|Other names||AOP2014, ropeginterferon alfa-2b-njft|
|Main uses||Polycythemia vera|
|Side effects||Low white blood cells, low platelets, muscle and joint pain, tiredness, flu-like symptoms, liver inflammation|
|Typical dose||100 to 500 ug q 2 weeks|
Ropeginterferon alfa-2b, sold under the brand name Besremi, is a medication used to treat polycythemia vera. It is used in those with a normal spleen. It is given by injection under the skin.
Common side effects include low white blood cells, low platelets, muscle and joint pain, tiredness, flu-like symptoms and liver inflammation. Other side effects may include allergic reactions, infections, pancreatitis, eye problems, and kidney problems. It should not be used in people with liver problems or severe depression. Use during pregnancy may harm the baby. It is a type of interferon.
Ropeginterferon alfa-2b was approved for medical use in Europe in 2019 and the United States in 2021. In the United Kingdom it costs the NHS about £1,800 for 250 mcg as of 2021. This amount in the United States is about 3,600 USD as of 2022.
In the European Union, ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythemia vera without symptomatic splenomegaly. In the United States it is indicated for the treatment of polycythemia vera.
It is generally started at a dose of 100 mcg every 2 weeks, which may be increased to 500 mcg every 2 weeks based on blood tests.
The effectiveness and safety of ropeginterferon alfa-2b were evaluated in a multicenter, single-arm trial that lasted 7.5 years. In this trial, 51 adults with polycythemia vera received ropeginterferon alfa-2b for an average of about five years. The effectiveness of ropeginterferon alfa-2b was assessed by looking at how many participants achieved complete hematological response, which meant that participants had a red blood cell volume of less than 45% without a recent phlebotomy, normal white cell counts and platelet counts, a normal spleen size, and no blood clots. Overall, 61% of participants had a complete hematological response. The U.S. Food and Drug Administration (FDA) granted the application for Ropeginterferon_alfa-2b orphan drug designation and granted the approval of Besremi to PharmaEssentia Corporation Ropeginterferon alfa-2b is the first medication approved by the U.S. Food and Drug Administration (FDA) to treat polycythemia vera that people can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera.
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- Clinical trial number NCT01193699 for "Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PEGINVERA)" at ClinicalTrials.gov
- Clinical trial number NCT02218047 for "AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. (CONTI-PV)" at ClinicalTrials.gov