LUTATHERA® (lutetium [177Lu] oxodotreotide) Safety Information [1]
LUTATHERA® (lutetium [177Lu] oxodotreotide) Safety Information
LUTATHERA® has a well understood safety profile1
The overall safety profile is based on pooled data from clinical trials (NETTER-1 pivotal Phase III and ERASMUS long-term Phase I/II), and compassionate use programmes.
The most common adverse events observed were nausea (58.9%) and vomiting (45.5%).1
- The causality of nausea and vomiting is confounded by the emetic effect of the concomitant amino acid infusion administered for renal protection
- In NETTER-1, most cases of nausea and vomiting were low grade, and resolved once the amino acid infusions were completed2
Due to the bone marrow toxicity of LUTATHERA®, the most expected adverse reactions were related to haematological toxicity:1
- Thrombocytopenia (25%)
- Lymphopenia (22.3%)
- Anaemia (13.4%)
- Pancytopenia (10.2%)
Other very common adverse reactions reported include:1
- Fatigue (27.7%)
- Decreased appetite (13.4%)