antihemophilic factor recombinant

Action and Spectrum

Actions and spectrum: 

antihemophilic factor recombinant is a medication used to replace clotting factor VIII in patients with hemophilia A, a genetic bleeding disorder. It works by replacing the missing clotting factor VIII, which helps the blood to clot and prevent bleeding.

This medication is a recombinant version of clotting factor VIII that is produced using genetic engineering techniques. It has a broad spectrum of action and is effective in treating bleeding episodes, including those that occur spontaneously, during surgery, or after injury. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Hypotension (1%) 

Rash (1%) 

redness or swelling at injection site (1%) 

Pruritus (1%) 

Nausea (1-4.4%) 

Dyspnea (1.8%) 

Taste disorder (2.7%) 

Headache (3.5%) 

Dizziness (3.5%) 

Pyrexia (5.9%) 

 >10% 

factor VIII inhibitor (31.7%)  

Frequency not defined 

Asthenia 

Chills 

Hemorrhage 

Sore throat
Vomiting 

Joint pain/swelling 

Arthralgia 

Somnolence 

Vasodilation 

Rhinitis 

Stuffy nose 

Diarrhea 

Urticaria 

Black Box Warning

Black Box Warning: 

There is no black box warning for antihemophilic factor recombinant. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

antihemophilic factor recombinant (also known as factor VIII) is contraindicated in individuals who have known hypersensitivity to the product, including allergic reactions, as well as those with disseminated intravascular coagulation (DIC) and acute thrombosis. It should also be used under caution in patients with pre-existing cardiovascular disease, liver disease, or a history of thromboembolic events.  

Caution: 

• Allergic reactions: Patients with a history of allergic reactions to antihemophilic factor products or other components of the medication should not receive antihemophilic factor recombinant. 
• Formation of inhibitors: The formation of inhibitors to antihemophilic factor is a potential risk. Inhibitors can reduce the effectiveness of the medication and lead to bleeding complications. 
• Thromboembolic events: Thromboembolic events, including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke, have been reported in patients receiving antihemophilic factor products.  
• Hypersensitivity reactions: antihemophilic factor recombinant may cause hypersensitivity reactions, including anaphylaxis. 
• Hepatitis C virus transmission: antihemophilic factor recombinant is made from human plasma and may contain the hepatitis C virus.  
• Pregnancy and breastfeeding: The safety of antihemophilic factor recombinant in pregnancy and breastfeeding is not well established.

Comorbidities: 

The main comorbidity associated with hemophilia A is bleeding, which can lead to joint damage, neurological complications, and even death if left untreated. Patients with hemophilia A may also have an increased risk of developing inhibitors to factor VIII, which can make treatment more difficult. 

In addition, patients with hemophilia A may have other comorbidities such as hepatitis B or C, HIV, and other infections that may affect their ability to produce or use factor VIII. 

Pregnancy / Lactation

Pregnancy consideration: US FDA pregnancy category: Not assigned 

Lactation: It is not known whether the antihemophilic factor recombinant is excreted in human milk  

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh risks over benefits These category drugs should be prohibited for pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

antihemophilic factor recombinant, also known as recombinant factor VIII (rFVIII), is a genetically engineered form of human factor VIII, a clotting factor that is deficient in patients with hemophilia A. Recombinant factor VIII is designed to provide replacement therapy for these patients, allowing them to form stable blood clots and prevent bleeding episodes. 

The mechanism of action of recombinant factor VIII is like that of endogenous factor VIII. factor VIII binds to von Willebrand factor (vWF) to form a complex that stabilizes the clotting factor in the blood. The factor VIII-vWF complex is then activated by thrombin to cleave factor X to form factor Xa, which is an essential enzyme in the coagulation cascade. 

Recombinant factor VIII has a short half-life in the body and is rapidly cleared by the liver. It is administered intravenously and is used to prevent and treat bleeding episodes in patients with hemophilia A.  

Pharmacodynamics: 

The pharmacodynamics of antihemophilic factor recombinant include its ability to increase plasma levels of factor VIII activity, thereby improving clotting and reducing the risk of bleeding in individuals with hemophilia A. The onset of action is rapid, with peak levels observed within 1-2 hours after administration. 

The duration of action depends on the dose and individual patient factors but can range from 8-12 hours or longer. The half-life of antihemophilic factor recombinant is 12-18 hours.  

Pharmacokinetics: 

Absorption 

antihemophilic factor recombinant is administered intravenously, so it is fully absorbed and distributed into the bloodstream. 

Distribution 

factor VIII is distributed throughout the blood plasma. 

Metabolism 

factor VIII is metabolized by proteolysis and cleared by the liver. 

Elimination and excretion 

The elimination half-life of factor VIII varies based on the individual, but it is short (8-12 hours). Factor VIII is primarily excreted by the liver, but it can also be cleared by the kidneys and other tissues. 

Adminstartion

Administration: 

antihemophilic factor recombinant is administered by intravenous (IV) infusion. The specific dosage and administration schedule depend on the patient’s age, weight, severity of bleeding, and type of bleeding disorder. Before administration, the healthcare provider should carefully inspect the vial or infusion bag for any discoloration or particulate matter.

The solution should be administered slowly over a period of several minutes to reduce the risk of adverse reactions. The healthcare provider should monitor the patient closely during the infusion for any signs of hypersensitivity reactions or other adverse events. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: antihemophilic factor recombinant 

Pronounced: (an-tee-hee-muh-FIL-ik FAK-tor ree-KOM-bi-nuhnt)  

Why do we use antihemophilic factor recombinant? 

antihemophilic factor recombinant is used to treat and prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). It is also used for surgical and dental procedures in patients with hemophilia A. Additionally, it may be used for the management of bleeding in acquired factor VIII deficiency, which can occur in patients with liver disease, certain cancers, or autoimmune disorders. antihemophilic factor recombinant is administered by intravenous injection.