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Ceprotin (Protein C) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Hypersensitivity / Allergic Reactions

CEPROTIN may contain traces 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

CEPROTIN is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing a broad range of viruses during manufacture. See DESCRIPTION .

Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at 1-866-888-2472. The physician should discuss the risks and benefits of this product with the patient.

Some viruses, such as Human Parvovirus B19 (B19V) or Hepatitis A, are particularly difficult to remove or inactivate. B19V most seriously affects pregnant women (fetal infection), or immune-compromised individuals. Symptoms of B19V infection include fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of Hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular and/or repeated receipt of human plasma-derived Protein C.

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 Heparin-induced Thrombocytopenia. The platelet count should be determined immediately and discontinuation of CEPROTIN should be considered.

Low Sodium Diet / Renal Impairment

Patients on a low sodium diet should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Patients with renal impairment should be monitored more closely for sodium overload.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with CEPROTIN. It is also not known whether CEPROTIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CEPROTIN has not been studied for use in pregnancy.

Labor and Delivery

There has been one report of CEPROTIN exposure during labor and delivery with no adverse outcome. CEPROTIN has not been studied for use during labor and delivery.

Nursing Mothers

It is not known whether CEPROTIN is excreted in human milk. CEPROTIN has not been studied for use in nursing mothers.

Pediatric Use

Neonatal and pediatric subjects were included in several retrospective and prospective studies, evaluating the safety and effectiveness of CEPROTIN. Subjects were enrolled from as early as 2 days old throughout adolescence.

Geriatric Use

Clinical studies of CEPROTIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Renal/Hepatic Impairment

No experience in the treatment of patients with renal and/or hepatic impairment is available.

Page last updated: 2010-08-12

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