Active Ingredient: Ropeginterferon alfa-2b
Ropeginterferon alfa-2b is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, between 50 micrograms ropeginterferon alfa-2b and 100 micrograms ropeginterferon alfa-2b, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, between 100 micrograms ropeginterferon alfa-2b and 500 micrograms ropeginterferon alfa-2b, once every 2 weeks, over the duration of 1.5 years. The maximum allowed total dose is 500 micrograms ropeginterferon alfa-2b every 2 weeks.
The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy). The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 × 109/L and leukocytes <10 × 109/L). The maximum recommended single dose is 500 micrograms injected every two weeks. Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.
The dose at which stabilisation of the haematological parameters is achieved should be maintained in a two-week administration interval for at least 1.5 years. After that, the dose may be adapted and/or the administration interval prolonged up to every four weeks, as appropriate for the patient.
If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
If an increase of haematological parameters (haematocrit, platelets, leukocytes) is observed, the dose and/or dosing interval needs to be adapted individually.
The recommended injection site is the abdominal skin around but not within 5 cm of the navel or the thigh. Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred.
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