2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA [see Warnings and Precautions (5.3)].
- Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.4)].
2.2 Recommended Dosage for Plaque Psoriasis
TREMFYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.
2.3 Recommended Dosage for Psoriatic Arthritis
TREMFYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Week 0, Week 4, and every 8 weeks thereafter.
TREMFYA may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
2.4 Recommended Dosage for Ulcerative Colitis
Induction
The recommended induction dosage of TREMFYA is 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8 [see Dosage and Administration (2.6)].
Maintenance
The recommended maintenance dosage of TREMFYA/TREMFYA PEN is:
- 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
- 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.
Use the lowest effective recommended dosage to maintain therapeutic response.
2.5 Preparation and Administration Instructions for Subcutaneous Injection
- Administer TREMFYA/TREMFYA PEN subcutaneously. Each prefilled syringe, One-Press injector, or Prefilled Pen is for one time use in one patient only. Instruct patients to inject the full amount (1 mL or 2 mL), which provides 100 mg or 200 mg of TREMFYA.
- TREMFYA/TREMFYA PEN is intended for use under the guidance and supervision of a healthcare professional. TREMFYA/TREMFYA PEN may be administered by a healthcare professional, or a patient/caregiver may inject after proper training on correct subcutaneous injection technique.
- Before injection, remove TREMFYA/TREMFYA PEN from the refrigerator and allow to reach room temperature (30 minutes) without removing the needle cap.
- Inject into the front of the thighs, the lower abdomen except for the 2 inches around the navel, or the back of the upper arms (healthcare professional or caregiver only).
- Do not inject TREMFYA/TREMFYA PEN into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis [see Instructions for Use].
- The TREMFYA/TREMFYA PEN Instructions for Use contains more detailed patient instructions on the preparation and administration of TREMFYA/TREMFYA PEN [see Instructions for Use].
- If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
- Inspect TREMFYA/TREMFYA PEN visually for particulate matter and discoloration prior to administration. TREMFYA/TREMFYA PEN 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/TREMFYA PEN does not contain preservatives; therefore, discard any unused product remaining in the prefilled syringe, One-Press injector, or Prefilled Pen.
2.6 Preparation and Administration Instructions for Intravenous Infusion (Ulcerative Colitis)
Preparation Instructions:
- Withdraw and then discard 20 mL of the 0.9% Sodium Chloride Injection from the 250 mL infusion bag which is equal to the volume of TREMFYA to be added.
- Withdraw 20 mL of TREMFYA from the vial and add it to the 250 mL intravenous infusion bag of 0.9% Sodium Chloride Injection for a final concentration of 0.8 mg/mL. Gently mix the diluted solution. Discard the vial with any remaining solution.
- Visually inspect the diluted solution for particulate matter and discoloration before infusion. Infuse the diluted solution over a period of at least one hour.
- Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein binding filter (pore size 0.2 micrometer).
- Do not infuse TREMFYA concomitantly in the same intravenous line with other medicinal products.
- Dispose any unused medicinal product in accordance with local requirements.
Administration Instructions:
- TREMFYA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. TREMFYA does not contain preservatives. Each vial is for one time use in one patient only.
- 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 is cloudy.
Storage of Diluted Solution:
- The diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 10 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 10 hours after the dilution in the infusion bag.
- Do not freeze.
- Discard any unused portion of the infusion solution.
