Generic
Eptacog Alfa
1 brands available in the market
At a glance
Eptacog Alfa is a blood clotting factor used for the prevention and treatment of bleeding in patients with hemophilia and other bleeding disorders.
Description
Eptacog Alfa is used in the treatment and prevention of bleeding. It helps prevent excessive bleeding after surgery or other important treatments specifically in patients with hemophilia or those with other bleeding disorders.
Eptacog Alfa works by facilitating the formation of a blood clot at the bleeding site in the case when the clotting factors of body are not working. This injection must be administered under the supervision of a healthcare professional.
Eptacog Alfa is a blood clotting factor. It works by facilitating the formation of blood clot at the site of bleeding, when the body's own clotting factors are not working.
Indications
- Bleeding in patients with haemophilia: Bleeding episodes and control of bleeding during surgery in haemophilia A or B patients.
- Bleeding due to factor VII deficiency: Bleeding control during surgery or invasive procedures in patients with factor VII deficiency.
- Glanzmann's thrombasthenia: Bleeding control during surgery or invasive procedures in patients with Glanzmann's thrombasthenia.
Therapeutic class
Anti-fibrinolytic drugs
Pharmacological class
Recombinant Coagulation Factor VIIa
Pharmacology
Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X and factor IX.
Mechanism of action
Eptacog Alfa is a blood clotting factor. It works by facilitating the formation of blood clot at the site of bleeding, when the body's own clotting factors are not working.
Dosage
Adult Dose:
- Bleeding in haemophilia patients: 90 mcg/kg IV bolus (2-5 min); additional doses may be given 2-3 hrly as needed.
- Bleeding due to factor VII deficiency: 15-30 mcg/kg IV bolus (2-5 min) 4-6 hrly until haemostasis achieved.
- Glanzmann's thrombasthenia: 90 mcg/kg IV bolus (2-5 min) 2 hrly; give at least 3 doses.
Administration
Your doctor or nurse will give you this medicine. Kindly do not self administer.
Missed dose
If you miss a dose of Eptacog Alfa, please consult your doctor.
Side effects
Common Side Effects:
- Blood clot in the blood vessels (thromboembolic events)
- Nausea
- Vomiting
- Skin reactions
- Fever
- Headache
- Changes in blood pressure
- Anaphylaxis (rare)
Precautions & warnings
Precautions:
- It is not known whether Eptacog Alfa alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
- Caution in advanced atherosclerotic disease, crush injury, septicemia or disseminated intravascular coagulation (DIC).
- Caution in patients with history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena.
- Remote possibility of hypersensitivity to mouse IgG, bovine IgG & other residual culture proteins.
- Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients.
Contraindications
Contraindications:
- Hypersensitivity to recombinant coagulation factor VIIa or to mouse, hamster or bovine protein.
- Rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency.
Drug interactions
Drug Interactions: Increased risk of thromboembolism with activated or non-activated prothrombin complex concentrate.
Food interactions
Food Interactions: It is not known whether it is safe to consume alcohol with Eptacog Alfa. Consult your doctor.
Use in pregnancy
Use in Pregnancy: It is preferable to avoid use during pregnancy. Animal studies have shown adverse effects on the fetus. Should be given only if potential benefit justifies potential risk.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: It is unknown whether Eptacog Alfa is excreted in human breast milk. Excretion in milk has not been studied in animals.
Pediatric use
Pediatric Use: Pediatric dosage same as adult. Caution in neonates.
Geriatric use
Geriatric Use: No specific dosage adjustment is necessary for elderly patients.
Renal / hepatic impairment
Renal Impairment: Limited information available on the use of Eptacog Alfa in patients with kidney disease. Consult your doctor.
Hepatic Impairment: Use with caution in patients with liver disease. Dose adjustment may be needed.
Overdose effects
Overdose: Overdose may cause thrombosis or thromboembolic events. In case of overdose, seek immediate medical attention.
Storage conditions
Storage: Store between 2-25°C prior to reconstitution. Do not freeze. Protect from light. For reconstitution, add the recommended diluent (histidine) and swirl gently until dissolved.
Chemical structure
Eptacog Alfa