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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.
Overall safety profile now confirmed at 2-years1,2
- In the all-treated population:1
- The most frequent TEAEs were increased GGT, neutropenia and thrombocytopenia
- The most frequent Grade 3 ≥ TEAEs were neutropenia, thrombocytopenia, increased GGT and anaemia
- Most common TEAEs leading to discontinuation:1
- All-treated population: increased GGT (12.4%), peripheral oedema (2.8%), localised oedema (2.1%), and pleural effusion (2.1%)
- CR population: increased GGT (19.4%), peripheral oedema (8.3%), localised oedema (5.6%), and pericardial effusion (5.6%)
- TEAEs were similar between the all-treated population and those patients achieving a CR1
- No deaths were considered to be related to ZYNLONTA1
Long-term safety profile with no new signals reported in the 2-year follow-up1
Full TEAEs table – 2-year analysis
See SmPC for full safety information
▼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.
PP-24864