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HSA Approval

TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML

SIN15508P

TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML

TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML

June 21, 2018

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence HolderJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Active Ingredients

guselkumab

100mg/mL

Guselkumab

Documents

Package Inserts

Tremfya Solution for Injection (PFS)_PI.pdf

Approved: February 19, 2023

Download

Patient Information Leaflets

Tremfya Solution for Injection (PFS)_PIL.pdf

Approved: February 19, 2023

Download

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