Factor IX


Thông tin thuốc gốc
Chỉ định và Liều dùng
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.
Chống chỉ định
Hypersensitivity to factor IX or hamster protein. Disseminated intravascular coagulation, signs of fibrinolysis.
Thận trọng
Patient at risk of thromboembolism or disseminated intravascular coagulation (DIC). Hepatic impairment. Childn. Pregnancy and lactation.
Tác dụng không mong muốn
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.
Chỉ số theo dõi
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.
Tác dụng
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).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light.
Phân loại MIMS
Thuốc cầm máu
Phân loại ATC
B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Tài liệu tham khảo
Alphanine SD (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/02/2017 .

Alprolix (Biogen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/02/2017 .

Anon. Factor IX (Human), Factor IX Complex (Human). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 16/02/2017 .

Anon. Factor IX (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/02/2017 .

Anon. Factor IX (Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/02/2017 .

Benefix (Wyeth BioPharma). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/02/2017 .

Buckingham R (ed). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/02/2017 .

Idelvion (CSL Behring Recombinant Facility AG). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/02/2017 .

Joint Formulary Committee. Factor IX Fraction, Dried. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/02/2017 .

McEvoy GK, Snow EK, Miller J et al (eds). Factor IX (Recombinant). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 16/02/2017 .

Rixubis (Baxalta US Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/02/2017 .

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