Minjuvi · 4.1 Therapeutic indications · 1

HOS-099663 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile Patients with relapsed or refractory DLBCL The safety of tafasitamab in patients with DLBCL was evaluated in the open-label, multicentre, single- arm phase 2 study L-MIND in 81 patients with relapsed or refractory DLBCL. Patients received tafasitamab 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. The median duration of exposure to tafasitamab was 7.7 months. The most common adverse reactions were: infections (73%), neutropenia (51%), asthenia (40%), anaemia (36%), diarrhoea (36%), thrombocytopenia (31%), cough (26%), oedema peripheral (24%), pyrexia (24%), decreased appetite (22%). The most common serious adverse reactions were infection (26%) including pneumonia (7%), and febrile neutropenia (6%). Permanent discontinuation of tafasitamab due to an adverse reaction occurred in 15% of patients. The most common adverse reactions leading to permanent discontinuation of tafasitamab were infections and infestations (5%), nervous system disorders (2.5%), and respiratory, thoracic and mediastinal disorders (2.5%). The frequency of dose modification or interruption due to adverse reactions was 65%. The most common adverse reactions leading to tafasitamab treatment interruption were blood and lymphatic system disorders (41%). Patients with relapsed or refractory FL after at least one line of systemic therapy The safety of tafasitamab in patients with FL was evaluated in the randomised, double-blind, placebo- controlled multicenter phase 3 study inMIND in 652 patients, including 546 participants with relapsed or refractory (R/R) follicular lymphoma and 106 participants with R/R marginal zone lymphoma. Patients received tafasitamab 12 mg/kg (n = 327) or placebo (n = 325) intravenously in combination with rituximab 375 mg/m2 intravenously (for a maximum of 5 cycles) and lenalidomide 20 mg orally (for a maximum of 12 cycles). Tafasitamab treatment was stopped after 12 cycles. Among patients who received tafasitamab, 83% were exposed for 6 months or longer. The median duration of exposure to tafasitamab was 322 days. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%) and

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HOS-099659 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099658 · has-indication-information · PDF-Seite 2

MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). MINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.

HOS-099661 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed.

HOS-099662 · has-pregnancy-information · PDF-Seite 7

Treatment with tafasitamab in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded. Please also refer to the SmPC of lenalidomide. Women of childbearing potential/Contraception in females Women of childbearing potential should be advised to use effective contraception during and for at least 3 months after end of treatment with tafasitamab. Pregnancy Reproductive and developmental toxicity studies have not been conducted with tafasitamab. There are no data on the use of tafasitamab in pregnant women. However, IgG is known to cross the placenta and tafasitamab may cause foetal B-cell depletion based on the pharmacological properties (see section 5.1). In case of exposure during pregnancy, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant’s B-cell count has recovered (see section 4.4). Tafasitamab is not recommended during pregnancy and in women of childbearing potential not using contraception. Lenalidomide can cause embryo-foetal harm and is contraindicated for use in pregnancy and in women of childbearing potential unless all of the conditions of the lenalidomide pregnancy prevention programme are met. Breast-feeding It is not known whether tafasitamab is excreted in human milk. However, maternal IgG is known to be excreted in human milk. There are no data on the use of tafasitamab in breast-feeding women and a risk for breast-feeding children cannot be excluded. Women should be advised not to breast-feed during and for at least 3 months after the last dose of tafasitamab. Fertility No specific studies have been conducted to evaluate potential effects of tafasitamab on fertility. No adverse effects on male and female reproductive organs were observed in a repeat-dose toxicity study in animals (see section 5.3).

HOS-099660 · has-warning-information · PDF-Seite 5

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions Infusion-related reactions may occur and have been reported more frequently during the first infusion (see section 4.8). Patients should be monitored closely throughout the infusion. Patients should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion-related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion. Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted (see section 4.2). 5 Myelosuppression Treatment with tafasitamab can cause serious and/or severe myelosuppression including neutropenia, thrombocytopenia and anaemia (see section 4.8). Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. Based on the severity of the adverse reaction, tafasitamab infusion should be withheld (see Table 1). Refer to the lenalidomide SmPC for dosage modifications. Neutropenia Neutropenia, including febrile neutropenia, has been reported during treatment with tafasitamab. Administration of granulocyte colony-stimulating factors (G-CSF) should be considered, in particular in patients with Grade 3 or 4 neutropenia. Any symptoms or signs of developing infection should be anticipated, evaluated and treated. Thrombocytopenia Thrombocytopenia has been reported during treatment with tafasitamab. Withholding of concomitant medicinal products that may increase bleeding risk (e.g. platelet inhibitors, anticoagulants) should be considered. Patients should be advised to report signs or symptoms of bruising or bleeding immediately. Infections Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with tafasitamab. Tafasitamab should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their he

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