Active Ingredient: Pegcetacoplan
Pegcetacoplan is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1,080 milligrams pegcetacoplan, 2 times weekly.
Pegcetacoplan is administered twice weekly as a 1 080 mg subcutaneous infusion with a commercially available syringe system infusion pump or on-body delivery system. The twice weekly dose should be administered on Day 1 and Day 4 of each treatment week.
C3G is a chronic disease. Discontinuation of this medicinal product is not recommended unless clinically indicated.
If a dose of pegcetacoplan for treatment of C3G is missed, it should be administered as soon as possible, then the regular schedule should be resumed even if this results in an interval of less than 3 days between the replacement dose and the subsequent dose.
Diagnosis of post-transplant recurrent C3G should be made based on a renal allograft biopsy. C3G recurrence may be detected in a routine post-transplant biopsy; otherwise, a biopsy should be performed when clinical signs indicate recurrent disease. As done in study APL2-C3G-204, treatment with pegcetacoplan can be started before the onset of clinical signs such as estimated glomerular filtration rate (eGFR) decrease or urine to protein-to-creatine ratio (uPCR) increase. There is limited experience with the use of pegcetacoplan in patients with recurrent C3G after transplantation in clinical studies.
Although there were no apparent age-related differences observed in clinical studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. There is no evidence indicating any special precautions are required for treating an elderly population.
Pegcetacoplan should only be administered via subcutaneous administration using a commercially available syringe system infusion pump or on-body delivery system.
When using a syringe system infusion pump, pegcetacoplan should be infused in the abdomen, thighs, hips, or upper arms. Infusion sites should be at least 7.5 cm apart from each other. The infusion sites should be rotated between administrations. The infusion time is approximately 30 minutes (if using two sites) or approximately 60 minutes (if using one site).
When using an on-body delivery system, pegcetacoplan should be infused at a site on the abdomen. The infusion site should be rotated between administrations following the device manufacturer's instructions. The infusion time varies by patient and typically ranges from 30 to 60 minutes.
Infusion into areas where the skin is tender, bruised, red, or hard should be avoided. Infusion into tattoos, scars, or stretch marks should be avoided. The infusion should be started promptly after drawing this medicinal product into the syringe. Administration should be completed within 2 hours after preparing the syringe.
For:
Regimen A, in case that patient weight is ≥ 50 kg
Subcutaneous, 1,080 milligrams pegcetacoplan, 2 times weekly.
Regimen B, in case that patient weight is ≥ 35 kg and patient weight is < 50 kg
Subcutaneous, 648 milligrams pegcetacoplan, one dose, over the duration of 3 days. Afterwards, subcutaneous, 810 milligrams pegcetacoplan, one dose, over the duration of 3 days. Afterwards, subcutaneous, 810 milligrams pegcetacoplan, 2 times weekly.
Regimen C, in case that patient weight is ≥ 30 kg and patient weight is < 35 kg
Subcutaneous, 540 milligrams pegcetacoplan, one dose, over the duration of 3 days. Afterwards, subcutaneous, 540 milligrams pegcetacoplan, one dose, over the duration of 3 days. Afterwards, subcutaneous, 648 milligrams pegcetacoplan, 2 times weekly.
Pegcetacoplan is administered twice weekly as a subcutaneous infusion with a commercially available syringe system infusion pump or on-body delivery system. The twice weekly dose should be administered on Day 1 and Day 4 of each treatment week.
C3G is a chronic disease. Discontinuation of this medicinal product is not recommended unless clinically indicated.
For adolescent patients, the dosing regimen is based on the patient´s body weight and consists of the following:
| Body weight | First dose (infusion volume) | Second dose (infusion volume) | Maintenance dose (infusion volume) |
| ≥50 kg | 1 080 mg twice weekly | ||
| 35 to <50 kg | 648 mg | 810 mg | 810 mg twice weekly |
| 30 to <35 kg | 540 mg | 540 mg | 648 mg twice weekly |
If a dose of pegcetacoplan for treatment of C3G is missed, it should be administered as soon as possible, then the regular schedule should be resumed even if this results in an interval of less than 3 days between the replacement dose and the subsequent dose.
Diagnosis of post-transplant recurrent C3G should be made based on a renal allograft biopsy. C3G recurrence may be detected in a routine post-transplant biopsy; otherwise, a biopsy should be performed when clinical signs indicate recurrent disease. As done in study APL2-C3G-204, treatment with pegcetacoplan can be started before the onset of clinical signs such as estimated glomerular filtration rate (eGFR) decrease or urine to protein-to-creatine ratio (uPCR) increase. There is limited experience with the use of pegcetacoplan in patients with recurrent C3G after transplantation in clinical studies.
Pegcetacoplan should only be administered via subcutaneous administration using a commercially available syringe system infusion pump or on-body delivery system.
When using a syringe system infusion pump, pegcetacoplan should be infused in the abdomen, thighs, hips, or upper arms. Infusion sites should be at least 7.5 cm apart from each other. The infusion sites should be rotated between administrations. The infusion time is approximately 30 minutes (if using two sites) or approximately 60 minutes (if using one site).
When using an on-body delivery system, pegcetacoplan should be infused at a site on the abdomen. The infusion site should be rotated between administrations following the device manufacturer's instructions. The infusion time varies by patient and typically ranges from 30 to 60 minutes.
Infusion into areas where the skin is tender, bruised, red, or hard should be avoided. Infusion into tattoos, scars, or stretch marks should be avoided. The infusion should be started promptly after drawing this medicinal product into the syringe. Administration should be completed within 2 hours after preparing the syringe.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.