Home Drug Guide Ustekinumab-kfce

Drug Guide

Generic Name

Ustekinumab-kfce

Brand Names Yesintek

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 binds to the p40 subunit of interleukin-12 and interleukin-23, thereby inhibiting their interaction with their receptor, which downregulates inflammatory pathways involved in psoriasis and other autoimmune conditions.

Dosage and Administration

Adult: Initial dose s injections at weeks 0 and 4, then maintenance doses every 12 weeks. Dosing varies based on indication and body weight.

Pediatric: Limited approval; dosing guided by weight and clinician's discretion.

Geriatric: Adjust dose based on efficacy and tolerability; no specific guidelines, but caution due to immune suppression.

Renal Impairment: No specific dose adjustment recommended.

Hepatic Impairment: No specific data; use with caution. monitor closely.

Pharmacokinetics

Absorption: Peak serum concentrations typically occur 1 hour after subcutaneous injection.

Distribution: Distributed mainly in the vascular and extravascular compartments.

Metabolism: Processed by proteolytic catabolism into small peptides and amino acids.

Excretion: Eliminated via catabolic pathways; no clinically significant renal excretion.

Half Life: Approximately 3 weeks.

Contraindications

Hypersensitivity to ustekinumab or its components.

Precautions

Risk of infections due to immune suppression; screenings for tuberculosis prior to initiation. Monitor for hypersensitivity reactions. Use with caution in patients with a history of malignancy or demyelinating diseases. Consider pregnancy and lactation status; consult current guidelines.

Adverse Reactions - Common

Nasopharyngitis (Frequent)
Headache (Common)
Fatigue (Less common)
Injection site reactions (Common)

Adverse Reactions - Serious

Serious infections (e.g., tuberculosis, sepsis) (Rare)
Malignancies (e.g., lymphoma) (Rare)
Hypersensitivity reactions, including anaphylaxis (Rare)

Drug-Drug Interactions

Immunosuppressants, other biologics

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infection, check TB status before therapy, assess for hypersensitivity reactions.

Diagnoses:

Risk for infection
Impaired immune response

Implementation: Administer as per dosing schedule, educate patient on infection risk, ensure timely monitoring.

Evaluation: Effectiveness of therapy assessed by symptom improvement, monitor for adverse reactions.

Patient/Family Teaching

Report signs of infection immediately.
Understand the importance of adherence to dosing schedule.
Keep follow-up appointments for monitoring.
Inform about possible side effects and when to seek medical attention.

Special Considerations

Black Box Warnings:

Serious infections, including tuberculosis and invasive fungal infections, can occur.
Malignancies have been reported in clinical trials.

Genetic Factors: N/A

Lab Test Interference: N/A

Overdose Management

Signs/Symptoms: Overdose could potentially increase risk of infection or adverse immune reactions.

Treatment: Supportive care; no specific antidote; monitor closely and provide symptomatic treatment as needed.

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 the expiration date when stored properly. Keep in original packaging until use.