Myborte Adverse Reactions

Summary of the safety profile: Serious adverse reactions uncommonly reported during treatment with MYBORTE 1.0MG 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 MYBORTE 1.0MG 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: Undesirable effects in Table 8 were considered to have at least a possible or probabale causal relationship to BORTEZOMIB. Overall, BORTEZOMIB was administered for the treatment of 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. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Tables 8a and 8b.)

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Mantle Cell Lymphoma (MCL): 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. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 9.)

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Description of selected adverse reactions: Herpes zoster virus reactivation: Multiple myeloma: The incidence of herpes zoster among patients in the Vc+M+P treatment was higher for patients not administered antiviral prophylaxis compared to patients administered antiviral prophylaxis.
Mantle cell lymphoma: The incidence of herpes zoster among patients in the VcR-CAP was higher for patients not administered antiviral prophylaxis compared to patients administered antiviral prophylaxis.
Hepatitis B Virus (HBV) reactivation and infection: Mantle cell lymphoma: The overall incidence of hepatitis B infections was similar in patients treated with VcR-CAP or with R-CHOP.
Peripheral neuropathy in combination regimens: Multiple Myeloma: Where MYBORTE 1.0MG was administered as induction treatment in combination with dexamethasone, and dexamethasone-thalidomide, the incidence of peripheral neuropathy in the combination regimens is presented in Table 10: See Table 10.

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Mantle cell lymphoma: Where BORTEZOMIB was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in Table 11: See Table 11.

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Elderly MCL patients: Although in patients aged ≥75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was higher compared to R-CHOP group.
Retreatment of patients with relapsed multiple myeloma: Where 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.