RECOMBINATE antihemophilic factor recombinant Kit
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- RECOMBINATE is a lab-made version of Factor VIII — the clotting protein that people with hemophilia A are missing. Without enough Factor VIII, your blood has trouble forming clots,...
- What exactly is RECOMBINATE, and why do I need it?
- Your care team will monitor your Factor VIII blood levels through regular lab tests to confirm the medication is raising them as expected. If a bleeding episode isn't stopping afte...
- How will I know if RECOMBINATE is working?
Patient education
Supplement & herbal interactions
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🧪 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
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💲 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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7192 | $1.580 / J7192 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Recombinatethis 00944-2841-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Recombinate 00944-2844-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7850-01 | Novo | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7825-01 | Novo | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7820-01 | Novo | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7830-01 | Novo | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7810-01 | Novo | 1 kit | — | — | FDA listed | — |
| Recombinate 00944-2843-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Novoeight 00169-7815-01 | Novo | 1 kit | — | — | FDA listed | — |
| Recombinate 00944-2842-10 | Takeda | 1 kit | — | — | FDA listed | — |
| Recombinate 00944-2845-10 | Takeda | 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.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00944-2841-10 You're viewing this | 1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) | 2009-04-10 | 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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?
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Does this product have a billing J-code?
Where does this data come from?
📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS and USAGE The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. 2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.
3 In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand’s disease.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. This potency assignment is referenced to the World Health Organization International Standard for Factor VIII:C Concentrate and is evaluated by appropriate methodology to ensure accuracy of the results. The expected in vivo peak increase in Factor VIII level expressed as IU/dL of plasma or % (percent) of normal can be estimated by multiplying the dose administered per kg body weight (IU/kg) by two.
This calculation is based on the clinical findings of Abildgaard et al 4 and is supported by the data generated by 419 clinical pharmacokinetic studies with RECOMBINATE in 67 patients over time. This pharmacokinetic data demonstrated a peak recovery point above the pre-infusion baseline of approximately
2.0IU/dL per IU/kg body weight. Examples (Assuming patient’s baseline Factor VIII level is at <1%): (1) A dose of 1750 IU RECOMBINATE administered to a 70 kg patient, i.e. 25 IU/kg (1750 IU/70 kg), should be expected to cause a peak post-infusion Factor VIII increase of 25 IU/kg x 2 (IU/dL)/(IU/kg) = 50 IU/dL (50% of normal).
(2) A peak level of 70% is required in a 40 kg child. In this situation, the dose would be 70 IU/dL/[2(IU/dL)/(IU/kg)] x 40 kg = 1400 IU. Recommended Dosage Schedule Physician supervision of the dosage is required.
The following dosage schedule may be used as a guide. Hemorrhage Degree of hemorrhage Required peak post infusion Factor VIII activity in the blood (as % of normal or IU/dL plasma) Frequency of Infusion Early hemarthrosis or muscle bleed or oral bleed 20-40 Begin infusion every 12 to 24 hours for one-three days until the bleeding episode is resolved (as indicated by pain), or healing is achieved. More extensive hemarthrosis, muscle bleed, or hematoma 30-60 Repeat infusion every 12 to 24 hours for (usually) three days or more until pain and disability are resolved.
Life threatening bleeds such as head injury, throat bleed, severe abdominal pain 60-100 Repeat infusion every 8 to 24 hours until threat is resolved Surgery Type of Operation Minor surgery, including tooth extractions 60-80 A single infusion plus oral antifibrinolytic therapy within one hour is sufficient in approximately 70% of cases. Major surgery 80-100 (pre- and post-operative) Repeat infusion every 8 to 24 hours depending on state of healing. If bleeding is not controlled with the recommended dose, the plasma level of Factor VIII should be determined and a sufficient dose of RECOMBINATE should be administered to achieve a satisfactory clinical response.
The careful control of the substitution therapy is especially important in cases of major surgery or life threatening hemorrhages. In presence of a low titer inhibitor, doses larger than those recommended may be necessary as per standard care. Although dosage can be estimated by the calculations above, it is strongly recommended that whenever possible, appropriate laboratory tests including serial Factor VIII assays be performed on the patient’s plasma at suitable intervals to assure that adequate Factor VIII levels have been reached and are maintained.
Patients should be evaluated for the development of Factor VIII inhibitors, if the expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose. Reconstitution: Use Aseptic Technique Bring RECOMBINATE (dry factor concentrate) and Sterile Water for Injection, USP, (diluent) to room temperature. Remove caps from concentrate and diluent vials.
Cleanse stoppers with germicidal solution and allow to dry prior to use. Place vials on a flat surface. Open the BAXJECT II device package by peeling away the lid, without touching the inside.
Do not remove the device from the package. Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper.
Grip the BAXJECT II package at its edge and pull the package off the device. D…
⛔ Contraindications ▾
CONTRAINDICATIONS RECOMBINATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins.
⚠️ Warnings ▾
WARNINGS General The clinical response to RECOMBINATE may vary. If bleeding is not controlled with the recommended dose, the plasma level of factor VIII should be determined and a sufficient dose of RECOMBINATE should be administered to achieve a satisfactory clinical response. If the patient’s plasma factor VIII 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 PRECAUTIONS - Monitoring Laboratory Tests ). Anaphylaxis and Severe Hypersensitivity Reactions Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with RECOMBINATE and have been manifested as dizziness pruritus, rash, urticaria, flushing, angioedema/face swelling, laryngeal edema, dyspnea, pallor, pyrexia, nausea, paresthesia, hypotension, and loss of consciousness. Discontinue RECOMBINATE if symptoms occur and seek immediate emergency treatment.
RECOMBINATE contains trace amounts of bovine proteins, mouse immunoglobulin G (MuIgG), and hamster (CHO) proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins. Neutralizing Antibodies Patients treated with antihemophilic factor (AHF) products should be carefully monitored for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.
Inhibitors have been reported following administration of RECOMBINATE predominantly in previously untreated and minimally treated patients. The risk of developing inhibitors is highest during the first 20 exposure days. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, an assay that measures factor VIII inhibitor concentration should be performed ( see PRECAUTIONS - Monitoring Laboratory Tests ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse Reactions from Clinical Trials During controlled clinical studies with RECOMBINATE enrolling 210 subjects, the most commonly reported adverse drug reactions were chills, flushing, rash and epistaxis. System Organ Class (SOC) Preferred MedDRA Term Number of Subjects Percent of Evaluable Subjects Number of evaluable subjects experiencing the event/total number of evaluable subjects [% relative to 210, the total number of unique subjects who received at least 1 infusion of RECOMBINATE]. GASTROINTESTINAL DISORDERS Nausea 1
0.48GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Chills Fatigue Pyrexia 3 1 1 1.43 0.48
0.48 INFECTIONS AND INFESTATIONS Ear infections 1
0.48 INVESTIGATIONS Acoustic stimulation tests abnormal 1
0.48 MUSCULOSKELETAL AND CONNECTIVE TISSUES DISORDERS Pain in extremity 1
0.48NERVOUS SYSTEM DISORDERS Dizziness Tremors 1 1 0.48
0.48 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Pharyngolaryngeal pain 1
0.48SKIN AND SUBCUTANEOUS TISSUE DISORDERS Hyperhidrosis Pruritus Rash Rash maculopapular 1 1 2 1 0.48 0.48 0.95
0.48VASCULAR DISORDERS Epistaxis Flushing Hematoma Hypotension Pallor Peripheral coldness 1 One subject experienced 11 events of epistaxis 2 1 1 1 1 0.48 0.95 0.48 0.48 0.48
0.48During the Previously Treated Patients (PTP) study, none of the 71 subjects developed de novo evidence of Factor VIII inhibitor. However, during the phase II/III portion of the study, 1 subject with a history of inhibitors exhibited inhibitor activity at 6 months (0.8 Bethesda Units [BU]), which resolved by 9 months. One other subject in this study had detectable Factor VIII inhibitor at baseline (1.26 BU) and exhibited an anamnestic response at 6 months (10.3 BU).
During During a prospective pharmaco-surveillance study of subjects who received batches of RECOMBINATE containing modestly increased Chinese Hamster Ovary (CHO) cell protein levels, none of the 34 treated subjects developed a Factor VIII inhibitor. During the Previously Untreated Patients (PUP) study, 22 of the 73 evaluable subjects developed inhibitors to Factor VIII. Of these, 13 subjects displayed no detectable Factor VIII inhibitors at study exit.
Post-Marketing Adverse Reactions In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience. These adverse reactions are listed by MedDRA (version 12.1) System Organ Class (SOC), then by MedDRA coding system Preferred Term in order of severity. BLOOD AND LYMPHATIC SYSTEM DISORDERS: Factor VIII inhibition CARDIAC DISORDERS: Tachycardia, Cyanosis GASTROINTESTINAL DISORDERS: Vomiting, Abdominal pain GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Malaise, Injection site reactions.
Chest pain, Chest discomfort IMMUNE SYSTEM DISORDERS: Anaphylactic reaction, Hypersensitivity NERVOUS SYSTEM DISORDERS: Loss of consciousness, Headache, Paresthesia RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Dyspnea, Cough, Laryngeal edema SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Angioedema, Urticaria, Erythema
🤰 Pregnancy ▾
Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RECOMBINATE. The safety of RECOMBINATE for use in pregnant women has not been established.
It is not known whether RECOMBINATE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing RECOMBINATE. RECOMBINATE should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use RECOMBINATE is appropriate for use in children of all ages, including the newborn. Safety and efficacy studies have been performed in both previously treated (n=23) and previously untreated (n=75) children. (See Clinical Pharmacology and Precautions ).
🧓 Geriatric Use ▾
Instructions for UseRECOMBINATE [Antihemophilic Factor (Recombinant)](For intravenous use only) Do not attempt to do an infusion to yourself unless you have been taught how by your doctor or hemophilia center. 1. In a quiet place, prepare a clean flat surface and gather all the materials you will need for the infusion.
Check the expiration date, and let the vial with the RECOMBINATE concentrate and the Sterile Water for Injection, USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional.
2. Remove caps from the RECOMBINATE concentrate and diluent vials to expose the centers of the rubber stoppers. 3.
Disinfect the stoppers with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center) by rubbing the stoppers firmly for several seconds, and allow to dry prior to use. Place the vials on a flat surface. 4.
Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. Do not remove the BAXJECT II device from the package . 5.
Turn the package with the BAXJECT II device upside down, and place it over the top of the diluent vial. Fully insert the clear plastic spike of the device into the center of the diluent vial’s stopper by pushing straight down. Grip the package at its edge and lift it off the device.
Be careful not to touch the white plastic spike. Do not remove the blue cap from the BAXJECT II device. The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the RECOMBINATE vial.
6. To connect the diluent vial to the RECOMBINATE vial, turn the diluent vial over and place it on top of the vial containing RECOMBINATE concentrate. Fully insert the white plastic spike into the RECOMBINATE vial’s stopper by pushing straight down.
Diluent will flow into the RECOMBINATE vial. This should be done right away to keep the liquid free of germs. 7.
Swirl the connected vials gently and continuously until the RECOMBINATE is completely dissolved. Do not shake . The RECOMBINATE solution should be colorless to light yellow in appearance.
If not, do not use it and notify Baxter immediately. 8. Take off the blue cap from the BAXJECT II device and connect the syringe.
BE CAREFUL TO NOT INJECT AIR . 9. Turn over the connected vials so that the RECOMBINATE vial is on top.
Draw the RECOMBINATE solution into the syringe by pulling back the plunger slowly. Disconnect the syringe from the vials. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available.
Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle. If you are using more than one vial of RECOMBINATE, the contents of more than one vial may be drawn into the same syringe. However, you will need a separate diluent and BAXJECT II device to mix each additional vial of RECOMBINATE.
10. Apply a tourniquet, and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center). 11.
Insert the needle into the vein, and remove the tourniquet. Slowly infuse the RECOMBINATE. Do not infuse any faster than 5 mL per minute for RECOMBINATE dissolved with 5 mL of sWFI .
Redness of the skin or irritation may be seen when infusing RECOMBINATE dissolved with 5 mL diluent. 12. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Do not recap the needle . Place it with the used syringe in a hard-walled Sharps container for proper disposal. 13.
Remove the peel-off label from the RECOMBINATE vial and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or a any household disinfecting solution. 14.
Dispose of the used vials and BAXJECT II system in your hard-w…
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Factor VIII is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). Hemophilia A is a genetic bleeding disorder characterized by hemorrhages, which may occur spontaneously or after minor trauma. The administration of RECOMBINATE provides an increase in plasma levels of Factor VIII and can temporarily correct the coagulation defect in these patients.
Pharmacokinetic studies on sixty-nine (69) patients revealed the circulating mean half-life for RECOMBINATE to be 14.6 ± 4.9 hours (n=67), which was not statistically significantly different from plasma-derived HEMOFIL M, [Antihemophilic Factor (Human), Method M, Monoclonal Purified]. The mean half-life of HEMOFIL M was 14.7 ± 5.1 hours (n=61). The actual baseline recovery observed with RECOMBINATE was 123.9 ±
47.7IU/dL (n=23), which is significantly higher than the actual HEMOFIL M baseline recovery of 101.7 ±
31.6IU/dL (n=61). However, the calculated ratio of actual to expected recovery with RECOMBINATE (121.2 ± 48.9%) is not different on average from HEMOFIL M (123.4 ± 16.4%). The clinical study of RECOMBINATE in previously treated patients (individuals with hemophilia A who had been treated with plasma derived Factor VIII) was based on observations made on a study group of 69 patients.
These individuals received cumulative amounts of Factor VIII ranging from 20,914 to 1,383,063 IU over the 48 month study. Patients were given a total of 17,700 infusions totaling 28,090,769 IU RECOMBINATE. These patients were successfully treated for bleeding episodes on a demand basis and also for the prevention of bleeds (prophylaxis).
Spontaneous bleeding episodes successfully managed include hemarthroses, soft tissue and muscle bleeds. Management of hemostasis was also evaluated in surgeries. A total of 24 procedures on 13 patients were performed during this study.
These included minor (e.g. tooth extraction) and major (e.g. bilateral osteotomies, thoracotomy and liver transplant) procedures. Hemostasis was maintained perioperatively and postoperatively with individualized Factor VIII replacement. A study of RECOMBINATE in previously untreated patients was also performed as part of an ongoing study.
The study group was comprised of seventy-nine (79) 1 patients, of whom seventy-six (76) had received at least one infusion of RECOMBINATE. To date, this cohort has been given 12,209 infusions totaling over 11,277,043 IU of RECOMBINATE. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED RECOMBINATE is available in three different strengths in single-dose vials. The strength is designated on the outer box and on the vial label using the following color codes: Color Code Dosage Strength RECOMBINATE Supplied with 5 mL sWFI Light blue bar Low 220-400 IU per vial NDC 0944-2841-10 Light pink bar Mid 401-800 IU per vial NDC 0944-2842-10 Light green bar High 801-1240 IU per vial NDC 0944-2843-10 RECOMBINATE is packaged with 5 mL of Sterile Water for Injection, USP, a BAXJECT II Needleless Transfer Device, one physician insert and one patient insert.
📦 Storage and Handling ▾
STORAGE RECOMBINATE can be refrigerated [2° - 8°C (36° - 46°F)] or stored at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box.
📋 Description ▾
DESCRIPTION RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns.
A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII.
RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500 and 1000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80.
Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand’s disease. The product contains no preservative.
Manufacturing of RECOMBINATE is shared by Baxter Healthcare Corporation and Wyeth BioPharma. The recombinant Antihemophilic Factor Concentrate (For Further Manufacturing Use), is produced by Baxter Healthcare Corporation and Wyeth BioPharma (For Further Manufacturing Use) and subsequently formulated and packaged at Baxter Healthcare Corporation. Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial.
Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.
💬 Information for Patients ▾
Information for Patients The patient and physician should discuss the risks and benefits of this product. Allergic type hypersensitivity reactions have been observed with RECOMBINATE. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, symptoms of laryngeal edema, and anaphylaxis.
Patients should be advised to discontinue use of the product and contact their physician if these symptoms occur. Additionally, patients should be informed that local tissue irritation may occur when infusing RECOMBINATE reconstituted with 5 mL sWFI.