Nurses Compass
Drug Guide
Guselkumab
Classification
Therapeutic: Immunomodulator, Antirheumatic, Biologic
Pharmacological: Interleukin-23 (IL-23) inhibitor
FDA Approved Indications
- Plaque psoriasis in adults
- Active psoriatic arthritis in adults
Mechanism of Action
Guselkumab is a human monoclonal antibody that binds selectively to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor, thereby reducing inflammation associated with psoriasis and psoriatic arthritis.
Dosage and Administration
Adult: Initial dose of 100 mg by subcutaneous injection at week 0, week 4, then every 8 weeks.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustment; monitor for increased risk of infections.
Renal Impairment: No specific adjustment needed.
Hepatic Impairment: No specific adjustment needed.
Pharmacokinetics
Absorption: Subcutaneous absorption; maximum concentration achieved in about 4-7 days.
Distribution: Limited to vascular and interstitial spaces.
Metabolism: Catabolized into small peptides and amino acids.
Excretion: Via normal protein degradation pathways.
Half Life: Approximately 15-18 days.
Contraindications
- Hypersensitivity to guselkumab or any excipients.
Precautions
- Risk of infections, including tuberculosis, cancer, hypersensitivity reactions. Use with caution in patients with active infections or a history of recurrent infections. Not recommended during pregnancy unless benefits outweigh risks. Immunogenicity may develop.
Adverse Reactions - Common
- Upper respiratory infections (Occasional)
- Headache (Common)
- CMR (cell-mediated immune response) reactions (Less common)
Adverse Reactions - Serious
- Serious infections such as tuberculosis, sepsis (Rare)
- Hypersensitivity reactions including anaphylaxis (Rare)
- Malignancies (Infrequent, long-term safety data ongoing)
Drug-Drug Interactions
- No clinically significant interactions identified.
- Monitor when used with immunosuppressants or live vaccines.
Drug-Food Interactions
- No known food interactions.
Drug-Herb Interactions
- No known herbal interactions.
Nursing Implications
Assessment: Monitor for signs of infection, TB screening recommended before initiation.
Diagnoses:
- Risk for infection
- Impaired skin integrity
Implementation: Administer subcutaneously as prescribed, monitor injection sites, educate patients on infection signs.
Evaluation: Monitor for effectiveness in skin clearance or symptom reduction, assess adverse reactions.
Patient/Family Teaching
- Report signs of infection or unusual symptoms immediately.
- Adherence to injection schedule.
- Avoid live vaccines during therapy.
- Discuss pregnancy planning with healthcare provider.
Special Considerations
Black Box Warnings:
- Serious infections, including tuberculosis, and malignancy
Genetic Factors: Limited data, no specific genetic considerations.
Lab Test Interference: Possibly false-positive tuberculosis tests; screening recommended prior to therapy.
Overdose Management
Signs/Symptoms: Potential immunosuppression leading to severe infections.
Treatment: Supportive care, infection management, no specific antidote.
Storage and Handling
Storage: Store in the refrigerator (36°F to 46°F / 2°C to 8°C). Protect from light.
Stability: Stable until expiration date when stored as recommended.