Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SOLUTION
**Dosage and Administration** **Dosage – Adults (18 years and older)** TREMFYA® is administered by subcutaneous injection. _**Plaque psoriasis**_ The recommended dose of TREMFYA® is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. **General considerations for administration** TREMFYA® is intended for use under the guidance and supervision of a physician. TREMFYA® may be administered by a health care professional, or a patient may self-inject after proper training in subcutaneous injection technique. Comprehensive instructions for the administration of TREMFYA® are given in “Instructions for use, handling, and disposal” and in the package leaflet, “Instructions for preparation and giving an injection of TREMFYA®” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Full amount of TREMFYA® should be injected according to the directions provided in the patient information leaflet. **Special populations** _**Pediatrics (below 18 years of age)**_ The safety and efficacy of TREMFYA® in pediatric patients have not been evaluated; therefore, no recommendations on dosing can be made (see _Pharmacodynamic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Elderly (65 years of age and older)**_ Of the 2177 plaque psoriasis subjects exposed to TREMFYA® in Phase 2 and Phase 3 clinical trials, a total of 111 subjects were 65 years or older, and 9 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger patients who received TREMFYA® in clinical studies. However, the number of patients aged 65 years and older was not sufficient to determine whether they respond differently from younger patients (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Renal impairment**_ Specific studies of TREMFYA® have not been conducted in patients with renal insufficiency. _**Hepatic impairment**_ Specific studies of TREMFYA® have not been conducted in patients with hepatic insufficiency.
SUBCUTANEOUS
Medical Information
**Indications** TREMFYA® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
**Contraindications** None.
L04AC16
guselkumab
Manufacturer Information
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Cilag AG