Elzonris · 4.8 Undesirable effects · 1

HOS-287643 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The most serious adverse reaction that may occur during ELZONRIS treatment is CLS (see sections 4.2 and 4.4) which was reported in 18% of patients with a median time to onset of CLS of 6 days. Adverse reactions occurring in ≥ 20% of patients treated with ELZONRIS were hypoalbuminemia, increased transaminases, thrombocytopenia, nausea, fatigue and pyrexia. Adverse reactions grade 3 and above according to the Common Terminology Criteria for Adverse events (CTCAE) and occurring in > 5% of patients were increased transaminases, thrombocytopenia and anaemia. Tabulated list of adverse reactions The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level. Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100). The adverse reactions described in this section were identified in clinical studies of patients with haematologic malignancies (N=176), including 89 patients with BPDCN. In these studies, ELZONRIS was administered as monotherapy at doses of 7 mcg/kg (12/176, 7%), 9 mcg/kg (9/176, 5%) and 12 mcg/kg (155/176, 88%). Incidence and severity of adverse reaction in patients with BPDCN were similar to those of the entire studied population. 7 Table 3: Tabulated list of adverse reactions by MedDRA System Organ Class MedDRA System Frequency of CTCAE grade 3 and Frequency of all CTCAE grades Organ Class above Infections and Common None infestations Cellulitis Uncommon Pneumonia Urinary tract infection Gingivitis Blood and lymphatic Very Common Very Common system disorders Thrombocytopenia Thrombocytopenia Anaemia Common Common Febrile neutropenia Febrile neutropenia Anaemia Neutropenia Neutropenia Leukopenia Leukopenia Leukocytosis Lymphopenia Lymphope

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HOS-287639 · has-contraindication-information · PDF-Seite 5

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

HOS-287638 · has-indication-information · PDF-Seite 2

ELZONRIS is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (see section 5.1).

HOS-287641 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed.

HOS-287642 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential/Contraception 6 In women of childbearing potential, a negative pregnancy test should be obtained within 7 days prior to initiation of therapy. Effective contraception should be used before the first dose is administered and for at least one week after the last dose. Pregnancy There are no data from the use of ELZONRIS in pregnant women. Animal reproduction studies have not been conducted with tagraxofusp (see section 5.3). ELZONRIS should not be used during pregnancy unless the clinical condition of the woman requires treatment with tagraxofusp. Breast-feeding It is unknown whether tagraxofusp/metabolites are excreted in human milk. A risk to breast-feeding newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with ELZONRIS and for at least one week after the last dose. Fertility No fertility studies have been conducted with tagraxofusp (see section 5.3). There are no data on the effect of tagraxofusp on human fertility.

HOS-287640 · 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. Capillary leak syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases have been reported with most events occuring during the first five days of the first cycle of treatment. The most frequent signs and symptoms of CLS included weight increased, hypoalbuminemia and hypotension. The incidence of weight increased, hypoalbuminemia, hypotension, and blood alkaline phosphatase increased are all higher among patients who experienced CLS compared to patients that did not experience CLS. Renal failure and acute kidney injury have been reported in two patients with BPDCN and in one patient with AML secondary to CLS (see section 4.8). Before initiating therapy, ensure that the patient has adequate cardiac function and serum albumin ≥ 3.2 g/dL. During treatment, regularly monitor serum albumin levels prior to the initiation of each dose, or more often as clinically indicated. Additionally, assess patients for other signs/symptoms of CLS including weight gain, new onset or worsening oedema, including pulmonary oedema, and hypotension including haemodynamic instability (see Table 2). Patients should be made aware of identifying CLS symptoms and when to seek immediate medical attention. Intravenous albumin supplementation and dosing interruptions may be required (see section 4.2). Hypersensitivity reactions Severe hypersensitivity reactions have been reported with ELZONRIS. Commonly reported reactions include rash (generalised / maculo-papular); wheezing; pruritus; angioedema; swelling face; and flushing (see section 4.8). Monitor patients for hypersensitivity reactions during treatment. Depending on the severity and the required interventions, temporarily withhold treatment and resume after symptoms have resolved (see section 4.2). 5 Haematological abnormalities Thrombocytopenia and neutropenia have been reported in patients treated with ELZONRIS monotherapy (see section 4.8). The majority of events were reported in cycle 1 and cycle 2 of treatment, were not dose-limiting and did not recur in subsequent cycles. Patients should be routinely monitored and treated as clinically indicated. Tumour lysis syndrome ELZONRIS can cause tumour lysis syndrome (TLS), which may be fatal as a result of its rapid anti-tumour activi

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