AFSTYLA 250 IU Powder and Solvent for Solution for Injection

What is AFSTYLA 250 IU

AFSTYLA 250 IU is a recombinant antihemophilic factor (recombinant DNA origin), specifically a single-chain version of Factor VIII known as Lonoctocog alfa. It is used in the management of bleeding episodes and for prophylaxis in patients with Hemophilia A (congenital Factor VIII deficiency).

• Formulation: AFSTYLA is supplied as a powder and solvent for solution for injection. The kit includes:
  • 1 glass vial of powder (250 IU)
  • 1 glass vial of 2.5 mL Water for Injections (WFI)
  • 1 filter transfer device 20/20
  • 1 administration set (disposable 5 mL syringe, venipuncture set, alcohol swabs, and plaster)
• Indication: It is indicated for use in both adults and children with Hemophilia A for:
  • Treatment of bleeding episodes
  • Routine prophylaxis to reduce the frequency of bleeding
  • Perioperative management (surgical prophylaxis)
• Not suitable for treatment of von Willebrand disease.

How to use AFSTYLA 250 IU

AFSTYLA should be used exactly as prescribed by a healthcare provider experienced in treating Hemophilia A. Proper training in reconstitution and administration technique is essential for patients or caregivers managing the treatment at home.

• Reconstitution Instructions:
  • Warm both vials (powder and solvent) to room temperature before use.
  • Use the filter transfer device to mix the solvent with the powder.
  • Gently swirl until fully dissolved—do not shake.
  • Inspect the solution—it should be clear or slightly pearly; do not use if particles or discoloration are present.
• Administration:
  • Use the provided administration set.
  • Inject intravenously over several minutes as directed by the healthcare provider.
  • Discard any unused solution appropriately.
• Frequency of use: Depends on the condition being treated and physician’s assessment (e.g., on-demand treatment vs. prophylaxis).
• Do not mix with other medications in the same infusion line or syringe.

Mode of Action AFSTYLA 250 IU

AFSTYLA (Lonoctocog alfa) is a genetically engineered single-chain recombinant Factor VIII product designed to mimic the function of endogenous Factor VIII in the coagulation cascade.

• Mechanism: Once administered, AFSTYLA is activated by thrombin, transforming it into its active form (Factor VIIIa), which then:
  • Acts as a cofactor for Factor IXa
  • Accelerates the conversion of Factor X to Factor Xa
  • Leads to the generation of thrombin and formation of a stable fibrin clot
• Extended half-life: The single-chain design binds tightly to von Willebrand factor (vWF), increasing stability and half-life in circulation.
• Goal: To temporarily replace the missing or deficient Factor VIII in Hemophilia A patients, thereby restoring normal clotting function.

AFSTYLA 250 IU Interactions AFSTYLA 250 IU

While AFSTYLA has a targeted mechanism and low systemic interaction potential, certain considerations must still be taken into account to ensure safe use.

• Drug Interactions:
  • No formal drug interaction studies have been conducted with AFSTYLA.
  • It is a biologic agent, and interaction with traditional small-molecule drugs is unlikely.
• Inhibitors:
  • Development of neutralizing antibodies (inhibitors) to Factor VIII is a known complication in Hemophilia A treatment.
  • Such inhibitors reduce the effectiveness of AFSTYLA and may require specialized treatment options (e.g., bypassing agents).
• Live vaccines: Caution is advised when co-administering with live vaccines. Avoid injection at the same site.
• Laboratory tests: AFSTYLA may interfere with certain coagulation assays; ensure the laboratory is aware of its use.

Dosage of AFSTYLA 250 IU

The dosage of AFSTYLA is individualized based on body weight, severity of Factor VIII deficiency, clinical condition, and desired Factor VIII activity level.

• General Formula:

  1 IU/kg body weight raises Factor VIII plasma level by approximately 2 IU/dL.

• On-demand bleeding episodes:
  • Mild bleeding: 20–30 IU/kg
  • Moderate to severe bleeding: 30–50 IU/kg
  • Life-threatening bleeding: 60–80 IU/kg
• Prophylaxis (routine prevention):
  • Adults and adolescents (≥12 years): 20–50 IU/kg two to three times weekly
  • Children (<12 years): Higher or more frequent doses may be needed
• Surgical prophylaxis:
  • Pre-operative and post-operative levels maintained per clinical guidelines
  • Repeat dosing may be required based on half-life and surgical stress
• Monitoring: Regular monitoring of Factor VIII activity is recommended to tailor and adjust dosage.

Possible side effects of AFSTYLA 250 IU

As with all protein-based biologics, AFSTYLA may cause adverse reactions. While generally well tolerated, it’s important to monitor for both common and serious side effects.

• Common side effects:
  • Headache
  • Fever (pyrexia)
  • Injection site reactions (pain, redness)
  • Nausea or dizziness
• Serious side effects:
  • Development of Factor VIII inhibitors (antibodies)
  • Allergic reactions including rash, urticaria, or anaphylaxis (rare)
  • Thromboembolic events (very rare, mostly in patients with other risk factors)
• Immediate medical attention should be sought if symptoms of hypersensitivity appear such as:
  • Swelling of face/lips/throat
  • Chest tightness
  • Difficulty breathing

AFSTYLA 250 IU Contraindications AFSTYLA 250 IU

AFSTYLA is generally safe when used as prescribed, but there are specific contraindications where it must not be administered.

• Known hypersensitivity:
  • To Lonoctocog alfa or any component of the formulation
  • Includes known hypersensitivity to hamster proteins (as it is produced in CHO cells)
• History of anaphylaxis to Factor VIII products should be a red flag unless otherwise cleared by a specialist.
• Active inhibitor presence:
  • Patients with high-titer inhibitors may not respond to treatment with AFSTYLA
  • These cases require alternate therapies such as bypassing agents

Storage of AFSTYLA 250 IU

Proper storage ensures stability and efficacy of the product. Always follow packaging and pharmacist instructions.

• Temperature:
  • Store in a refrigerator at 2°C–8°C (36°F–46°F)
  • May be kept at room temperature (≤25°C) for up to 3 months; do not return to fridge after this
• Do not freeze—freezing can damage the product.
• Keep in original packaging to protect from light.
• After reconstitution:
  • Use immediately
  • If not used immediately, the solution may be stored at room temperature and must be used within 4 hours
• Do not use after the expiration date printed on the label.