L04AB04 - Adalimumab |
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 adalimumab 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
Adalimumab is protein preparation not metabolized by CYP enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Adalimumab is a human monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-alpha). It is an immunoglobulin G1 (IgG1) made by phage display technology with amino acid sequences from the human germline.
Therapeutic characteristics
Adalimumab is a biologic response modifier used in the treatment of moderate to severe, active rheumatoid arthritis and active and progressive psoriatic arthritis, active ankylosing spondylitis. It can also be used in the treatment of moderate to severe active Crohns disease and moderate to severe chronic plaque psoriasis in patients unresponsive to conventional treatment. It is given by subcutaneous injection.
Metabolism and pharmakokinetics
Adalimumab is a human monoclonal antibody. 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).
IPNet drug reports
Uneventful use reported in 2 patients with acute porphyria.
References
- Scientific articles
- Keizer RJ, Huitema AD et al. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010 Aug; 49 (8):493-507. #2040
- Drug reference publications
- McEvoy GK, editor. Adalimumab. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (31.09.10). #2295
- Sweetman SC, editor. Martindale: The complete drug reference. Adalimumab. Pharmaceutical Press 2009. #2296
- Government bodies
- European Public Assessment Report, Humira (Scientific discussion).European Medicines Agency (EMEA). Accessible from: emea.europa.eu #2294
- Summary of Product Characteristics
- The electronic Medicines Compendium (eMC). Humira. Summary of Product Characteristics (SPC). #2297
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