:* Each vial of Profilnine is labeled with total units expressed as international units (IU) according to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.
:* Each vial of Profilnine is labeled with total units expressed as international units (IU) according to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.
A 1% increase in factor IX (0.01 units)/units administered/kg can be expected(1,5). The amount of Profilnine required to establish hemostasis will vary with each patient and depends on the circumstances. The following formula may be used as a guide in determining the number of units to be administered:
:* A 1% increase in factor IX (0.01 units)/units administered/kg can be expected(1,5). The amount of Profilnine required to establish hemostasis will vary with each patient and depends on the circumstances. The following formula may be used as a guide in determining the number of units to be administered:
: [[File:{{PAGENAME}}03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
=====Coagulopathy of Chronic Liver Disease=====
* Dosing Information
:* '''20 mL of factor IX complex containing 2000 units of factors II, IX, and X'''<ref>{{Cite journal | issn = 0017-5749 | volume = 16 | issue = 8 | pages = 621–625 | last = Gazzard | first = B. G. | coauthors = J. M. Henderson, R. Williams | title = The use of fresh frozen plasma or a concentrate of factor IX as replacement therapy before liver biopsy | journal = Gut | date = 1975-08 | pmid = 1102399 | pmc = PMC1411020 }}</ref>
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Each vial of Profilnine is labeled with total units expressed as international units (IU) according to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.
A 1% increase in factor IX (0.01 units)/units administered/kg can be expected(1,5). The amount of Profilnine required to establish hemostasis will vary with each patient and depends on the circumstances. The following formula may be used as a guide in determining the number of units to be administered:
This image is provided by the National Library of Medicine.
In normal clinical practice there is variability among patients and their clinical condition. Therefore, the factor IX level of each patient should be monitored frequently during replacement therapy.
This image is provided by the National Library of Medicine.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Factor IX complex in adult patients.
Non–Guideline-Supported Use
Coagulopathy of Chronic Liver Disease
Dosing Information
20 mL of factor IX complex containing 2000 units of factors II, IX, and X[1]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients below the age of 16 have not been established. However, across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine responded similarly when compared with the adult patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Factor IX complex in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Factor IX complex in pediatric patients.
Contraindications
None known.
Warnings
Because Profilnine is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as DEAE chromatography, solvent detergent treatment and nanofiltration in the manufacturing process. Despite these measures, such products can potentially transmit disease: therefore the risk of infectious agents cannot be totally eliminated. The physician must weigh the risks and benefits of using this product and discuss these issues with the patient. Appropriate vaccination (hepatitis A and B) for patients in receipt of plasma derived factor IX complex concentrates is recommended.
The use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications and the use of such products may be potentially hazardous in patients undergoing surgery, in patients post surgery, in patients with known liver disease, and in patients with signs of fibrinolysis, thrombosis or disseminated intravascular coagulation (DIC)(6). For these patients, clinical surveillance for early signs of consumptive coagulopathy should be initiated with appropriate biological testing when administering this product. Profilnine should only be administered to patients when the beneficial effects of use outweigh the serious risk of potential hypercoagulation.
Precautions
Exercise caution when handling Profilnine due to the limited risk of exposure to viral infection.
Discard any unused Profilnine vial contents. Discard administration equipment after single use. Do not resterilize components. Do not reuse components.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Factor IX complex in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Factor IX complex in the drug label.
