Lutathera Adverse Reactions




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Adverse Reactions
Summary of safety profile: The overall safety profile of Lutathera is based on pooled data from patients from clinical trials (NETTER-1 phase III and Erasmus phase I/II Dutch patients) and from compassionate use programs.
The most common adverse reactions in patients receiving Lutathera treatment were nausea and vomiting which occurred at the beginning of the infusion in 58.9% and 45.5% of patients, respectively. The causality of nausea / vomiting is confounded by the emetic effect of the concomitant amino acids infusion administered for renal protection.
Due to the bone marrow toxicity of Lutathera, the most expected adverse reactions were related to haematological toxicity: thrombocytopenia (25%), lymphopenia (22.3%), anaemia (13.4%), pancytopenia (10.2%).
Other very common adverse reactions reported include fatigue (27.7%) and decreased appetite (13.4%).
Tabulated list of adverse reactions: The adverse reactions are listed in Table 12 according to the frequency and the MedDRA System Organ Class (SOC). The frequencies are categorized as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). (See Tables 12a and 12b.)

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Description of selected adverse reactions: Bone marrow toxicity: Bone marrow toxicity (myelo-/hematotoxicity) manifested with reversible / transient reductions in blood counts affecting all lineages (cytopenias in all combinations, i.e., pancytopenia, bicytopenias, isolated monocytopenias - anemia, neutropenia, lymphocytopenia, and thrombocytopenia). In spite of an observed significant selective B-cell depletion, no increase in the rate of infectious complications occurs after PRRT.
Cases of irreversible hematological pathologies, i.e., premalignant and malignant blood neoplasms (i.e., myelodysplastic syndrome and acute myeloid leukemia, respectively) have been reported following Lutathera treatment.
Nephrotoxicity: Lutetium (177Lu) oxodotreotide is excreted by the kidney.
The long-term trend of progressive glomerular filtration function deterioration demonstrated in the clinical studies confirms that Lutathera-related nephropathy is a chronic kidney disease that develops progressively over months or years after exposure. An individual benefit-risk assessment is recommended prior to treatment with Lutathera in patients with mild and moderate renal impairment, for additional details see Dosage & Administration (Table 8) and Precautions. The use of Lutathera is contraindicated in patients with severe kidney failure (see Contraindications).
Hormonal crises: Hormonal crises related to bioactive substances release (probably due to lysis of the neuroendocrine tumour cells) have rarely been observed and resolved after appropriate medical treatment (Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the local reporting system.
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