Antihemophilic Factor (Human) – Factor VIII Concentrate
Pronunciation: (HEM-oh-fil EM) (FAK-tor eight concentrate).
- Generic name
- Antihemophilic Factor (Human) – Factor VIII concentrate
- Brand names
- Kogenate FS, Monoclate-P, Hemofil-M, Advate, Kogenate
- Drug class
- Antihemophilic Agent; Blood Coagulation Factor
Availability and supply rules vary by country
Trade names by country: United Kingdom
Australia: · Full directory
What Antihemophilic Factor (Human) – Factor VIII concentrate is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Antihemophilic Factor (Human) – Factor VIII concentrate works
Hemofil-M (Factor VIII concentrate) provides exogenous human factor VIII, which is essential for the intrinsic pathway of blood coagulation. Factor VIII acts as a cofactor for factor IXa, enabling the conversion of factor X to Xa, which is critical for the formation of a stable fibrin clot. (2)
What Antihemophilic Factor (Human) – Factor VIII concentrate is used for
Treatment of Hemophilia A
Treatment of Hemophilia A (2)
Prevention of bleeding episodes in Hemophilia A
Prevention of bleeding episodes in Hemophilia A (2)
Perioperative management in patients with Hemophilia A
Perioperative management in patients with Hemophilia A (2)
On-demand treatment of bleeding in Hemophilia A
On-demand treatment of bleeding in Hemophilia A (2)
Before taking Antihemophilic Factor (Human) – Factor VIII concentrate
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to human antihemophilic factor, mouse proteins, or any component of the product. (Contraindication) (2)
Tell your clinician about
(2)How to take Antihemophilic Factor (Human) – Factor VIII concentrate
- General Instructions: Hemofil-M is administered by intravenous injection, usually by a healthcare professional or after proper training at home. Always follow your doctor's instructions for dosing and administration.. Adult Dosing: Dosing is individualized based on the severity of factor VIII deficiency, the location and extent of bleeding, and patient weight. Typical doses range from 10 to 50 IU/kg, repeated as needed.. Pediatric Dosing: Children are dosed similarly to adults, with adjustments based on weight and clinical response. Close monitoring is required.. Administration: Reconstitute the lyophilized powder with the provided diluent, then inject slowly into a vein. Do not mix with other medications.. When To Stop: Continue treatment as prescribed. Do not stop without consulting your healthcare provider, even if you feel well.. Storage: Store unopened vials in the refrigerator (2–8°C). Do not freeze. After reconstitution, use within 3 hours and do not refrigerate.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose—do not double up. Contact your healthcare provider for guidance.
Overdose
Overdose is rare but may increase the risk of thrombosis or hypersensitivity reactions. In case of suspected overdose, seek immediate medical attention or contact your local poison control center. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Allergic reactions (rash, itching, hives)
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Fever
Incidence: Reported in the clinician-authored database; frequency not established
Chills
Incidence: Reported in the clinician-authored database; frequency not established
Injection site reactions (pain, redness, swelling)
Incidence: Reported in the clinician-authored database; frequency not established
Development of inhibitors (antibodies to Factor VIII)
Incidence: Reported in the clinician-authored database; frequency not established
Signs of an allergic reaction during or after infusion: rash, hives, itching, wheezing/difficulty breathing, or facial/throat swelling — seek emergency care if severe
(1)Bleeding that does not respond to treatment as expected — possible sign of an inhibitor (antibody) developing
(2)Signs of a blood clot: swelling, pain, or warmth in a limb, chest pain, or shortness of breath
(1)Serious warnings
Serious allergic reactions, including anaphylaxis, can occur — serious
Symptoms: Serious allergic reactions, including anaphylaxis, can occur. Development of inhibitors (antibodies) may reduce effectiveness. Risk of transmission of infectious agents, although minimized by screening and viral inactivation. Monitor for signs of thrombosis, especially in patients with risk factors. Use with caution in patients with liver disease or cardiovascular risk.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
The FDA label adds specifics beyond the clinician database — serious
Symptoms: The FDA label adds specifics beyond the clinician database: allergic-type hypersensitivity reactions including anaphylaxis can present with bronchospasm, difficulty breathing, or facial swelling. The risk of developing inhibitors (antibodies) is highest during the first 20 exposure days, particularly in previously untreated patients — your care team will monitor for an inadequate response to treatment as a sign of this. As a plasma-derived product, there remains a residual risk of transmitting infectious agents, including viruses, despite solvent/detergent treatment and nanofiltration during manufacturing. If your pulse rate increases significantly during administration, tell the person administering the infusion (or your healthcare provider if self-infusing) — the infusion rate may need to be adjusted by a clinician.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to human antihemophilic factor, mouse proteins, or any component of the product. Use with caution in patients with a history of inhibitors, liver disease, or at risk for thrombosis. Monitor for allergic reactions and development of inhibitors.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Hemofil-M is not known to have significant drug interactions. However, always inform your healthcare provider about all medications, supplements, and herbal products you are taking. Immune tolerance induction regimens or other clotting factor concentrates may affect response. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Safety in pregnancy has not been formally established in controlled human studies, per the FDA label; use only if clearly needed, as determined by your prescriber. Hemophilia A itself is rare in females, so this most often applies to a carrier or an affected patient requiring treatment during pregnancy. (2)
Breastfeeding
Safety while breastfeeding has not been formally established, per the FDA label; use only if clearly needed, as determined by your prescriber. (2)
Children
Frequency: Every 12-24 hours as needed.. Weight Based: 20-40 units/kg body weight for initial treatment of bleeding episodes.. Max Daily Dose: Dosing may be repeated every 12-24 hours as needed.. Max Single Dose: Up to 80 units/kg may be administered in severe cases.. Age Restrictions: Not recommended for pediatric use in children under 1 year of age due to insufficient safety data. (2)
Renal_impairment
No specific renal- or hepatic-impairment dosing guidance is established in either source reviewed; the clinician database advises general caution in patients with liver disease given its role in coagulation. Use with clinician oversight. (2)
Hepatic_impairment
No specific renal- or hepatic-impairment dosing guidance is established in either source reviewed; the clinician database advises general caution in patients with liver disease given its role in coagulation. Use with clinician oversight. (2)
Monitoring
(2)Storage
Store unopened vials refrigerated at 2-8°C (36-46°F); do not freeze. If needed, unopened vials may alternatively be stored at room temperature up to 30°C (86°F) per the FDA label — check the product's specific labeling for the permitted room-temperature duration. After reconstitution, use within 3 hours and do not refrigerate the reconstituted solution.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Treatment of Hemophilia A
Dose summary: Expected peak factor VIII level (IU/dL) = dose (IU/kg) x 2, per FDA labeling. Early/minor bleeds: target 20-40 IU/dL, every 12-24h for 1-3 days. Moderate bleeds: target 30-60 IU/dL, every 12-24h for 3+ days. Life-threatening bleeds: target 60-100 IU/dL, every 8-24h until resolved. Minor surgery: target 60-80 IU/dL, often single infusion. Major surgery: target 80-100 IU/dL pre/post-operatively, every 8-24h. Administer IV at up to 10 mL/minute.
Renal context: No specific renal- or hepatic-impairment dosing guidance is established in either source reviewed. (2)
Frequently asked questions
What is Hemofil-M used for?
Hemofil-M is used to treat and prevent bleeding episodes in people with hemophilia A by replacing missing factor VIII in the blood.
How is Hemofil-M administered?
Hemofil-M is given by intravenous injection, either by a healthcare professional or self-administered after training. The powder is reconstituted with a diluent before injection.
Can Hemofil-M be used for von Willebrand disease?
No, Hemofil-M is not effective for treating von Willebrand disease. It is specifically indicated for hemophilia A.
What should I do if I develop a rash or difficulty breathing after taking Hemofil-M?
Seek emergency medical attention immediately, as these may be signs of a serious allergic reaction; the treating team will decide on further doses or treatment.
Can Hemofil-M be used during pregnancy or breastfeeding?
There is limited data on use during pregnancy or breastfeeding. Use only if clearly needed and prescribed by your doctor.
What are inhibitors and why are they important?
Inhibitors are antibodies that can develop against factor VIII, making treatment less effective. Regular monitoring is important to detect and manage inhibitors.
How should Hemofil-M be stored?
Store unopened vials in the refrigerator (2–8°C). Do not freeze. Use reconstituted solution within 3 hours at room temperature.
What happens if I take too much Hemofil-M (Factor VIII concentrate)?
Taking too much Hemofil-M (Factor VIII concentrate) can lead to an increased risk of thrombotic events, as excessive clotting factor can promote unwanted clot formation. Symptoms might include chest pain, shortness of breath, or swelling in the limbs. If you suspect an overdose, seek immediate emergency medical attention. Your healthcare provider will monitor your coagulation parameters and provide supportive care.
Can I drink alcohol while taking Hemofil-M (Factor VIII concentrate)?
There are no specific known direct interactions between Hemofil-M (Factor VIII concentrate) and alcohol. However, alcohol can impair liver function, which plays a role in coagulation, and may also increase the risk of bleeding in some individuals. It is generally advisable to discuss alcohol consumption with your healthcare provider to understand any potential risks specific to your condition and treatment plan.
Is Hemofil-M (Factor VIII concentrate) safe during pregnancy?
The pregnancy category for Hemofil-M (Factor VIII concentrate) is not definitively established, and its safety during pregnancy has not been fully evaluated in controlled human studies. Therefore, it is crucial to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your healthcare provider will weigh the potential benefits against any risks to you and your baby.
What is the mechanism of action of Antihemophilic Factor (Human) – Factor VIII concentrate?
Hemofil-M (Factor VIII concentrate) provides exogenous human factor VIII, which is essential for the intrinsic pathway of blood coagulation. Factor VIII acts as a cofactor for factor IXa, enabling the conversion of factor X to Xa, which is critical for the formation of a stable fibrin clot. (2)
What is the generic name of Antihemophilic Factor (Human) – Factor VIII Concentrate?
The generic name is Antihemophilic Factor (Human) – Factor VIII concentrate. It is sold under brand names including Kogenate FS, Monoclate-P, Hemofil-M, Advate, Kogenate.
What class of drug is Antihemophilic Factor (Human) – Factor VIII concentrate?
Antihemophilic Factor (Human) – Factor VIII Concentrate is classed as: Antihemophilic Agent; Blood Coagulation Factor.
References
- Hemofil-M (Factor VIII concentrate) clinician-authored medicine recordMedGuideGlobal · United States · accessed 2026-08-06 · source 1
- HEMOFIL M (antihemophilic factor human) prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
Brand names by country
Single-ingredient Antihemophilic Factor (Human) – Factor VIII concentrate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United Kingdom
- Haemoctin 10001000 IU · Grifols UK Ltd
- Octanate LV 100 IU/ml powder and solvent for solution for injection100 IU/ml · Octapharma Limited
- Octanate LV 200 IU/ml powder and solvent for solution for injection200 IU/ml · Octapharma Limited
- Optivate 100 IU/ml powder and solvent for solution for injection100 IU/ml · Bio Products Laboratory Limited
- Dried Factor VIII Fraction Type 8Y 25 IU/ml powder for solution for injection25 IU/ml · Bio Products Laboratory Limited
- Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion1000 IU FVIII / 2400 IU VWF · CSL Behring UK Limited