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BeneFIX coagulation factor ix (recombinant) Kit — NDC 58394-0635-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BeneFIX coagulation factor ix (recombinant) Kit — NDC 58394-635-03 (Billing 58394-0635-03)

by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · 1 KIT in 1 CARTON * 5 mL in 1 SYRINGE * 1 mL in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE

This is a package of BeneFIX coagulation factor ix (recombinant) Kit from Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, marketed since Feb 1997 and currently FDA-listed. It is this product's only package size.

NDC 58394-0635-03
🏷️ FDA NDC (as labeled) 58394-635-03 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 4, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 58394-635-03 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
58394 labeler · 635 product · 03 package
Package marketed since
Feb 1, 1997
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5839463503 3
Medicaid fills, this package
42 prescriptions in the last four reported quarters
FDA record last changed
Oct 4, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58394-635-03
Product NDC 58394-635
11-digit billing NDC 58394063503
NCPDP billing unit EA — each (per item)
Application # BLA103677
SPL Set ID 85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-02-01
Dosage form KIT
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 85100028206440
GPI class BeneFIX
GCN Seq No 071164
GCN 34873
HICL code 012793
Ingredient (HICL) Factor Ix Human Recombinant
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0F
Therapeutic class — specific (HIC3) Factor Ix Preparations
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name BENEFIX 1,000 UNIT RANGE
FDB brand name Benefix
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071164
  • GCN: 34873
  • GPI-14 (Medi-Span): 85100028206440
  • HICL (First Databank): 012793
  • AHFS class code: 20:28.16.00
Why two NDCs? The FDA registers this code as 58394-635-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58394-0635-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name BENEFIX 1,000 UNIT RANGE Ingredient Factor Ix Human Recombinant

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1.19 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7195 $1.864 / J7195 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)58394-635-03
11-digit billing NDC58394-0635-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7195
DescriptorInjection, factor ix (antihemophilic factor, recombinant) per iu, not otherwise specified
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is 1 IU, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$6,210,784 · 193 claims · $32,180.23 per claim (all NDCs under J7195)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58394-0635-03 You're viewing this Main listing 1 KIT in 1 CARTON * 5 mL in 1 SYRINGE * 1 mL in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE 1997-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
BeneFIXthis 58394-0635-03 Wyeth 1 kit — — FDA listed —
Rixubis 00944-3034-02 Takeda 1 kit — — FDA listed —
Rixubis 00944-3030-02 Takeda 1 kit — — FDA listed —
BeneFIX 58394-0636-03 Wyeth 1 kit — — FDA listed —
Ixinity 59137-0282-05 Medexus 1 kit — — FDA listed —
Ixinity 59137-0284-05 Medexus 1 kit — — FDA listed —
Rixubis 00944-3032-02 Takeda 1 kit — — FDA listed —
BeneFIX 58394-0634-03 Wyeth 1 kit — — FDA listed —
Ixinity 59137-0289-05 Medexus 1 kit — — FDA listed —
Rixubis 00944-3026-02 Takeda 1 kit — — FDA listed —
Rixubis 00944-3028-02 Takeda 1 kit — — FDA listed —
BeneFIX 58394-0637-03 Wyeth 1 kit — — FDA listed —
BeneFIX 58394-0633-03 Wyeth 1 kit — — FDA listed —
Ixinity 59137-0287-05 Medexus 1 kit — — Discontinued —
Ixinity 59137-0283-05 Medexus 1 kit — — FDA listed —
Ixinity 59137-0288-05 Medexus 1 kit — — Discontinued —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
1997
First FDA approval
Feb 1997
📍
2026
Currently FDA-listed
29 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
BenefixCoagulation Factor IX (Recombinant) IxinityCoagulation Factor IX (Recombinant) RixubisCoagulation Factor IX (Recombinant)
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
FDA applicationBLA103677 (BLA)
Labeler code58394
First marketedFeb 1997
Product typePlasma Derivative
Portfolio16 products on file

More NDCs from Wyeth BioPharma Division of Wyeth Pharmaceutical... labeler code 58394

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 161 words ▾

1 INDICATIONS AND USAGE BeneFIX RTS is an antihemophilic factor (recombinant) indicated for: Control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B. ( 1.1 ) Peri-operative management in adult and pediatric patients with hemophilia B. ( 1.2 )

1.1Control and Prevention of Bleeding Episodes in Hemophilia B BeneFIX ®RTS , Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease).

1.2Peri-operative Management in Patients with Hemophilia B BeneFIX RTS , Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B. BeneFIX RTS , Coagulation Factor IX (Recombinant), is NOT indicated for: treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), treatment of hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, treatment of bleeding due to low levels of liver-dependent coagulation factors.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For Intravenous Use only The initial estimated dose may be determined using the following formula: ( 2 ) Required units = body weight (kg) x desired factor IX increase (IU/dL or % of normal) x reciprocal of observed recovery (IU/kg per IU/dL) Average Recovery: Adult and Pediatric (<15 years) Patients In clinical studies with adult and pediatric (<15 years) patients, one IU of BeneFIX RTS per kilogram of body weight increased the circulating activity of factor IX as follows: Adults: 0.8 ±

0.2IU/dL [range 0.4 to

1.2IU/dL]. ( 2.3 ) Pediatric: 0.7 ±

0.3IU/dL [range 0.2 to

2.1IU/dL]. ( 2.3 ) Dosing of BeneFIX RTS may differ from that of plasma-derived factor IX products. Dosage and duration of treatment with BeneFIX RTS depends on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX. ( 2.1 )

2.1General Considerations for Administration For Intravenous Use after Reconstitution Treatment with BeneFIX RTS , Coagulation Factor IX (Recombinant), should be initiated under the supervision of a physician experienced in the treatment of hemophilia B. Each vial of BeneFIX RTS has the rFIX potency in the International Units (IU) stated on the vial. Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

To ensure that the desired factor IX activity level has been achieved, precise monitoring using the factor IX activity assay is advised. Doses should be titrated using the factor IX activity, pharmacokinetic parameters, such as half-life and recovery, as well as taking the clinical situation into consideration in order to adjust the dose as appropriate. Dosing of BeneFIX RTS may differ from that of plasma-derived factor IX products [ see Clinical Pharmacology ( 12 ) ].

Subjects at the low end of the observed factor IX recovery may require upward dosage adjustment of BeneFIX RTS to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity. The safety and efficacy of BeneFIX RTS administration by continuous infusion have not been established [ see Warnings and Precautions ( 5 ) ].

2.2Method of Calculating Initial Estimated Dose The method of calculating the factor IX dose is shown in Table 1 . Table 1 number of factor IX IU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL) Average Recovery Adult Patients in Clinical Trial In adult PTPs, on average, one International Unit (IU) of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.8 ±

0.2IU/dL (range 0.4 to

1.2IU/dL). The method of dose estimation is illustrated in Table 2 . If you use

0.8IU/dL average increase of factor IX per IU/kg body weight administered, then: Table 2 number of factor IX IU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.3 (IU/kg per IU/dL) Average Recovery Pediatric Patients (<15 years) in Clinical Trial In pediatric patients, on average, one international unit of BeneFIX per kilogram of body weight increased the circulating activity of factor IX by 0.7 ±

0.3IU/dL (range 0.2 to

2.1 IU/dL; median of

0.6IU/dL per IU/kg). The method of dose estimation is illustrated in Table 3 . If you use

0.7IU/dL average increase of factor IX per IU/kg body weight administered, then: Table 3 number of factor IX IU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg per IU/dL) Doses administered should be titrated to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to BeneFIX RTS . Although the dose can be estimated by the calculations above, it is highly recomm… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS BeneFIX RTS is supplied as a white lyophilized powder in the following dosages: 250 IU 500 IU 1000 IU 2000 IU BeneFIX RTS lyophilized powder is available as 250, 500, 1000, or 2000 IU in single-use vials. ( 3 )

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS BeneFIX RTS is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. BeneFIX RTS is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought. ( 5.2 ) BeneFIX RTS has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter.

( 5.3 ) Development of activity-neutralizing antibodies has been detected in patients receiving factor IX-containing products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed. ( 5.5 ) Patients may develop hypersensitivity to hamster (CHO) protein as BeneFIX RTS contains trace amounts.

( 5.2 )

5.1General The clinical response to BeneFIX RTS may vary. If bleeding is not controlled with the recommended dose, the plasma level of factor IX should be determined, and a sufficient dose of BeneFIX should be administered to achieve a satisfactory clinical response. If the patient's plasma factor IX level fails to increase as expected or if bleeding is not controlled after the expected dose, the presence of an inhibitor (neutralizing antibodies) should be suspected, and appropriate testing performed [ see Warnings and Precautions ( 5.6 ) ].

5.2Anaphylaxis and Severe Hypersensitivity Reactions Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX RTS and have manifested as pruritus, rash, urticaria, hives, facial swelling, dizziness, hypotension, nausea, chest discomfort, cough, dyspnea, wheezing, flushing, discomfort (generalized) and fatigue. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Advise patients to discontinue use of the product and contact their physician and/or seek immediate emergency care.

BeneFIX RTS contains trace amounts of hamster (CHO) proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

5.3Thromboembolic Complications The safety and efficacy of BeneFIX RTS administration by continuous infusion have not been established [ see Dosage and Administration ( 2 ) ]. There have been post-marketing reports of thrombotic events in patients receiving continuous-infusion BeneFIX RTS through a central venous catheter, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates [ see Adverse Reactions ( 6 ) ].

5.4Nephrotic Syndrome Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. The safety and efficacy of using BeneFIX RTS for immune tolerance induction have not been established.

5.5Neutralizing Antibodies (Immunogenicity) Patients using BeneFIX RTS should be monitored for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of BeneFIX RTS [ see Clinical Pharmacology ( 12 ) ]. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.

Patients with factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with factor IX. 2 Patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. Patients should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.

Because of the potential for allergic reactions with factor IX concentrates, the initial (approximately 10 - 20) administrations of factor IX should be performed under medica… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reactions are systemic hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to factor IX replacement therapy. The most common adverse reactions observed in clinical trials (frequency > 5% of PTPs or PUPs) were headaches, dizziness, nausea, injections site reaction, injection site pain and skin-related hypersensitivity reactions (e.g., rash, hives).

The most common adverse reactions (incidence >5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During uncontrolled open-label clinical studies with BeneFIX, Coagulation Factor IX (Recombinant), conducted in previously treated patients (PTPs), 113 adverse reactions with known or unknown relation to BeneFIX therapy were reported among 38.5% (25 of 65) of subjects (with some subjects reporting more than one event) who received a total of 7,573 infusions.

These adverse reactions are summarized in Table 5 . Table 5: Adverse Reactions Reported for PTPs* Body System Adverse Reaction Number of patients (%) *Adverse reactions reported within 72 hours of an infusion of BeneFIX. 1 Low-titer transient inhibitor formation.

2 The renal infarct developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode. The relationship of the infarct to the prior administration of BeneFIX is uncertain. Blood and lymphatic system disorders Factor IX inhibition 1 1 (1.5%) Eye disorders Blurred vision 1 (1.5%) Gastrointestinal disorders Nausea 4 (6.2%) Vomiting 1 (1.5%) General disorders and administration site conditions Injection site reaction 5 (7.7%) Injection site pain 4 (6.2%) Fever 2 (3.1%) Infections and infestations Cellulitis at IV site 1 (1.5%) Phlebitis at IV site 1 (1.5%) Nervous system disorders Headache 7 (10.8%) Dizziness 5 (7.7%) Taste perversion (altered taste) 3 (4.6%) Shaking 1 (1.5%) Drowsiness 1 (1.5%) Renal and urinary disorders Renal infarct 2 1 (1.5%) Respiratory, thoracic and mediastinal disorders Dry cough 1 (1.5%) Hypoxia 1 (1.5%) Chest tightness 1 (1.5%) Skin and subcutaneous disorders Rash 4 (6.2%) Hives 2 (3.1%) Vascular disorders Flushing 2 (3.1%) In the 63 previously untreated patients (PUPs), who received a total of 5,538 infusions, 10 adverse reactions were reported among 9.5% of the patients (6 out of 63) having known or unknown relationship to BeneFIX.

These events are summarized in Table 6 . Table 6: Adverse Reactions Reported for PUPs* Body System Adverse Reaction Number of Patients (%) *Adverse reactions reported within 72 hours of an infusion of BeneFIX. 1 Two subjects developed high-titer inhibitor formation during treatment with BeneFIX.

Blood and lymphatic system disorders Factor IX inhibition 1 2 (3.2%) General disorders and administration site conditions Injection site reaction 1 (1.6%) Chills 1 (1.6%) Respiratory, thoracic and mediastinal disorders Dyspnea (respiratory distress) 2 (3.2%) Skin and subcutaneous disorders Hives 3 (4.8%) Rash 1 (1.6%) For adverse reactions thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped. Immunogenicity In clinical studies with 65 PTPs (defined as having more than 50 exposure days), a low-titer inhibitor was observed in one patient.

The inhibitor was transient, the patient continued on study and had normal factor IX recovery pharmacokinetics at… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 10 words ▾

7 DRUG INTERACTIONS None known. None known. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS On average, lower recovery has been observed in pediatric patients (<15 years). A dose adjustment may be needed. ( 12.3 , 14 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

8.1Pregnancy Pregnancy Category C Animal reproduction and lactation studies have not been conducted with BeneFIX RTS , Coagulation Factor IX (Recombinant). It is not known whether BeneFIX RTS can affect reproductive capacity or cause fetal harm when given to pregnant women. BeneFIX RTS should be administered to pregnant and lactating women only if needed.

8.2Labor and Delivery There is no information available on the effect of factor IX replacement therapy on labor and delivery. Use only if needed.

8.3Nursing Mothers It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if BeneFIX RTS is administered to nursing mothers. Use only if needed.

8.4Pediatric Use Safety, efficacy, and pharmacokinetics of BeneFIX have been evaluated in previously treated (PTP) and previously untreated pediatric patients (PUP) [ see Dosage and Administration ( 2 ), Clinical Pharmacology ( 12 ), Clinical Studies ( 14 ) and Adverse Reactions ( 6 ) ]. On average, lower recovery has been observed in pediatric patients (<15 years). A dose adjustment may be needed [ see Dosage and Administration ( 2 ) and Clinical Pharmacology ( 12 ) ].

8.5Geriatric Use Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be individualized [ see Dosage and Administration ( 2 ) ].

🤰 Pregnancy 55 words ▾

8.1Pregnancy Pregnancy Category C Animal reproduction and lactation studies have not been conducted with BeneFIX RTS , Coagulation Factor IX (Recombinant). It is not known whether BeneFIX RTS can affect reproductive capacity or cause fetal harm when given to pregnant women. BeneFIX RTS should be administered to pregnant and lactating women only if needed.

🧒 Pediatric Use 80 words ▾

8.4Pediatric Use Safety, efficacy, and pharmacokinetics of BeneFIX have been evaluated in previously treated (PTP) and previously untreated pediatric patients (PUP) [ see Dosage and Administration ( 2 ), Clinical Pharmacology ( 12 ), Clinical Studies ( 14 ) and Adverse Reactions ( 6 ) ]. On average, lower recovery has been observed in pediatric patients (<15 years). A dose adjustment may be needed [ see Dosage and Administration ( 2 ) and Clinical Pharmacology ( 12 ) ].

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be individualized [ see Dosage and Administration ( 2 ) ].

🆘 Overdosage 9 words ▾

10 OVERDOSAGE No symptoms of overdose have been reported.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action BeneFIX RTS temporarily replaces the missing clotting factor IX that is needed for effective hemostasis.

12.2Pharmacodynamics The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX RTS , Coagulation Factor IX (Recombinant), increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.

12.3Pharmacokinetics After single intravenous (IV) doses of 50 IU/kg of previously marketed BeneFIX, Coagulation Factor IX (Recombinant) [reconstituted with Sterile Water for Injection], in 37 previously treated adult patients (>15 years), each given as a 10-minute infusion, the mean increase from pre-infusion level in circulating factor IX activity was 0.8 ±

0.2IU/dL per IU/kg infused (range 0.4 to

1.4IU/dL per IU/kg) and the mean biologic half-life was 18.8 ± 5.4 hours (range 11 to 36 hours). In the original randomized, cross-over pharmacokinetic study in previously treated patients (PTPs), the in vivo recovery using previously marketed BeneFIX was statistically significantly less (28% lower, p<0.05) than the recovery using a highly purified plasma-derived factor IX product (pdFIX). A summary of pharmacokinetic data for BeneFIX and pdFIX are presented in Table 7 .

Table 7: Pharmacokinetic Parameter Estimates for BeneFIX and pdFIX in Previously Treated Patients with Hemophilia B Parameter BeneFIX, n = 11 pdFIX, n = 11 Mean ± SD Mean ± SD Abbreviations: AUC ∞ = area under the plasma concentration-time curve from time zero to infinity; K-value = incremental recovery; t 1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation. AUC ∞ (IU∙hr/dL) 548 ± 92 928 ± 191 t 1/2 (hr) 18.1 ± 5.1 17.7 ±

5.3CL (mL/hr/kg) 8.62 ± 1.7 6.00 ±

1.4K-value (IU/dL per IU/kg) 0.84 ± 0.30 1.17 ±

0.26In vivo Recovery (%) 37.8 ± 14.0 52.6 ±

12.4There was no significant difference in biological half-life. Structural differences of the BeneFIX molecule compared with pdFIX were shown to contribute to the lower recovery. In subsequent evaluations for up to 24 months, the pharmacokinetic parameters were similar to the initial results.

In a subsequent randomized, cross-over pharmacokinetic study, BeneFIX RTS reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with Sterile Water for Injection) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg. In addition, pharmacokinetic parameters were followed up in 23 previously treated patients after repeated administration of BeneFIX RTS for six months and found to be unchanged compared with those obtained at the initial evaluation.

A summary of pharmacokinetic data are presented in Table 8 : Table 8: Pharmacokinetic Parameter Estimates for BeneFIX at Baseline (Cross-over phase) and Month 6 (Follow-up phase) in Previously Treated Patients with Hemophilia B Parameter Parameters at Initial Visit (Cross-over phase), n = 24 Mean ± SD Parameters at Month 6 (Follow-up phase), n = 23 Mean ± SD Abbreviations: AUC ∞ = area under the plasma concentration-time curve from time zero to infinity; AUC t = area under the plasma concentration-time curve from zero to the last measurable concentration; C max = peak concentration; K-value = incremental recovery; t 1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.

C max (IU/dL) 54.5 ± 15.0 57.3 ±

13.2AUC ∞ (IU∙hr/dL) 940 ± 237 923 ± 205 t 1/2 (hr) 22.4 ± 5.3 23.8 ±

6.5CL (mL/hr/kg) 8.47 ± 2.12 8.54 ±

2.04K-value (IU/dL per IU/kg) 0.73 ± 0.20 0.76 ±

0.18In vivo Recovery (%) 34.5 ± 9.3 36.8 ±

8.7Pediatric Patients (≤15 years) Nineteen (19) previously treated pediatric patients (range 4 to ≤15 years) underwent pharmacokinetic evaluations for up to 24 months. Fifty-eight previously untreated… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action BeneFIX RTS temporarily replaces the missing clotting factor IX that is needed for effective hemostasis.

📦 How Supplied / Storage and Handling 219 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BeneFIX RTS , Coagulation Factor IX (Recombinant), is supplied in single-use vials which contain nominally 250, 500, 1000 or 2000 IU per vial (NDC 58394-003-06, 58394-002-06, 58394-001-06, and 58394-008-02, respectively) with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage and one gauze pad. Actual factor IX activity in IU is stated on the label of each vial.

16.2Storage and Handling Product as packaged for sale: BeneFIX RTS , Coagulation Factor IX (Recombinant), can be stored at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F). Do not use BeneFIX RTS after the expiration date on the label. Do not freeze to prevent damage to the diluent syringe. Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.

16.1How Supplied BeneFIX RTS , Coagulation Factor IX (Recombinant), is supplied in single-use vials which contain nominally 250, 500, 1000 or 2000 IU per vial (NDC 58394-003-06, 58394-002-06, 58394-001-06, and 58394-008-02, respectively) with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage and one gauze pad. Actual factor IX activity in IU is stated on the label of each vial.

📦 Storage and Handling 74 words ▾

16.2Storage and Handling Product as packaged for sale: BeneFIX RTS , Coagulation Factor IX (Recombinant), can be stored at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F). Do not use BeneFIX RTS after the expiration date on the label. Do not freeze to prevent damage to the diluent syringe. Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.

📋 Description ~2 min read ▾

11 DESCRIPTION BeneFIX RTS , Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA. It has a primary amino acid sequence that is identical to the Ala 148 allelic form of plasma-derived factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX RTS is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized.

No human or animal proteins are added during the purification and formulation processes of BeneFIX RTS . BeneFIX RTS is not derived from human blood and contains no preservatives, and the manufacture of BeneFIX RTS includes no added animal or human components. The stored cell banks are free of human blood or plasma products.

The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain any proteins derived from animal or human sources, and the recombinant factor IX is purified by a chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX RTS is a single component by SDS-polyacrylamide gel electrophoresis evaluation.

The potency (in International Units, IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One International Unit is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. The specific activity of BeneFIX RTS is greater than or equal to 200 IU per milligram of protein.

BeneFIX RTS is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. BeneFIX RTS is intended for intravenous (IV) injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in IU.

Each vial contains nominally 250, 500, 1000 or 2000 IU of Coagulation Factor IX (Recombinant). After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. All dosage strengths yield a clear, colorless solution upon reconstitution.

🍼 Nursing Mothers 39 words ▾

8.3Nursing Mothers It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if BeneFIX RTS is administered to nursing mothers. Use only if needed.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics After single intravenous (IV) doses of 50 IU/kg of previously marketed BeneFIX, Coagulation Factor IX (Recombinant) [reconstituted with Sterile Water for Injection], in 37 previously treated adult patients (>15 years), each given as a 10-minute infusion, the mean increase from pre-infusion level in circulating factor IX activity was 0.8 ±

0.2IU/dL per IU/kg infused (range 0.4 to

1.4IU/dL per IU/kg) and the mean biologic half-life was 18.8 ± 5.4 hours (range 11 to 36 hours). In the original randomized, cross-over pharmacokinetic study in previously treated patients (PTPs), the in vivo recovery using previously marketed BeneFIX was statistically significantly less (28% lower, p<0.05) than the recovery using a highly purified plasma-derived factor IX product (pdFIX). A summary of pharmacokinetic data for BeneFIX and pdFIX are presented in Table 7 .

Table 7: Pharmacokinetic Parameter Estimates for BeneFIX and pdFIX in Previously Treated Patients with Hemophilia B Parameter BeneFIX, n = 11 pdFIX, n = 11 Mean ± SD Mean ± SD Abbreviations: AUC ∞ = area under the plasma concentration-time curve from time zero to infinity; K-value = incremental recovery; t 1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation. AUC ∞ (IU∙hr/dL) 548 ± 92 928 ± 191 t 1/2 (hr) 18.1 ± 5.1 17.7 ±

5.3CL (mL/hr/kg) 8.62 ± 1.7 6.00 ±

1.4K-value (IU/dL per IU/kg) 0.84 ± 0.30 1.17 ±

0.26In vivo Recovery (%) 37.8 ± 14.0 52.6 ±

12.4There was no significant difference in biological half-life. Structural differences of the BeneFIX molecule compared with pdFIX were shown to contribute to the lower recovery. In subsequent evaluations for up to 24 months, the pharmacokinetic parameters were similar to the initial results.

In a subsequent randomized, cross-over pharmacokinetic study, BeneFIX RTS reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with Sterile Water for Injection) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg. In addition, pharmacokinetic parameters were followed up in 23 previously treated patients after repeated administration of BeneFIX RTS for six months and found to be unchanged compared with those obtained at the initial evaluation.

A summary of pharmacokinetic data are presented in Table 8 : Table 8: Pharmacokinetic Parameter Estimates for BeneFIX at Baseline (Cross-over phase) and Month 6 (Follow-up phase) in Previously Treated Patients with Hemophilia B Parameter Parameters at Initial Visit (Cross-over phase), n = 24 Mean ± SD Parameters at Month 6 (Follow-up phase), n = 23 Mean ± SD Abbreviations: AUC ∞ = area under the plasma concentration-time curve from time zero to infinity; AUC t = area under the plasma concentration-time curve from zero to the last measurable concentration; C max = peak concentration; K-value = incremental recovery; t 1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.

C max (IU/dL) 54.5 ± 15.0 57.3 ±

13.2AUC ∞ (IU∙hr/dL) 940 ± 237 923 ± 205 t 1/2 (hr) 22.4 ± 5.3 23.8 ±

6.5CL (mL/hr/kg) 8.47 ± 2.12 8.54 ±

2.04K-value (IU/dL per IU/kg) 0.73 ± 0.20 0.76 ±

0.18In vivo Recovery (%) 34.5 ± 9.3 36.8 ±

8.7Pediatric Patients (≤15 years) Nineteen (19) previously treated pediatric patients (range 4 to ≤15 years) underwent pharmacokinetic evaluations for up to 24 months. Fifty-eight previously untreated patients [PUPs] less than 15 years of age at baseline underwent at least one recovery assessment within 30 minutes post-infusion in the presence or absence of hemorrhage during the study. A total of 202 recovery assessments collected during the 60-month period from these 58 PUPs are combined with 19 recovery assessments from PTPs and were summarized by age group in Table 9 .

There was one recovery assessment in a neonate, which had a value of

0.46IU/dL per IU/kg. The overall mean recovery and FIX elimination half-life values were 0.7 ±

0.3IU… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 56 words ▾

12.2Pharmacodynamics The activated partial thromboplastin time (aPTT) is prolonged in people with hemophilia B. Treatment with factor IX concentrate may normalize the aPTT by temporarily replacing the factor IX. The administration of BeneFIX RTS , Coagulation Factor IX (Recombinant), increases plasma levels of factor IX, and can temporarily correct the coagulation defect in these patients.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Efficacy of BeneFIX has been evaluated in clinical studies in which a total of 128 subjects received BeneFIX either for the treatment of bleeding episodes on an on-demand basis, for the prevention of bleeds (prophylaxis) or for management of hemostasis in the surgical setting (surgical prophylaxis). Fifty-six PTPs and sixty-three PUPs were treated for bleeding episodes on an on-demand basis or for the prevention of bleeds (see Tables 9 and 10). The PTPs were followed over a median interval of 24 months (mean 23.4 ± 5.3 months) and for a median of 83.5.

The PUPs were followed over a median interval of 37 months (mean 38.1 ± 16.4 months) and for a median of 89 exposure days. Fifty-five PTPs and fifty-four PUPs received BeneFIX for the treatment of bleeding episodes (see Table 10 ). Bleeding episodes that were managed successfully included hemarthrosis and bleeding in soft tissue and muscle.

Data concerning the severity of bleeding episodes were not reported. In the PTPs, 88% of total infusions administrated for on-demand treatment were rated as an “excellent” or “good” response. Table 10: Efficacy of BeneFIX for on-demand treatment of PTPs and PUPs Median dose: IU/kg (range) Rate of bleeds resolved with 1 infusion Response to 1 st Infusion Rating c Excellent/Good Moderate No Response a One subject discontinued the study after one month of treatment due to bleeding episodes that were difficult to control; he did not have a detectable inhibitor. b Three subjects were not successfully treated including one episode in a subject due to delayed time to infusion and insufficient dosing and in 2 subjects due to inhibitor formation. c Response ratings not provided for 1.3% and 2% of 1 st infusions for PTPs and PUPs, respectively.

PTPs N=55 a 42.8 (6.5 - 224.6) 81 % 90.9% 7.1% 0.7% PUPs N=54 b 62.7 (8.2 - 292) 75 % 94.1% 2.9% 1.0% A total of 20 PTPs were treated with BeneFIX for secondary prophylaxis (the regular administration of FIX replacement therapy to prevent bleeding in patients who may have already demonstrated clinical evidence of hemophilic arthropathy or joint disease) at some regular interval during the study with a mean of 2.0 infusions per week (see Table 11). Thirty-two PUPs were administered BeneFIX for routine (primary and secondary) prophylaxis (see Table 11 ).

Twenty-four PUPs were administered BeneFIX at least twice weekly, and eight PUPs were administered BeneFIX once weekly. Seven PTPs experienced a total of 26 spontaneous bleeding episodes within 48 hours after an infusion. Six spontaneous bleeds within 48 hours after an infusion were reported in 5 PUPs.

Prophylaxis therapy was rated as “excellent” or “effective” in 93% of PTPs receiving prophylaxis one to two times per week. Table 11: Efficacy of Prophylaxis of BeneFIX in PTPs and PUPs Total exposure (infusions) Duration of prophylaxis (months) (mean ± SD) Dose IU/kg (mean ± SD) Spontaneous bleeds within 48 hrs of infusion Response rating a Excellent Effective Inadequate a Response ratings provided at approximately 3-month intervals. In total, 116 and 172 assessments reported for PTPs and PUPs, respectively.

Response ratings not provided for 2.6% and 0.6% of intervals for PTPs and PUPs, respectively. b N = 19 PTPs 20 2985 18.2 ± 8.4 b 40.3 ± 15.2 b 28 56.0% 37.1% 4.3% PUPs 32 3158 14.4 ± 8.1 73.3 ± 33.1 6 91.3% 6.4% 1.7% Management of hemostasis was evaluated in the surgical setting in both PTPs and PUPs (see Table 12 ). Thirty-six surgical procedures have been performed in 28 PTPs with 23 major surgical procedures performed (including 6 complicated dental extractions). Thirty surgical procedures have been performed in 23 PUPs.

Twenty-eight of these procedures were considered minor. Hemostasis was maintained throughout the surgical period; however, one PTP subject required evacuation of a surgical wound-site hematoma, and another PTP subject who received BeneFIX after a tooth extraction required further surgical intervention due to oozing at the… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 44 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility BeneFIX RTS , Coagulation Factor IX (Recombinant), has been shown to be nonmutagenic in the Ames assay and non-clastogenic in a chromosomal aberrations assay. No investigations on carcinogenesis or impairment of fertility have been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 41 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility BeneFIX RTS , Coagulation Factor IX (Recombinant), has been shown to be nonmutagenic in the Ames assay and non-clastogenic in a chromosomal aberrations assay. No investigations on carcinogenesis or impairment of fertility have been conducted.

📚 References 47 words ▾

15 REFERENCES Roberts HR, Eberst ME. Current management of hemophilia B. Hematol Oncol Clin North Am . 1993;7(6):1269-1280. Shapiro AD, Ragni MV, Lusher JM, et al. Safety and efficacy of monoclonal antibody purified factor IX concentrate in previously untreated patients with hemophilia B. Thromb Haemost . 1996;75(1):30-35.

📄 Patient Package Insert ~3 min read ▾

BeneFIX ®RTS (BEN-uh-fiks) [Coagulation Factor IX (Recombinant)] Please read this Patient Leaflet carefully before using BeneFIX RTS and each time you get a refill. There may be new information. This Patient Leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is BeneFIX RTS ? BeneFIX RTS is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease.

BeneFIX RTS is NOT used to treat hemophilia A. What should I tell my doctor before using BeneFIX RTS ? Tell your doctor and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

Tell your doctor about all of your medical conditions, including if you: are pregnant or planning to become pregnant. It is not known if BeneFIX RTS may harm your unborn baby. are breastfeeding. It is not known if BeneFIX RTS passes into the milk and if it can harm your baby.

How should I infuse BeneFIX RTS ? The initial administrations of BeneFIX RTS should be administered under proper medical supervision, where proper medical care for severe allergic reactions could be provided. See the step-by-step instructions for infusing BeneFIX RTS at the end of this leaflet.

You should always follow the specific instructions given by your doctor. The steps listed below are general guidelines for using BeneFIX RTS . If you are unsure of the procedures, please call your doctor or pharmacist before using.

Call your doctor right away if bleeding is not controlled after using BeneFIX RTS . Your doctor will prescribe the dose that you should take. Your doctor may need to test your blood from time to time.

BeneFIX RTS should not be administered by continuous infusion. What if I take too much BeneFIX RTS ? Call your doctor if you take too much BeneFIX RTS .

What are the possible side effects of BeneFIX RTS ? Allergic reactions may occur with BeneFIX RTS . Call your doctor or get emergency treatment right away if you have any of the following symptoms: wheezing difficulty breathing chest tightness turning blue (look at lips and gums) fast heartbeat swelling of the face faintness rash hives Your body can also make antibodies, called “inhibitors,” against BeneFIX RTS , which may stop BeneFIX RTS from working properly.

Some common side effects of BeneFIX RTS are nausea, injection site reaction, injection site pain, headache, dizziness and rash. BeneFIX RTS may increase the risk of thromboembolism (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter through which BeneFIX RTS is given by continuous infusion. There have been reports of severe blood clotting events, including life-threatening blood clots in critically ill neonates, while receiving continuous-infusion BeneFIX RTS through a central venous catheter.

The safety and efficacy of BeneFIX RTS administration by continuous infusion have not been established. These are not all the possible side effects of BeneFIX RTS . Tell your doctor about any side effect that bothers you or that does not go away.

How should I store BeneFIX RTS ? DO NOT FREEZE BeneFIX RTS . BeneFIX RTS can be stored at room temperature (below 86°F) or under refrigeration.

Store the diluent syringe at 36° to 86° F (2° to 30° C). Throw away any unused BeneFIX RTS and diluent after the expiration date. Freezing should be avoided to prevent damage to the pre-filled diluent syringe.

BeneFIX RTS does not contain a preservative. After reconstituting BeneFIX RTS , you can store it at room temperature for up to 3 hours. If you have not used it in 3 hours, throw it away.

Do not use BeneFIX RTS if the reconstituted solution is not clear and colorless. What else should I know about BeneFIX RTS ? Medicines are sometimes prescribed for purposes… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 250 IU SINGLE USE VIAL - LABEL NDC 58394-103-06 BeneFIX ® Coagulation Factor IX (Recombinant) No Preservatives Single Use Store refrigerated at 2 to 8°C (36 to 46°F). See package insert for room temperature storage information, reconstitution instructions, and complete information on dosage and directions for use. RECONSTITUTE ONLY WITH THE DILUENT SYRINGE PROVIDED US Govt.

License No. 3 Rx only Wyeth ® Principal Display Panel - 250 IU Single Use Vial Label

PRINCIPAL DISPLAY PANEL - 5 ML DISPOSABLE SYRINGE - DILUENT 0.234% Sodium Chloride Diluent 5 mL DISPOSABLE SYRINGE FOR DRUG DILUENT USE WITH BeneFIX ® Coagulation Factor IX (Recombinant) Sterile, nonpyrogenic. Contains no preservatives. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel - 5 mL Diluent

PRINCIPAL DISPLAY PANEL - 250 IU SINGLE USE – TRAY LABEL NDC 58394-003-06 BeneFIX ® Coagulation Factor IX (Recombinant) For Intravenous Administration. Store in a refrigerator at 2 to 8°C (36 to 46°F). Do not freeze. Keep this container in the outer carton. See enclosed package insert US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel -250 IU Single Use Tray Label

PRINCIPAL DISPLAY PANEL - 250 IU SINGLE USE VIAL - CARTON NDC 58394-003-06 BeneFIX ® Coagulation Factor IX (Recombinant) Plasma-Free, Albumin-Free Reconstitute BeneFIX ® with the enclosed sterile pre-filled syringe of 0.234% Sodium Chloride for Injection, ONLY. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel - 250 IU Single Use Carton

PRINCIPAL DISPLAY PANEL – 500 IU SINGLE USE VIAL - LABEL NDC 58394-102-06 BeneFIX ® Coagulation Factor IX (Recombinant) No Preservatives Single Use Store refrigerated at 2 to 8°C (36 to 46°F). See package insert for room temperature storage information, reconstitution instructions, and complete information on dosage and directions for use. RECONSTITUTE ONLY WITH THE DILUENT SYRINGE PROVIDED US Govt.

License No. 3 Rx only Wyeth ® Principal Display Panel - 500 IU Single Use Vial Label

PRINCIPAL DISPLAY PANEL - 500 IU SINGLE USE – TRAY LABEL NDC 58394-002-06 BeneFIX ® Coagulation Factor IX (Recombinant) For Intravenous Administration. Store in a refrigerator at 2 to 8°C (36 to 46°F). Do not freeze. Keep this container in the outer carton. See enclosed package insert. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel - 500 IU Single Use Tray Label

PRINCIPAL DISPLAY PANEL - 500 IU SINGLE USE VIAL - CARTON NDC 58394-002-06 BeneFIX ® Coagulation Factor IX (Recombinant) Plasma-Free, Albumin-Free Reconstitute BeneFIX ® with the enclosed sterile pre-filled syringe of 0.234% Sodium Chloride for Injection, ONLY. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel-500 IU Single Use Vial Carton

PRINCIPAL DISPLAY PANEL – 1000 IU SINGLE USE VIAL - LABEL NDC 58394-101-06 BeneFIX ® Coagulation Factor IX (Recombinant) No Preservatives Single Use Store refrigerated at 2 to 8°C (36 to 46°F). See package insert for room temperature storage information, reconstitution instructions, and complete information on dosage and directions for use. RECONSTITUTE ONLY WITH THE DILUENT SYRINGE PROVIDED US Govt.

License No. 3 Rx only Wyeth ® Principal Display Panel - 1000 IU Single Use Vial Label

PRINCIPAL DISPLAY PANEL - 1000 IU SINGLE USE – TRAY LABEL NDC 58394-001-06 BeneFIX ® Coagulation Factor IX (Recombinant) For Intravenous Administration. Store in a refrigerator at 2 to 8°C (36 to 46°F). Do not freeze. Keep this container in the outer carton. See enclosed package insert. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel - 1000 IU Single Use Tray Label

PRINCIPAL DISPLAY PANEL - 1000 IU SINGLE USE VIAL - CARTON NDC 58394-001-06 BeneFIX ® Coagulation Factor IX (Recombinant) Plasma-Free, Albumin-Free Reconstitute BeneFIX ® with the enclosed sterile pre-filled syringe of 0.234% Sodium Chloride for Injection, ONLY. US Govt. License No. 3 Rx only Wyeth ® Principal Display Panel - 1000 IU Single Use Carton

PRINC… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
42
Units reimbursed last 4 qtrs
143.1K
Gross reimbursed last 4 qtrs
$169.7K
Avg / prescription
$4,040.23
Avg / unit
$1.1859
Latest quarter Q1 2026
11Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 42 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 81,139 units · 647 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 61,952 units · 3,132 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6473,132
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 3,132 /100k
2 Illinois 647 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7195 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 58394-0634-03 · Wyeth 58394-0636-03 · Wyeth →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.