Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology.1

Indications

TREMFYA is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1

PBS Information

This product is not listed on the PBS.

Dosage and Administration

Dosage (dose and interval) 

The recommended dose of TREMFYA is 100 mg to be given as a subcutaneous injection at week 0, week 4 and every 8 weeks thereafter. 1

Method of Administration

TREMFYA is administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. TREMFYA is intended for use under the guidance and supervision of a physician. TREMFYA may be administered by a healthcare professional, or a patient may self-inject after proper training in subcutaneous injection technique.1

After removing the pre-filled syringe from the refrigerator, keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting TREMFYA. The pre-filled syringe should not be shaken.1

Comprehensive instructions for the subcutaneous administration of TREMFYA are given in the Instructions for Use leaflet. Patients should be instructed to inject the full amount of TREMFYA according to the directions provided in this leaflet.1

TREMFYA is for single use in one patient only. Following administration of TREMFYA, discard any unused portion. The syringe should be
disposed of using accepted medical practices for used syringes. The syringe and needle must never be re-used.1

Substitution by any other biological medicinal product requires the consent of the prescribing physician.1

Special Populations

Renal or hepatic impairment
Specific studies of TREMFYA have not been conducted in patients with renal or hepatic insufficiency.1
Elderly (>65 years of age)
No dose adjustment is required.1
Paediatrics (< 18 years of age)
The safety and efficacy of TREMFYA in paediatric patients (< 18 years of age) have not been evaluated.1

Safety Information

Please review the Product Information before prescribing.


Reference: 1. TREMFYA (guselkumab) Approved Product Information, 15 March 2018.