AFSTYLA 3000 IU Powder and Solvent for Solution for Injection

What is AFSTYLA 3000 IU

AFSTYLA 3000 IU is a recombinant coagulation factor VIII product, indicated for the treatment and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency). Its active ingredient is Lonoctocog alfa, a single-chain recombinant factor VIII produced using recombinant DNA technology in a human cell line (HEK 293F) that is modified to express human coagulation factor VIII.

• Form: Powder and solvent for solution for injection
• Kit Contents: 1 vial (powder), 1 vial (2.5 ml Water for Injections), 1 filter transfer device, 1 administration set (including 5 ml syringe, venipuncture set, alcohol swabs, and non-sterile plaster)
• Indication: For routine prophylaxis, on-demand treatment of bleeding episodes, and perioperative management in individuals with hemophilia A
• Type: Recombinant, human coagulation Factor VIII (single-chain)

AFSTYLA is not intended for use in patients with von Willebrand disease or for those with hemophilia B (Factor IX deficiency).

How to use AFSTYLA 3000 IU

AFSTYLA must be reconstituted and administered via intravenous injection. It should be used exactly as prescribed by a healthcare professional experienced in the treatment of hemophilia.

• Reconstitution:
  • Bring both vials (powder and solvent) to room temperature (do not exceed 37°C).
  • Connect the vials using the filter transfer device provided in the kit.
  • Allow the solvent to transfer completely into the powder vial; gently swirl (do not shake) until the powder is fully dissolved.
  • The solution should be clear or slightly opalescent. Do not use if particles or discoloration are present.
• Administration:
  • Draw the solution into the provided disposable syringe.
  • Inject slowly via intravenous route, typically over several minutes.
  • Do not mix with other drugs or infusions.
  • Dispose of all used materials appropriately.
• Frequency: Based on bleeding severity, individual factor VIII levels, and clinical response.

Always follow healthcare provider instructions strictly and never self-administer unless trained.

Mode of Action AFSTYLA 3000 IU

AFSTYLA (Lonoctocog alfa) works by replacing the deficient or inactive Factor VIII in patients with hemophilia A, thereby restoring the coagulation cascade required for proper blood clot formation.

• Mechanism:
  • Once administered intravenously, AFSTYLA enters circulation and functions like endogenous factor VIII.
  • It binds to von Willebrand factor, which stabilizes it and prolongs its half-life.
  • During the coagulation cascade, activated factor VIII (FVIIIa) acts as a cofactor for factor IXa to convert factor X to Xa, leading to fibrin clot formation.
• Structure Advantage:
  • AFSTYLA is a single-chain recombinant FVIII designed to have enhanced binding affinity to von Willebrand factor compared to full-length FVIII.
  • This design improves molecular stability and may provide a prolonged half-life, allowing for less frequent injections in some patients.

By promoting thrombin generation and fibrin clot formation, AFSTYLA reduces bleeding and supports wound healing in hemophilia A patients.

AFSTYLA 3000 IU Interactions AFSTYLA 3000 IU

AFSTYLA has a low potential for drug-drug interactions due to its protein-based nature and targeted mechanism. However, certain considerations should be kept in mind:

• Known Interactions:
  • No significant drug interactions have been identified in clinical trials.
  • AFSTYLA should not be mixed with other intravenous medications in the same infusion line or syringe.
• Immunologic Considerations:
  • Inhibitor development (neutralizing antibodies to factor VIII) may reduce effectiveness and require alternative therapy.
  • Immune response may be influenced by concomitant immunosuppressants or immune-modifying drugs.
• Lab Testing Interference:
  • Use of chromogenic assays based on bovine reagents may underestimate AFSTYLA activity.
  • One-stage clotting assay and human chromogenic assays are appropriate for monitoring.

Always consult a hematologist before combining AFSTYLA with any new medication or when interpreting clotting assay results.

Dosage of AFSTYLA 3000 IU

The dosage of AFSTYLA is individualized based on body weight, clinical condition, and pharmacokinetic response. It is expressed in International Units (IU), where 1 IU corresponds to the activity of 1 unit of human factor VIII.

• On-demand treatment of bleeding episodes:
  • Mild to moderate bleeds: 20–40 IU/kg
  • Major bleeds or life-threatening hemorrhages: 40–60 IU/kg or more
• Prophylaxis:
  • Adults and adolescents: 20–50 IU/kg every 3–4 days
  • Some patients may benefit from twice-weekly or every-other-day dosing
• Perioperative management:
  • Pre-surgery loading doses and post-operative maintenance dosing vary depending on the procedure and bleeding risk.
• Dose adjustments:
  • Regular factor VIII activity monitoring is essential.
  • Adjust dose based on response and target factor VIII levels.

Dosing should be performed under the supervision of a physician experienced in treating hemophilia A.

Possible side effects of AFSTYLA 3000 IU

AFSTYLA is generally well tolerated, but like all biologics, it may cause side effects. Most reactions are mild and manageable.

• Common side effects:
  • Headache
  • Injection site reactions (pain, redness, swelling)
  • Pyrexia (fever)
  • Nausea or abdominal discomfort
• Less common/serious side effects:
  • Hypersensitivity reactions (rash, pruritus, urticaria)
  • Anaphylaxis (rare but potentially life-threatening)
  • Development of neutralizing antibodies (inhibitors) against factor VIII
• Immune response:
  • Especially in previously untreated patients (PUPs), inhibitors may develop and reduce efficacy.

Patients should report any adverse reactions to their healthcare provider promptly and seek immediate medical attention for signs of anaphylaxis (e.g., chest tightness, difficulty breathing, dizziness).

AFSTYLA 3000 IU Contraindications AFSTYLA 3000 IU

AFSTYLA is contraindicated in patients with the following conditions:

• Known hypersensitivity:
  • To Lonoctocog alfa or any of the excipients (e.g., polysorbate 80, mannitol, histidine)
  • To mouse or hamster proteins (residual traces from manufacturing)
• History of severe allergic or anaphylactic reactions:
  • Use of AFSTYLA may cause serious reactions in sensitized individuals
• Use in von Willebrand disease:
  • AFSTYLA is not indicated for von Willebrand disease and may not be effective

Patients with known inhibitor development should undergo appropriate testing and individualized treatment plans.

Storage of AFSTYLA 3000 IU

Proper storage of AFSTYLA is essential to maintain its stability and effectiveness.

• Unopened vials:
  • Store at 2°C–8°C (in a refrigerator)
  • May be stored at room temperature (not above 25°C) for a single period of up to 6 months
  • Do not return to refrigeration after room temperature storage
• Do not freeze:
  • Freezing may damage the vial or affect the efficacy of the product
• After reconstitution:
  • Use immediately or within 4 hours if stored at room temperature
  • Do not refrigerate the reconstituted solution
  • Protect from light and do not use if the solution is cloudy or contains particulates

Always keep AFSTYLA out of reach of children and dispose of expired or unused medication as per local guidelines.