Factor IX


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Replacement therapy in haemophilia B Human plasma-derived or recombinant: Dosage and duration depends on the preparation used, severity of the disease and type of surgery to be performed. Suggested target factor IX concentrations: Mild to moderate haemorrhage: 20-40% of normal. More serious haemorrhage or minor surgery: 30-60% of normal. Severe haemorrhage or major surgery: 60-100% of normal. Prophylaxis in severe haemophilia B Human plasma-derived: 20-40 IU/kg every 3-4 days as required. Recombinant: As nonacog alfa: 40 IU/kg (range 13 to 78 IU/kg) every 3-4 days. As nonacog gamma: 40-60 IU/kg every 3-4 days. As albutrepenonacog alfa: 35-50 IU/kg once wkly, or up to 75 IU/kg every 10 or 14 days in some patients. As eftrenonacog alfa: 50 IU/kg once wkly or 100 IU/kg once every 10 days, adjust based on response.
Dosage Details
Intravenous
Prophylaxis in severe haemophilia B
Adult: Human plasma-derived: 20-40 IU/kg every 3-4 days as required. Recombinant: As nonacog alfa: 40 IU/kg (range 13 to 78 IU/kg) every 3-4 days. As nonacog gamma: 40-60 IU/kg every 3-4 days, may be titrated based on age, bleeding pattern, or physical activity. As albutrepenonacog alfa: 35-50 IU/kg once wkly, or up to 75 IU/kg every 10 or 14 days in patients w/ well-controlled conditions. As eftrenonacog alfa: 50 IU/kg once wkly or 100 IU/kg once every 10 days, adjust based on individual response.
Child: Recombinant: As nonacog alfa: 63.7 (±19.1) IU/kg every 3 to 7 days. Shorter intervals or higher doses may be necessary in younger patients. As nonacog gamma: <12 yr 40-80 IU/kg every 3-4 days; ≥12 yr Same as adult dose. Doses may be titrated based on age, bleeding pattern, or physical activity. As albutrepenonacog alfa: 35-50 IU/kg once wkly. As eftrenonacog alfa: <12 yr 50-60 IU/kg once wkly; ≥12 yr Same as adult dose. Max: 100 IU/kg.

Intravenous
Replacement therapy in haemophilia B
Adult: Human plasma-derived or recombinant: Dosage and duration is individualised depending on the preparation used, severity of the disease, and type of surgery to be performed. Suggested target factor IX concentrations: Mild to moderate haemorrhage: Increase to 20-40% of normal. More serious haemorrhage or minor surgery: Increase to 30-60% of normal. Severe haemorrhage or major surgery: Increase to 60-100% of normal.
Contraindications
Hypersensitivity to factor IX or hamster protein. Disseminated intravascular coagulation, signs of fibrinolysis.
Special Precautions
Patient at risk of thromboembolism or disseminated intravascular coagulation (DIC). Hepatic impairment. Childn. Pregnancy and lactation.
Adverse Reactions
Significant: Disseminated intravascular coagulation, thromboembolism (e.g. arterial or venous thrombosis, pulmonary embolism), hypotension, bronchospastic reactions, nephrotic syndrome (in patients w/ factor IX inhibitors), antibody formation.
Nervous: Headache, dizziness, drowsiness.
GI: Nausea, vomiting, dysgeusia.
Resp: Dyspnoea.
Dermatologic: Hives, rash, urticaria.
Others: Fever, chills, lethargy, flushing; pain, stinging, or burning at inj site.
Potentially Fatal: Anaphylaxis.
IV/Parenteral: C
MonitoringParameters
Measure factor IX levels 15 min after infusion. Monitor aPTT, BP, heart rhythm. Monitor for signs of bleeding, DIC, or thromboembolic complications. Perform screening for factor IX inhibitors if patient experiences hypersensitivity reaction, will undergo surgery, or if suboptimal response to treatment occur.
Action
Description: Factor IX is vit K-dependent clotting factor which may be obtained from human plasma or produced by recombinant DNA technology. It is activated by factor XIa in the intrinsic coagulation pathway and by factor VII/tissue factor complex in the extrinsic coagulation pathway. Activated factor IX (IXa), in combination w/ activated factor VIII, converts factor X to Xa, resulting in the conversion of factor II (prothrombin) to thrombin and the formation of a fibrin clot.
Pharmacokinetics:
Distribution: Readily diffuses through interstitial fluid and distributed into both intra- and extravascular compartments. Circulates in plasma (as free molecule) and binds to vascular endothelium.
Excretion: Elimination half-life: Approx 18-25 hr (human).
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
ATC Classification
B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Disclaimer: This information is independently developed by MIMS based on Factor IX from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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