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
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% |
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 |
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.
Transmission of infectious agents: Because CEPROTIN is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeld-Jakob disease (CJD) agent.
Bleeding episodes: Several bleeding episodes have been observed in clinical studies. Concurrent anticoagulant medication may have been responsible for these bleeding episodes. However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events. Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.
Heparin-induced thrombocytopenia (HIT): CEPROTIN contains trace amounts of heparin which may lead to HIT, which can be associated with a rapid decrease of the number of thombocytes. If HIT is suspected, determine the platelet count immediately and consider discontinuation of CEPROTIN.
Low sodium diet/Renal impairment: Patients on a low sodium diet or who have renal impairment should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Monitor patients with renal impairment closely for sodium overload.
Adverse Reactions
Common adverse reactions related to CEPROTIN observed in clinical trials were hypersensitivity or allergic reactions: lightheadedness, itching and rash.
INDICATION
CEPROTIN [Protein C Concentrate (Human)] is indicated for neonates, pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
Please click for Full Prescribing Information.
References:
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CEPROTIN [Protein C Concentrate (Human)] Prescribing information. Lexington, MA: Baxalta US Inc.