Monograph
M05BX04 - Denosumab |
Not porphyrinogenic |
NP |
Rationale
Denosumab is not metabolised by CYP enzymes, and does not inhibit or induce CYP3A4.
Chemical description
Denosumab is human monoclonal antibody (IgG2).
Therapeutic characteristics
Denosumab is indicated for the treatment of osteoporosis at increased risk of fractures and treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
Common side effects are urinary tract infections, upper respiratory tract infections, obstipation and pain in extremity.
Metabolism and pharmacokinetics
Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms. Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids (SPC).
Denosumab showed no effect on the pharmacokinetics of midazolam (a CYP3A4 substrate). This indicates that denosumab does not inhibit or induce CYP3A4 (SPC).
References
| # | Citation details | PMID |
|---|---|---|
| * | Summary of Product Characteristics | |
| 1. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Denosumab.
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