Monograph
L04AB06 - Golimumab |
Propably not porphyrinogenic |
PNP |
Important Information
Patients on immunosuppressive therapy have an increased risk of infections. Since infections have a potential to trigger acute porphyric attacks vigilance is motivated regarding signs or symptoms of infection and/or possible symptoms of a porphyric attack. Side effects like nausea and vomiting may potentially be porphyrinogenic through reduction in carbohydrate intake.
Side effects
Infections are common in patients using immunosuppressants and since infections might trigger an acute porphyric attack, vigilance regarding signs and symptoms of an infection and/ or a porphyric attack is recommended. Common adverse reactions of golimumab that can be confused with an acute porphyric attack are nausea and vomiting. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake.
Rationale
Golimumab is an antibody preparation not metabolized by CYP enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Golimumab is a human IgG-kappa monoclonal antibody against tumor necrosis factor (TNF). Golimumab is produced by insertion of human genes into mice.
Therapeutic characteristics
Golimumab is an anti TNF agent used together with metothrexate in rheumatoid arthritis, psoriasis arthritis and anchylosing spondylitis. It is administered as a subcutaneous injection.
Metabolism and pharmacokinetics
Golimumab is a human antibody protein and it is not metabolized by hepatic cytochrome P-450 (CYP) enzymes. Mechanisms for elimination of monoclonal antibodies are not well documented but are reported to include proteolysis by the liver and the reticuloendothelial system, target-mediated elimination and nonspecific endocytosis (Keizer 2010). The elimination half-life of golimumab is about 14 days.
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | Keizer, R.J., Huitema, A.D.R., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies.
Clin Pharmacokinet. 2010 Aug 1;49(8):493-507 |
20608753 |
| 2. | Lee, J.I., Zhang, L., CYP-Mediated Therapeutic Protein-Drug Interactions, clinical findings, proposed mechanisms and regulatory implications.
Clin Pharmacokinet. 2010 May 1;49(5):295-310 |
20384392 |
| 3. | Golimumab and certolizumab: The two new anti-tumor necrosis factor kids on the block. Indian J Dermatol Venereol Leprol 2010;76:602-9
Mittal M, Raychaudhuri SP. |
21079302 |
| * | Drug reference publications | |
| 4. | Sweetman SC, editor. Martindale: The complete drug reference. Golimumab. Pharmaceutical Press 2009.
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| * | Summary of Product Characteristics | |
| 5. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Simponi.
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