Drug Guide

Generic Name

Ustekinumab-aauz

Brand Names Otulfi

Classification

Therapeutic: Immunosuppressant, Monoclonal Antibody

Pharmacological: Interleukin-12 and Interleukin-23 Antagonist

FDA Approved Indications

Mechanism of Action

Ustekinumab-aauz binds to the p40 subunit shared by interleukin-12 and interleukin-23, inhibiting their activity and modulating inflammatory pathways involved in autoimmune disease.

Dosage and Administration

Adult: Not approved for adult use; dosing in pediatric JIA is weight-based, typically administered via subcutaneous injection every 8 weeks after initial dosing.

Pediatric: Dosing varies by weight; typically, initial dose followed by maintenance doses every 8 weeks. Exact dosing should follow prescribing guidelines.

Geriatric: Limited data; caution advised due to immunosuppressive effects.

Renal Impairment: No specific adjustment indicated.

Hepatic Impairment: No specific adjustment indicated.

Pharmacokinetics

Absorption: Subcutaneously absorbed; bioavailability approximately 57%.

Distribution: Distributed primarily in the blood and tissues, specific volume of distribution data limited.

Metabolism: Metabolized via proteolytic degradation into small peptides and amino acids.

Excretion: Excretion pathways not well defined; likely via normal protein degradation processes.

Half Life: Approximately 3 weeks.

Contraindications

Precautions

Adverse Reactions - Common

Adverse Reactions - Serious

Drug-Drug Interactions

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infection, injection site reactions, and screening for latent tuberculosis before therapy.

Diagnoses:

  • Risk for infection related to immunosuppression.
  • Impaired skin integrity related to injection site reactions.

Implementation: Administer subcutaneously as prescribed; educate patient on infection prevention.

Evaluation: Assess for therapeutic efficacy and adverse effects throughout treatment.

Patient/Family Teaching

Special Considerations

Black Box Warnings:

Genetic Factors: No specific genetic testing recommended.

Lab Test Interference: Can affect immune function tests; interpret with caution.

Overdose Management

Signs/Symptoms: Unusual or severe side effects, increased risk of infection.

Treatment: Supportive care; no specific antidote. Immediate medical attention recommended.

Storage and Handling

Storage: Store in a refrigerator (36°F to 46°F / 2°C to 8°C).

Stability: Stable until the expiration date; do not freeze. If needed, can be kept at room temperature for a limited time as specified by the package insert.

This guide is for educational purposes only and is not intended for clinical use.