protein C concentrate

Action and Spectrum

Actions and Spectrum: 

Protein C is a natural anticoagulant protein that plays a critical role in regulating blood clotting. protein C concentrate, also known as human protein C concentrate, is a medication that contains purified protein C and is used to treat certain clotting disorders, particularly in patients with hereditary or acquired protein C deficiency. 

The main action of protein C concentrate is to activate the coagulation cascade by inactivating the activated forms of clotting factors V and VIII, which are involved in the formation of blood clots. By doing so, protein C concentrate helps to prevent the formation of blood clots and is used to treat or prevent conditions such as the deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. 

The spectrum of protein C concentrate refers to the range of conditions that it can be used to treat or prevent. protein C concentrate is primarily used in the treatment of patients with severe protein C deficiency, which can be either hereditary or acquired. It is also generally used in the management of patients with severe sepsis or disseminated intravascular coagulation, conditions in which there is excessive clotting and consumption of clotting factors in the body. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Itching 

Hypersensitivity 

Allergic reactions 

Rash 

Lightheadedness 

Restlessness 

Hemothorax 

Fever 

Hypotension 

Heparin-induced thrombocytopenia 

Hyperhidrosis 

Black Box Warning

Black Box Warning: 

The black box warning for protein C concentrate is related to the risk of thrombosis or blood clots, particularly when the medication is used at high doses or in patients with an increased risk of thrombosis.

protein C concentrate is a potent anticoagulant medication that can increase the risk of bleeding, but paradoxically, it can also increase the risk of thrombosis in certain patients.

The black box warning advises healthcare providers to closely monitor patients receiving protein C concentrate for signs of thrombosis, and to adjust the dose accordingly. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

protein C concentrate is contraindicated in the following situations: 

• Hypersensitivity: protein C concentrate should not be used in patients with a known hypersensitivity or allergic reaction to any of the components of the medication. 
• Active Bleeding: protein C concentrate should not be used in patients with active bleeding or a high risk of bleeding, as it can exacerbate bleeding. 
• Disseminated Intravascular Coagulation (DIC): protein C concentrate should not be used in patients with DIC, a condition in which there is widespread activation of blood clotting and consumption of clotting factors, as it can increase the risk of bleeding. 
• Thrombosis: protein C concentrate should not be used in patients with a history of thrombosis or an increased risk of thrombosis, as it can increase the risk of blood clots. 
• Warfarin-Induced Skin Necrosis: protein C concentrate should not be used in patients with warfarin-induced skin necrosis, a rare but serious complication of warfarin therapy. 

Caution 

There are several cautions that healthcare providers should consider before prescribing protein C concentrate, including: 

• Bleeding Risk: protein C concentrate is a potent anticoagulant medication and can increase the risk of bleeding, particularly in patients with a history of bleeding disorders, recent surgery, or trauma. Healthcare providers should carefully monitor patients for signs of bleeding and adjust the dose accordingly. 
• Renal or Hepatic Impairment: protein C concentrate is firstly cleared from the body through the kidneys and liver, so patients with renal or hepatic impairment may be at increased risk of adverse effects. Healthcare providers should closely monitor these patients and adjust the dose as necessary. 
• Pregnancy and Breastfeeding: The safety of protein C concentrate during pregnancy and breastfeeding is not well established. Healthcare providers should carefully weigh the potential risks and benefits before prescribing protein C concentrate to pregnant or breastfeeding women. 
• Concomitant Anticoagulant Therapy: protein C concentrate, caution in patients receiving other anticoagulant medications, as this can increase the risk of bleeding. Healthcare providers should monitor these patients closely and adjust the dose as necessary. 
• Pediatric Patients: The safety and effectiveness of protein C concentrate in pediatric patients have not been well established. Healthcare providers should use caution when prescribing protein C concentrate to children and closely monitor them for adverse effects. 

Pregnancy / Lactation

Pregnancy consideration:  

AU TGA pregnancy category: B2 

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk is Not known. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/later trimester.        
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women        
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.       
• Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.        
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.        
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

protein C concentrate is a purified form of human protein C, a natural anticoagulant protein that is synthesized in the liver. Protein C works by inactivating clotting factors in the blood, including factors V and VIII, which are necessary for the formation of blood clots. 

Protein C is activated by the thrombin-thrombomodulin complex, which is located on the surface of endothelial cells. Once activated, protein C forms a complex with protein S, another anticoagulant protein, and inactivates factors V and VIII by cleaving them at specific sites. This process helps to prevent the formation of blood clots and promotes the breakdown of existing clots. 

Pharmacodynamics: 

Mechanism of action: The liver synthesizes a precursor molecule of a vitamin K-dependent anticoagulant glycoprotein, which is a type of serine protease. This precursor molecule is then converted into activated Protein C (APC) on the endothelial cell surface by the thrombin/thrombomodulin-complex, thereby contributing to the regulation of blood coagulation. 

Pharmacokinetics: 

The pharmacokinetics of protein C concentrate are characterized by a rapid distribution throughout the body, followed by a short half-life and rapid clearance from the circulation. The exact pharmacokinetic properties may vary depending on the patient’s individual factors, such as weight, age, and degree of protein C deficiency. 

After intravenous administration of protein C concentrate, the medication is rapidly distributed throughout the body and is immediately available for use. The half-life of protein C concentrate is relatively short, ranging from about 4 to 6 hours in healthy individuals, and may be shorter in patients with renal or hepatic impairment. As a result, repeated doses of protein C concentrate may be necessary to maintain therapeutic levels in the blood. 

protein C concentrate is primarily eliminated from the body through the kidneys and liver. Patients with renal or hepatic impairment may have a longer half-life and may be at increased risk of adverse effects. Healthcare providers should monitor these patients carefully and adjust the dose as necessary to avoid potential toxicity. 

Adminstartion

Administration: 

Intravenous administration 

protein C concentrate is administered intravenously (IV) by a healthcare provider, usually in a hospital or clinical setting. The medication comes in a lyophilized powder form, which must be reconstituted with sterile water or another appropriate diluent prior to use. 

The dosage of protein C concentrate is based on the patient’s weight, medical history, and individual risk factors for clotting disorders. Healthcare providers may need to adjust the dose based on the patient’s response to treatment and any adverse effects that may occur. 

protein C concentrate should be infused slowly over a period of 30 to 60 minutes to minimize the risk of adverse effects, such as hypotension or allergic reactions. Patients should be monitored closely during and after the infusion for any signs of adverse effects. 

protein C concentrate should be stored in a refrigerator at a temperature between 2-8°C (36-46°F). The medication should not be frozen, and any unused portions should be discarded according to the manufacturer’s instructions. 

It is key for patients to follow their healthcare provider’s instructions carefully regarding the administration of protein C concentrate, and to report any unexpected or severe symptoms to their healthcare provider immediately. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: protein C concentrate 

Pronounced: [ PROE-teen-cee-KON-suhn-trate-HYU-man] 

Why do we use protein C concentrate? 

protein C concentrate is primarily used as a treatment for severe cases of congenital or acquired protein C deficiency, a rare genetic disorder that can increase the risk of blood clots. Protein C is a natural anticoagulant protein that helps to stops the formation of blood clots by inactivating clotting factors in the blood. When protein C levels are low or absent, the risk of blood clots can increase. 

protein C concentrate is also sometimes used off-label for the treatment of other conditions, such as: 

• Sepsis-induced coagulopathy: Some studies suggest that protein C concentrate may help to improve outcomes in patients with sepsis-induced coagulopathy, a condition in which the body’s clotting system becomes overactive in response to an infection. 
• Venous thromboembolism: protein C concentrate may be used in some cases of venous thromboembolism (VTE), particularly in patients with congenital or acquired protein C deficiency. 
• Disseminated intravascular coagulation: protein C concentrate has been used in some cases of disseminated intravascular coagulation (DIC), a condition in which the clotting system becomes overactive and leads to widespread clotting and bleeding.