Factor IX

Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Haemophilia B
Adult: As treatment and control of bleeding episodes: Dosage is individualised based on the severity of factor IX deficiency, extent and location of bleeding, and patient's clinical response. Recommended target factor IX concentrations: Early haemarthrosis, muscle or oral bleeding: Increase to 20-40% of normal; doses are given 24 hourly and continued for at least 1 day until the bleeding episode (as indicated by pain) is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding or haematoma: Increase to 30-60% of normal; doses are given 24 hourly for 3-4 days or more until pain and acute disability are resolved. Life-threatening haemorrhages: Increase to 60-100% of normal; doses are given 8-24 hourly until threat is resolved. Minor surgery including tooth extraction: Increase to 30-60% of normal; doses are given 24 hourly and continued for at least 1 day until healing is obtained. Major surgery (pre-operative and post-operative): Increase to 80-100% of normal; doses are given 8-24 hourly until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor IX activity of 30-60%. As long-term prophylaxis against bleeding in severe cases: 20-40 international units/kg at intervals of 3-4 days. Dosing recommendations may vary among individual products and between countries. Refer to specific product or local treatment guidelines for further information.
Các sản phẩm có chứa hoạt chất Factor IX tại Việt Nam?
  • Replenine-VF
Hướng dẫn pha thuốc
Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
Chống chỉ định
Hypersensitivity. Disseminated intravascular coagulation, history of heparin-induced thrombocytopenia.
Thận trọng
Patient with factor IX inhibitors, CV risk factors; at risk of thromboembolic phenomena or disseminated intravascular coagulation; signs of fibrinolysis. Patients who have undergone surgery. Hepatic impairment. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Development of neutralising antibodies or inhibitors, hypersensitivity and anaphylactic reactions, intravascular coagulation or thrombosis; central venous access device (CVAD)-related complications (e.g. local infections, bacteraemia, catheter site thrombosis).
General disorders and administration site conditions: Inj site reaction. Rarely, pyrexia.
Nervous system disorders: Headache.
Renal and urinary disorders: Rarely, nephrotic syndrome.
Chỉ số theo dõi
Obtain factor IX levels at baseline and during administration. Monitor heart rate and blood pressure (before and during administration); Hb, haematocrit; factor IX inhibitor development. Assess for signs and symptoms of hypersensitivity reaction and intravascular haemolysis.
Tác dụng
Description:
Mechanism of Action: Factor IX is a vitamin K-dependent coagulation factor. It replaces the deficient clotting factor IX present in haemophilia B, thereby causing a temporary correction of the factor deficiency and bleeding tendencies.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 21-25 hours (factor IX component).
Bảo quản
Store between 2-8°C. Do not freeze. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
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 [SG]). MIMS Singapore. http://www.mims.com/singapore. Accessed 05/07/2024.

AlphaNine SD (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2024.

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 04/07/2024.

Brayfield A, Cadart C (eds). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/07/2024.

CSL Behring (NZ) Limited. MonoFIX-VF 500 IU Powder and Diluent (5 mL or 10 mL) and 1,000 IU Powder and Diluent (10 mL) for Solution for Injection data sheet 22 November 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 05/07/2024.

Factor IX (Human). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/07/2024.

Joint Formulary Committee. Factor IX. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/07/2024.

Octanine 500 IU and 1,000 IU Powder and Solvent for Solution for Injection (Octapharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2024.

Octanine F Lyophilised Powder for Intravenous Administration (Pharmaniaga Marketing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/07/2024.

Replenine-VF 50 IU/mL Powder and Solvent for Solution for Injection (Bio Products Laboratory Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2024.

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