BESREMi 500mcg/mL solution for injection in prefilled syringe

Manufacturer
PharmaEssentia Corporation, Taichung Plant(TAIWAN)

Registraction Number
MAL24066032AZ

Content:
The BESREMi 500mcg/mL solution for injection in a prefilled syringe contains ropeginterferon alfa-2b-njft, which is used for the treatment of adults with polycythemia vera. Each prefilled syringe contains 500 micrograms (mcg) of ropeginterferon alfa-2b-njft in a 1 mL solution.
Indication:
BESREMi (ropeginterferon alfa-2b-njft) is indicated for the treatment of adults with polycythemia vera. Polycythemia vera is a rare blood cancer characterized by the overproduction of red blood cells, which can lead to blood clots, strokes, and other complications.
Instructions:

1. Starting Dose: 100 mcg by subcutaneous injection every 2 weeks.
2. Dose Titration: Increase the dose by 50 mcg every 2 weeks, up to a maximum of 500 mcg, until hematological parameters are stabilized.
3. Maintenance Dose: Once stabilized, maintain the dose and interval that achieved stability.
4. Monitoring: Regular blood counts should be performed every 2 weeks during titration and every 3-6 months during maintenance.