GNH USA

Europe — EMA

Kedcom

GNH USA supplies Kedcom (Human coagulation factor IX/II/X), a coagulation factor concentrate for hemophilia B, prothrombin deficiency and factor X

Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X

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What is Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X?

Human coagulation factor IX/II/X, the active ingredient in Kedcom, is a coagulation factor concentrate presented as an injectable concentrate for intravenous use. It replaces deficient clotting factors in patients with hemophilia B (factor IX deficiency), prothrombin deficiency (factor II), factor X deficiency, or combined deficiencies of these factors, thereby helping to control and prevent bleeding episodes.

GNH USA supplies Kedcom as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies, clinics and research institutions worldwide through its global network.

What is Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X used for?

Kedcom is used to treat bleeding disorders that involve deficiencies in the intrinsic and common pathways of the coagulation cascade. - Hemophilia B (Factor IX deficiency): restores factor IX activity to achieve hemostasis and reduce bleeding frequency. - Prothrombin deficiency (Factor II deficiency): replaces missing factor II, supporting clot formation and controlling hemorrhage. - Factor X deficiency: provides factor X to re‑establish the common pathway and stop bleeding. - Combined deficiencies of Factors IX, II, and X: supplies all three factors simultaneously to manage acute bleeding episodes.

What are the side effects of Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X?

Kedcom may be associated with a range of adverse reactions following intravenous administration.

Common Side Effects: - Infusion‑related reactions (e.g., chills, flushing, or mild fever) - Headache - Nausea or vomiting - Mild arthralgia - Transient increase in liver enzymes

Serious or Rare Side Effects: - Anaphylactic or severe allergic reactions - Development of neutralizing inhibitors (antibodies) against the infused factors - Thromboembolic events (e.g., deep vein thrombosis) - Viral transmission risk from plasma‑derived products - Severe hemolysis or disseminated intravascular coagulation

What precautions apply to Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X?

When using Kedcom, clinicians should observe several precautionary measures to ensure safety and efficacy. - Dose adjustment: individualize dosing based on factor activity levels and clinical response. - Monitoring: perform regular coagulation assays (e.g., PT, aPTT, factor activity) to guide therapy. - Allergy assessment: evaluate patients for hypersensitivity to plasma‑derived proteins before infusion. - Inhibitor development: watch for emergence of neutralizing antibodies that may reduce effectiveness. - Pregnancy and lactation: use only when the potential benefit justifies any potential risk to the fetus or infant. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X interact with?

Kedcom can interact with other medicines that affect hemostasis or immune response.

Major Interactions (Avoid): - Concurrent use of anticoagulants (e.g., warfarin, direct oral anticoagulants) may diminish clotting effectiveness and increase bleeding risk. - High‑dose factor replacement together with pro‑thrombotic agents can precipitate thrombosis. - Simultaneous administration of other plasma‑derived factor concentrates may increase the risk of inhibitor formation.

Moderate Interactions (Monitor Closely): - Antibiotics such as rifampin that induce hepatic enzymes may alter plasma protein turnover, affecting factor levels. - Immunosuppressive drugs (e.g., rituximab) can modify the immune response to infused factors. - Vaccines administered shortly before or after infusion may enhance the chance of allergic reactions.

Frequently asked questions

What is Kedcom used for?+
Kedcom is a plasma‑derived concentrate that provides the clotting proteins factor IX, factor II and factor X. It is prescribed for patients with hemophilia B, prothrombin deficiency, factor X deficiency, or combined deficiencies of these factors to control acute bleeding episodes and to prevent recurrent hemorrhage.
How does Human coagulation factor IX/II/X work?+
The three recombinant proteins replace the missing natural clotting factors in the blood. Factor IX restores the intrinsic pathway, while factors II and X re‑activate the common pathway, together enabling the generation of thrombin and formation of a stable fibrin clot, which stops bleeding.
What determines the dose of Kedcom?+
The exact dose is individualized by the prescribing clinician based on the patient’s specific factor deficiency, measured factor activity levels, severity of bleeding, body weight and clinical response. Dosing regimens are adjusted through regular laboratory monitoring.
Is Kedcom safe during pregnancy or breastfeeding?+
Kedcom may be used in pregnancy or while breastfeeding only when the anticipated benefit to the mother outweighs any potential risk to the fetus or infant. The decision should be made by a specialist familiar with the patient’s bleeding disorder.
How do I order Kedcom from GNH USA?+
To request Kedcom, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain logistics) and necessary import documentation.
How does Kedcom compare with other factor concentrates?+
Kedcom combines three clotting factors in a single vial, which can simplify treatment for patients with multiple deficiencies compared with using separate single‑factor products. Its plasma‑derived nature offers a broad spectrum of activity, while recombinant single‑factor concentrates may provide a lower risk of viral transmission but require separate administrations.
How should Kedcom be stored and handled?+
Kedcom must be stored at 2‑8 °C in a refrigerator. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. Before use, inspect for particulate matter and ensure the solution is clear.
How is Kedcom administered?+
Kedcom is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and volume are determined by the prescribed dose and the patient’s vascular access. Monitoring for infusion reactions is recommended during and after administration.
What are the most serious risks to watch for with Kedcom?+
The most critical risks include severe allergic reactions such as anaphylaxis, the development of neutralizing inhibitors that reduce efficacy, thromboembolic events when high doses are used, and the theoretical risk of pathogen transmission from plasma‑derived products.
Who should not use Kedcom?+
Kedcom is contraindicated in patients with known hypersensitivity to any of its components, including plasma proteins, or in individuals who have previously developed severe allergic reactions to similar factor concentrates. It should also be avoided in patients with active, uncontrolled thrombosis.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Human Coagulation Factor Ix, Human Coagulation Factor Ii, Human Coagulation Factor X
Route
Intravenous Use
Manufacturer
Kedrion S.P.A.
Origin
EU

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