Tremfya

Tremfya Dosage/Direction for Use

guselkumab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
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 by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered.
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment.
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.
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 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 healthcare 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 and Handling and Disposal under Cautions for Usage and Instructions for preparation and giving an injection of TREMFYA under Patient Counselling Information." Full amount of TREMFYA should be injected according to the directions provided in the patient information leaflet.
Switching from other biologics to TREMFYA: TREMFYA has been shown to be safe and effective in patients with plaque psoriasis with an inadequate response to ustekinumab or adalimumab therapy (see Pharmacology: Pharmacodynamics: Clinical studies under Actions). When switching to treatment with TREMFYA in patients with plaque psoriasis, administer TREMFYA at week 0, week 4 and every 8 weeks thereafter.
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 Pharmacology: Pharmacokinetics under Actions).
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 subjects were 65 years or older, and 19 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 Pharmacology: Pharmacokinetics under Actions).
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.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in