Factor IX complex


Concise Prescribing Info
Indications/Uses
Replacement therapy in haemophilia B.
Dosage/Direction for Use
Adult : IV Dosage and duration is individualised based on preparation used, severity of factor IX deficiency, extent and location of bleeding, and patient’s clinical status. Dose may be titrated as needed based on clinical response. 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. Refer to detailed product guideline.
Dosage Details
Intravenous
Replacement therapy in haemophilia B
Adult: Dosage and duration is individualised based on preparation used, severity of factor IX deficiency, extent and location of bleeding, and patient’s clinical status. Dose may be titrated as needed based on clinical response. 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. Refer to detailed product guideline.
Reconstitution
Refer to individual product labelling for specific details.
Contraindications
Hypersensitivity to factor IX complex, history of heparin-induced thrombocytopaenia, heparin allergy (Bebulin).
Special Precautions
Patient with risk for thromboembolic complications [e.g. fibrinolysis, thrombosis, disseminated intravascular coagulation (DIC), undergoing or underwent surgery], risk of transmitting infectious agents (e.g. risk of variant Creutzfeldt-Jakob disease (vCJD), Creutzfeldt-Jakob disease (CJD) and parvovirus B19 infections). Hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Antibody formation.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Pyrexia, chills, lethargy.
Nervous system disorders: Headache, dizziness, somnolence.
Skin and subcutaneous tissue disorders: Erythema.
Vascular disorders: Flushing.
Potentially Fatal: Serious thromboembolic complications (e.g. venous thrombosis, DIC, stroke, MI, pulmonary embolism), hypersensitivity (e.g. anaphylaxis, urticaria, angioedema, dyspnoea, hypotension, tachycardia).
IV/Parenteral: C
MonitoringParameters
Monitor factor IX plasma levels, prothrombin time, partial thromboplastin time; signs and symptoms of hypersensitivity, thromboembolic complications, development of inhibitors.
Action
Description: Factor IX complex is a mixture of vitamin K-dependent clotting factors II, IX, X and low, non-therapeutic levels of factor VII. It increases the plasma levels of factor IX in patients with haemophilia B (factor IX deficiency) thereby, temporarily correcting the deficiency and restoring haemostasis.
Synonym: 3-factor prothrombin complex concentrate.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 19-25 hours (factor IX).
Storage
Bebulin: Store between 2-8°C. Profilnine: Store below 25°C.
MIMS Class
ATC Classification
B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
B02BD01 - coagulation factor IX, II, VII and X in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
References
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 08/06/2018.

Anon. Factor IX Complex (Human) [(Factors II, IX, X)]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/06/2018.

Bebulin (Baxalta Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/06/2018.

Buckingham R (ed). Factor IX. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/06/2018.

Profilnine (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/06/2018.

Disclaimer: This information is independently developed by MIMS based on Factor IX complex 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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