Factor IX complex

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# Overview
Factor IX complex is a compelx of coagulation factors IX, II, and X and low levels of factor VII that is FDA approved for the {{{indicationType}}} of bleeding in patients with factor IX deficiency (hemophilia B).   Common adverse reactions include flushing, nausea, fever, and shivering.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Dosing Information
- 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. 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:
- 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.

## 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.

### NonGuideline-Supported Use
- Dosing Information
- 20 mL of factor IX complex containing 2000 units of factors II, IX, and X

# 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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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). 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.

## Postmarketing Experience
- As with other intravenous administration of other plasma-derived products, the following reactions may be observed following administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, or manifestation of allergic reactions.
- 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 Drug Interactions of Factor IX complex in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- 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.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
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 with respect to nursing mothers.

### 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 with respect to geriatric patients.

### 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
- Intravenous

### Monitoring
- 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.

# IV Compatibility
There is limited information regarding IV Compatibility of Factor IX complex in the drug label.

# Overdosage

## Acute Overdose
There is limited information regarding Acute Overdose of Factor IX complex in the drug label.

## Chronic Overdose
There is limited information regarding Chronic Overdose of Factor IX complex in the drug label.

# Pharmacology
There is limited information regarding Factor IX complex Pharmacology in the drug label.

## Mechanism of Action
- Profilnine is a mixture of the vitamin K-dependent clotting factors IX, II, X and low levels of VII. The administration of Profilnine temporarily increases the plasma levels of factor IX, thus enabling a temporary correction of the factor deficiency.

## Structure
- Factor IX Complex, Profilnine, is a solvent detergent treated, nanofiltered, sterile, lyophilized concentrate of coagulation factors IX, II, and X and low levels of factor VII. The factor II content is not more than (NMT) 150 units- per 100 factor IX units, the factor X content is NMT 100 units per 100 factor IX units, and the factor VII content is NMT 35 units per 100 factor IX units. Profilnine is intended for intravenous administration only. Each vial is a single dose container and is labeled with the factor IX potency expressed in international units. Profilnine does not contain heparin and contains no preservatives. Profilnine contains few, if any, activated factors based on results from the non-activated partial thromboplastin time (NAPTT) test.
- Profilnine is prepared from pooled human plasma and purified by diethylaminoethyl (DEAE) cellulose adsorption. The risk of transmission of infective agents by Profilnine has been substantially reduced by donor selection procedures and virus screening of individual donations and plasma pools by serological and nucleic acid testing. In addition, specific, effective virus elimination steps such as nanofiltration(3) and solvent/detergent (tri-n-butyl phosphate/TNBP) treatment(4) have been incorporated into the Profilnine manufacturing process. Additional removal of some viruses occurs during the DEAE cellulose product purification step.
- The ability of the manufacturing process to eliminate virus from Profilnine was evaluated in the laboratory by intentionally adding virus to product just prior to the elimination step and monitoring virus removal. Table 1 shows the amounts of virus that can be removed by solvent detergent treatment, nanofiltration and purification by DEAE chromatography when vesicular stomatitis virus (VSV), human immunodeficiency virus-1 and 2 (HIV-1, HIV-2), parvo virus, West Nile virus (WNV), bovine viral diarrhea virus (BVDV), hepatitis A virus (HAV) and pseudorabies virus (PRV) were evaluated in these virus spiking studies. The results indicate that the solvent detergent treatment step effectively inactivates enveloped viruses and the nanofiltration step effectively removes both enveloped and non-enveloped viruses.

## Pharmacodynamics
- A clinical study that evaluated twelve subjects with hemophilia B indicated that, following administration of Profilnine, the factor IX in vivohalf-life was 24.68  8.29 hours and recovery was 1.15  0.16 units/dL per unit infused per kg body weight.
- Administration of factor IX complex can result in higher than normal levels of factor II due to its significantly longer half-life.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Factor IX complex in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Factor IX complex in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Factor IX complex in the drug label.

# 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:
- 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.

## Storage
There is limited information regarding Factor IX complex Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# 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
- Profilnine

# Look-Alike Drug Names
- N/A

# Drug Shortage Status

# Price