Europe — EMA
Nanofix (Human Coagulation Factor Ix)
GNH USA supplies Nanofix (Human Coagulation Factor IX), a blood coagulation factor for hemophilia B and acquired factor IX deficiency.
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What is Human Coagulation Factor Ix?
Human Coagulation Factor IX, the active ingredient in Nanofix, is a blood coagulation factor presented as a sterile intravenous solution for intravenous use. It treats hemophilia B and acquired factor IX deficiency by replacing the missing protein in patients.
GNH USA supplies Nanofix as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, pharmacies and clinics worldwide.
What is Human Coagulation Factor Ix used for?
Nanofix is used to replace deficient factor IX in the intrinsic coagulation pathway for several bleeding disorders.
- Hemophilia B: restores normal clotting and reduces bleeding episodes in patients with congenital factor IX deficiency. - Acquired factor IX deficiency: provides temporary replacement to control bleeding caused by acquired loss of factor IX. - Peri‑operative management in hemophilia B: ensures adequate haemostasis during surgery or invasive procedures.
What are the side effects of Human Coagulation Factor Ix?
Nanofix may be associated with a range of adverse reactions following intravenous administration.
Common Side Effects: - Fever or chills - Headache - Nausea or vomiting - Mild infusion site erythema - Transient increase in blood pressure - Mild fatigue
Serious or Rare Side Effects: - Anaphylactic or severe allergic reaction - Development of inhibitors (antibodies) to factor IX - Thromboembolic events (deep vein thrombosis, pulmonary embolism) - Hemolysis or renal impairment - Severe hypotension during infusion - Viral transmission (theoretical risk with plasma‑derived products).
What precautions apply to Human Coagulation Factor Ix?
Before using Nanofix, consider the following safety measures.
- Screening: test for inhibitors to factor IX prior to initiation. - Monitoring: observe patients during and after infusion for signs of allergic reaction. - Concomitant therapy: avoid simultaneous use of other clotting factor concentrates unless medically indicated. - Pregnancy and lactation: use only if the potential benefit justifies the potential risk; data are limited. - Renal or hepatic impairment: adjust monitoring frequency as these conditions may affect clearance. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.
What does Human Coagulation Factor Ix interact with?
Nanofix can interact with other agents that affect haemostasis or immune response.
Major Interactions (Avoid): - Antifibrinolytics (e.g., tranexamic acid) combined with high‑dose factor IX may increase thrombosis risk. - Other clotting factor concentrates administered concurrently without specialist guidance.
Moderate Interactions (Monitor Closely): - Immunosuppressants (e.g., rituximab) may alter inhibitor development risk. - Antibiotics such as beta‑lactams that can cause hypersensitivity may increase allergic reaction likelihood. - Heparin or low‑molecular‑weight heparin: monitor coagulation parameters closely when used together.



