"The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.
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Psoriatic Arthritis (PsA)
DOSAGE AND ADMINISTRATION
STELARA® is administered by subcutaneous injection.
- For patients weighing ≤ 100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
- For patients weighing > 100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
- In subjects weighing > 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies].
- 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 > 100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
General Considerations For Administration
STELARA® is for subcutaneous administration. 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.
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).
Prior to administration, STELARA® should be visually inspected for particulate matter and discoloration. STELARA® is colorless to light yellow and may contain a few small translucent or white particles. STELARA® should not be used if it is discolored or cloudy, or if other particulate matter is present. STELARA® does not contain preservatives; therefore, any unused product remaining in the vial and/or syringe should be discarded.
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-use vial, a 27 gauge, ½ inch needle is recommended.
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.
- 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.
Dosage Forms And Strengths
STELARA® solution is colorless to slightly yellow in appearance and contains 90 mg ustekinumab per mL.
- Injection: 45 mg/0.5 mL in a single-use prefilled syringe
- Injection: 90 mg/mL in a single-use prefilled syringe
- Injection: 45 mg/0.5 mL in a single-use vial
- Injection: 90 mg/mL in a single-use vial
Storage And Handling
STELARA® does not contain preservatives. STELARA® is available in single-use prefilled syringes or single-use vials containing 45 mg or 90 mg of ustekinumab. Each prefilled syringe is equipped with a needle safety guard.
The NDC number for the 45 mg
prefilled syringe is 57894-060-03.
The NDC number for the 90 mg prefilled syringe is 57894-061-03.
The NDC number for the 45 mg vial is 57894-060-02.
The NDC number for the 90 mg vial is 57894-061-02.
Storage And Stability
STELARA® vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA® vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. STELARA® does not contain a preservative; discard any unused portion.
Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland. Revised 03/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/18/2014
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