Coagulation Factor X Human
Generic Name: coagulation factor x human
Brand Names:
Coagadex
11 DESCRIPTION COAGADEX is a plasma-derived, sterile, purified concentrate of human coagulation Factor X that contains sucrose as a stabilizer. It is formulated as a lyophilized powder for solution for intravenous administration. When reconstituted with Sterile Water for Injection it forms a colorless, clear or slightly pearl-like solution.
Overview
11 DESCRIPTION COAGADEX is a plasma-derived, sterile, purified concentrate of human coagulation Factor X that contains sucrose as a stabilizer. It is formulated as a lyophilized powder for solution for intravenous administration. When reconstituted with Sterile Water for Injection it forms a colorless, clear or slightly pearl-like solution.
Uses
1 INDICATIONS AND USAGE COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management of bleeding in patients with mild, moderate and severe heredi...
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only For intravenous use only after reconstitution. Each vial of COAGADEX contains the labeled amount of Factor X in international units (IU) ( 2 ) The dosage and duration of treatment depend on the severity of the Factor X deficiency, the location and extent of the bleeding and the patient's clinical condition ( 2.1 ) For prophylaxis of bleeding episodes ( 2.1 ): Age Initial dose Further management Children: Less than 12 years of age 40 IU/kg twice weekly Monitor trough blood levels of Factor X targeting ≥5 IU/dL and adjust dosage to clinical response and trough levels. Do not exceed a peak level of 120 IU/dL.
Side Effects
6 ADVERSE REACTIONS The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain. The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue and back pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact BPL USA Inc., at 1-844-427-5872 or medinfo@bpl-us.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain Factor X (e.g. fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, COAGADEX is likely to be counteracted by direct and indirect Factor Xa inhibitors [ see Clinical Pharmacology (12.1) ].
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue COAGADEX and administer appropriate treatment ( 5.1 ). Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor X activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor X inhibitor concentration ( 5.2 ). COAGADEX is made from human blood and therefore carries a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent ( 5.4 ). 5.1 Hypersensitivity Reactions Allergic type hypersensitivity reactions, including anaphylaxis, are possible. 4 CONTRAINDICATIONS COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [ see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary There is limited data with COAGADEX in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using COAGADEX. It is not known whether COAGADEX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Storage
Storage and Handling Store COAGADEX in its original package to protect it from light. Store the COAGADEX package in a refrigerator or at room temperature at 36°F to 86°F (2°C to 30°C). Do not freeze. Do not use COAGADEX or the Sterile Water for Injection after the expiration date printed on the vial and carton labels. Use reconstituted COAGADEX within one hour of reconstitution.
Frequently Asked Questions
What is Coagulation Factor X Human used for?▼
1 INDICATIONS AND USAGE COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management of bleeding in patients with mild, moderate and severe heredi...
What are the side effects of Coagulation Factor X Human?▼
6 ADVERSE REACTIONS The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain. The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue and back pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact BPL USA Inc., at 1-844-427-5872 or medinfo@bpl-us.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Coagulation Factor X Human during pregnancy?▼
8.1 Pregnancy Risk Summary There is limited data with COAGADEX in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using COAGADEX. It is not known whether COAGADEX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What are the important warnings for Coagulation Factor X Human?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue COAGADEX and administer appropriate treatment ( 5.1 ). Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor X activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor X inhibitor concentration ( 5.2 ). COAGADEX is made from human blood and therefore carries a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent ( 5.4 ). 5.1 Hypersensitivity Reactions Allergic type hypersensitivity reactions, including anaphylaxis, are possible. 4 CONTRAINDICATIONS COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [ see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).
Related Medications
Potassium Iodide
potassium iodide
Purpose Thyroid blocking
Regorafenib
regorafenib
11 DESCRIPTION STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula: Regorafenib is a monohydrate and it has a molecular formula C 21 H 15 ClF 4 N 4 O 3 • H 2 O and a molecular weight of 500.83.
Antimonium Crudum, Apis Mellifica, Chamomilla, Echinacea (angustifolia), Ferrum Phosphoricum, Pulsatilla (pratensis), Rhus Tox, Sulphur, Urtica Urens
antimonium crudum, apis mellifica, chamomilla, echinacea (angustifolia), ferrum phosphoricum, pulsatilla (pratensis), rhus tox, sulphur, urtica urens
Standardized Insect Venom Allergenic Extract [EPC]
PURPOSE: Antimonium Crudum – Immune Support, Apis Mellifica - Fever, Chamomilla - Fatigue, Echinacea (Angustifolia) – Sore Throat, Ferrum Phosphoricum - Cough, Pulsatilla (Pratensis) – Runny Nose, Rhus Tox - Rash, Sulphur – Joint Pain, Urtica Urens – Muscle Aches
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.