Generic name: ustekinumab 45mg in 0.5mL
Dosage form: injection, solution
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Subcutaneous Adult Dosage Regimen
- For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14)].
Subcutaneous Adult Dosage Regimen
- The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
Intravenous Induction Adult Dosage Regimen
A single intravenous infusion dose of STELARA® using the weight-based dosage regimen specified in Table 1 [see Instructions for dilution of STELARA® 130 mg vial for intravenous infusion (2.6)].
|Body Weight of Patient at the time of dosing||Dose||Number of 130 mg/26 mL (5 mg/mL) STELARA® vials|
|55 kg or less||260 mg||2|
|more than 55 kg to 85 kg||390 mg||3|
|more than 85 kg||520 mg||4|
General Considerations for Administration
- After proper training in subcutaneous injection technique, a patient may self-inject with STELARA® if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide [see Medication Guide].
- The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex.
- It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated. When using the single-dose vial, a 27 gauge, ½ inch needle is recommended.
- STELARA® is intended for use under the guidance and supervision of a physician. STELARA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
- Prior to administration, visually inspect STELARA® for particulate matter and discoloration. STELARA® is clear, colorless to light yellow and may contain a few small translucent or white particles. 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.
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.
- 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.
- 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:
- Used syringes should be placed in a puncture-resistant container.
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.
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