Yesintek Dosage

Recommended Dosage in Plaque Psoriasis

Recommended Dosage in Psoriatic Arthritis

Recommended Dosage in Crohn's Disease and Ulcerative Colitis

General Considerations for Administration

• YESINTEK is intended for use under the guidance and supervision of a healthcare provider. YESINTEK should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider. The appropriate dose should be determined by a healthcare provider using the patient's current weight at the time of dosing. In pediatric patients, it is recommended that YESINTEK be administered by a healthcare provider. If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject YESINTEK after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Medication Guide.

• 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 1 mL syringe with a 27 gauge, ½ inch needle is recommended.

• Prior to administration, visually inspect YESINTEK for particulate matter and discoloration. YESINTEK is a clear, colorless to pale yellow solution. Do not use YESINTEK if it is discolored or cloudy, or if other particulate matter is present. YESINTEK does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.

Instructions for Administration of YESINTEK Prefilled Syringes Equipped with Needle Safety Guard

Refer to the diagram below for the provided instructions.

• 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 YESINTEK 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.

Preparation and Administration of YESINTEK 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis)

YESINTEK solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of YESINTEK vials needed based on patient weight (Table 4). Each 26 mL vial of YESINTEK contains 130 mg of ustekinumab-kfce.

2. 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 YESINTEK to be added (discard 26 mL sodium chloride for each vial of YESINTEK needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used.

3. Withdraw 26 mL of YESINTEK 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.

4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completely administered within four hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).

7. Do not infuse YESINTEK concomitantly in the same intravenous line with other agents.

8. YESINTEK does not contain preservatives. Each vial is for one-time use in only one patient. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.