Active Ingredient: Catumaxomab
Catumaxomab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intraperitoneal
10 - 150 mg
From 10 To 150 mg once every 3 day(s) for 20 day(s)
10 mg
Prior to the intraperitoneal infusion, pre-medication with analgesic/antipyretic/non-steroidal antiphlogistic medicinal products is recommended.
Catumaxomab dosing schedule comprises the following four intraperitoneal infusions:
1st dose 10 micrograms on day 0
2nd dose 20 micrograms on day 3
3rd dose 50 micrograms on day 7
4th dose 150 micrograms on day 10
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 four doses an infusion time of 6 hours may be considered depending on the patient’s health condition.
An interval of at least two infusion free calendar days must elapse between infusion days. The interval between the infusion days can be prolonged in case of relevant adverse reactions. The overall treatment period should not exceed 20 days.
Adequate monitoring of the patient after end of catumaxomab infusion is recommended. In the pivotal study patients were monitored for 24 h after each infusion.
Catumaxomab must be administered as an intraperitoneal infusion only.
Catumaxomab must not be administered by intraperitoneal bolus or by any other route of administration.
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