Drug Guide
Ustekinumab-auub
Classification
Therapeutic: Immunosuppressant, Monoclonal Antibody
Pharmacological: Interleukin-12 and Interleukin-23 Antagonist
FDA Approved Indications
- Plaque Psoriasis
- Psoriatic Arthritis
Mechanism of Action
Ustekinumab binds to the p40 subunit of interleukin-12 and interleukin-23, preventing their interaction with the IL-12 receptor, thereby modulating the inflammatory pathway involved in psoriasis and psoriatic arthritis.
Dosage and Administration
Adult: Initial dose of 45 mg or 90 mg subcutaneously, depending on weight and condition, administered at weeks 0, 4, then every 12 weeks.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dose adjustments required, but caution due to comorbidities.
Renal Impairment: No specific dose adjustment needed.
Hepatic Impairment: No specific dose adjustment needed.
Pharmacokinetics
Absorption: Subcutaneous administration with peak levels in 1 week.
Distribution: Distributed in vascular and extravascular compartments.
Metabolism: Metabolized via catabolism similar to IgG antibodies.
Excretion: Excreted mainly via proteolytic catabolism.
Half Life: Approximately 3 weeks.
Contraindications
- Hypersensitivity to ustekinumab or excipients.
Precautions
- Increased risk of infections, including serious infections. Use with caution in patients with active infections, history of malignancy, or demyelinating disease. Pregnancy category B; weigh benefits and risks.
Adverse Reactions - Common
- Lower respiratory tract infections (Occasional)
- Headache (Common)
- Fatigue (Common)
Adverse Reactions - Serious
- Serious infections (e.g., pneumonia, cellulitis) (Rare)
- Malignancies (non-melanoma skin cancer) (Rare)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines, TNF inhibitors
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of infection, skin cancers, and neurological symptoms.
Diagnoses:
- Risk for Infection
- Impaired Skin Integrity
Implementation: Administer as prescribed, observe for adverse reactions, educate patient on infection signs.
Evaluation: Evaluate skin health, infection frequency, and patient's response to therapy.
Patient/Family Teaching
- Report signs of infection promptly.
- Avoid live vaccines during therapy.
- Use sunscreen and skin protection to monitor for skin malignancies.
- Follow injection instructions carefully.
Special Considerations
Black Box Warnings:
- Serious infections and malignancy
Genetic Factors: None specified.
Lab Test Interference: May affect tuberculin skin test reactivity.
Overdose Management
Signs/Symptoms: Unknown, but potential for exaggerated immunosuppressive effects.
Treatment: Supportive care; no specific antidote.
Storage and Handling
Storage: Store in a refrigerator (36°F to 46°F / 2°C to 8°C). Do not freeze.
Stability: Stable until the expiration date on the package when stored properly.