Tremfya

Tremfya Dosage/Direction for Use

guselkumab

Manufacturer:

Cilag AG

Distributor:

Johnson & Johnson
Full Prescribing Info
Dosage/Direction for Use
Dosage - Adults (18 years and older): Guselkumab (Tremfya) is administered by subcutaneous injection.
Plaque psoriasis: The recommended dose of Guselkumab (Tremfya) is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter.
Psoriatic arthritis: Guselkumab (Tremfya) should be administered using a dose regimen of: 100 mg at Week 0, Week 4 and every 8 weeks thereafter or; 100 mg at Week 0 and every 4 weeks thereafter. (See Pharmacology: Pharmacodynamics: Clinical studies: Radiographic response under Actions.)
Guselkumab (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 Guselkumab (Tremfya) is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter.
General considerations for administration: Guselkumab (Tremfya) is intended for use under the guidance and supervision of a physician. Guselkumab (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 Guselkumab (Tremfya) are given in "Instructions for use, handling, and disposal" and in the package leaflet, "Instructions for preparation and giving an injection of Guselkumab (Tremfya)." Full amount of Guselkumab (Tremfya) should be injected according to the directions provided in the patient information leaflet.
Switching from other biologics to Guselkumab (Tremfya): Guselkumab (Tremfya) has been shown to be safe and effective in patients with an inadequate response to ustekinumab or adalimumab therapy (see Pharmacology: Pharmacodynamics: Clinical studies under Actions). When switching to treatment with Guselkumab (Tremfya), administer Guselkumab (Tremfya) at week 0, week 4 and every 8 weeks thereafter.
Special populations: Pediatrics (below 18 years of age): The safety and efficacy of Guselkumab (Tremfya) in pediatric patients have not been evaluated; therefore, no recommendations on dosing can be made (see Pharmacology: Pharmacodynamics under Actions).
Elderly (65 years of age and older): Of the 3940 plaque psoriasis and psoriatic arthritis patients exposed to Guselkumab (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 Guselkumab (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 Guselkumab (Tremfya) have not been conducted in patients with renal insufficiency.
Hepatic impairment: Specific studies of Guselkumab (Tremfya) have not been conducted in patients with hepatic insufficiency.
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