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Guselkumab parenteral


Injection of guselkumab.

Drugs List

  • guselkumab 100mg/1ml injection
  • TREMFYA 100mg/1ml injection
  • Therapeutic Indications


    Moderate to severe plaque psoriasis
    Psoriatic arthritis (unresp to DMARD) monotherapy or combination with MTX

    Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

    Treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to prior disease-modifying antirheumatic drug (DMARD) therapy, either alone or in combination with methotrexate (MTX).


    Guselkumab should only be used under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.


    Plaque psoriasis
    100mg injection initially at weeks 0 and 4, followed by a maintenance dose every 8 weeks.

    Psoriatic arthritis
    100mg injection initially at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
    Patients at high risk for joint damage a dose of 100mg every 4 weeks may be considered, according to clinical judgement.

    Consideration should be given to discontinuing treatment in patients who show no response after 24 weeks of treatment.


    For subcutaneous injection.

    If possible avoid injecting areas of skin affected by psoriasis.

    Upon training of subcutaneous injection technique, patients may inject guselkumab if a physician determines it is appropriate, and follow up medical appointments are arranged. The full amount of guselkumab should be injected according to the instructions of use.


    Children under 18 years
    Severe infection
    Within 2 weeks of live viral or live bacterial vaccination

    Precautions and Warnings

    Patients over 75 years
    Hepatic impairment
    Latent or healed tuberculosis
    Renal impairment

    Live virus vaccine should not be given for 3 months after treatment
    Before starting therapy ensure immunisations are up to date
    Prior to starting therapy screen for latent tuberculosis
    Record name and batch number of administered product
    Psoriatic arthritis: Monitor hepatic enzymes at baseline and periodically
    Monitor patient for signs of serious infection
    Advise patient to report symptoms of infection immediately
    Advise patient to seek med advice if signs/symptoms of tuberculosis develop
    Discontinue if a serious infection develops
    Discontinue if hypersensitivity reactions occur
    Discontinue if no response to treatment after 16 weeks
    Suspend if drug induced liver injury is suspected
    Female: Contraception required during and for 3 months after treatment

    Pregnancy and Lactation


    Guselkumab is contraindicated during pregnancy.

    The manufacturer recommends avoiding the use of guselkumab during pregnancy as a precautionary measure. At the time of writing there is limited data from the use of guselkumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Risks are unknown.


    Guselkumab is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues guselkumab or discontinues breastfeeding. It is not known whether guselkumab is excreted in human milk. A risk to the breastfeeding child cannot be excluded because immunoglobulins are excreted in human milk.

    Side Effects

    Erythema at injection site
    Herpes infections
    Hypersensitivity reactions
    Increase of liver transaminases
    Local pain (injection site)
    Reduced neutrophil count
    Respiratory tract infection
    Tinea infections


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: September 2020

    Reference Sources

    Summary of Product Characteristics: Tremfya 100mg solution for injection. Janssen-Cilag International NIV. Revised November 2020.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.