps the bodys immune system fight the infection. This medicine has similar actions to natural interferons and is used to treat aidsrelated kaposis sarcoma, certain types of hepatitis or certain cancers. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is a recombinant form of the protein interferon alpha2 that was originally sequenced and produced recombinantly in e. Pegylated interferon alpha 2a world health organization. Peginterferon alfa 2a belongs to the class of medications known as interferons. Peginterferon alfa 2b consists of interferon alfa 2b covalently linked to a 12kd linear polyethylene glycol peg. The first study is designed to provide clinical data on the use of victrelis boceprevir, an oral hcv ns34a protease inhibitor, in combination with mericitabine ro5024048, roches investigational oral hcv ns5b nucleoside polymerase inhibitor, pegasys pegylated interferon alfa2a and copegus ribavirin, in adult patients with chronic hcv genotype 1 infection who. Peginterferon alfa2a oel fastrac with ade affygility. Single use syringe peginterferon alfa2a pegasys photo.
Peginterferon alfa2a is also used to treat chronic hepatitis b infection. Pegasys is a sterile, preservativefree, colorless to. While this reaction may improve zidovudines effectiveness, it also may increase the risk of blood and liver toxicity. Pegasys peginterferon alfa2a package leaflet l03ab11. Peginterferon alfa2b consists of interferon alfa2b covalently linked to a 12kd linear polyethylene glycol peg. Peginterferon alfa2a injection pegasys side effects. A box containing 180 mcg per 1 ml solution in a singledose vial. Peginterferon alfa2a pegasys treatment hepatitis c online. Pegasys contains the active substance peginterferon alfa 2a, which is a longacting interferon. Interferons help your bodys immune system respond to bacteria, viruses, cancer, or other invading substances.
Interferon alfa2a, interferon alfa2b, peginterferon beta1a, and interferon beta1b may increase blood levels of zidovudine azt, retrovir. Peginterferon alfa2a side effects, dosage, interactions. Therefore, the dose of zidovudine may need to be reduced by as much as 75%. After treatment has ended, normal hair growth should return. Infergen is not yet available in the pegylated form. Pegasys contains the active substance peginterferon alfa2a, which is a longacting interferon. Peginterferon alfa 2b is also approved to treat chronic hepatitis c. Peginterferon alpha pegifn 2a and 2b, or pegifn alpha, in combination with ribavirin, is used to treat hepatitis c virus hcv infection. Ribavirin and interferon alfa2a for severe middle east. Interferon alfa2a is in the fda pregnancy category c.
This is the same patient assistance program for the genetech manufactured ribavirin copegus. Interferon alfa 2a is produced biosynthetically using recombinant dna technology and is the product of a cloned human leukocyte interferon gene. Peginterferon alfa2a would provide an alternative first line treatment to lamivudine and interferon alfa2a in the treatment of chronic hepatitis b infection. Find patient medical information for interferon alfa2a injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Natural interferons are produced in the body to help the immune system fight viral infections and certain cancer growths. The peg moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to. Randomized trial of pegylated interferon alfa2a versus. Baseline characteristics were generally similar between patients who received ribavirin and interferon alfa2a therapy and those who did not, with the exception that endstage renal failure was present in three patients who did not receive study treatment and in none who did. Pharmaceutical benefits scheme pbs peginterferon alfa2a. Interferon alfa 2b is an antiviral or antineoplastic drug. Some people respond better to 2a and some to 2b, so. Peginterferon alfa2b pegintron treatment hepatitis c online. Women must use birth control while taking peginterferon alfa2a.
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