Poteligeo · 4.4 Special warnings and precautions for use · 1

HOS-097919 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis. The most frequently reported adverse reactions were infusion-related reaction and rash (drug eruption); most of these reactions were non-serious and Grades 1 or 2. Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each). Tabulated list of adverse reactions The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from 5 the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1: Adverse drug reactions identified with POTELIGEO System organ class (SOC) Frequency Adverse reaction Anaemia, neutropenia, leukopenia, Blood and lymphatic system disorders Common Thrombocytopenia Endocrine disorders Common Hypothyroidism Very common Constipation, diarrhoea, nausea, stomatitis Gastrointestinal disorders Common Vomiting Common Colitis General disorders and administration site Very common Fatigue, oedema peripheral, pyrexia conditions Hepatobiliary disorders Uncommon Hepatitis acute, hepatitis Very common Infectionsa Infections and infestations Common Upper respiratory tract infection Injury, poisoning and procedural complications Very common Infusion related reaction

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HOS-097915 · has-contraindication-information · PDF-Seite 3

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

HOS-097914 · has-indication-information · PDF-Seite 2

POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

HOS-097917 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed.

HOS-097918 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential/Contraception in females Women of childbearing potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment. Pregnancy There are no data from the use of mogamulizumab in pregnant women. Although mogamulizumab crosses the placental barrier in cynomolgus monkey, apart from the pharmacological effect in foetuses, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy. Breast-feeding It is unknown whether mogamulizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. Afterwards POTELIGEO could be used during breast-feeding if clinically needed. Fertility There are no clinical data available on the effect of mogamulizumab on human fertility. No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility. No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).

HOS-097916 · has-warning-information · PDF-Seite 3

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. Dermatologic reactions Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious. When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes. Patients should be closely monitored for symptoms or signs that suggest SJS or TEN. If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less. If SJS/TEN occur, appropriate medical therapy should be administered. See section 4.2 for dose modification information. 3 Infusion-related reactions Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab. The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3). The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments. Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered. If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. See section 4.2 for pre- medication and dose modification information. Infections Patients with MF or SS treated with mogamulizumab are at increased risk of serious infection (see section 4.8) and/or viral reactivation. Patients should be monitored for signs and symptoms of infection and treated promptly. Patients should be tested for hepatitis B infection before initiating treatment with mogamulizumab. For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of

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