Factor IX complex: Uses, Dosage, Side Effects and More

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Haemophilia B

Adult: For the prevention and control of bleeding: 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: Mild to moderate haemorrhage: Increase to 20-30%. Major haemorrhage or surgeries: Increase to 30-50%. Doses are given via IV inj or infusion at a rate not exceeding 10 mL/min. Refer to specific product guidelines for further instructions on dosage and administration.

Reconstitution

Factor IX complex may be available as a single dose vial with a suitable volume of diluent (e.g. sterile wate for inj) and a specific filter transfer set for use during administration. Refer to specific product guidelines for further instructions on reconstitution.

Special Precautions

Patient with history of CAD; increased risk of thrombotic events (e.g. signs of fibrinolysis, thrombosis, or disseminated intravascular coagulation). Patient undergoing surgery or post surgery. Hepatic impairment. Pregnancy.

Adverse Reactions

Significant: Hypersensitivity, anaphylaxis; thrombotic events (e.g. pulmonary embolism, thrombotic strokes, DVT).
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Fever, chills, lethargy.
Nervous system disorders: Headache.
Vascular disorders: Flushing.

Pregnancy Category (US FDA)

IV/Parenteral: C

Monitoring Parameters

Obtain factor IX levels at baseline and during therapy. Monitor blood pressure, heart rate, Hb, and haematocrit. Assess for signs and symptoms of hypersensitivity reaction or intravascular haemolysis.

Action

Description:
Mechanism of Action: Factor IX complex is composed of a mixture of vitamin K-dependent clotting factors IX, II, X, and low levels of VII. It temporarily increases the plasma levels of factor IX, resulting in the temporary correction of the factor deficiency.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 19-25 hours (factor IX component).

Storage

Store below 25°C. Do not freeze.

MIMS Class

Haemostatics

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 01/04/2024.

Factor IX Complex (Human) [Factors II, IX, X]. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/04/2024.

Profilnine (Grifols [SG]). MIMS Singapore. http://www.mims.com/singapore. Accessed 01/04/2024.

Profilnine (Grifols Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2024.

Profilnine (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2024.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com