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Prescribing Information
Adverse Event Reporting
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This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
Myelosuppression
Treatment with ZYNLONTA can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anaemia. Grade 3 or 4 neutropenia occurred in 24.2%, Grade 3 or 4 thrombocytopenia in 15.8%, and Grade 3 or 4 anaemia in 11.6% of patients. Febrile neutropenia occurred in 3.3% of patients. Thrombocytopenia and neutropenia led to discontinuation of treatment in 1.9% and 0.5% of patients, respectively. No patients discontinued treatment due to anaemia. Median time to onset for Grade 3 or 4 neutropenia, thrombocytopenia and anaemia was 36.0 days, 28.5 days, and 22.0 days, respectively.
Complete blood cell counts should be monitored prior to each dose of ZYNLONTA. Cytopenias may require more frequent lab monitoring and/or interruption, dose reduction, or discontinuation of ZYNLONTA. Prophylactic granulocyte colonystimulating factor administration should be considered, as applicable.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754.