anti-inhibitor coagulant complex

Action and Spectrum

Actions and Spectrum:  

The action of this drug is to replace the missing clotting factors in patients with hemophilia, allowing for the formation of a stable blood clot and stopping the bleeding. VWF is also important in the clotting process as it helps to stabilize and protect factor VIII in the bloodstream, increasing its effectiveness. 

The spectrum of this drug is specific to treating hemophilia A or B, and it is ineffective in treating bleeding disorders caused by other factors. It is administered through injection, and the dosage is tailored to the individual patient’s needs based on the severity of the bleeding episode and the patient’s weight. 

Drug Interaction

Adverse Reaction

Frequency not defined  

Headache 

Nausea 

Chest discomfort 

Flushing 

Injection site pain 

Rash 

Fever 

Hypotension 

Tachycardia 

Chills 

Thromboembolic events 

Urticaria 

Hypersensitivity reactions 

Lethargy 

Myocardial infarction 

Black Box Warning

Black Box Warning:  

The Black box warning of this drug is associated with a high risk of thromboembolic events, including stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism, and arterial thrombosis.  

Contraindication / Caution

Contraindication/Caution:  

Hypersensitivity: If a patient is known to have hypersensitivity  

Disseminated Intravascular Coagulation (DIC): It should not be used in patients with DIC, a severe condition in which blood clots form throughout the body and can lead to organ failure. 

Thrombosis: it should not be used in patients with a history of thrombosis (blood clots), as it can increase the risk of further clotting. 

Renal Impairment: Patients with renal impairment should exercise caution when using this drug, as it has the potential to accumulate in the body and result in toxicity. 

Liver Impairment: it should be used with caution in patients with liver impairment, as it can exacerbate liver disease. 

Pregnancy and Breastfeeding: It is advisable to exercise caution while administering to pregnant or breastfeeding women, as the impact on fetal development and breastfed infants is not fully comprehended. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

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 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:

it is a medication used in the treatment of bleeding episodes in patients with hemophilia A or B who have developed inhibitors to clotting factors VIII or IX. It contains factors II, IX, and X and proteins C and S, which work together to promote blood clotting. 

Pharmacodynamics:

The pharmacodynamics mechanism involves replacing missing or deficient clotting factors, promoting the formation of a stable clot, and preventing excessive clotting by the action of natural anticoagulants. 

MOA: The mechanism of action is to replace the missing or defective clotting factors in patients with hemophilia who have developed inhibitors. The development of the prothrombinase complex, which transforms prothrombin to thrombin, is facilitated by Factors II, IX, and X. Subsequently, thrombin changes fibrinogen to fibrin, which leads to clot formation. 

Pharmacokinetics: 

Absorption:  

The administration is done intravenously, which implies that the medication is directly infused into the patient’s bloodstream. This facilitates prompt and thorough absorption of the drug. 

Distribution:  

It is distributed throughout the body, reaching the sites where it is needed to control bleeding. The medication binds to clotting factors in the patient’s blood and enhances their activity, forming a stable blood clot. 

Metabolism:  

It is metabolized in the liver and cleared from the bloodstream. The medication has a relatively short half-life, which means it is eliminated from the body relatively quickly. 

Excretion and elimination: 

It is primarily excreted in the urine and feces. The medication is eliminated from the body within a few hours after administration. 

Adminstartion

Administration:  

Reconstitute the powder with the appropriate amount of sterile water for injection. The amount of water needed depends on the specific product and dose prescribed by the physician. 

Draw up the reconstituted into a sterile syringe using a filter needle to remove any particulate matter. 

Choose a site for injection. It can be injected into a vein (intravenous) or under the skin (subcutaneous). The specific site and method of injection will depend on the patient’s individual needs and the recommendation of the physician. 

Administer the injection according to the prescribed dose and method. 

After administration, apply pressure to the injection site with a sterile gauze pad for several minutes to minimize bleeding. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: anti-inhibitor coagulant complex 

Why do we use anti-inhibitor coagulant complex?  

It is prescribed to individuals with hemophilia and inhibitors to help manage bleeding episodes. Hemophilia is a genetic condition that impacts the normal clotting function of blood, causing excessive bleeding and bruising. 

Inhibitors are antibodies that develop in some individuals with hemophilia as a result of treatment with clotting factor replacement therapy. When individuals with hemophilia develop inhibitors, it can hinder the effectiveness of the clotting factor, resulting in challenges in managing bleeding episodes. It is formulated with clotting factors II, VII, IX, and X, along with proteins C and S, which collaborate to facilitate blood clotting and regulate bleeding. 

This drug is used in individuals with hemophilia who have developed inhibitors to clotting factor replacement therapy. It helps to bypass the inhibitors and restore the blood’s ability to clot, reducing the risk of bleeding and improving overall health outcomes.