Active Ingredient: Iptacopan
Iptacopan is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 200 milligrams iptacopan, 2 times daily.
The recommended dose is 200 mg taken orally twice daily.
Healthcare professionals should advise patients about the importance of adherence to the dosing schedule.
Diagnosis of recurrent C3G should be made based on histological C3 deposition in the glomeruli of the transplanted kidney. C3 deposition may be detected in a routine post-transplantation biopsy; otherwise, a biopsy should be performed when clinical signs indicate recurrent C3G. As done in study X2202, treatment with iptacopan can be started before the onset of clinical signs such as estimated glomerular filtration rate (eGFR) decrease or urine protein-to-creatinine ratio (UPCR) increase. There is limited experience with the use of iptacopan in patients with recurrent C3G after transplantation in clinical studies.
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