Monograph
L04AG03 - Natalizumab |
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 natalizumab 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
Natalizumab is not metabolized by cytochrome P450 enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Natalizumab is a recombinant, humanized form of a murine monoclonal antibody that binds to the alpha4 subunit of alpha4 beta1 and alpha4 beta7 integrin.
Therapeutic characteristics
Natalizumab is used as monotherapy to prevent relapses and delay progression of disability in patients with highly active relapsing-remitting multiple sclerosis. It is also used for inducing and maintaining response and remission in moderate to severe Crohns disease. It is given by intravenous infusion.
Metabolism and pharmacokinetics
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).
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. | McEvoy GK, editor. Bleomycin. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (30.08.10).
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| 3. | Sweetman SC, editor. Martindale: The complete drug reference. Natalizumab. Pharmaceutical Press 2009.
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| * | Summary of Product Characteristics | |
| 4. | The electronic Medicines Compendium (eMC). Tysabri. Summary of Product Characteristics (SPC).
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