Factor VIII, human plasma-derived: Drug information

(For additional information see "Factor VIII, human plasma-derived: Patient drug information" and see "Factor VIII, human plasma-derived: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Hemofil M;
Koate;
Koate-DVI

Pharmacologic Category

Antihemophilic Agent;
Blood Product Derivative

Dosing: Adult

Hemophilia A, without inhibitors

Hemophilia A, without inhibitors:

Treatment and control of bleeding episodes or perioperative management:

Intermittent IV bolus dosing: IV: Utilize steps 1 to 3 to determine intermittent bolus dosing strategy. Individualize dosage based on coagulation studies performed prior to treatment and at regular intervals during treatment. In general, administration of factor VIII 1 unit/kg will increase circulating factor VIII levels by ~2 units/dL (Ref).

Step 1: Determine desired factor VIII peak level and anticipated duration of therapy based on the World Federation of Hemophilia (WFH) treatment recommendations; see table. Selection of the lower-dose practice pattern requires closer observation with the potential for requiring escalation to higher doses based on clinical response.

Note: For patients without inhibitors and receiving emicizumab who experience breakthrough bleeding, antihemophilic factor should be dosed to target the desired peak factor VIII levels outlined in the table as emicizumab is not indicated for treatment of bleeding episodes.

**Antihemophilic Factor (Human) WFH Treatment Recommendations^d**
Type of hemorrhage or surgery	Lower-dose practice pattern		Higher-dose practice pattern
Type of hemorrhage or surgery	Desired peak factor VIII level (units/dL)	Treatment duration (days)	Desired peak factor VIII level (units/dL)	Treatment duration (days)
^aMay be longer if response is inadequate. ^bSometimes longer as secondary prophylaxis during physical therapy. ^cA single dose may be sufficient for some joint bleeds; determine need for additional doses based on clinical response. ^dWFH [Srivastava 2020].
Joint	10 to 20	1 to 2^a,c	40 to 60	1 to 2^a,c
Superficial muscle/no neurovascular compromise (except iliopsoas)	10 to 20	2 to 3^a	40 to 60	2 to 3^a
Iliopsoas or deep muscle with neurovascular injury or substantial blood loss:
Initial	20 to 40	1 to 2	80 to 100	1 to 2
Maintenance	10 to 20	3 to 5^b	30 to 60	3 to 5^b
Intracranial:
Initial	50 to 80	1 to 3	80 to 100	1 to 7
Maintenance	30 to 50	4 to 7	50	8 to 21
Maintenance	20 to 40	8 to 14	-	-
Throat and Neck:
Initial	30 to 50	1 to 3	80 to 100	1 to 7
Maintenance	10 to 20	4 to 7	50	8 to 14
Gastrointestinal:
Initial	30 to 50	1 to 3	80 to 100	7 to 14
Maintenance	10 to 20	4 to 7	50	-
Renal	20 to 40	3 to 5	50	3 to 5
Deep laceration	20 to 40	5 to 7	50	5 to 7
Surgery (major):
Preop	60 to 80	-	80 to 100	-
Postop	30 to 40	1 to 3	60 to 80	1 to 3
	20 to 30	4 to 6	40 to 60	4 to 6
	10 to 20	7 to 14	30 to 50	7 to 14
Surgery (minor):
Preop	40 to 80	-	50 to 80	-
Postop	20 to 50	1 to 5	30 to 80	1 to 5

Step 2: Calculate dose using desired peak factor VIII level from step 1 and the following equation:

Factor VIII units required = [(desired peak factor VIII level − patient’s baseline factor VIII level) × body weight (kg)]/2

Note: Factor VIII level units are units/dL.

Example for 50 kg patient with desired peak factor VIII level of 35 units/dL and baseline factor VIII level of 5 units/dL:

Factor VIII units required = [(35 units/dL − 5 units/dL) × 50 kg]/2 = 750 units of factor VIII

Step 3: Determine need for repeat dosing based on manufacturer’s recommended frequency of repeat dosing. Note: Frequency of administration must also take into consideration subsequent factor VIII activity measurements and the clinical response.

**Antihemophilic Factor (Human) Administration Frequency According to Clinical Scenario**
Product	Bleeding event			Surgery
Product	Minor severity	Moderate severity	Major severity	Minor bleeding risk	Major bleeding risk
Hemofil-M	Every 12 to 24 hours	Every 12 to 24 hours	Every 8 to 24 hours	Single dose typically adequate	Every 8 to 24 hours
Koate	Every 12 hours	Every 12 hours	Every 12 hours	Every 12 hours	Every 12 hours

Continuous infusion dosing (Ref):

Note: Continuous infusion administration is preferred over intermittent bolus administration for patients requiring prolonged treatment courses (eg, postoperative management after surgery with major bleeding risk). To ensure safe and effective use, only products with extended stability information should be used. Extended stability information may not be available for all products; contact product manufacturer to obtain current recommendations. Use of a smart infusion pump with small volume infusion capability is also necessary.

IV: Administer an initial bolus to achieve the desired factor VIII level (see steps 1 and 2 under intermittent bolus dosing), then initiate continuous infusion at 2 to 4 units/kg/hour. Adjust dose based on frequent factor assays (at least daily) and calculation of factor VIII clearance at steady-state using the below equations.

Factor VIII clearance (mL/kg/hour) = (current infusion rate in units/kg/hour) divided by (measured factor VIII level in units/mL)

New infusion rate (units/kg/hour) = (factor VIII clearance in mL/kg/hour) x (desired factor VIII level in units/mL)

Note: With infusion dose increases, re-bolus should be considered to achieve target factor VIII level more quickly. See steps 1 and 2 under intermittent bolus dosing to determine re-bolus dose.

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with moderate/severe hemophilia A, without inhibitors: IV: 25 to 40 units/kg of factor VIII concentrate every 2 to 3 days. Preferably, dosing should be tailored to ensure trough factor VIII levels of at least 1% and ideally ≥3% to 5% are achieved, but prophylaxis targets should be tailored to individual level of activity, lifestyle, and pharmacokinetics. Dose escalation should be considered for patients adherent to prescribed prophylaxis but still experiencing breakthrough bleeding events (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Obesity: Adult

There are insufficient data to recommend the best dosing weight to use in patients with obesity. Dose adjustments should ultimately be made based on individual patient response to therapy. Due to the paucity of data, refer to institutional protocols. Refer to adult dosing for indication-specific dosing.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Factor VIII, human plasma-derived: Pediatric drug information")

Hemophilia A

Hemophilia A: Individualize dosage based on clinical response and factor VIII activity evaluated at baseline and at regular intervals during treatment. In general, administration of factor VIII 1 unit/kg will increase circulating factor VIII levels by ~2% of normal. Patients with inhibitory antibodies to factor VIII may require higher doses, more frequent administration, and/or selection of alternative therapy.

General dosing for control and prevention of bleeding episodes or perioperative management: Note: Dosage is expressed in units of factor VIII activity and must be individualized based on formulation, severity of factor VIII deficiency, extent and location of bleed, individualized incremental recovery using factor VIII activity assays, and clinical situation of patient.

Infants, Children, and Adolescents (ages vary by product; see product-specific labeling for approved ages): IV:

Formula for units required to raise blood level:

Number of Factor VIII Units required = body weight (in kg) x 0.5 units/kg per units/dL x desired factor VIII level increase (units/dL or %)

For example, for a desired 100% level in a 25 kg patient who has an actual level of 20%: Number of Factor VIII Units needed = 25 kg x 0.5 units/kg per units/dL x 80% = 1,000 units

Treatment recommendations (Ref): Note: Factor VIII level may either be expressed as % or as units/dL.

Intermittent IV: Infants, Children and Adolescents: The following recommendations reflect guideline recommendations for general dosing requirements; may vary from those found within prescribing information or practitioner preference. Frequency is based on type of bleed or surgery and varies by product; see specific product labeling for details. Dosing frequency most commonly corresponds to the half-life of factor VIII but should be determined based on an assessment of factor VIII levels (if available) before the next dose.

Site of Hemorrhage/Clinical Situation	Desired Factor VIII Peak Level	Frequency^A	Duration
^AFrequency is based on type of bleed or surgery and varies by product; see specific product labeling for details.
Joint	40% to 60%	Every 8 to 24 hours	1 to 2 days, may be longer if response is inadequate
Superficial muscle/no neurovascular compromise	40% to 60%	Every 8 to 24 hours	2 to 3 days, sometimes longer if response is inadequate
Iliopsoas and deep muscle with neurovascular injury, or substantial blood loss	Initial: 80% to 100%	Every 8 to 24 hours	Initial: 1 to 2 days
	Maintenance: 30% to 60%	Every 8 to 24 hours	Maintenance: 3 to 5 days, sometimes longer as secondary prophylaxis during physiotherapy
CNS/Head	Initial: 80% to 100%	Every 8 to 24 hours	Initial: 1 to 7 days
CNS/Head	Maintenance: 50%	Every 8 to 24 hours	Maintenance: 8 to 21 days
Throat and neck	Initial: 80% to 100%	Every 8 to 24 hours	Initial: 1 to 7 days
Throat and neck	Maintenance: 50%	Every 8 to 24 hours	Maintenance: 8 to 14 days
Gastrointestinal	Initial: 80% to 100%	Every 8 to 24 hours	Initial: 7 to 14 days
Gastrointestinal	Maintenance: 50%	Every 8 to 24 hours	Maintenance: Not specified
Renal	50%	Every 8 to 24 hours	3 to 5 days
Deep laceration	50%	Every 8 to 24 hours	5 to 7 days
Surgery (major)	Preop: 80% to 100%	Single dose
	Postop: 60% to 80%	Every 8 to 24 hours	Postop: 1 to 3 days
	Postop: 40% to 60%		Postop: 4 to 6 days
	Postop: 30% to 50%		Postop: 7 to 14 days
Surgery (minor)	Preop: 50% to 80%	Single dose
Surgery (minor)	Postop: 30% to 80%	Every 8 to 24 hours	Postop: 1 to 5 days depending on procedure type

Continuous IV infusion: Infants, Children, and Adolescents: Note: In general, administration of factor VIII 4 units/kg/hour will increase circulating factor VIII levels by 1 unit/mL (Ref).

Control and prevention of bleeding episodes: Limited data available: Note: For patients who require prolonged periods of treatment (eg, intracranial hemorrhage or surgery) to avoid peaks and troughs associated with intermittent infusions (Ref):

Following initial bolus to achieve the desired factor VIII level: Initial dosing: 2 to 4 units/kg/hour; adjust dose based on frequent factor VIII assays and calculation of factor VIII clearance at steady-state using the following equations:

Factor VIII clearance (mL/kg/hour) = (current infusion rate in units/kg/hour) / (plasma factor VIII level in units/mL)

New infusion rate (units/kg/hour) = (factor VIII clearance in mL/kg/hour) x (desired plasma factor VIII level in units/mL)

Perioperative management: Limited data available: Initial: 25 to 50 units/kg prior to surgery, followed by continuous infusion at a rate of 3 to 5 units/kg/hour; regimen based on 2 studies evaluating use in pediatric surgery patients (age range: 0.9 to 17 years); rate was adjusted and additional boluses given as needed to maintain desired factor VIII level (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Gastrointestinal: Abdominal pain (5%), nausea (5%)

Hematologic & oncologic: Increased factor VIII inhibitors (6%)

Local: Inflammation at injection site (2%)

Nervous system: Headache (≤5%), nervousness (10%), paresthesia (5%)

Ophthalmic: Blurred vision (5%)

<1%:

Cardiovascular: Chest tightness

Gastrointestinal: Dysgeusia

Nervous system: Dizziness

Miscellaneous: Fever

Postmarketing:

Cardiovascular: Bradycardia, chest pain, edema, flushing, hypotension, tachycardia

Dermatologic: Hyperhidrosis, pruritus, skin rash, urticaria

Gastrointestinal: Diarrhea, vomiting

Hematologic & oncologic: Hemolytic anemia

Hypersensitivity: Facial edema, hypersensitivity reaction (including anaphylaxis)

Nervous system: Chills, fatigue, irritability, tonic-clonic seizure

Neuromuscular & skeletal: Musculoskeletal pain

Ophthalmic: Ocular hyperemia, visual impairment

Respiratory: Bronchospasm, cough, cyanosis, dyspnea, hyperventilation

Contraindications

Hypersensitivity (eg, anaphylaxis) to antihemophilic factor (human) or any component of the formulation; hypersensitivity to mouse proteins (Hemofil M only).

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: The development of factor VIII antibodies has been reported with antihemophilic factors; monitor for signs of formation of antibodies to factor VIII. Suspect factor VIII antibodies if the plasma factor VIII level does not increase as expected or if bleeding is not controlled after administration.

• Hypersensitivity reactions: Hypersensitivity reactions (including anaphylaxis) may occur; discontinue immediately if hypersensitivity symptoms occur and administer appropriate treatment.

Special populations:

• Blood types A, B, and AB: Contains trace amounts of blood groups A and B isohemagglutinins; use caution when large or frequently repeated doses are given to individuals with blood groups A, B, and AB. Monitor patients for signs of intravascular hemolysis and falling hematocrit; discontinue therapy and consider administration of serologically compatible type O red blood cells if progressive hemolytic anemia occurs.

Dosage form specific issues:

• Albumin: Products vary by preparation method; final formulations contain human albumin.

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer. Hepatitis A and B vaccination is recommended for all patients receiving plasma derivatives.

• Mouse protein: Hemofil M contains trace amounts of mouse protein; use is contraindicated in patients with hypersensitivity to mouse protein.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• von Willebrand factor: Some products may contain naturally occurring von Willebrand factor for stabilization; however, efficacy has not been established for the treatment of von Willebrand disease.

Other warnings/precautions:

• Appropriate use: Dosage requirements will vary in patients with factor VIII inhibitors; optimal treatment should be determined by clinical response. Frequency of use is determined by the severity of the disorder or bleeding pattern.

Warnings: Additional Pediatric Considerations

Formation of factor VIII inhibitors (neutralizing antibodies to AHF human) may occur; reported incidence is 3% to 52%; an increase of inhibitor antibody concentration is seen at 2 to 7 days, with peak concentrations at 1 to 3 weeks after therapy; children <5 years of age are at greatest risk; higher doses of AHF may be needed if antibody is present; if antibody concentration is >10 Bethesda units/mL, patients may not respond to larger doses and alternative treatment modalities may be needed; monitor patients appropriately. Allergic-type hypersensitivity reactions, including anaphylaxis, may occur; discontinue therapy immediately if urticaria, hives, hypotension, tightness of the chest, wheezing, dyspnea, faintness, or anaphylaxis develop; emergency treatment and resuscitative measures (eg, epinephrine, oxygen) may be needed.

Dosage Forms Considerations

Strengths expressed with approximate values. Consult individual vial labels for exact potency within each vial.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Koate: ~250 units (1 ea); ~500 units (1 ea); ~1000 units (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]

Solution Reconstituted, Intravenous [preservative free]:

Hemofil M: ~250 units (1 ea); ~500 units (1 ea); ~1000 units (1 ea); ~1700 units (1 ea) [contains albumin human, polyethylene glycol (macrogol)]

Koate-DVI: ~500 units (1 ea); ~1000 units (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Hemofil M Intravenous)

250 unit (Price provided is per AHF Unit): $1.92

500 unit (Price provided is per AHF Unit): $1.92

1000 unit (Price provided is per AHF Unit): $1.92

1700 unit (Price provided is per AHF Unit): $1.92

Solution (reconstituted) (Koate Intravenous)

250 unit (Price provided is per AHF Unit): $1.73

500 unit (Price provided is per AHF Unit): $1.73

1000 unit (Price provided is per AHF Unit): $1.73

Solution (reconstituted) (Koate-DVI Intravenous)

500 unit (Price provided is per AHF Unit): $1.58

1000 unit (per each): $1.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer at a rate comfortable to the patient (≤10 mL/minute).

Continuous infusion (off-label rate): Has also been administered as a continuous infusion to avoid peaks and troughs associated with intermittent infusions in patients who require prolonged treatment periods. Use a smart infusion pump with small volume infusion capability. Refer to protocols for product selection and preparation details (Ref).

Administration: Pediatric

Parenteral: IV administration only; use administration sets/tubing provided by manufacturer (if provided). Administer through a separate line, do not mix with drugs or other IV fluids.

Intermittent IV: Rate of administration should be determined by patient tolerability (maximum rates vary by product).

Hemofil M, Koate: 10 mL/minute.

Monoclate-P: 2 mL/minute.

WFH recommendations (Ref): Infuse at a rate determined by age: Young children: 100 units/minute; Adults: 3 mL/minute.

Continuous IV infusion: Further dilution after initial reconstitution is unnecessary (Ref).

Use: Labeled Indications

Hemophilia A: Control and prevention of bleeding episodes in patients with hemophilia A (classic hemophilia); perioperative management of hemophilia A.

Limitations of use: Not indicated for the treatment of von Willebrand disease.

Medication Safety Issues

Sound-alike/look-alike issues:

Factor VIII may be confused with Factor XIII

Other safety concerns:

Confusion may occur due to the omitting of “Factor VIII” from some product labeling. Review product contents carefully prior to dispensing any antihemophilic factor.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Pregnant carriers of hemophilia A may have an increased bleeding risk following invasive procedures, spontaneous miscarriage, termination of pregnancy, and delivery; close surveillance is recommended. Factor VIII levels should be monitored at the first antenatal visit, once or twice during the third trimester, prior to surgical or invasive procedures, and at delivery. Although factor VIII concentrations increase in pregnant patients, factor VIII replacement is recommended if concentrations are <50 units/dL and any of the following occur: need for invasive procedures (including delivery), spontaneous miscarriage, insertion and removal of epidural catheters, or active bleeding. Hemostatic factor VIII concentrations should be maintained for at least 3 to 5 days following invasive procedures or postpartum. If a replacement product is indicated, a recombinant product is preferred (NHF 2017; RCOG [Pavord 2017]; WFH [Srivastava 2020]).

Breastfeeding Considerations

It is not known if antihemophilic factor (human) is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother

Monitoring Parameters

Monitoring assay selection: For plasma-derived factor VIII products, the World Federation of Hemophilia (WFH) recommends use of a one-stage or chromogenic factor VIII activity assay calibrated with a plasma standard traceable to a World health Organization (WHO) international standard. Note: For patients receiving concomitant emicizumab therapy, emicizumab interferes with chromogenic factor VIII assays that use human factor IXa and factor X; use of chromogenic assays with bovine factor IXa and X is required to obtain reliable factor VIII activity when emicizumab is present (WFH [Srivastava 2020]).

Monitoring frequency: During treatment of an acute bleeding event or in the perioperative setting using intermittent bolus administration, factor VIII levels should be measured at baseline, and as peaks 15 to 30 minutes after infusion to assess target level achievement. Measurement of FVIII trough levels may aid in calculation of subsequent doses. Subsequent doses should ideally be based on the FVIII half-life and on the factor recovery of the individual patients. The frequency of peak factor VIII activity monitoring during active treatment depends on the indication, clinical response, and treatment day (WFH [Srivastava 2020]).

When administered as a continuous infusion, monitor factor VIII activity at baseline, peak factor VIII activity 15 to 30 minutes after initial bolus administration, and at least daily while on continuous infusion therapy. Frequently assess proper functioning of vascular access devices and infusion pumps for pump failure (WFH [Srivastava 2020]).

For long-term bleeding prophylaxis, trough factor VIII measurements should be obtained to tailor prophylaxis regimens, with the goal of achieving factor VIII troughs >3 to 5 units/dL; prophylaxis targets should be tailored to individual level of activity, lifestyle, and pharmacokinetics. Patients with low-titer inhibitors receiving factor VIII concentrate products should undergo frequent assessment of factor VIII levels and inhibitor titers to ensure response is maintained.

Additional monitoring considerations: Heart rate and BP before and during IV administration, signs of hypersensitivity reactions, hemoglobin/hematocrit, and signs and symptoms of intravascular hemolysis.

For both intermittent bolus and continuous infusion administration, lower than expected factor VIII recovery or reduced half-life are early signs of inhibitor formation.

Reference Range

Classification of hemophilia; normal is defined as 100% factor VIII (WFH [Srivastava 2020]).

Severe: Factor level <1% of normal.

Moderate: Factor level 1% to 5% of normal.

Mild: Factor level 5% to <40% of normal.

Mechanism of Action

Protein (factor VIII) in normal plasma which is necessary for clot formation and maintenance of hemostasis; activates factor X in conjunction with activated factor IX; activated factor X converts prothrombin to thrombin, which converts fibrinogen to fibrin, and with factor XIII forms a stable clot

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Does not readily cross the placenta

Half-life elimination: Mean: 14.8 to 17.5 hours

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Factor viii | Koate dvi;
(AR) Argentina: Beriate p | Emoclot | Fanhdi | Hemofil m | Koate dvi | Octanate | Optivate;
(AT) Austria: Beriate p | Haemoctin sdh | Octanate;
(BE) Belgium: Factane | Monoclate P;
(BG) Bulgaria: Beriate | Emoclot DI | Hemofil m | Koate | Octanate;
(BR) Brazil: Beriate p | Fanhdi | Hemofil | Koate dvi;
(CH) Switzerland: Beriate | Haemoctin | Octanate;
(CL) Chile: Koate dvi | Octanate;
(CN) China: Hemoraas | Kang si ping;
(CO) Colombia: Beriate | Emoclot | Factane | Fanhdi | Haemoctin sdh | Hemofil m | Koate | Koate dvi | Koate HP | Koate mr dvi | Octanate | Optivate;
(CZ) Czech Republic: Beriate | Beriate p | Criostat | Fanhdi | Haemoctin sdh | Octanate;
(DE) Germany: Beriate | Beriate p | Fanhdi | Haemoctin sdh | Hemofil m | Monoclate P | Octanate | Optivate | Profilate;
(EC) Ecuador: Emoclot | Fanhdi | Octanate;
(EE) Estonia: Beriate | Hemofil m | Octanate | Octonativ-M;
(EG) Egypt: Koate dvi | Octanate;
(ES) Spain: Beriate p | Fanhdi | Haemoctin | Hemofil m | Octanate;
(FI) Finland: Amofil | Octafil | Octafil low;
(FR) France: Factane | Hemofil m | Monoclate | Octanate LV;
(GB) United Kingdom: Beriate p | Fanhdi | Haemoctin | Hemofil m | Monoclate P | Octanate | Optivate | Profilate;
(GR) Greece: Fanhdi | Haemoctin | Octanate;
(HK) Hong Kong: Haemoctin sdh | Koate | Koate dvi;
(HU) Hungary: Beriate | Beriate hs | Beriate p | Fanhdi | Haemoctin sdh | Hemofil m | Koate dvi | Octanate | Octonativ-M;
(ID) Indonesia: Aafact | Beriate | Haemoctin | Koate dvi | Koate HP | Koate HT | Octanate;
(IN) India: Beriate | Hemorel a;
(IT) Italy: Beriate p | Emoclot d.i. | Fanhdi | Haemoctin | Hemofil m | Koate | Octanate;
(JP) Japan: Koate | Profilate;
(KR) Korea, Republic of: Monoclate P;
(KW) Kuwait: Beriate;
(LB) Lebanon: Beriate;
(LT) Lithuania: Haemoctin sdh | Hemofil m | Koate HP | Octanate;
(LU) Luxembourg: Octanate;
(LV) Latvia: Cilveka koagulacijas faktora VIII | Haemoctin sdh | Hemofil m | Kaote dvi | Koate dvi | Octanate;
(MX) Mexico: Beriate | Beriate p | Fanhdi | Haemoctin sdh | Hemofil m | Koate dvi | Monoclate P | Octanate | Optivate | Plasmaclot;
(MY) Malaysia: Beriate | Factor viii | Hemofil m | Octanate | Optivate;
(NL) Netherlands: Aafact | Octanate;
(NO) Norway: Octanate;
(PE) Peru: Factor viii | Octanate | Optivate;
(PH) Philippines: Hemofil m | Koate | Octanate;
(PL) Poland: Beriate | Emoclot | Fanhdi | Octanate;
(PR) Puerto Rico: Hemofil m | Koate dvi | Koate HP;
(PT) Portugal: Beriate p | Emoclot | Factor viii | Fanhdi | Hemofil m | Monoclate P | Octanate;
(PY) Paraguay: Factor viii green cross | Koate dvi;
(RO) Romania: Fanhdi | Haemoctin sdh | Octanate | Optivate;
(RU) Russian Federation: Agemfil a | Beriate | Emoclot | Emoclot d.i. | Fanhdi | Haemoctin | Hemofil m | Koate dvi | Octanate;
(SA) Saudi Arabia: Factor viii | Koate dvi | Octanate | Optivate;
(SE) Sweden: Ahf-Koncentrat | Beriate | Beriate p | Hemofil m | Koate | Monoclate P | Octanate | Octonativ-M | Profilate;
(SG) Singapore: Octanate;
(SI) Slovenia: Octanate;
(SK) Slovakia: Fanhdi;
(TH) Thailand: Fanhdi | Haemoctin sdh | Hemofil m | Profilate;
(TN) Tunisia: Beriate | Emoclot DI | Haemoctin sdh | Octanate;
(TR) Turkey: AHF M | Beriate p | Emoclot | Factane | Factor viii | Fanhdi | Haemoctin sdh | Hemofil m | Koate dvi | Koate HP | Nordiate | Octanate;
(TW) Taiwan: Beriate p | Factor viii | Haemoctin sdh | Koate dvi | Koate HP | Monoclate P;
(UA) Ukraine: Beriate | Emoclot | Koate dvi | Octanate;
(UY) Uruguay: Emoclot | Haemoctin sdh | Hemofil m | Koate dvi | Koate HP;
(VE) Venezuela, Bolivarian Republic of: Factor viii

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Factor VIII, human plasma-derived: Drug information