Monograph
S01LA04 - Ranibizumab |
Not porphyrinogenic |
NP |
Side effects
Nasofaryngatis is common in patients using ranibizumab and since infections might trigger an acute porphyric attack, vigilance regarding signs and symptoms of an infection and/or a porphyric attack is recommended.
Nausea is a common side effect that can be potentially porphyrinogenic through reduction in carbohydrate intake and that also can be confused with an acute porphyria attack.
Rationale
Monoclonal antibodies are not metabolized via CYP enzymes, and they are not expected to directly influence the expression of CYP enzymes. In addition ranibizumab has minimal hepatic exposure and interactions with CYP enzymes are not likely.
Chemical description
Ranibizumab is a humanized recombinant monoclonal antibody fragment.
Therapeutic characteristics
Ranibizumab is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD), the treatment of visual impairment due to diabetic macular oedema (DME), the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and for the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).
Hepatic exposure
Ranibizumab has minimal hepatic exposure.
Metabolism and pharmacokinetics
Upon monthly intravitreal administration of ranibizumab 0.5 mg/eye, Cmax of ranibizumab in serum is predicted to range between 0.79 and 2.90 ng/ml, which is equivalent to < 1 µM hepatic exposure. This means that it has minimal hepatic exposure. The elimination half-life is approximately 9 days.
Monoclonal antibodies are metabolized to peptides and amino acids. Drug interactions with CYP enzymes are not expected (Keizer 2010).
Similar drugs
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 |
|
* | Summary of Product Characteristics | |
2. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Ranibizumab.
|
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