Tremfya Dosage/Direction for Use

This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which it is indicated.
Posology: Plaque psoriasis: The recommended dose is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks (q8w).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Psoriatic arthritis: The recommended dose 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 (q4w) may be considered (see Pharmacology: Pharmacodynamics under Actions).
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment.
Special populations: Elderly (≥65 years): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
There is limited information in subjects aged ≥65 years and very limited information in subjects aged ≥75 years (see Pharmacology: Pharmacokinetics under Actions).
Renal or hepatic impairment: Tremfya has not been studied in these patient populations. No dose recommendations can be made. For further information on elimination of guselkumab, see Pharmacology: Pharmacokinetics under Actions.
Paediatric population: The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not been established. No data are available.
Method of administration: Subcutaneous use. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate. However, the physician should ensure appropriate medical follow-up of patients. Patients should be instructed to inject the full amount of solution according to the 'Instructions for use' provided in the carton.
For instructions on preparation of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.