Myborte Adverse Reactions

Summary of the safety profile: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Tabulated summary of adverse reactions: Multiple myeloma: Adverse reactions are listed as follows by system organ class and frequency grouping. Frequencies are defined as: Very common; common; uncommon; rare; very rare, not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 5 has been generated using Version 14.1 of the MedDRA. (See Table 5.)

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Mantle Cell Lymphoma (MCL): The safety profile of bortezomib in patients treated with bortezomib at 1.3 mg/m² in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Bortezomib-R-CAP) versus patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described as follows. Additional adverse drug reactions identified associated with the use of the combination therapy (Bortezomib-R-CAP) were hepatitis B infection and myocardial ischaemia. The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone. Very common incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders were seen with patients in the multiple myeloma.
Adverse drug reactions identified as those with common incidence, similar or higher incidence in the bortezomib-R-CAP arm and with at least a possible or probable causal relationship to the components of the bortezomib-R-CAP arm, are listed in Table 6 as follows. Also included are adverse drug reactions identified in the bortezomib-R-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Adverse reactions are listed as follows by system organ class and frequency grouping. Frequencies are defined as: Very common; common; uncommon; rare; very rare; not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 6 has been generated using Version 16 of the MedDRA. (See Table 6.)

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Description of selected adverse reactions: Retreatment of patients with relapsed multiple myeloma: Bortezomib retreatment was administered in patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in patients were thrombocytopenia, neuropathy, anaemia, diarrhoea, and constipation. All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed.