Drug Guide
Adalimumab-afzb
Classification
Therapeutic: Antirheumatic, Immunosuppressant
Pharmacological: Tumor Necrosis Factor (TNF) Inhibitor
FDA Approved Indications
- Rheumatoid arthritis (moderate to severe)
- Juvenile idiopathic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Psoriasis psoriasis vulgaris
- Hidradenitis suppurativa
- Uveitis
Mechanism of Action
Adalimumab binds to tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine, neutralizing its activity and thereby reducing inflammation.
Dosage and Administration
Adult: Initial dose varies by condition; typically 40 mg subcutaneously every other week. Dose adjustments depend on the specific disease and response.
Pediatric: Dosing varies based on weight and condition; generally, 20 mg every other week for children ≥2 years old with juvenile idiopathic arthritis.
Geriatric: Dosing generally similar to adults; monitor for increased risk of infections.
Renal Impairment: Adjustments not specifically required, but caution advised.
Hepatic Impairment: No specific adjustments; use with caution especially in moderate to severe impairment.
Pharmacokinetics
Absorption: Subcutaneous administration with bioavailability approximately 64%.
Distribution: Widely distributed; volume of distribution roughly 5.5 L.
Metabolism: Metabolized via proteolytic degradation into small peptides and amino acids.
Excretion: Excreted mainly via catabolism; no specific renal elimination data.
Half Life: Approximately 2 weeks, allowing for biweekly dosing.
Contraindications
- Hypersensitivity to adalimumab or excipients
- Active serious infections
Precautions
- Screen for latent tuberculosis before initiation.
- Monitor for signs of infection.
- Use with caution in patients with comorbid conditions that predispose to infections.
- Avoid live vaccines during treatment.
Adverse Reactions - Common
- Injection site reactions (Common)
- Upper respiratory infections (Common)
- Headache (Common)
Adverse Reactions - Serious
- Serious infections (e.g., TB, invasive fungal infections) (Serious)
- Hypersensitivity reactions (Serious)
- Demyelinating disease (Serious)
- Heart failure exacerbation (Serious)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of infection, TB screening prior to initiation, and monitor injection sites.
Diagnoses:
- Risk of infection
- Impaired skin integrity
Implementation: Administer as prescribed, observe injection sites, educate patients on infection risks.
Evaluation: Assess for signs of response in the specific condition, monitor for adverse effects.
Patient/Family Teaching
- Report signs of infection promptly.
- Follow injection techniques as instructed.
- Do not administer live vaccines during treatment.
- Keep regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Increased risk of serious infections, including TB and invasive fungal infections.
- Malignancies, including lymphoma.
- Demyelinating neurological diseases.
Genetic Factors: Genetic polymorphisms in immune response genes may influence efficacy and risk.
Lab Test Interference: Can alter TB test results; screen for latent TB before therapy.
Overdose Management
Signs/Symptoms: Potential increased risk of infections, allergic reactions.
Treatment: Supportive care; no specific antidote. Consider discontinuation and medical management of adverse effects.
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.