Ropeginterferon Alfa-2b｜Soft Tissue Sarcoma

Ropeginterferon Alfa-2b Application Scope

Ropeginterferon alfa-2b, marketed under the brand name BESREMi, is indicated for the treatment of adults with polycythemia vera (PV), a chronic myeloproliferative neoplasm characterized by the overproduction of red blood cells.

Ropeginterferon Alfa-2b Besremi Package Insert

• Ingredients: Each prefilled syringe contains 500 micrograms (mcg) of ropeginterferon alfa-2b-njft in 1 mL of solution.
• Properties: Ropeginterferon alfa 2b is a long-acting, mono-pegylated interferon that binds to interferon alfa/beta receptors (IFNAR) on body cells, initiating reactions that reduce the bone marrow’s production of red blood cells.
• Specification: 500 mcg/1 mL solution for subcutaneous injection.
• Packaging Specification: Supplied in single-dose prefilled syringes.
• Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
• Expiry Date: Refer to the packaging for the expiration date.
• Executive Standard: Complies with U.S. FDA regulations.
• Approval Number: Biologics License Application (BLA) 761166.
• Date of Revision: November 2021.
• Manufacturer: PharmaEssentia Corporation, 35 Corporate Drive, Suite 325, Burlington, MA 01803, USA.

 

Guidelines for the Use of Ropeginterferon Alfa-2b

• Dosage and Administration:
  • Recommended starting dose: 100 mcg by subcutaneous injection every two weeks (50 mcg if receiving hydroxyurea).
  • Increase the dose by 50 mcg every two weeks (up to a maximum of 500 mcg) until hematological parameters are stabilized.
  • Interrupt or discontinue dosing if certain adverse reactions occur.
• Adverse Reactions:
  • Common adverse reactions (incidence ≥10%) include influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.
• Contraindications:
  • Patients with a history of severe psychiatric disorders, particularly severe depression or suicidal ideation.
  • Patients with hypersensitivity to interferon alfa products or any component of the product.
• Precautions:
  • Monitor patients for signs and symptoms of neuropsychiatric, autoimmune, ischemic, and infectious disorders.
  • Obtain baseline blood counts and liver function tests before initiating treatment and periodically thereafter.
  • Advise females of reproductive potential to use effective contraception during treatment.

Ropeginterferon Alfa-2b Interactions

• Drug Interactions:
  • Concomitant use with other myelosuppressive agents may increase the risk of bone marrow suppression.
  • May potentiate the effects of other interferons and immunosuppressive therapies.
  • Monitor for potential interactions with drugs metabolized by cytochrome P450 enzymes.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.