Antihemophilic Factor Recombinant
Antihemophilic Factor Recombinant is a laboratory-made clotting protein used to prevent and control bleeding in people with hemophilia A.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Antihemophilic Factor Recombinant: Patient Information Guide
A plain-language walkthrough of Antihemophilic Factor Recombinant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
RECOMBINATE (Antihemophilic Factor Recombinant) is used for people with hemophilia A who need help controlling or preventing bleeding.
- RECOMBINATE is indicated to prevent and control bleeding episodes in patients with hemophilia A (classical hemophilia), including spontaneous bleeds such as joint bleeds (hemarthroses), soft tissue bleeds, and muscle bleeds.
- RECOMBINATE is used to manage bleeding before, during, and after surgery (perioperative management) in patients with hemophilia A.
- RECOMBINATE may be used in patients who have developed acquired Factor VIII inhibitors, provided the inhibitor level does not exceed 10 Bethesda Units per mL — and requires close laboratory monitoring in these cases.
- RECOMBINATE is not indicated for von Willebrand's disease.
⚙️How it works▾
Hemophilia A is a genetic bleeding disorder caused by a deficiency of Factor VIII, one of the proteins the body needs to form blood clots. Without enough Factor VIII, even minor injuries can lead to prolonged or serious bleeding. RECOMBINATE provides a recombinant (lab-engineered) form of Factor VIII that, when infused into the bloodstream, temporarily raises Factor VIII levels and restores the body's ability to clot properly.
In patients who have developed inhibitors — antibodies that neutralize Factor VIII — RECOMBINATE may still provide benefit if the inhibitor level is low enough, though higher doses and careful monitoring are needed.
💊How it's taken▾
RECOMBINATE is given as an intravenous (IV) infusion directly into a vein. Each vial is labeled with its specific Factor VIII activity in international units (IU). The dose is calculated based on the patient's body weight and the desired increase in Factor VIII blood levels, and it varies depending on the severity and location of bleeding or the type of surgery planned.
- Dosing frequency and duration depend on the clinical situation — acute bleeds, surgical coverage, or ongoing prophylaxis (prevention) each have different schedules.
- Factor VIII blood levels should be measured regularly to confirm the dose is working as expected.
- Always follow your prescriber's specific instructions; do not adjust your dose without guidance from your care team.
🤒Side effects — in detail▾
Most side effects from RECOMBINATE are mild, but serious reactions can occur and should be acted on quickly.
- Chills
- Flushing (warmth or redness)
- Rash, including maculopapular (flat, red, blotchy) rash
- Itching (pruritus)
- Nosebleeds (epistaxis)
- Nausea
- Dizziness or tremors
- Fever (pyrexia)
Serious reactions — including anaphylaxis (severe allergic reaction), throat swelling (laryngeal edema), difficulty breathing, loss of consciousness, low blood pressure, and rapid heartbeat — require immediate emergency care. Stop the infusion and call for help right away if any of these occur.
⚠️Warnings & precautions▾
- Severe allergic reactions (anaphylaxis): RECOMBINATE can cause life-threatening allergic reactions, including anaphylaxis. Signs include difficulty breathing, throat or face swelling, hives, dizziness, low blood pressure, and loss of consciousness. Stop the infusion immediately and seek emergency treatment if these occur.
- Factor VIII inhibitors: Some patients — especially those receiving RECOMBINATE for the first time — may develop inhibitors (antibodies that block Factor VIII). The risk is highest during the first 20 exposure days. Regular lab testing is essential to detect inhibitors early. If bleeding is not controlled at an expected dose, inhibitors should be suspected and tested for.
- Non-human protein sensitivity: RECOMBINATE contains trace amounts of bovine, mouse (MuIgG), and hamster (CHO) proteins. Patients may develop hypersensitivity to these proteins over time.
🔀What it interacts with▾
The FDA label for RECOMBINATE does not describe specific drug, food, or supplement interactions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use RECOMBINATE if you have ever had a life-threatening allergic reaction (anaphylaxis) to this product or to bovine (cow), mouse, or hamster proteins.
- Tell your doctor if you have a history of Factor VIII inhibitors, as special monitoring and possible dose adjustments will be needed.
- Previously untreated patients — especially young children — are at the greatest risk of developing inhibitors and require especially close monitoring during early treatment.
- Patients with known inhibitor activity at any level should have their Factor VIII levels checked frequently during treatment.
📡Pharmacodynamics — effects in the body▾
RECOMBINATE raises plasma levels of Factor VIII after infusion, temporarily correcting the clotting defect in patients with hemophilia A. The expected rise in Factor VIII activity can be estimated based on body weight and the dose given — clinical data with RECOMBINATE showed a peak recovery of approximately 2.0 IU/dL of Factor VIII activity per IU/kg of body weight administered. This correction in clotting ability helps prevent and control bleeding episodes, including joint bleeds, soft tissue bleeds, and surgical bleeding.
🔬Pharmacokinetics — how your body processes it▾
After IV infusion, RECOMBINATE is distributed in the bloodstream where it acts as replacement Factor VIII. Studies in 69 patients showed a mean circulating half-life of approximately 14.6 hours — meaning the Factor VIII level drops by half roughly every 14–15 hours, which is why repeat dosing is needed for ongoing protection. The actual baseline recovery observed with RECOMBINATE was higher than that seen with a plasma-derived Factor VIII product, though the calculated ratio of actual to expected recovery was similar between the two.
📦How to store it▾
RECOMBINATE can be refrigerated or stored at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the diluent vial.
📄 Written from Antihemophilic Factor Recombinant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Antihemophilic Factor Recombinant — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is RECOMBINATE, and why do I need it? ▾
How will I know if RECOMBINATE is working? ▾
What side effects should I watch for? ▾
What are inhibitors, and how do I know if I've developed them? ▾
Is RECOMBINATE safe for children? ▾
Can RECOMBINATE be used if I've already developed inhibitors? ▾
When was Antihemophilic Factor Recombinant first available? ▾
Who makes Antihemophilic Factor Recombinant? ▾
💬 Answers drafted from Antihemophilic Factor Recombinant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
📊 Antihemophilic Factor Recombinant across the U.S. market
How Antihemophilic Factor Recombinant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (21) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Antihemophilic Factor Recombinant is used
A general measure of how commonly Antihemophilic Factor Recombinant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Antihemophilic Factor Recombinant is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Antihemophilic Factor Recombinant prescribed? Of the 1,596 medications we measure, Antihemophilic Factor Recombinant ranks #1,510 by Medicaid prescriptions — more than 5% of them.
Utilization by Antihemophilic Factor Recombinant product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Antihemophilic Factor Recombinant products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 11 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Antihemophilic Factor Recombinant, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 11 listed Antihemophilic Factor Recombinant NDCs with Medicaid activity.
🔍 Compare Antihemophilic Factor Recombinant products
A representative set of FDA-listed product records for Antihemophilic Factor Recombinant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|
| 💊Kits | ||
| Baxalta US Inc. × 5 listings | BLA | View NDC → |
| Novo Nordisk × 6 listings | BLA | View NDC → |
| Takeda Pharmaceuticals America, Inc. × 10 listings | BLA | View NDC → |
Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Antihemophilic Factor Recombinant NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Antihemophilic Factor Recombinant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Antihemophilic Factor Recombinant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Antihemophilic Factor Recombinant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4257 2 dose forms · 10 strengths
-
Dose form (SCDF) Injection RxCUI 1718961No current FDA listingClinical drug / strength (SCD) antihemophilic factor (recombinant) pegylated 1 UNTRxCUI 1741407antihemophilic factor (recombinant) pegylated-exei 1 UNTRxCUI 2275724antihemophilic factor, human 1 UNTRxCUI 1718962antihemophilic factor, human recombinant 1 UNTRxCUI 1719222antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNTRxCUI 1718993antihemophilic factor, porcine B-domain truncated recombinant 1 UNTRxCUI 1593154lonoctocog alfa 1 UNTRxCUI 1796379simoctocog alfa 1 UNTRxCUI 1729086turoctocog alfa 1 UNTRxCUI 1737559 -
Dose form (SCDF) Prefilled Syringe RxCUI 1050327No current FDA listingClinical drug / strength (SCD) antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNTRxCUI 1720165
Look up RxCUI 4257 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Antihemophilic Factor Recombinant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Antihemophilic Factor Recombinant belongs to the Human Antihemophilic Factor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Baxalta US Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.