Simponi Aria

Generic name:

Golimumab

Drug class:

TNF-alpha inhibitor monoclonal antibody; immunosuppressant

Dosage form:

Solution for intravenous infusion (100 mg/20 mL)

Root of administration:

Intravenous infusion

Dose:

Induction: 2 mg/kg IV infusion at weeks 0 and 4. Maintenance: 2 mg/kg every 8 weeks. Maximum single dose 400 mg. Ulcerative colitis induction: 2 mg/kg at weeks 0, 2, and 6, then every 8 weeks as maintenance.

Mechanism of action:

Golimumab is a human monoclonal antibody that binds with high affinity to tumor necrosis factor-alpha (TNF-alpha), neutralizing its activity and inhibiting the inflammatory cascade.

Drug usage cases:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis
• Off-label: Crohn’s disease
• Off-label: Juvenile idiopathic arthritis
• Off-label: Uveitis
• Off-label: Hidradenitis suppurativa

Drug contra indications:

• Hypersensitivity to golimumab or any component
• Active serious infections including tuberculosis, sepsis, opportunistic infections
• Moderate to severe heart failure (NYHA class III/IV)
• Concurrent use with other TNF inhibitors
• Live vaccines during treatment

Side effects:

• Upper respiratory tract infections
• Nasopharyngitis
• Urinary tract infections
• Serious infections (e.g., TB, sepsis, opportunistic)
• Infusion reactions: rash, pruritus, dyspnea, hypotension, anaphylaxis
• Headache
• Nausea
• Elevated liver enzymes
• Hepatitis
• Leukopenia, neutropenia, thrombocytopenia, pancytopenia
• Autoantibody formation
• Malignancies (e.g., lymphoma, skin cancer)
• Demyelinating disorders
• Heart failure exacerbation
• Psoriasis exacerbation or new-onset psoriasis

Warnings:

• Risk of serious infections; screen for latent TB before and during therapy
• Monitor for signs of malignancy
• Hepatitis B reactivation: screen carriers and monitor
• Avoid live vaccines during and after therapy (at least 3 months)
• Use with caution in heart failure; monitor cardiac function
• Potential demyelinating disease; avoid in multiple sclerosis
• Monitor blood counts and liver function periodically
• Infusion reactions: consider premedication in patients with prior reactions
• Immune modulation may lead to autoimmune phenomena

Use during pregnancy or breastfeeding:

Limited human data. Golimumab crosses the placenta; use only if potential benefit justifies risk. Infants exposed in utero should not receive live vaccines for at least 6 months. It is unknown if golimumab is excreted in human milk; caution is advised and breastfeeding is not recommended during treatment and for 6 months after the last dose.