- Approval Id
- c98d29f10a821f7f
- Drug Name
- TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
- Product Name
- TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
- Approval Number
- SIN15876P
- Approval Date
- 2020-01-17
- Registrant
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Licence Holder
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **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.
_**Psoriatic arthritis**_
The recommended dose of TREMFYA® is 100 mg to be given as subcutaneous injection at weeks 0 and 4 and every 8 weeks thereafter. For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered (see _Clinical studies, Radiographic response_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
TREMFYA® may be administered alone or in combination with a conventional synthetic disease-modifying antirheumatic drug (csDMARD) (e.g., methotrexate).
_**Palmoplantar pustulosis**_
The recommended dose of TREMFYA® is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter.
**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 _Pharmacokinetic 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 3940 plaque psoriasis and psoriatic arthritis patients exposed to TREMFYA® in Phase 2 and Phase 3 clinical trials, a total of 239 patients were 65 years or older, and 19 patients 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.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **Indications**
**Plaque psoriasis**
**_Adults_**
TREMFYA® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
**Psoriatic arthritis**
TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
**Palmoplantar pustulosis**
TREMFYA® by subcutaneous (SC) administration is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy.
- Contraindications
- **Contraindications**
None.
- Atc Code
- L04AC16
- Atc Item Name
- guselkumab
- Pharma Manufacturer Name
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/6cc7da6f3b9c1cd6/johnson-and-johnson-international-singapore-pte-ltd
