Home Drug Guide Ustekinumab-aekn

Drug Guide

Generic Name

Ustekinumab-aekn

Brand Names Selarsdi

Classification

Therapeutic: Immunosuppressant, Monoclonal Antibody

Pharmacological: Interleukin-12 and Interleukin-23 Inhibitor

FDA Approved Indications

Plaque Psoriasis
Crohn's Disease
Ulcerative Colitis
Psoriatic Arthritis

Mechanism of Action

Ustekinumab-aekn binds to the p40 subunit of interleukin-12 and interleukin-23, preventing them from interacting with their receptors, thereby inhibiting the inflammatory pathways involved in psoriasis, Crohn's disease, and other autoimmune conditions.

Dosage and Administration

Adult: Typically, for plaque psoriasis, an initial dose of 45 mg or 90 mg administered via subcutaneous injection, with subsequent doses every 12 weeks. Dose may vary based on indication.

Pediatric: Dosing in pediatric patients is less established; consult specific prescribing information.

Geriatric: Adjustments generally not required but consider comorbidities.

Renal Impairment: No specific adjustments; use cautiously.

Hepatic Impairment: No specific adjustments; use cautiously.

Pharmacokinetics

Absorption: Subcutaneous absorption with peak levels in approximately 1 week.

Distribution: Limited data; expected to distribute broadly in tissues.

Metabolism: Metabolized via proteolytic catabolism similar to other IgG monoclonal antibodies.

Excretion: Limited data, primarily via catabolism; renal excretion not significant.

Half Life: Approximately 3 weeks.

Contraindications

Hypersensitivity to ustekinumab or any component of the formulation.

Precautions

Risk of infections; monitor for signs of infections.
History of malignancy; use caution.
Screen for latent tuberculosis prior to treatment.

Adverse Reactions - Common

Upper respiratory infections (Common)
Headache (Common)
Fatigue (Common)

Adverse Reactions - Serious

Serious infections (e.g., tuberculosis, bacterial, viral, fungal) (Uncommon)
Malignancies (Rare)
Hypersensitivity reactions including anaphylaxis (Rare)

Drug-Drug Interactions

Immunosuppressants

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infection, evaluate skin for reactions, assess for new or worsening symptoms.

Diagnoses:

Risk for infection
Impaired skin integrity

Implementation: Administer as prescribed, watch for adverse reactions, educate patient about infection prevention.

Evaluation: Efficacy assessed by improvement in condition, absence of adverse effects, and patient adherence.

Patient/Family Teaching

Report signs of infection immediately.
Do not receive live vaccines during therapy.
Inform about potential side effects and when to seek medical help.
Maintain good personal hygiene.

Special Considerations

Black Box Warnings:

Increased risk of infections and malignancies.
Serious infections including tuberculosis and fungal infections have been reported.

Genetic Factors: Pharmacogenomic data ongoing; no specific genetic markers currently used in prescribing.

Lab Test Interference: May alter immune response; interpret lab results with caution.

Overdose Management

Signs/Symptoms: Unknown, but likely includes severe immunosuppression.

Treatment: Supportive care; no specific antidote. Consider hospitalization and broad-spectrum antibiotics if infection suspected.

Storage and Handling

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until expiration date when stored properly.