Difference between revisions of "Peginterferon alfa-2b (Sylatron)"
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*2001-01-19: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm FDA approved] (as PegIntron) for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.<ref name="pegintron"></ref> | *2001-01-19: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm FDA approved] (as PegIntron) for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.<ref name="pegintron"></ref> | ||
*2011-03-29: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm249263.htm FDA approved] for the adjuvant treatment of [[melanoma]] with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. ''(Based on EORTC 18991)'' | *2011-03-29: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm249263.htm FDA approved] for the adjuvant treatment of [[melanoma]] with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. ''(Based on EORTC 18991)'' | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2015-05-26: new additional indication and a new dosage for the adjuvant treatment of [[melanoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' SCH 54031 | *'''Code name:''' SCH 54031 | ||
Revision as of 19:20, 9 June 2023
Note: Merck has announced plans to discontinue Sylatron by December 2019 for business reasons.
General information
Class/mechanism: Immune system activator; binds to human type 1 interferon, activating downstream intracellular signal transduction pathways initially mediated by the JAK/STAT pathway. Also has been seen to activate NFκB (NF kappa B) in many cell types. Interferon α-2b activates multiple biologic effects which are not fully understood. Pegylation results in a longer half-life compared to Interferon alfa-2b (Intron-A).[1][2][3][4][5][6]
Route: SC
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it was used
Patient drug information
- Peginterferon alfa-2b (Sylatron) patient drug information (Chemocare)[7]
- Patient counseling information can be found on page 11 of the Peginterferon alfa-2b (Sylatron) package insert[1]
- Peginterferon alfa-2b (Sylatron) patient drug information (UpToDate)[8]
History of changes in FDA indication
- 2001-01-19: FDA approved (as PegIntron) for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.[4]
- 2011-03-29: FDA approved for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. (Based on EORTC 18991)
History of changes in PMDA indication
- 2015-05-26: new additional indication and a new dosage for the adjuvant treatment of melanoma.
Also known as
- Code name: SCH 54031
- Generic names: PEG-IFN alfa-2b, pegylated interferon alfa-2b, polyethylene glycol IFN-A2b, polyethylene glycol interferon alfa-2b
- Brand names: PEG-Intron, PegIntron, Sylatron, ViraferonPeg
References
- ↑ 1.0 1.1 1.2 Peginterferon alfa-2b (Sylatron) package insert
- ↑ Peginterferon alfa-2b (Sylatron) package insert (locally hosted backup)
- ↑ Sylatron manufacturer's website
- ↑ 4.0 4.1 Peginterferon alfa-2b (PegIntron) package insert
- ↑ Peginterferon alfa-2b (PegIntron) package insert (locally hosted backup)
- ↑ PegIntron manufacturer's website
- ↑ Peginterferon alfa-2b (Sylatron) patient drug information (Chemocare)
- ↑ Peginterferon alfa-2b (Sylatron) patient drug information (UpToDate)