May 27, 2016
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Ceprotin

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

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

Because CEPROTIN is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

ALL infections suspected 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. Discuss the risks and benefits of this product with your patient.

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, which can be associated with a rapid decrease of the number of thrombocytes. Identifying HIT is complicated because these symptoms may already be present in acute phase patients with severe congenital protein C deficiency. Determine the platelet count immediately and consider discontinuation of CEPROTIN. 5.5 Low Sodium Diet/Renal Impairment Inform patients on a low sodium diet that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Monitor patients with renal impairment closely for sodium overload. 6. ADVERSE REACTIONS The common adverse reactions related to CEPROTIN treatment observed were the following hypersensitivity or allergic reactions: lightheadedness and itching and rash.

Patient Counseling Information

Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, as the risk of an allergic type hypersensitivity reaction cannot be excluded. In addition, CEPROTIN may contain traces of mouse protein or heparin as a result of the manufacturing process. Allergic reactions to mouse protein or heparin cannot be ruled out. Inform patients to immediately discontinue the injection/infusion and inform their physician as soon as possible if symptoms of hypersensitivity/allergic reaction occur. Maintain CEPROTIN in the original carton to protect from light prior to reconstitution.

Reconstitute the lyophilized CEPROTIN powder with the supplied diluent (Sterile Water for Injection) using the sterile transfer needle. Gently swirl the vial until all powder is dissolved.

Visually inspect the solution for discoloration and particulate matter. The reconstituted solution should be colorless to slightly yellowish and clear to slightly opalescent and free from visible particles. Do not administer CEPROTIN if discoloration or particulate matter is observed. The solution is drawn through the sterile filter needle into a sterile disposable syringe.

The reconstituted solution contains no preservatives and is intended for single use only. Once reconstituted, administer the product by intravenous injection within 3 hours. Appropriately discard all unused solution, empty vials and used needles.

The attached CEPROTIN (Protein C Concentrate [Human]) “PATIENT INFORMATION” contains more detailed instructions on the preparation of CEPROTIN.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis And Impairment Of Fertility

Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C. Studies in heterologous species to evaluate carcinogenicity, reproductive toxicology and developmental toxicology have not been performed. CEPROTIN has not demonstrated mutagenic potential in the Salmonella Thyphimurium reverse mutation assay (Ames test).

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 should be given to pregnant women only if clearly needed.

Labor And Delivery

CEPROTIN has not been studied for use during labor and delivery. Use only if clearly needed.

Nursing Mothers

CEPROTIN has not been studied for use in nursing mothers. Use CEPROTIN only if clearly needed.

Pediatric Use

Neonatal and pediatric subjects were enrolled during the prospective and retrospective studies described in CLINICAL STUDIES (14). Of the 18 subjects enrolled during the prospective study, 1 was newborn, 3 were between 28 days and 23 months, 9 were between 2 and 11 years, 1 was between 12 and 16 years, and 4 were older than 16 years [see Clinical Studies: Pivotal Study]. Of the 11 subjects enrolled and treated during the retrospective study, 9 were between 2 and 11 years, and 2 were older than 16 years [see Clinical Studies: Retrospective Analysis].

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/17/2016

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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