Factor VIII: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: January 23, 2026🚩 Report this page

Factor VIII

Blood Coagulation Factors

GB MHRA

Drug class: Blood Coagulation Factors
Availability: See label
Markets covered: 1
Products on record: 3

Overview

Factor VIII is an active pharmaceutical ingredient in the Blood Coagulation Factors group (B02BD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	January 23, 2026

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised January 23, 2026[1]

Fanhdi® is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Despite the von Willebrand factor content and functionality of this product there are no data from clinical trials supporting use in von Willebrand disease.
This product may be used in the management of acquired factor VIII deficiency.

How to take

Sources & citations

[1]MHRA (UK) · PL129300002 · revised January 23, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. Posology The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient’s clinical condition.
On demand treatment The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. 4% of normal activity. 5 The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
The following table can be used to guide dosing in bleeding episodes and surgery:
Degree of haemorrhage/ Type of surgical procedure Factor VIII level required (%) (IU/dl) Frequency of doses (hours)/ Duration of therapy (days) Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding 20 - 40 Repeat every 12 to 24 hours.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding or haematoma 30 - 60 Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages 60 - 100 Repeat infusion every 8 to 24 hours until threat is resolved. Surgery Minor including tooth extraction 30 - 60 Every 24 hours, at least 1 day, until healing is achieved. Major 80 - 100 (pre-and postoperative) Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Prophylaxis For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Continuous infusion During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives. Paediatric population There are insufficient data from clinical trials to recommend the use of Fanhdi® in children less than 6 years of age.
As the posology is adjusted to the clinical outcome of the above mentioned conditions, the posology in children, by body weight, is not considered to be different to that of adults. 6. The product should be administered via the intravenous route.
Fanhdi® should be administered at a rate of no more than 10 ml/min.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised January 23, 2026[1]

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to severe anaphylaxis (including shock).
On rare occasions, fever has been observed. The adverse drug reactions reported are summarised and categorised according to the MedDRA system organ class in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing of seriousness.
) System Organ Class Body System Preferred Term ADR frequency evaluation Blood and lymphatic system disorders FVIII inhibitors Uncommon (PTPs)* Very common (PUPs)* General disorders and administration site conditions Pyrexia Rare * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A.
1). If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk.

GBOfficial regulatory label· Warnings and precautions· revised January 23, 2026[1]

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor VIII. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. In case of shock, the current medical standards for shock-treatment should be observed. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19. g. haemolytic anaemia). Inhibitors The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A.
These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days.
Rarely, inhibitors may develop after the first 100 exposure days. Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch. The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations