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CEPROTIN to prevent
purpura fulminans
and venous thrombosis

Prophylaxis may be necessary in certain severe cases of Protein C deficiency.1 In the pivotal trial, all 7 of the short-term prophylaxis treatments with CEPROTIN were free of complications of PF or thromboembolic events.1

CEPROTIN WAS SHOWN TO BE COMPLICATION FREE FOR SHORT-TERM* PROPHYLAXIS

Study design
In the pivotal trial, 7 short-term prophylaxis treatments with CEPROTIN were administered either as an anticoagulation therapy or because the patient was about to undergo a surgical procedure.1

100%
n=7

Of patients (n=7) treated with CEPROTIN for short-term prophylaxis were free of complications of purpura fulminans or thromboembolic events during treatment.1

SUMMARY OF COMPLICATIONS DURING SHORT TERM PROPHYLAXIS IN THE PROTEIN C CONCENTRATE (HUMAN) STUDY1

REASON
FOR TREATMENT
NUMBER OF TREATMENTS PRESENTATION OF PURPURA FULMINANS DURING TREATMENT EPISODES THROMBOEMBOLIC COMPLICATIONS DURING TREATMENT EPSIODE NUMBER OF
TREATMENTS FREE
OF COMPLICATIONS
N%
N%
N%
ANTICOAGULATION THERAPY 3
00.0%
00.0%
3100.0%
SURGICAL PROCEDURE 4
00.0%
00.0%
4100.0%
TOTAL 7
00.0%
00.0%
7100.0%
*short-term prophylaxis of surgery, short-term prophylaxis for initiation of anticoagulation, or postpartum short-term prophylaxis

NO EPISODES OF PF OCCURRED IN FOUR PATIENTS RANGING FROM
42 TO 338 DAYS OF LONG-TERM PROPHYLACTIC TREATMENT WITH CEPROTIN1

No episodes of PF occurred in four patients ranging from 42 to 338 days of long-term prophylactic treatment with CEPROTIN. When not on prophylactic treatment and receiving CEPROTIN on-demand, the same four patients experienced a total of 13 (median of 3) episodes of PF over a range of 19 to 323 days. The time to first episode of PF after exiting from long-term prophylaxis treatment ranged from 12 to 32 days for these four patients.1

NUMBER AND RATE OF EPISODES OF SKIN LESIONS OR THROMBOSIS FOR FOUR SUBJECTS WHO RECEIVED LONG-TERM PROPHYLACTIC TREATMENT AND WERE TREATED ON-DEMAND IN THE PROTEIN C CONCENTRATE (HUMAN) STUDY1

  LONG-TERM PROPHYLACTIC TREATMENT WHILE ON-DEMAND  
SUMMARY STATISTIC NUMBER OF EPISODES PER SUBJECT NUMBER OF DAYS NOT RECEIVING STUDY DRUG MONTHLY RATE OF EPISODES NUMBER OF EPISODES PER SUBJECT NUMBER OF DAYS NOT RECEIVING STUDY DRUG MONTHLY RATE OF EPISODES TIME TO 1st EPISODE AFTER EXITING LONG TERM PROPHYLAXIS
MEAN 0 229 0.0 3.3 165 1.91 23.3
MEDIAN 0 268 0.0 3.0 159 0.49 24.5
MINIMUM 0 42 0.0 1.0 19 0.25 12.0
MAXIMUM 0 338 0.0 6.0 323 6.40 32.0
†Total number of episodes while subjects were On-Demand was 13

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Warnings and Precautions

Hypersensivity: CEPROTIN may contain trace amounts of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, discontinue the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment are to be observed.

References:

  1. CEPROTIN [Protein C Concentrate (Human)] Prescribing information. Lexington, MA: Baxalta US Inc.

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