Xyntha antihemophilic factor (recombinant) Kit
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1.04 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7185 | $1.371 / J7185 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Advate 00944-3052-02 | Takeda | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0013-01 | Wyeth | 1 kit | — | — | FDA listed | — |
| Kovaltry 00026-3828-50 | Bayer | 1 kit | — | — | FDA listed | — |
| Kovaltry 00026-3821-25 | Bayer | 1 kit | — | — | FDA listed | — |
| Advate 00944-3045-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Advate 00944-3046-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Advate 00944-3047-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0014-01 | Wyeth | 1 kit | — | — | FDA listed | — |
| Kovaltry 00026-3824-25 | Bayer | 1 kit | — | — | FDA listed | — |
| Kovaltry 00026-3826-50 | Bayer | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0023-03 | Wyeth | 1 kit | — | — | FDA listed | — |
| Xynthathis 58394-0025-03 | Wyeth | 1 kit | — | — | FDA listed | — |
| Advate 00944-3053-02 | Takeda | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0022-03 | Wyeth | 1 kit | — | — | FDA listed | — |
| Advate 00944-3051-02 | Takeda | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0015-01 | Wyeth | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0016-03 | Wyeth | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0024-03 | Wyeth | 1 kit | — | — | FDA listed | — |
| Advate 00944-3054-02 | Takeda | 1 kit | — | — | FDA listed | — |
| Xyntha 58394-0012-01 | Wyeth | 1 kit | — | — | FDA listed | — |
| Kovaltry 00026-3822-25 | Bayer | 1 kit | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58394-0025-03 You're viewing this | 1 KIT in 1 CARTON (58394-025-03) * 4 mL in 1 SYRINGE (58394-125-03) * 1 mL in 1 PACKET | 2011-08-01 | Active |
🧭 About this NDC listing & data coverage
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.
What data is (and isn’t) available for this NDC — tap to expand
| 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 |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Does this product have a billing J-code?
Where does this data come from?
📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE XYNTHA is an Antihemophilic (Recombinant) Factor indicated for: Control and prevention of bleeding episodes in patients with hemophilia A ( 1.1 ) Surgical prophylaxis in patients with hemophilia A ( 1.2 )
1.1Control and Prevention of Bleeding Episodes in Hemophilia A XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.
1.2Surgical Prophylaxis in Patients with Hemophilia A XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for surgical prophylaxis in patients with hemophilia A.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For Intravenous Use After Reconstitution Treatment with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free should be initiated under the supervision of a physician experienced in the treatment of hemophilia A. Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response.
In the presence of an inhibitor, higher doses may be required. 1 One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL.
2 The required dosage is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL) The labeled potency of XYNTHA is based on the European Pharmacopoeia chromogenic substrate assay, in which the Wyeth manufacturing standard has been calibrated using a one-stage clotting assay. This method of potency assignment is intended to harmonize XYNTHA with clinical monitoring using a one-stage clotting assay [ see Clinical Pharmacology ( 12.3 ) ].
For intravenous use after reconstitution only ( 2 ) The required dosage is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL) Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician. ( 2.1 , 2.2 )
2.1Control and Prevention of Bleeding Episodes In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period. The following chart can be used to guide dosing in bleeding episodes: Type of Bleeding Episode Factor VIII Level Required (IU/dL or % of normal) Frequency of Doses / Duration of Therapy Minor Early hemarthrosis, minor muscle or oral bleeds. 20–40 Repeat every 12-24 hours as necessary until resolved.
At least 1 day, depending upon the severity of the bleeding episode. Moderate Bleeding into muscles. Mild head trauma.
Bleeding into the oral cavity. 30–60 Repeat infusion every 12-24 hours for 3-4 days or until adequate local hemostasis is achieved. Major Gastrointestinal bleeding.
Intracranial, intra-abdominal or intrathoracic bleeding. Fractures. 60–100 Repeat infusion every 8-24 hours until bleeding is resolved.
2.2Surgical Prophylaxis in Patients with Hemophilia A In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period. Monitoring of replacement therapy by means of plasma factor VIII activity is recommended, particularly for surgical intervention. The following chart can be used to guide dosing in surgery: Type of Surgery Factor VIII Level Required (IU/dL or % of normal) Frequency of Doses / Duration of Therapy Minor Minor operations, including tooth extraction.
30–60 Repeat infusion every 12-24 hours for 3-4 days or until adequate local hemostasis is achieved. For tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient. Major Major operations.
60–100 Repeat infusion every 8-24 hours until threat is resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.
2.3Instructions for Use XYNTHA is administered by intravenous (IV) infusion after reconstitution of the freeze-dried powder with the diluent (0.9% Sodium Chlorid…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS XYNTHA is supplied as a white to off-white freeze-dried powder in the following dosage: 3000 IU XYNTHA freeze-dried powder is available as: 3000 IU in a single-use prefilled dual-chamber syringe. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Anaphylaxis and severe hypersensitivity reactions are possible. Should such reactions occur, treatment with the product should be discontinued, and appropriate treatment should be administered. ( 5.1 ) Development of activity-neutralizing antibodies has been detected in patients receiving factor VIII-containing products.
If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay that measures factor VIII inhibitor concentration should be performed. ( 5.2 , 5.4 ) Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in the product. ( 5.3 )
5.1Anaphylaxis and Severe Hypersensitivity Reactions Allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs or symptoms of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, and hypotension] and anaphylaxis [ see Patient Counseling Information ( 17 ) ]. Patients should be advised to discontinue use of the product and contact their physicians if these symptoms occur.
5.2Neutralizing Antibodies The occurrence of neutralizing antibodies (inhibitors) is well known in the treatment of patients with hemophilia A. Inhibitors have been detected in patients receiving factor VIII-containing products. Inhibitors are common in previously untreated patients 4,5,6 and have been observed in previously treated patients on factor VIII products.
7,8,9,10,11,12 Patients using coagulation factor VIII products, including XYNTHA, should be monitored for the development of factor VIII inhibitors. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present [ see Warnings and Precautions ( 5.4 ) ]. If detected, inhibitors should be titered in Bethesda Units (BU).
5.3Formation of Antibodies to Hamster Protein XYNTHA contains trace amounts of hamster proteins. Patients treated with this product could develop hypersensitivity to these non-human mammalian proteins.
5.4Monitoring: Laboratory Tests Monitor plasma factor VIII activity levels by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained, when clinically indicated [ see Dosage and Administration ( 2 ) ]. It is recommended that individual factor VIII values for recovery and, if clinically indicated, other pharmacokinetic characteristics be used to guide dosing and administration. Monitor for development of factor VIII inhibitors.
Perform assay to determine if factor VIII inhibitor is present when expected factor VIII activity plasma levels are not attained, or when bleeding is not controlled with the expected dose of XYNTHA. Use Bethesda Units (BU) to titer inhibitors.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction in study 1 is headache (24% of subjects) and in study 2 is pyrexia (41% of subjects). The most common adverse reaction in Study 1 is headache (24% of subjects) and in Study 2 is pyrexia (41% of subjects). ( 6.1 ) Two out of 89 subjects (who completed ≥ 50 exposure days) developed an inhibitor during the course of the study.
The observation of 2 inhibitors in 89 subjects who completed ≥ 50 exposure days was consistent with a 95% probability that the inhibitor formation rate with XYNTHA is less than 4.17% using a Bayesian analysis. ( 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. Study 1 is a pivotal phase 3 (safety and efficacy) study in which previously treated patients (PTPs) with hemophilia A received XYNTHA for routine prophylaxis and on-demand treatment, 94 subjects received at least one dose of XYNTHA, resulting in a total of 6,775 infusions [ see Clinical Studies ( 14 ) ].
In Study 1, the most frequently reported treatment-emergent adverse reaction was headache (24% of subjects). Other adverse reactions reported in ≥ 5% of subjects were: nausea (6%), diarrhea (5%), asthenia (5%) and pyrexia (5%). No subject developed anti-CHO or anti-TN8.2 antibodies.
Study 2 (surgery) is an on-going, open-label, single-arm study of at least 25 evaluable PTPs with severe or moderately severe hemophilia A (factor VIII activity in plasma [FVIII:C] ≤ 2%) who required elective major surgery and were planned to receive XYNTHA replacement therapy for at least 6 days post-surgery. Twenty-two subjects received at least one dose of XYNTHA, resulting in 766 infusions [ see Clinical Studies ( 14 ) ]. In Study 2, the most frequently reported treatment-emergent adverse reaction was pyrexia (41% of subjects).
Other adverse reactions reported in ≥ 5% of subjects were: headache (9%), nausea (9%), diarrhea (5%), vomiting (5%) and asthenia (5%). The adverse reactions reported in either study were considered mild or moderate in severity. Immunogenicity In Study 1, the incidence of FVIII inhibitors to XYNTHA was the primary safety endpoint.
Two subjects with inhibitors were observed in 89 subjects (2.2%) who completed ≥ 50 exposure days. These results were consistent with the pre-specified endpoint that no more than 2 inhibitors may be observed in at least 81 subjects. In a Bayesian statistical analysis, results from this study were used to update PTP results from a prior supporting study using XYNTHA manufactured at the initial facility, where one de novo and two recurrent inhibitors were observed in 110 subjects, and the experience with predecessor product (1 inhibitor in 113 subjects).
This Bayesian analysis indicates that the population (true) inhibitor rate for XYNTHA, the estimate of the 95% upper limit of the true inhibitor rate, was 4.17% (see Table 1 ). Table 1: Bayesian Posterior Distribution of Inhibitor Rate ---Posterior Beta Distribution Characteristics--- a Prior alpha of 2.5 plus the number of observed inhibitors. b Prior beta of 110 plus the number of subjects analyzed minus the number of observed inhibitors. c Posterior probability is the probability that the true inhibitor rate is less than the upper acceptable limit of 4.4%.
A posterior probability greater than 0.95 is deemed acceptable. d The 95% upper limit of the true inhibitor rate (the maximum rate calculated with at least 95% probability) based on the posterior distribution. An inhibitor rate less than 4.4% is deemed acceptable. FVIII Inhibitor Nijmegen Result (BU/mL) Number of Inhibitors Number of Subjects Analyzed Observed Inhibito…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS None known. None.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
8.1Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free. It is also not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.
8.2Labor and Delivery There is no information available on the effect of factor VIII replacement therapy on labor and delivery. XYNTHA should be used only if clinically indicated.
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 XYNTHA is administered to nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated.
8.4Pediatric Use A study of XYNTHA in previously treated patients less than 6 years of age is currently ongoing. Pharmacokinetics of XYNTHA was studied in 7 previously treated patients 12-16 years of age. Pharmacokinetic parameters in these patients were similar to those obtained for adults after a dose of 50 IU/kg. For these 7 patients, the mean (± SD) C max and AUC ∞ were 1.09 ±
0.21IU/mL and 11.5 ±
5.2IU∙h/mL, respectively. The mean clearance and plasma half‑life values were 5.23 ± 2.36 mL/h/kg and 8.03 ± 2.44 hours (range 3.52 – 10.6 hours), respectively. The mean K‑value and in vivo recoveries were 2.18 ±
0.41IU/dL per IU/kg and 112 ± 23%, respectively.
8.5Geriatric Use Clinical studies of XYNTHA did not include subjects aged 65 and over. In general, dose selection for an elderly patient should be individualized.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free. It is also not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.
🧒 Pediatric Use ▾
8.4Pediatric Use A study of XYNTHA in previously treated patients less than 6 years of age is currently ongoing. Pharmacokinetics of XYNTHA was studied in 7 previously treated patients 12-16 years of age. Pharmacokinetic parameters in these patients were similar to those obtained for adults after a dose of 50 IU/kg. For these 7 patients, the mean (± SD) C max and AUC ∞ were 1.09 ±
0.21IU/mL and 11.5 ±
5.2IU∙h/mL, respectively. The mean clearance and plasma half‑life values were 5.23 ± 2.36 mL/h/kg and 8.03 ± 2.44 hours (range 3.52 – 10.6 hours), respectively. The mean K‑value and in vivo recoveries were 2.18 ±
0.41IU/dL per IU/kg and 112 ± 23%, respectively.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of XYNTHA did not include subjects aged 65 and over. In general, dose selection for an elderly patient should be individualized.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Factor VIII is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). 15 Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. 15 Activated factor X converts prothrombin into thrombin.
15 Thrombin then converts fibrinogen into fibrin, and a clot is formed. 15 Factor VIII activity is greatly reduced in patients with hemophilia A, and, therefore, replacement therapy is necessary. The administration of XYNTHA increases plasma levels of factor VIII activity and can temporarily correct the coagulation defect in these patients.
12.2Pharmacodynamics The administration of XYNTHA increases plasma levels of factor VIII activity and can temporarily correct the coagulation defect in hemophilia A patients.
12.3Pharmacokinetics In a pivotal crossover clinical study, 30 evaluable previously treated patients [PTP] (≥ 12 years) received a single infusion of 50 IU/kg of XYNTHA followed by a full-length recombinant FVIII (FLrFVIII, Advate ® ) or a single infusion of FLrFVIII followed by XYNTHA in a randomized crossover design. The one-stage clotting assay method was used to determine the concentrations of these two products in blood. XYNTHA was shown to be pharmacokinetically equivalent to FLrFVIII as the 90% confidence intervals for XYNTHA-to-FLrFVIII ratios of the mean values of C max and AUC ∞ were within pre-established limits of 80% to 125%.
The pharmacokinetic parameters of XYNTHA in the above group of patients are summarized in Table 2 . In addition, 25 PTPs received a single infusion of 50 IU/kg of XYNTHA for a 6-month follow-up PK study. The pharmacokinetic parameters were comparable between baseline and month 6, indicating no time-dependent changes in the pharmacokinetic properties of XYNTHA; the 90% confidence intervals for XYNTHA 6 month-to-baseline ratios of the mean values of C max and AUC ∞ were within pre‑established limits of 80% to 125%.
Table 2: Pharmacokinetic Parameter Estimates for XYNTHA at Baseline (Cross-over phase) and Month 6 (Follow-up phase) in Previously Treated Patients with Hemophilia A Parameter Parameters at Initial Visit (Crossover phase, n = 30) Mean ± SD Parameters at Month 6 (Follow-up phase, n = 25) Mean ± SD Abbreviations: AUC ∞ = area under the plasma concentration-time curve from zero to infinity; C max = peak concentration; K‑value = incremental recovery; t 1/2 = plasma elimination half-life; CL = clearance; n = number of subjects; SD = standard deviation. *One subject was excluded from the calculation due to lack of a well-defined terminal phase.
C max (IU/mL) 1.08 ± 0.22 1.24 ±
0.42AUC ∞ (IU∙hr/mL) 13.5 ± 5.6 15.0 ± 7.5 t 1/2 (hr) 11.2 ± 5.0 11.8 ± 6.2* CL (mL/hr/kg) 4.51 ± 2.23 4.04 ±
1.87K-value (IU/dL per IU/kg) 2.15 ± 0.44 2.47 ±
0.84 In vivo Recovery (%) 103 ± 21 116 ± 40
🧬 Mechanism of Action ▾
12.1Mechanism of Action Factor VIII is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). 15 Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. 15 Activated factor X converts prothrombin into thrombin.
15 Thrombin then converts fibrinogen into fibrin, and a clot is formed. 15 Factor VIII activity is greatly reduced in patients with hemophilia A, and, therefore, replacement therapy is necessary. The administration of XYNTHA increases plasma levels of factor VIII activity and can temporarily correct the coagulation defect in these patients.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied XYNTHA ® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is supplied in a kit that includes the XYNTHA freeze-dried powder that contain nominally 3000 IU and 4 mL 0.9 % Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe: 3000 IU Kit: NDC 58394-016-03 In addition, each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Kit contains: one plunger rod for assembly, one sterile infusion set, two alcohol swabs, one bandage, one gauze pad, one vented sterile cap, and one package insert.
XYNTHA ® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is also supplied in kits that include single-use vials that contain nominally 250, 500, 1000, or 2000 IU of freeze‑dried powder per vial: 250 IU Kit: NDC 58394-012-01 500 IU Kit: NDC 58394-013-01 1000 IU Kit: NDC 58394-014-01 2000 IU Kit: NDC 58394-015-01 Actual factor VIII activity in IU is stated on the label of each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free prefilled dual-chamber syringe or vial.
16.2Storage and Handling Product as Packaged for Sale: Store XYNTHA under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label. XYNTHA may also be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. The starting date at room temperature storage should be clearly recorded in the space provided on the outer carton.
At the end of the 3-month period, the product must not be put back into the refrigerator, but must be used immediately or discarded. Do not use XYNTHA after the expiration date stated on the label or after 3 months when stored at room temperature, whichever is earlier. Do not freeze, to prevent damage to the XYNTHA Prefilled Dual-Chamber Syringe.
During storage, avoid prolonged exposure of XYNTHA to light. Product After Reconstitution: Administer XYNTHA within 3 hours after reconstitution or after removal of the grey rubber tip cap from the XYNTHA Prefilled Dual-Chamber Syringe. The reconstituted solution may be stored at room temperature prior to administration.
16.1How Supplied XYNTHA ® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is supplied in a kit that includes the XYNTHA freeze-dried powder that contain nominally 3000 IU and 4 mL 0.9 % Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe: 3000 IU Kit: NDC 58394-016-03 In addition, each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Kit contains: one plunger rod for assembly, one sterile infusion set, two alcohol swabs, one bandage, one gauze pad, one vented sterile cap, and one package insert.
XYNTHA ® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is also supplied in kits that include single-use vials that contain nominally 250, 500, 1000, or 2000 IU of freeze‑dried powder per vial: 250 IU Kit: NDC 58394-012-01 500 IU Kit: NDC 58394-013-01 1000 IU Kit: NDC 58394-014-01 2000 IU Kit: NDC 58394-015-01 Actual factor VIII activity in IU is stated on the label of each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free prefilled dual-chamber syringe or vial.
📋 Description ▾
11 DESCRIPTION Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic Factor (Recombinant), Plasma/Albumin‑Free in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain. 13 The amino acid sequence of Antihemophilic Factor (Recombinant), Plasma/Albumin‑Free in XYNTHA is comparable to the 90 + 80 kDa form of human factor VIII.
The Antihemophilic Factor (Recombinant), Plasma/Albumin‑Free in XYNTHA is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources. The Antihemophilic Factor (Recombinant), Plasma/Albumin‑Free in XYNTHA is purified by a process that uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand.
14 The process also includes a solvent-detergent viral inactivation step and a virus‑retaining nanofiltration step. The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay.
The specific activity of XYNTHA is 5,500 to 9,900 IU per milligram of protein. XYNTHA is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried powder preparation for intravenous (IV) injection. Each single-use prefilled dual-chamber syringe contains nominally 3000 IU of XYNTHA.
Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride and polysorbate 80.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See Patient Product Information and Instructions for Using XYNTHA. Advise patients to report any adverse reactions or problems following XYNTHA administration to their physician or healthcare provider. Advise patients that allergic-type hypersensitivity reactions are possible and inform them of the early signs of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, hypotension] and anaphylaxis.
Advise patients to discontinue use of the product and contact their physicians if these symptoms occur. Advise patients to contact their physician or treatment facility for further treatment and/or assessment, if they experience a lack of a clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor. Advise female patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
Advise nursing mothers to notify their physician if they are breastfeeding. Advise patients that local irritation may occur when infusing XYNTHA after the reconstitution in the prefilled dual-chamber syringe. Advise patients to consult with their healthcare professional prior to travel and to bring an adequate supply of XYNTHA, based on their current regimen, for anticipated treatment when traveling.