Drug Guide
Ustekinumab-srlf
Classification
Therapeutic: Immunosuppressant, Monoclonal Antibody
Pharmacological: Interleukin-12 and Interleukin-23 Antagonist
FDA Approved Indications
- Plaque Psoriasis (Adults)
- Crohn’s Disease (Adults and Pediatrics)
- Ulcerative Colitis (Adults)
- Active Psoriatic Arthritis
Mechanism of Action
Ustekinumab binds to the p40 subunit of interleukin-12 and interleukin-23, inhibiting their interaction with the IL-12R and IL-23R, thus modulating the inflammatory pathways involved in autoimmune conditions.
Dosage and Administration
Adult: Administer subcutaneously, initial dose at 45 mg or 90 mg depending on the condition, followed by maintenance doses every 12 weeks.
Pediatric: Dosing varies based on weight and condition; specific pediatric dosing guidelines should be consulted.
Geriatric: No specific adjustment required, but monitor for infections.
Renal Impairment: No specific adjustment, caution advised.
Hepatic Impairment: No specific adjustment indicated.
Pharmacokinetics
Absorption: Bioavailability approximately 57% after subcutaneous administration.
Distribution: Highly bound to plasma proteins.
Metabolism: Degraded into small peptides and amino acids through catabolic pathways.
Excretion: Excreted via normal protein catabolic pathways.
Half Life: Approximately 3 weeks (21 days).
Contraindications
- Hypersensitivity to ustekinumab or excipients.
Precautions
- Risk of infection; contraindicated in active infections.
- Screen for tuberculosis before initiation.
- Potential for hypersensitivity reactions; monitor after administration.
- Use with caution in patients with a history of malignancy.
Adverse Reactions - Common
- Nasopharyngitis (Common)
- Headache (Common)
- Fatigue (Common)
Adverse Reactions - Serious
- Serious infections (e.g., TB, fungal infections) (Uncommon)
- Malignancies (e.g., lymphoma) (Rare)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- No significant direct interactions reported.
Drug-Food Interactions
- No specific food interactions.
Drug-Herb Interactions
- Limited data, caution advised with herbal supplements.
Nursing Implications
Assessment: Monitor for signs of infection (fever, malaise), assess for allergy or hypersensitivity reactions.
Diagnoses:
- Risk for infection related to immunosuppression.
- Impaired skin integrity related to injection site reactions.
Implementation: Administer as per prescribed schedule. Educate patient on infection prevention.
Evaluation: Evaluate for effectiveness of therapy, monitor for adverse reactions, especially infections.
Patient/Family Teaching
- Report any signs of infection immediately.
- Not to receive live vaccines while on therapy.
- Follow injection administration instructions carefully.
- Maintain regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Serious infection and Malignancy risk.
Genetic Factors: None specified.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Potential for increased risk of infections or hypersensitivity reactions.
Treatment: Supportive care; no specific antidote. Discontinue therapy and provide symptomatic treatment as needed.
Storage and Handling
Storage: Refrigerate at 2°C to 8°C (36°F to 46°F). Protect from light.
Stability: Stable until the expiration date when stored properly.