IntravenousRefractory mycosis fungoides, Refractory Sezary syndrome, Relapsed mycosis fungoides, Relapsed Sezary syndromeAdult: In patients who have received at least 1 prior systemic therapy: 1 mg/kg weekly on Days 1, 8, 15, and 22 of the 1st 28-day cycle, followed by 1 mg/kg every 2 weeks on Days 1 and 15 of each subsequent 28-day cycle. All doses are given via infusion over at least 60 minutes. Continue until disease progression or unacceptable toxicity. Premedicate with diphenhydramine and paracetamol before the 1st infusion and for subsequent treatments if infusion reactions occur during the 1st dose. Dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
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Withdraw the required volume into a syringe and transfer into an infusion bag of NaCl 0.9% solution for inj to make a final concentration of 0.1-3 mg/mL. Gently invert to mix. Do not shake.
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Patient with history of autoimmune disease, risk factors for cardiac disease, rapidly proliferating tumour, and high tumour burden. Patients who undergo allogeneic haematopoietic stem cell transplantation (HSCT) following mogamulizumab treatment. Pregnancy and lactation.
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Significant: New-onset hypothyroidism, tumour lysis syndrome; bone marrow suppression such as lymphocytopenia (including CD4 lymphocytes), anaemia, neutropenia, leucopenia, and thrombocytopenia; rash (drug eruption) including maculopapular or papular rash, morbilliform rash, and lichenoid, spongiotic or granulomatous dermatitis; HBV reactivation, cardiac disorders (e.g. stress cardiomyopathy, acute MI), infusion-related reactions (e.g. headache, chills, nausea, vomiting, fever, tachycardia); acute graft-versus-host disease (GVHD) and corticosteroid-refractory GVHD (in patients who had undergone HSCT).
Cardiac disorders: Cardiac arrhythmia.
Ear and labyrinth disorders: Otitis externa.
Eye disorders: Conjunctivitis.
Gastrointestinal disorders: Diarrhoea, constipation, stomatitis, abdominal pain.
General disorders and administration site conditions: Fatigue, peripheral oedema.
Immune system disorders: Antibody development.
Infections and infestations: Herpes virus infection, candidiasis.
Investigations: Increased ALT, AST, and blood alkaline phosphatase; increased or decreased weight.
Metabolism and nutrition disorders: Hyperuricaemia, hyperglycaemia, hypomagnesaemia, hypophosphataemia, decreased appetite.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, muscle spasm.
Nervous system disorders: Dizziness, peripheral neuropathy.
Psychiatric disorders: Insomnia, depression.
Renal and urinary disorders: Renal insufficiency.
Respiratory, thoracic and mediastinal disorders: URTI, cough, dyspnoea.
Skin and subcutaneous tissue disorders: Drug eruption including rash, alopecia, folliculitis, xeroderma, cellulitis.
Vascular disorders: Hypertension.
Potentially Fatal: Immune-mediated complications (e.g. myositis, myocarditis, polymyositis, pneumonitis, hepatitis, a variant of Guillain-Barre syndrome); sepsis, pneumonia, skin infections; dermatologic effects (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), severe infusion reactions.
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This drug may cause fatigue, if affected, do not drive or operate machinery. Women of childbearing potential should use proven birth control methods during therapy and for at least 6 months after stopping the treatment.
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Confirm pregnancy status in females of reproductive potential before therapy initiation. Perform HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis surface antigen prior to starting the treatment. Monitor for signs and symptoms of infusion-related reactions, infections, immune-mediated reactions, and dermatologic toxicities. Patients who have received HSCT must be closely monitored for early evidence of transplant-related complications.
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Description:
Mechanism of Action: Mogamulizumab is a defucosylated recombinant humanised IgG1 kappa monoclonal antibody. It selectively binds to C-C chemokine receptor 4 (CCR4), a G protein-coupled receptor involved in the trafficking of lymphocytes to the skin and various organs. CCR4 is also consistently expressed on the surface of some T-cell cancer cells. The binding of mogamulizumab to CCR4 targets a cell for antibody-dependent cellular toxicity, leading to target cell depletion.
Pharmacokinetics:
Distribution: Volume of distribution: 3.6 L.
Excretion: Elimination half-life: 17 days.
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Store between 2-8°C. Do not freeze. Protect from light. Diluted solution for infusion may be stored between 2-8°C for up to 24 hours. Recommendations on the stability of diluted solutions may vary between countries (refer to local detailed product guidelines).
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L01FX09 - mogamulizumab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
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Anon. Mogamulizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/04/2023. Anon. Mogamulizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/04/2023. Buckingham R (ed). Mogamulizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023. Joint Formulary Committee. Mogamulizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2023. Poteligeo 4 mg/mL Concentrate for Solution for Infusion (Kyowa Kirin Holdings B.V.). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2023. Poteligeo Injection (Kyowa Kirin, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/04/2023.
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