Korjuny

HOS-099955 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions were pyrexia (62%), abdominal pain (42%), nausea (41%), and vomiting (38%). The most serious adverse reactions are systemic inflammatory response syndrome and hepatic failure. Tabulated list of adverse reactions Adverse reactions are derived from an integrated safety analysis of 11 studies including 4 studies in patients with malignant ascites and 7 studies in patients with various other cancers. This includes data from the randomised, controlled main study period from pivotal study IP-REM-AC-01. Of 517 patients included in the analysis, 293 patients received catumaxomab intraperitoneally as 6-hour infusion and 224 patients received catumaxomab intraperitoneally as 3-hour infusion. In Table 2, adverse reactions are listed by MedDRA system organ class. Frequency groupings are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100). Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness. 6 Table 2 Adverse reactions reported from patients receiving catumaxomab treatment System Organ Frequency Adverse reactions Class Infections and Common Infection infestations Uncommon Oral candidiasis, Skin infection, Erythema induratum*, Herpes simplex*, Localised infection*, Pneumonia*, Urinary tract infection* Blood and Common Anaemia, Leukocytosis, Lymphopenia lymphatic Uncommon Coagulopathy*, Leukopenia*, Neutropenia*, system Thrombocytopenia*, Thrombocythaemia disorders Immune system Very common Cytokine release syndrome** disorders Common Systemic inflammatory response syndrome, Hypersensitivity* Metabolism Common Decreased appetite, Dehydration, Hypokalaemia, and nutrition Hyponatraemia, Hypoalbuminaemia, Hyperglycaemia*, disorders Hypocalcaemia*, Hypoproteinaemia* Uncommon Fluid retention*, Hypoglycaemia, Polydipsia, Hypomagnesaemia* Psychiatric Common Anxiety* disorders Uncommon Agitation, Depression* Nervous system Common Dizziness disorders Uncommon Syncope, Tremor, Paraesthesia, Convuls

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HOS-099951 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to murine (rat and/or mouse) proteins.

HOS-099950 · has-indication-information · PDF-Seite 2

Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.

HOS-099953 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed.

HOS-099954 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential Korjuny is not recommended in women of childbearing potential not using contraception. Pregnancy There are no or limited amount of data from the use of catumaxomab in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Korjuny is not recommended during pregnancy. Breast-feeding It is unknown whether catumaxomab/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Korjuny therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No data on the effect of catumaxomab on fertility are available.

HOS-099952 · has-warning-information · PDF-Seite 4

Korjuny must not be administered as a bolus or by any route other than intraperitoneally. Cytokine release related symptoms (CRS) As release of pro-inflammatory and cytotoxic cytokines is initiated by the binding of catumaxomab to immune and tumour cells, cytokine release related clinical symptoms have been reported during and after catumaxomab administration, including events of fever, hypotension, gastrointestinal symptoms, headache, myalgia, arthralgia, tachycardia, chills, respiratory symptoms, skin symptoms, and fatigue. Despite pre-medication (see sections 4.2 and 5.1), patients may experience CRS as described above with an intensity of up to grade 4, (see section 4.8). Patients should be counselled to seek immediate medical attention if signs or symptoms of CRS occur at any time. CRS should be treated as medically indicated and according to the current standard of care. Systemic inflammatory response syndrome (SIRS) Isolated incidence of SIRS (with concurrent fever, increased heart rate and respiratory rate, and abnormal leukocyte count) have been reported during and after treatment with catumaxomab. Patients should be counselled to seek immediate medical attention if signs or symptoms of SIRS occur at any time. SIRS should be treated as medically indicated and according to the current standard of care. Acute infections In presence of factors interfering with the immune system, in particular acute infections, the administration of catumaxomab is not recommended. Patients should be monitored for signs and symptoms of infection, before and after Korjuny administration and treated appropriately. Conditions affecting haemodynamic status of patients Appropriate medical management of ascites drainage is a prerequisite for Korjuny treatment in order to assure stable circulatory and renal functions. This must at least include ascites drainage until stop of spontaneous flow or symptom relief. Blood volume, blood protein, blood pressure, pulse and renal function should be assessed before each Korjuny infusion. Conditions such as hypovolaemia, hypoproteinaemia, hypotension, circulatory decompensation and acute renal impairment must be resolved prior to each Korjuny infusion. 4 Hepatic function No dose adjustment is needed for patients with mild to moderate hepatic impairment. Transient elevations of liver parameters after catumaxomab infusions were observed in clinical studies which subsequently

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