Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Darzalex

DARZALEX 1800 mg solution for injection · Abschnitt 4.8 · PDF-Seite 43

HOS-134759 · Präparat HOS-097602

The data reflects exposure to DARZALEX subcutaneous formulation (1800 mg) in 1187 patients with multiple myeloma (MM). The data includes 260 patients from a phase III active-controlled study (MMY3012) who received DARZALEX solution for subcutaneous injection as monotherapy, 149 patients from a phase III active-controlled study (MMY3013) who received DARZALEX subcutaneous formulation in combination with pomalidomide and dexamethasone (D-Pd), 351 patients from a phase III active-controlled study (MMY3014) who received DARZALEX subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone (D-VRd), and 197 newly diagnosed multiple myeloma patients for whom transplant was not planned as initial therapy or who were ineligible for transplant from a phase III active-controlled study (MMY3019) who received DARZALEX subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone (D-VRd). The data also reflects three open-label, clinical studies in which patients received DARZALEX solution for subcutaneous injection either as monotherapy (N=31, MMY1004 and MMY1008) and MMY2040 in which patients received DARZALEX solution for subcutaneous injection in combination with either bortezomib, melphalan and prednisone (D-VMP, n=67), lenalidomide and dexamethasone (D-Rd, n=65) or bortezomib, lenalidomide and dexamethasone (D-VRd, n=67). Data reflect exposure to 193 patients with smouldering multiple myeloma at high risk of developing multiple myeloma from a phase III randomised study (SMM3001) in which patients received DARZALEX subcutaneous fomulation as monotherapy. Additionally, data reflect exposure to 193 patients with newly diagnosed AL amyloidosis from a phase III active-controlled study (AMY3001) in which patients received DARZALEX subcutaneous formulation in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd).

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