POTELIGEO

/ Medison

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.
See prescribing information for full details.

Treatment of adult patients with mycosis fungoides (MF) or Sézary
syndrome (SS) who have received at least one prior systemic therapy.

Hypersensitivity to the active substance or to any of the excipients

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, mogamulizumab 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.
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.
Infections
Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation. Topical steroids or low doses of systemic corticosteroids may be used during treatment with mogamulizumab; however, the risk of serious infection and/or viral reactivation may be higher in case of concomitant administration with systemic immunosuppressive agents. 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 hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.
Complications of allogeneic hematopoietic stem cell transplantation (HSCT) after mogamulizumab
Complications, including severe graft versus host disease (GVHD), have been reported in patients with T-cell lymphomas other than MF or SS who received allogeneic HSCT after mogamulizumab.
A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT. Follow patients closely for early evidence of transplant-related complications.
Tumour lysis syndrome
Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab. TLS was observed most frequently during the first month of treatment. Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS. Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice. Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Cardiac disorders
One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab. In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case). The subjects had a medical history including various risk factors. Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
See prescribing information for full details.

Very common: Constipation, diarrhoea, nausea, stomatitis, fatigue, oedema peripheral, pyrexia, infections, infusion related reaction, headache, drug eruption (including skin rash).
Common: Anaemia, neutropenia, leukopenia, thrombocytopenia, hypothyroidism, vomiting, colitis, upper respiratory tract infection, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased.

No interaction studies have been performed

Women of childbearing potential/Contraception in females: Women of childbearing potential should use effective contraception during treatment with this medical product and for at least 6 months after treatment.
Pregnancy: There are no data from the use of mogamulizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Lactation: 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 this medical product could be used during breast-feeding if clinically needed.

There is no information on overdose with mogamulizumab. In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.