Generic Name

Golimumab

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Classification

FDA Approved Indications

• Rheumatoid arthritis (moderate to severe) in adults
• Psoriatic arthritis in adults
• Ankylosing spondylitis in adults
• Ulcerative colitis in adults

Mechanism of Action

Golimumab is a monoclonal antibody that binds specifically to tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, thereby inhibiting its activity and reducing inflammation.

Dosage and Administration

Adult: Typically 50 mg subcutaneously once monthly. Dosage may vary based on condition.

Pediatric: Not approved for pediatric use.

Geriatric: Adjust dosage with caution in elderly; renal or hepatic impairment considerations are minimal.

Renal Impairment: No specific adjustments necessary; available data limited.

Hepatic Impairment: Use with caution; no specific dosage adjustments are established.

Pharmacokinetics

Absorption: Approximately 53% bioavailable after subcutaneous injection.

Distribution: Limited data, presumed to stay within the vascular and interstitial spaces.

Metabolism: Metabolized via proteolytic pathways into small peptides and amino acids.

Excretion: Primarily via catabolism; not eliminated unchanged in urine or feces.

Half Life: Approximately 14 days.

Contraindications

• Hypersensitivity to golimumab or its components.
• Active severe infections.

Precautions

• Screen for tuberculosis before initiation, as TNF inhibitors can reactivate latent TB.
• Use caution in patients with heart failure, demyelinating diseases, or active infections.

Adverse Reactions - Common

• Upper respiratory infections (Frequent)
• Hypertension (Common)
• Headache (Common)

Adverse Reactions - Serious

• Serious infections (e.g., sepsis, opportunistic infections) (Infrequent)
• Lupus-like syndrome (Rare)
• Malignancies (e.g., lymphoma) (Rare)

Drug-Drug Interactions

• Other immunosuppressants, corticosteroids, live vaccines

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report signs of infection immediately.
• Use caution with live vaccines during therapy.
• Maintain regular follow-up appointments.

Special Considerations

Black Box Warnings:

• Serious infections, including tuberculosis, invasive fungal infections, and bacterial/viral infections that can be fatal.
• Malignancies, including lymphoma.
• Demyelinating disease.

Genetic Factors: None specified.

Lab Test Interference: May suppress inflammatory markers like ESR or CRP, which are used to assess disease activity.

Overdose Management

Signs/Symptoms: Unusual infections, hypersensitivity reactions.

Treatment: Supportive care; no specific antidote. Discontinue golimumab and provide symptomatic management.

Storage and Handling

Storage: Refrigerate between 2°C to 8°C (36°F to 46°F). Protect from light.

Stability: Stable until the expiration date; do not freeze or shake vigorously.