TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML [SIN15876P]

Product Info

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

[SIN15876P]

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.

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.

Contraindications
None.