Monograph
B01AF01 - Rivaroxaban |
Propably not porphyrinogenic |
PNP |
Rationale
Rivaroxaban is not an inducer or an inhibitor of CYP3A4, or other major CYP isoenzymes.
Risk for gastrointestinal adverse events in the form of nausea, vomiting and diarrhoea motivates vigilance against insufficient intake of food, especially of carbohydrate.
Therapeutic characteristics
Rivaroxoban is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Very common side effects that can be potentially porphyrinogenic through reduction in carbohydrate intake and that also can be confused with an acute porphyria attack are gastrointestinal and abdominal pain, dyspepsia, nausea, obstipation, diarrhoea and vomiting. Other common side effects are tachycardia and fever.
Metabolism and pharmacokinetics
Rivaroxaban is metabolized by CYP3A4, CYP2J2 and CYP-independent mechanisms (Mueck 2013 and SPC).
No clinical significant pharmacokinetic interactions were observed when rivaroxaban was co-administered with the CYP3A4 substrates, midazolam (Mueck 2013 and SPC) or atorvastatin (Kubitza 2012 and SPC), which indicates that rivaroxaban do not inhibit or induce CYP3A4.
References
| # |
Citation details |
PMID |
|---|
| * | Scientific articles |
| 1. |
Absence of clinically relevant interactions between rivaroxaban--an oral, direct Factor Xa inhibitor--and digoxin or atorvastatin in healthy subjects.
Kubitza D, Becka M, et al. J Int Med Res. 2012;40(5):1688-707. |
23206451 |
| 2. |
Co-administration of rivaroxaban with drugs that share its elimination pathways: pharmacokinetic effects in healthy subjects.
Mueck W, Kubitza D, Becka M. Br J Clin Pharmacol. 2013 Jan 11. |
23305158 |
| * | Summary of Product Characteristics |
| 3. |
Norwegian medicines agency. Summary of Product Characteristics (SPC). Rivaroksiban.
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