Factor ix complex
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]; Adeel Jamil, M.D. [3]
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Overview
Factor ix complex is an {{{drugClass}}} that is FDA approved for the treatment of hemophilia B. Common adverse reactions include headache, fever, chills, flushing, nausea, vomiting, tingling lethargy, hives, or manifestation of allergic reactions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Prevention and Ttreatment of Hemophilia B
- Dosing Information
- 0.01 units/units administered/kg(Find more details, see Administration and Monitoring)
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
There is limited information regarding Off-Label Non–Guideline-Supported Use of Factor ix complex in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Factor ix complex FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
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
General=
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.
Information for Patients
After repeated treatment with Profilnine, patients should be monitored for the development of neutralizing antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. Hypersensitivity and allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX complex concentrate products. Patients must be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia and anaphylaxis. Patients must be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care if these symptoms occur.
Pregnancy Category C
Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Profilnine should be given to a pregnant woman only if clearly indicated.
Pediatric Use
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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Factor ix complex Clinical Trials Experience in the drug label.
Postmarketing Experience
In addition, during post-approval use of Profilnine, cases of allergic/hypersensitivity reactions (including urticaria, shortness of breath, hypotension, and pruritus) and adverse reactions characterized by either thrombosis or disseminated intravascular coagulation (DIC) have been reported. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug Interactions
There is limited information regarding Factor ix complex Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C
Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Profilnine should be given to a pregnant woman only if clearly indicated.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Factor ix complex in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Factor ix complex during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Factor ix complex in women who are nursing.
Pediatric Use
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.
Geriatic Use
There is no FDA guidance on the use of Factor ix complex in geriatric settings.
Gender
There is no FDA guidance on the use of Factor ix complex with respect to specific gender populations.
Race
There is no FDA guidance on the use of Factor ix complex with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Factor ix complex in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Factor ix complex in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Factor ix complex in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Factor ix complex in patients who are immunocompromised.
Administration and Monitoring
Administration
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: {
Monitoring
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. {
IV Compatibility
There is limited information regarding the compatibility of Factor ix complex and IV administrations.
Overdosage
There is limited information regarding Factor ix complex overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Mechanism of Action
There is limited information regarding Factor ix complex Mechanism of Action in the drug label.
Structure
 |
Pharmacodynamics
There is limited information regarding Factor ix complex Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Factor ix complex Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Factor ix complex Nonclinical Toxicology in the drug label.
Clinical Studies
A clinical study that evaluated twelve subjects with hemophilia B indicated that, following administration of Profilnine, the factor IX in vivo half-life was 24.68 ± 8.29 hours and recovery was 1.15 ± 0.16 units/dL per unit infused per kg body weight(5). Administration of factor IX complex can result in higher than normal levels of factor II due to its significantly longer half-life(6).
How Supplied
Profilnine is supplied in sterile lyophilized form in single dose vials accompanied by a suitable volume of diluent (Sterile Water for Injection, USP), according to factor IX potency. Each vial is labeled with the factor IX potency expressed in International Units which is referenced to the WHO International Standard. Profilnine is packaged with a Mix2Vial filter transfer set for use in administration. It is available in the following potencies, and the product is also color coded based upon assay on the carton and vial label as follows:
Storage
Profilnine is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
After repeated treatment with Profilnine, patients should be monitored for the development of neutralizing antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. Hypersensitivity and allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX complex concentrate products. Patients must be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia and anaphylaxis. Patients must be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care if these symptoms occur.
Precautions with Alcohol
Alcohol-Factor ix complex interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Factor ix complex Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Factor ix complex Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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