Otulfi Dosage

Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

• For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients weighing more than 100 kg, the recommended dosage 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.

Recommended Dosage in Psoriatic Arthritis

Recommended Dosage in Crohn's Disease and Ulcerative Colitis

General Considerations for Administration

• OTULFI is intended for use under the guidance and supervision of a healthcare provider. OTULFI 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 OTULFI 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 OTULFI after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Medication Guide.
• The needle cover on the prefilled syringe is not made with natural rubber (a derivative of 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.
• Visually inspect OTULFI for particulate matter and discoloration prior to administration. OTULFI is a clear to slightly opalescent and colorless to slightly brown-yellow solution. Do not use OTULFI if it is discolored or cloudy, or if other particulate matter is present. OTULFI does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.

Instructions for Administration of OTULFI 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. Do not use the prefilled syringe if it is dropped or if it is dropped onto a hard surface.
• Inject OTULFI 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 OTULFI 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis)

OTULFI 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 OTULFI vials needed based on patient weight (Table 3). Each 26 mL vial of OTULFI contains 130 mg of ustekinumab-aauz.
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 OTULFI to be added (discard 26 mL sodium chloride for each vial of OTULFI 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 OTULFI 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 eight hours of the dilution in the infusion bag.
6. Use only polypropylene (PP) or polyvinylchloride (PVC) infusion sets with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Do not infuse OTULFI concomitantly in the same intravenous line with other agents.
8. OTULFI does not contain preservatives. Each vial is for a single-dose only. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.