Drug Guide
Ustekinumab-aauz
Classification
Therapeutic: Immunosuppressant, Monoclonal Antibody
Pharmacological: Interleukin-12 and Interleukin-23 Antagonist
FDA Approved Indications
- JIA (Juvenile Idiopathic Arthritis) for patients 4 years and older
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
- Hypersensitivity to ustekinumab or any of its components.
Precautions
- Risk of infection due to immunosuppression; screen for active infections before initiation.
- Monitor for signs of infection during therapy.
- Use with caution in patients with a history of malignancy or demyelinating disorders.
Adverse Reactions - Common
- Upper respiratory infections (Common)
- Headache (Common)
- Injection site reactions (Common)
Adverse Reactions - Serious
- Serious infections (e.g., tuberculosis, invasive fungal infections) (Uncommon)
- Malignancy (e.g., lymphoma) (Rare)
- Hypersensitivity reactions (Rare)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing 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
- Report any signs of infection or unusual symptoms.
- Maintain good hygiene and avoid contact with sick individuals.
- Inform about possible injection site reactions and how to manage them.
Special Considerations
Black Box Warnings:
- Serious infections, including tuberculosis and invasive fungal infections, have been reported.
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.