Active Ingredient: Catumaxomab
Catumaxomab is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intraperitoneal, 10 milligrams catumaxomab, one dose, over the duration of 3 days. Afterwards, intraperitoneal, 20 milligrams catumaxomab, one dose, over the duration of 4 days. Afterwards, intraperitoneal, 50 milligrams catumaxomab, one dose, over the duration of 3 days. Afterwards, intraperitoneal, 150 milligrams catumaxomab, one dose.
Prior to the intraperitoneal infusion, medication for the prophylactic treatment of cytokine release symptoms, including analgesic, antipyretic and non-steroidal antiphlogistic medicinal products is recommended.
Side effects of catumaxomab treatment should be treated as medically indicated and according to the current standard of care.
Catumaxomab dosing schedule comprises the 4 intraperitoneal infusions listed in the following table.
Catumaxomab dosing schedule:
| Infusion number | Dose | Day |
|---|---|---|
| 1 | 10 micrograms | 0 |
| 2 | 20 micrograms | 3 |
| 3 | 50 micrograms | 7 |
| 4 | 150 micrograms | 10 |
Patients should remain under close medical supervision for at least 24 hours after the first infusion of catumaxomab. For the remaining doses, patients may be hospitalised for at least 6 hours or for a longer time after infusions of catumaxomab at the discretion of the treating physician to safeguard patient safety.
The interval between the infusion days can be prolonged at the discretion of the treating physician if needed in order to minimise the risk of adverse reactions. The overall treatment period should not exceed 21 days.
Catumaxomab must be administered as an intraperitoneal infusion only.
Catumaxomab must not be administered by intraperitoneal bolus or by any other route of administration.
Catumaxomab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours. In clinical studies infusion times of 3 hours and 6 hours were investigated. For the first of the 4 doses, an infusion time of 6 hours may be considered depending on the patient’s health condition.
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