Poteligeo

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available. Posology The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes.

Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. POTELIGEO should be administered within 2 days of the scheduled day.

If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days. Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion.

If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions. Dose modification Dermatologic reactions Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.

• In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), treatment with mogamulizumab must be interrupted and the rash should be treated appropriately until rash improves to Grade 1 or less (mild severity), at which time mogamulizumab treatment may be resumed.

4). Infusion-related reactions • The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated. The infusion rate should be reduced by at least 50% when re-starting the infusion after symptoms resolve.

4). 4). Special populations Paediatric population The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years have not been established. No data are available. 2). 2). Hepatic impairment Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment.

2). Method of administration POTELIGEO is for intravenous use. It should be administered by intravenous infusion only, over at least 60 minutes. See above recommendations in case of infusion-related reaction. 6.

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.

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 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 Blood and lymphatic system disorders Common Anaemia, neutropenia, leukopenia, Thrombocytopenia Endocrine disorders Common Hypothyroidism Gastrointestinal disorders Very common Constipation, diarrhoea, nausea, stomatitis Common Vomiting Common Colitis General disorders and administration site conditions Very common Fatigue, oedema peripheral, pyrexia Hepatobiliary disorders Uncommon Hepatitis acute, hepatitis Infections and infestations Very common Infectionsa Common Upper respiratory tract infection Injury, poisoning and procedural complications Very common Infusion related reaction Investigations Common Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased Metabolism and nutrition disorders Uncommon Tumour lysis syndrome Nervous system disorders Very common Headache Skin and subcutaneous tissue disorders Very common Drug eruption (including skin rash) Not known Granulomab a Folliculitis, Cellulitis, Candidiasis, Pneumonia, Sepsis, Skin infection, Otitis externa, Herpes zoster, Staphylococcal skin infection, Urinary tract infection, Herpes simplex and cytomegalovirus b Including cases of granuloma of the skin (scalp, periauricular area, and trunk) and bone (sternum, skull, spine, costa, and pelvis).

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. 2 for dose modification information. 4 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. 2 for pre- medication and dose modification information. Infections Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.

1.