Ropeginterferon alfa-2b (Specialist drug)

INDICATION AND SCOPE: this is the dose for the page's primary identity — subcutaneous ropeginterferon alfa-2b (Besremi) in adult polycythaemia vera, the population this SPC addresses. Polycythaemia vera is named in the fetched text itself: section 4.4 compares the titration phase with hydroxycarbamide 'In a clinical study in polycythaemia vera', and section 4.8 reports reactions 'with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients'. Section 4.1 was not fetched, so no other licensed indication is asserted here. || VERBATIM (SPC posology, titration phase): '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 x 10 9 /L and leukocytes <10 x 10 9 /L). The maximum recommended single dose is 500 micrograms injected every two weeks. Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.' || VERBATIM (maintenance phase): '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.' || DOSE MODIFICATION, verbatim: '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.' || ELDERLY, verbatim: 'Adjustments in the recommended dose for ropeginterferon alfa-2b are not necessary when starting therapy in elderly patients.' RACE: 'No dose adjustment is necessary based on race.' OBESE OR UNDERWEIGHT PATIENTS, verbatim: 'The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients. No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.' || PAEDIATRIC — paedDose is null because the label carries no paediatric dose. SPC posology, verbatim: 'The safety and efficacy of Besremi in children and adolescents has not been established. No data are available.' || TITRATION IS SLOW — section 4.4, verbatim: 'In a clinical study in polycythaemia vera, the end of the mean individual titration phase for ropeginterferon alfa-2b was reached after approximately 3.7 months, for hydroxycarbamide after approximately 2.6 months of treatment. Thus, other products (e.g. hydroxycarbamide) may be preferred in patients for whom an early reduction in elevated blood counts is necessary to prevent thrombosis and bleeding. During the titration phase the efficacy to reduce the cardiovascular and thromboembolic risk of the underlying disease may not be fully established.' || NOT IN THIS BUNDLE: sections 4.4 and 4.8 both end at the source-fetch limit, so the full warnings text and the remainder of the adverse-reaction table were never retrieved; section 4.5 (interactions, other than the section 4.3 telbivudine contraindication) and section 4.1 were not fetched at all. No dose figure has been taken from anything but the section 4.2 text quoted above.