Ropeginterferon alfa-2b

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Ropeginterferon alfa-2b
Names
Trade namesBesremi
Other namesAOP2014, ropeginterferon alfa-2b-njft
Clinical data
Drug classInterferon[1]
Main usesPolycythemia vera[2]
Side effectsLow white blood cells, low platelets, muscle and joint pain, tiredness, flu-like symptoms, liver inflammation[3]
Pregnancy
category
  • Contraindicated
Routes of
use
Subcutaneous
Typical dose100 to 500 ug q 2 weeks[2]
External links
AHFS/Drugs.comMonograph
US NLMRopeginterferon alfa-2b
Legal
License data
Legal status

Ropeginterferon alfa-2b, sold under the brand name Besremi, is a medication used to treat polycythemia vera.[2][3] It is used in those with a normal spleen.[3] It is given by injection under the skin.[3]

Common side effects include low white blood cells, low platelets, muscle and joint pain, tiredness, flu-like symptoms and liver inflammation.[3] Other side effects may include allergic reactions, infections, pancreatitis, eye problems, and kidney problems.[2] It should not be used in people with liver problems or severe depression.[2] Use during pregnancy may harm the baby.[2] It is a type of interferon.[1]

Ropeginterferon alfa-2b was approved for medical use in Europe in 2019 and the United States in 2021.[3][2] In the United Kingdom it costs the NHS about £1,800 for 250 mcg as of 2021.[5] This amount in the United States is about 3,600 USD as of 2022.[6]

Medical uses

In the European Union, ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythemia vera without symptomatic splenomegaly.[3] In the United States it is indicated for the treatment of polycythemia vera.[2][4]

Dosage

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.[2]

History

The effectiveness and safety of ropeginterferon alfa-2b were evaluated in a multicenter, single-arm trial that lasted 7.5 years.[4] In this trial, 51 adults with polycythemia vera received ropeginterferon alfa-2b for an average of about five years.[4] 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.[4] Overall, 61% of participants had a complete hematological response.[4] 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[4] 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.[4]

References

  1. 1.0 1.1 Wagner SM, Melchardt T, Greil R (March 2020). "Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera". Drugs of Today. Barcelona, Spain. 56 (3): 195–202. doi:10.1358/dot.2020.56.3.3107706. PMID 32282866. S2CID 215758794.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 "Besremi- ropeginterferon alfa-2b injection". DailyMed. Archived from the original on 19 December 2021. Retrieved 19 December 2021.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "Besremi EPAR". European Medicines Agency (EMA). Archived from the original on 11 July 2022. Retrieved 14 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 "FDA Approves Treatment for Rare Blood Disease". U.S. Food and Drug Administration (FDA) (Press release). 12 November 2021. Archived from the original on 11 July 2022. Retrieved 12 November 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  5. "Ropeginterferon alfa-2b". SPS - Specialist Pharmacy Service. 15 December 2015. Archived from the original on 24 October 2022. Retrieved 24 October 2022.
  6. "Besremi". goodrx. Archived from the original on 24 October 2022. Retrieved 24 October 2022.

External links

Identifiers:
  • "Ropeginterferon alfa-2b". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2022-07-06. Retrieved 2022-01-31.
  • 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