Drug Guide
Ustekinumab
Classification
Therapeutic: Immunosuppressant, Monoclonal Antibody
Pharmacological: Interleukin-12 and Interleukin-23 Antagonist
FDA Approved Indications
- Psoriasis (plaque psoriasis in adult patients)
- Psoriatic Arthritis
- Crohn's Disease
- Ulcerative Colitis
Mechanism of Action
Ustekinumab binds to the p40 subunit of interleukin-12 and interleukin-23, inhibiting their activity and thereby modulating inflammatory and immune responses.
Dosage and Administration
Adult: For plaque psoriasis: 45 mg or 90 mg administered via subcutaneous injection at weeks 0 and 4, then every 12 weeks; dosage may vary based on weight and indication.
Pediatric: Not approved for patients under 18.
Geriatric: Adjusted doses not typically required; however, caution in elderly with comorbidities.
Renal Impairment: No specific dose adjustment indicated.
Hepatic Impairment: No specific dose adjustment indicated.
Pharmacokinetics
Absorption: Subcutaneous administration with peak serum concentrations in about 13 days.
Distribution: Limited data; presumed peripheral distribution.
Metabolism: Catabolized into small peptides and amino acids.
Excretion: Primarily via catabolic pathways; not through renal excretion.
Half Life: Approximately 3 weeks (23 days).
Contraindications
- Hypersensitivity to ustekinumab or any of its components.
Precautions
- Increased risk of infections, including tuberculosis; screening recommended before therapy.
- Avoid live vaccines during treatment.
- Caution in patients with a history of malignancy.
Adverse Reactions - Common
- Upper respiratory infections (Common)
- Headache (Common)
- Fatigue (Common)
Adverse Reactions - Serious
- Serious infections (e.g., pneumonia, cellulitis) (Uncommon)
- Malignancies, including lymphoma and non-melanoma skin cancer (Rare)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines, biologics that target similar pathways.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of infection, TB screening prior to initiation, and patient history of allergies.
Diagnoses:
- Risk for infection
- Impaired skin integrity
- Risk for bleeding
Implementation: Administer as per prescribed schedule, monitor for adverse effects, educate patient on infection risks.
Evaluation: Assess skin lesions, symptom improvement, and adverse reactions.
Patient/Family Teaching
- Report signs of infection or unusual symptoms immediately.
- Do not receive live vaccines during therapy.
- Adhere to scheduled injections and follow-up appointments.
- Maintain good skin hygiene and infection prevention measures.
Special Considerations
Black Box Warnings:
- Serious infections leading to hospitalization or death, including tuberculosis, bacterial, viral, fungal, and parasitic infections.
- Malignancies, including lymphomas and other cancers.
Genetic Factors: None specific.
Lab Test Interference: May affect immune function tests; monitor as guided by clinical indication.
Overdose Management
Signs/Symptoms: Unknown, but excessive immunosuppression may increase infection risk.
Treatment: Supportive care, monitor for infections, no specific antidote.
Storage and Handling
Storage: Store in a refrigerator (2°C to 8°C); do not freeze.
Stability: Stable until expiry date when stored properly.