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Mogamulizumab parenteral

Updated 2 Feb 2023 | Mogamulizumab

Presentation

Infusions of mogamulizumab.

Drugs List

  • mogamulizumab 20mg/5ml concentrate for solution for infusion vial
  • POTELIGEO 4mg/ml concentrate for solution for infusion
  • Therapeutic Indications

    Uses

    Mycosis fungoides
    Sezary syndrome

    Treatment of adults patients with mycosis fungoides or Sezary syndrome who have received at least one previous systemic treatment.

    Dosage

    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.

    Additional Dosage Information

    Mogamulizumab 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.

    Administration

    Mogamulizumab is for intravenous use. It should be administered by intravenous infusion only, over at least 60 minutes.

    Mogamulizumab should not be administered by rapid intravenous administration, or as an intravenous bolus.

    Contraindications

    Children under 18 years
    Pregnancy

    Precautions and Warnings

    Females of childbearing potential
    Risk factors for cardiovascular disorder
    Breastfeeding
    Dehydration
    Hepatitis B
    History of hepatitis B
    Severe hepatic impairment

    Before initiating screen all patients for hepatitis B infection
    Consider pre-medication with antihistamines and/or antipyretics
    Consider premedication with hypouricaemic agent
    Maintain adequate hydration of patient prior / during treatment
    Risk of serious transplant-related complications
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Resuscitation facilities must be immediately available
    Staff: Not to be handled by pregnant staff
    Monitor closely for signs and symptoms of toxic epidermal necrolysis
    Monitor closely for signs and sypmtoms of Stevens-Johnson syndrome
    Monitor closely patient at risk of cardiovascular disorders
    Monitor fluid and electrolyte status
    Monitor patient constantly for signs of new infection
    Monitor patients for signs of tumour lysis syndrome
    Monitor renal function
    Interrupt therapy/reduce infusion rate if infusion-related reactions occur
    Reactivation of latent chronic infections may occur
    Consider suspending treatment if grade 2 or 3 skin reaction occurs
    Discontinue if anaphylactoid reaction occurs
    Female: Contraception required during and for 6 months after treatment
    Male: Contraception required during and for 6 months after treatment
    Driving or operating machinery not advisable following treatment

    Dermatologic reactions
    If Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) 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.

    Infusion-related reactions
    Most of the infusion-related reactions are observed during or shortly after the first infusion (all within 24 hours of administration), with a reduction of the incidence over subsequent treatments.
    Infections
    Patients with mycosis fungoides or Sezary syndrome are at increased risk of serious infection due to the disruption of dermal integrity caused by cutaneous disease, as well as the immunosuppressive effects of extracutaneous disease, and treatment with mogamulizumab may increase that risk.

    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.

    For patients who test positive for current or previous hepatitis B infection, it will be recommended a consultation with an expert physician in the treatment of hepatitis B for advice concerning the appropriate measures against hepatitis B reactivation.

    Complications of hematopoietic stem cell transplantation (HSCT)
    An increased risk of complications has been observed if mogamulizumab is administered within a short time frame (approximately 50 days) before HSCT. Patients should be closely monitored for early evidence of transplant-related complications.

    The safety of treatment with mogamulizumab after autologous or allogenic HSCT has not been studied.

    Tumour lysis syndrome

    There have been cases of patients developing tumour lysis syndrome (TLS) after receiving mogamulizumab. TLS was observed with more frequency during the first month of the treatment. Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS. Patients should be closely monitored, especially after initiation of treatment (first month), for electrolyte status, hydration and renal function. Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.

    Pregnancy and Lactation

    Pregnancy

    Mogamulizumab is contraindicated during pregnancy.

    The manufacturer does not recommend using mogamulizumab during pregnancy.

    Animal studies have not shown direct or indirect harmful effects regarding reproductive toxicity. Some studies have demonstrated that mogamulizumab crosses the placenta in animals. There is no human data and as such a potential risk cannot be ruled out.

    Lactation

    Use mogamulizumab with caution during breastfeeding.

    The manufacturer does not recommend breastfeeding during the first few days after birth since human IgGs are known to be excreted in breast milk, in consequence a risk to the breast-fed child cannot be excluded. IgGs concentrations decreases to low concentrations soon afterwards, therefore Mogamulizumab could be used during breastfeeding if clinically required.

    It is unknown whether mogamulizumab is excreted in human milk. Mogamulizumab (LactMed 2018) is a large protein with a high molecular weight, therefore the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

    Side Effects

    Alanine aminotransferase increased
    Anaemia
    Aspartate aminotransferase increased
    Candidiasis
    Cellulitis
    Constipation
    Cytomegalovirus infection
    Diarrhoea
    Drug rash
    Fatigue
    Folliculitis
    Headache
    Hepatitis
    Herpes simplex
    Herpes zoster
    Hypothyroidism
    Increase in alkaline phosphatase
    Infections
    Infusion related reaction
    Infusion-related symptoms
    Leukopenia
    Nausea
    Neutropenia
    Otitis externa
    Peripheral oedema
    Pneumonia
    Polymyositis
    Pyrexia
    Rash
    Reduced lymphocyte count
    Respiratory failure
    Sepsis
    Skin infection
    Staphylococcal infection
    Stomatitis
    Thrombocytopenia
    Tumour lysis syndrome
    Upper respiratory tract infection
    Urinary tract infections
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: April 2020.

    Reference Sources

    Summary of Product Characteristics: Poteligeo 4mg/ml, concentrate for solution for infusion. Kyowa Kirin Ltd. October 2019.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Poteligeo Last revised: 03 December 2018
    Last accessed: 22 April 2020.

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