Guselkumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of guselkumab.
Drugs List
Therapeutic Indications
Uses
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).
Dosage
Guselkumab should only be used under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Adults
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.
Administration
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.
Contraindications
Children under 18 years
Severe infection
Within 2 weeks of live viral or live bacterial vaccination
Breastfeeding
Pregnancy
Tuberculosis
Precautions and Warnings
Infection
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
Pregnancy
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.
Lactation
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
Anaphylaxis
Arthralgia
Diarrhoea
Dyspnoea
Erythema at injection site
Gastro-enteritis
Headache
Herpes infections
Hypersensitivity reactions
Increase of liver transaminases
Local pain (injection site)
Rash
Reduced neutrophil count
Respiratory tract infection
Tinea infections
Urticaria
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: September 2020
Reference Sources
Summary of Product Characteristics: Tremfya 100mg solution for injection. Janssen-Cilag International NIV. Revised November 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.