rticles. Do not use STELARA® if it is discolored or cloudy, or if other particulate matter is present. STELARA® does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.
2.5 Instructions for Administration of STELARA® Prefilled Syringes Equipped with Needle Safety Guard
Refer to the diagram below for the provided instructions.
To prevent premature activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.
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Hold the BODY and remove the NEEDLE COVER. Do not hold the PLUNGER or PLUNGER HEAD while removing the NEEDLE COVER or the PLUNGER may move. Do not use the prefilled syringe if it is dropped without the NEEDLE COVER in place.
Inject STELARA® subcutaneously as recommended [see DOSAGE AND ADMINISTRATION (2.1, 2.2, 2.3)].
Inject all of the medication by pushing in the PLUNGER until the PLUNGER HEAD is completely between the needle guard wings. Injection of the entire prefilled syringe contents is necessary to activate the needle guard.
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After injection, maintain the pressure on the PLUNGER HEAD and remove the needle from the skin. Slowly take your thumb off the PLUNGER HEAD to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by the illustration below:
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Used syringes should be placed in a puncture-resistant container.
2.6 Preparation and Administration of STELARA® 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease)
STELARA® solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.
Calculate the dose and the number of STELARA® vials needed based on patient weight (Table 1). Each 26 mL vial of STELARA® contains 130 mg of ustekinumab.
Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of STELARA® to be added (discard 26 mL sodium chloride for each vial of STELARA® needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL).
Withdraw 26 mL of STELARA® from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion solution may be stored for up to four hours prior to infusion.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Do not infuse STELARA® concomitantly in the same intravenous line with other agents.
STELARA® does not contain preservatives. Each vial is for single use only. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.
Storage
If necessary, the diluted infusion solution may be stored for up to 4 hours at room temperature up to 25°C (77°F). Do not freeze. Discard any unused portion of the infusion solution.
3 DOSAGE FORMS AND STRENGTHS
STELARA® (ustekinumab) is colorless to slightly yellow solution.
Subcutaneous Injection
Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe
Injection: 45 mg/0.5 mL solution in a single-dose vial
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