Antihemophilic factor recombinant
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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 2.0 IU/dL per IU/kg body weight.
Examples (Assuming patient’s baseline Factor VIII level is at <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). A peak level of 70% is required in a 40 kg child.
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.
The vacuum will draw the diluent into the RECOMBINATE vial. Swirl gently until RECOMBINATE is completely dissolved. After reconstitution, the solution should be colorless to faint yellow, and substantially free from foreign particles. NOTE: Do not refrigerate after reconstitution. (See Administration ) Administration: Use Aseptic Technique RECOMBINATE is administered by intravenous (IV) injection after reconstitution.
Administer at room temperature. RECOMBINATE should be administered not more than 3 hours after reconstitution. Intravenous Syringe Injection Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be colorless to faint yellow in appearance.
If not, do not use the solution and notify Baxter immediately. Plastic syringes are recommended for use with this product since proteins such as RECOMBINATE tend to stick to the surface of glass syringes. Remove the blue cap from the BAXJECT II device. Connect the syringe to the BAXJECT II device. DO NOT INJECT AIR. Turn over the connected vials so that the RECOMBINATE vial is on top.
Please note that the BAXJECT II device is intended for use with a single vial of RECOMBINATE and Sterile Water for Injection only, therefore reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device . Rate of Administration The rate of administration should be a rate that ensures the comfort of the patient.
Preparations of RECOMBINATE can be administered at a rate of up to 5 mL per minute when reconstituted with 5 mL of sWFI. The pulse rate should be determined before and during administration of RECOMBINATE. Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
| 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. |
Drug interactions
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- Antihemophilic factor recombinant
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.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for antihemophilic factor recombinant. Check the label's hepatic warnings.
Pregnancy and lactation
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.
Lactation
Nursing Mother 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 RECOMBINATE is administered to nursing mothers. RECOMBINATE should be given to nursing mothers only if clinically needed.
Breastfeeding (LactMed)
No information is available on the clinical use of antihemophilic factor (coagulation factor VIII) during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, antihemophilic factor should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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