Columvi Glofitamab Injection

1. Indications and Usage
Rheumatoid Arthritis (RA): Indicated for reducing signs and symptoms, improving physical function, and slowing structural damage in moderate to severely active RA in adult patients. Usually used in combination with methotrexate (MTX).
Polyarticular Juvenile Idiopathic Arthritis (pJIA): Indicated for treatment in patients 2 years of age and older.
Ankylosing Spondylitis (AS): Indicated for treatment of adults with active AS.
Psoriatic Arthritis (PsA): Indicated for treatment of adults with active PsA (with or without MTX).
Ulcerative Colitis (UC): Indicated for treatment of moderately to severely active UC in adults.
2. Dosage and Administration
Route of Administration:
RA, AS, PsA, pJIA: Subcutaneous Injection (SC) ONLY.
Ulcerative Colitis (UC): Intravenous Infusion (IV) ONLY for induction; SC for maintenance.
Recommended Dosage:
RA, AS, PsA: 50 mg once monthly (every 4 weeks).
pJIA: Body weight-based dosing (e.g., 30 mg for <30 kg; 50 mg for ≥30 kg) once monthly.
UC Induction: 200 mg at Week 0, followed by 100 mg at Week 2 (IV).
UC Maintenance: 50 mg once monthly (SC) starting at Week 4.
Administration Instructions:
Allow pre-filled syringe to reach room temperature (approx. 30 mins) before injection.
Do not shake. Do not use if solution is discolored or contains particles.
3. Mechanism of Action
TNF-α Blocking:
Golimumab binds specifically to both soluble and transmembrane forms of TNF-α.
Anti-Inflammatory Action:
By blocking the interaction of TNF-α with its p55 and p75 cell surface receptors, it neutralizes TNF-α biological activity, thereby reducing inflammatory responses and preventing tissue damage.
4. Safety and Warnings
Serious Infections:
Increased risk of bacterial, fungal, and viral infections (including Tuberculosis and Sepsis). Do not initiate in patients with active infections.
Malignancy:
Increased risk of lymphoma and other malignancies, including hepatosplenic T-cell lymphoma.
Hepatitis B Reactivation (HBV):
Screening for HBV is required prior to initiation.
Heart Failure:
Postmarketing cases of new onset or worsening congestive heart failure have been reported. Use with caution in patients with heart failure.
Demyelinating Disease:
Use with caution in patients with central or peripheral nervous system demyelinating disorders.
5. Adverse Reactions
Most Common:
Upper respiratory infections (nasopharyngitis, pharyngitis), injection site reactions (erythema, pain), elevated liver enzymes (ALT/AST), and neutropenia.
6. Drug Interactions
Live Vaccines:
Contraindicated to administer live vaccines concurrently.
Immunosuppressants:
Abatacept / Anakinra: Concomitant use is not recommended due to increased risk of serious infection.
Methotrexate / Azathioprine: Can be used in combination to enhance efficacy.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Golimumab.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Storage: Store at 2°C–8°C. Do not freeze or shake.