Generic name: Guselkumab 100mg in 1mL
Dosage form: injection
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TREMFYA is administered by subcutaneous injection. The recommended dose is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.
Tuberculosis Assessment Prior to Initiation of TREMFYA
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.2)].
Important Administration Instructions
Administer TREMFYA subcutaneously. Each prefilled syringe is for single-dose only. Instruct patients to inject the full amount (1 mL), which provides 100 mg of TREMFYA.
Do not inject TREMFYA into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis [see Instructions for Use].
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.
The TREMFYA Instructions for Use contains more detailed patient instructions on the preparation and administration of TREMFYA [see Instructions for Use].
Preparation for Use of TREMFYA Prefilled Syringe
Before injection, remove TREMFYA prefilled syringe from the refrigerator and allow TREMFYA to reach room temperature (30 minutes) without removing the needle cap.
Inspect TREMFYA visually for particulate matter and discoloration prior to administration. TREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. Do not use if the liquid contains large particles, is discolored or cloudy. TREMFYA does not contain preservatives; therefore, discard any unused product remaining in the prefilled syringe.
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