TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML [SIN15508P]

Product Info

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

[SIN15508P]

Indications
TREMFYA® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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.

Contraindications
None.