Generic Name

Adalimumab-fkjp

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Classification

FDA Approved Indications

• Juvenile idiopathic arthritis (including polyarticular and systemic forms)
• Rheumatoid arthritis
• Crohn's disease (moderate to severe)
• Ulcerative colitis
• Plaque psoriasis
• Hidradenitis suppurativa
• Ankylosing spondylitis
• Psoriatic arthritis

Mechanism of Action

Adalimumab binds specifically to tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, thereby inhibiting its interaction with p55 and p75 cell surface TNF receptors. This reduces inflammation and immune response involved in autoimmune diseases.

Dosage and Administration

Adult: Dose varies by condition; for rheumatoid arthritis, typically 40 mg subcutaneously every other week. Adjustments may be needed based on clinical response.

Pediatric: Dosing based on weight and condition; specific protocols provided by FDA or prescribing guidelines.

Geriatric: Use with caution; monitor for infections, adjust if renal/hepatic impairment present.

Renal Impairment: No specific adjustment, but caution advised.

Hepatic Impairment: No specific adjustment, monitor closely.

Pharmacokinetics

Absorption: Subcutaneous administration with peak serum concentrations typically reached in 131 hours.

Distribution: Distributed mainly within the vascular and extravascular spaces; volume of distribution approximately 7.5 L.

Metabolism: Proteolytic degradation into small peptides and amino acids; minor hepatic involvement.

Excretion: Primarily via catabolism; no specific renal excretion data.

Half Life: approximately 2 weeks (around 10-20 days)

Contraindications

• Hypersensitivity to adalimumab or its components.
• Active infections, including tuberculosis.
• Demonstrated hypersensitivity reactions.

Precautions

• Screen for latent TB before initiation.
• SScreen for hepatitis B virus prior to treatment.
• Monitor for infections during therapy.
• Use with caution in patients with demyelinating diseases, heart failure, or a history of cancer.

Adverse Reactions - Common

• Injection site reactions (redness, rash, pain) (Common)
• Respiratory infections (nasopharyngitis, cough) (Common)
• Headache (Common)

Adverse Reactions - Serious

• Serious infections (bacterial, viral, fungal) (Less common)
• Lupus-like syndrome (Rare)
• Encephalitis, demyelinating diseases (Rare)
• Lymphoma and other malignancies (Rare, but increased risk noted)

Drug-Drug Interactions

• Other immunosuppressants (e.g., abatacept, anakinra)
• Live vaccines (risk of vaccine-related infection)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report signs of infection immediately.
• Do not receive live vaccines during therapy.
• Follow infusion and injection schedules precisely.
• Maintain good hygiene and regular medical follow-up.

Special Considerations

Black Box Warnings:

• Increased risk of serious infections, including tuberculosis and invasive fungal infections.
• Risk of lymphoma and other malignancies.

Genetic Factors: No specific genetic markers required for dosing, but genetic factors may influence infection risk.

Lab Test Interference: May interfere with immune response assessments, including screening tests.

Overdose Management

Signs/Symptoms: Unusual injection site reactions, hypersensitivity, general symptoms of infections.

Treatment: Supportive care; no specific antidote. Monitor closely, provide symptomatic relief, and treat infections aggressively.

Storage and Handling

Storage: Store in the refrigerator (2°C to 8°C). Do not freeze.

Stability: Stable until the expiration date when stored properly. Allow to reach room temperature before injection if refrigerated.