Aafact

Aafact is a purified monoclonal factor VIII concentrate used primarily in the management of haemophilia A.

Bottles of factor VIII haemophilia treatment

Origin and Composition

Made from FFP

Aafact is derived from a protein fraction that is prepared from fresh-frozen human plasma.

Therapeutic Indications

Aafact is primarily indicated for:

• Treatment of acute haemorrhages
• Pre-operative and post-operative care
• Prophylaxis in haemophilia A patients, including those with congenital factor VIII deficiency and those with acquired reductions in factor VIII activity.

Contraindications

Aafact is not effective for:

• Patients with congenital factor IX deficiency (haemophilia B)
• Acquired factor IX shortage
• Von Willebrand’s disease, an inherited coagulation disorder

Product Information

Formulation

Aafact is available as a powder intended for intravenous infusion. Each package is supplied with a vial of 5 or 10 ml of water for injections.

Active substance

• The primary component in Aafact is human coagulation factor VIII.
• Upon reconstitution with water, it has a concentration of 100 IU factor VIII per ml.
• Other ingredients include: polyethylene glycol, sodium chloride, albumin, L-histidine, and calcium chloride.

Contents of the pack

• Commercial packages contain a vial of Aafact designed for either 5 ml (500 IU) or 10 ml (1000 IU) of solution.

Storage

• Store the vial containing the powder within its box at 2°C - 8°C. A refrigerator is ideal.
• Before expiration, Aafact can also be stored at room temperature (15°C - 25°C) for up to 2 months.

Dosage

The dosage is variable and is set by the treating physician based on:

• The patient's factor VIII blood level
• The location and extent of bleeding
• Clinical severity
• Body weight

Usual dosage recommendations:

• Prophylaxis: 20 – 40 IU Aafact per kilogram of body weight, 2 – 3 times weekly.
• For active bleeding or surgery: sufficient amount to achieve the desired factor VIII blood level.

Risks and Precautions

Risk of diseases

In the past, the use of plasma byproducts, such as Aafact, raised concerns about the potential transmission of diseases like HIV and hepatitis. This risk was substantially diminished as purification techniques advanced.

Recombinant technology

By the early 1990s, several recombinant synthesized factor products emerged, which virtually eliminated disease transmission concerns during replacement therapy.

Side effects

• Potential development of antibodies (inhibitors) against factor VIII in haemophilia A patients
• Rare cases of sensitivity or allergic reactions, including life-threatening anaphylaxis
• Potential for shock in severe allergic reactions

Contra-indications

Aafact should not be used in patients allergic to its active ingredient or any of its excipients.

Cautions and warnings

• Consult a physician if bleeding does not stop as anticipated with Aafact treatment.
• The reconstituted product should be clear and free of particles or clumps. If turbidity or particles are observed, do not administer.

Manufacturer

Aafact is manufactured by Sanquin Plasma Products B.V. located at Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands.

See Also

• Damoctocog alfa pegol - recombinant antihemophilic factor VIII
• Efmoroctocog alfa - recombinant antihemophilic factor VIII
• Moroctocog alfa - recombinant antihemophilic factor VIII
• Susoctocog alfa - recombinant antihemophilic factor VIII
• Turoctocog alfa - recombinant antihemophilic factor VIII
• factor VIII - the primary active ingredient in Aafact

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