Monograph
L04AG04 - Belimumab |
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 belimumab 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
Belimumab is not metabolized by cytochrome P450 enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Belimumab is a human IgG1-lambda monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein.
Therapeutic characteristics
Belimumab is used in the treatment of active, autoantibody-positive systemic lupus erythematosus in adults as an addition to standard therapy. It is administered as an intravenous infusion.
Metabolism and pharmacokinetics
Belimumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes. Classical biotransformation studies have not been conducted (SPC, Keizer 2010).
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | Clinical pharmacokinetics of therapeutic monoclonal antibodies.
Keizer RJ, Huitema AD et al. Clin Pharmacokinet. 2010 Aug; 49 (8):493-507. |
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| * | Drug reference publications | |
| 2. | Micromedex® 2.0 (online). Belimumab (Drugdex System).
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| * | Summary of Product Characteristics | |
| 3. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Benlysta.
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