ADVATE 250 IU Injection/Powder for

What is ADVATE 250 IU

ADVATE 250 IU is a recombinant form of coagulation factor VIII, used for the treatment and prevention of bleeding episodes in individuals with Hemophilia A (congenital factor VIII deficiency). This product is not indicated for the treatment of von Willebrand disease.

• Generic Name: Octocog alfa (Recombinant human coagulation factor VIII)
• Form: Injection/Powder for reconstitution
• Packaging: 1 Vial (Powder) + 1 Solvent Vial (5ml) + Kit (2 Alcohol Swabs + 2 Dermaplasts + 1 Syringe + 1 Butterfly Infusion Set)
• Indication: Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis in patients with Hemophilia A

ADVATE is produced by recombinant DNA technology, eliminating the risk of contamination with human blood-borne viruses. It is identical in structure to naturally occurring factor VIII but is free of human or animal-derived proteins.

How to use ADVATE 250 IU

ADVATE should be used strictly under the guidance and supervision of a healthcare professional experienced in treating hemophilia.

• Preparation:
  • Wash hands thoroughly.
  • Use aseptic technique throughout preparation and administration.
  • Reconstitute the powder with the provided 5ml solvent vial using the transfer device.
  • Gently swirl (do not shake) the vial until the powder is completely dissolved (clear solution).
• Administration:
  • Inspect the solution for particulates or discoloration—do not use if cloudy or contains particles.
  • Withdraw the solution into the provided syringe.
  • Inject intravenously using the included butterfly infusion set, typically over 5 minutes or as directed by the physician.
• Frequency: Dosage and frequency depend on the patient’s weight, severity of factor VIII deficiency, and clinical situation (e.g., acute bleeding vs. prophylaxis).

Dispose of all used materials safely. Never reuse needles or syringes. Always keep a log of doses used and any reactions.

Mode of Action ADVATE 250 IU

ADVATE (Octocog alfa) works by replacing the missing or deficient clotting factor VIII in patients with Hemophilia A.

• Mechanism:
  • Factor VIII plays a central role in the intrinsic pathway of the coagulation cascade.
  • In normal physiology, when vascular injury occurs, factor VIII is activated (VIIIa) and serves as a cofactor for factor IXa to convert factor X to Xa, a key step in the generation of thrombin and the formation of a stable fibrin clot.
  • In Hemophilia A patients, this process is impaired, resulting in prolonged bleeding.
• Effect of ADVATE:
  • By supplying recombinant factor VIII, ADVATE temporarily restores hemostasis, enabling clot formation and preventing or controlling bleeding.
  • It mimics the physiological activity of endogenous factor VIII, allowing proper blood coagulation.

Since ADVATE is recombinant, it eliminates risks associated with plasma-derived products, such as potential transmission of human pathogens.

ADVATE 250 IU Interactions ADVATE 250 IU

Although ADVATE is generally well-tolerated, caution must be exercised when it is administered with certain medications or in specific clinical settings.

• No known drug interactions: ADVATE has no established pharmacokinetic or pharmacodynamic interactions with commonly used drugs. However, since no specific interaction studies have been conducted, potential interactions cannot be ruled out entirely.
• Antibody interference:
  • Development of neutralizing antibodies (inhibitors) to factor VIII is a known immunological reaction that can reduce the efficacy of the product.
  • Patients with inhibitors may require bypassing agents such as activated prothrombin complex concentrates (aPCC) or recombinant factor VIIa, which are not used concurrently with ADVATE.
• Concurrent use in surgeries:
  • In perioperative management, the use of antifibrinolytics like tranexamic acid or aminocaproic acid may be considered to improve hemostasis but should be monitored by the physician.

Always inform your healthcare provider of any other medicines, supplements, or herbal products being used before starting ADVATE therapy.

Dosage of ADVATE 250 IU

ADVATE dosage must be individualized according to the severity of the factor VIII deficiency, location and extent of bleeding, and the patient’s clinical condition.

• Formula-based Dosage Calculation:

  Estimated required dose (IU) = Body Weight (kg) × Desired Factor VIII Rise (% or IU/dL) × 0.5

• On-demand treatment:
  • Mild bleeding: 20–40 IU/kg
  • Moderate bleeding: 30–60 IU/kg
  • Severe bleeding or surgery: 60–100 IU/kg
• Prophylactic treatment:
  • 20–40 IU/kg every other day or 3 times per week to prevent bleeding episodes
• Monitoring:
  • Factor VIII levels should be monitored regularly to adjust dosing appropriately, especially during major bleeding or surgery.
  • Monitor for signs of inhibitor development with regular inhibitor assays (Bethesda test).

Dosing recommendations may vary based on patient response, half-life of the product in individual patients, and clinical judgment.

Possible side effects of ADVATE 250 IU

ADVATE is generally well-tolerated, but like all medications, it may cause side effects in some individuals.

• Common Side Effects:
  • Headache
  • Nausea
  • Fever (pyrexia)
  • Injection site reactions (pain, redness, swelling)
• Less Common but Serious Side Effects:
  • Allergic reactions such as rash, itching, urticaria
  • Anaphylaxis (rare but potentially life-threatening)
  • Development of neutralizing antibodies (inhibitors) to factor VIII
• Immunogenicity:
  • Especially in previously untreated patients (PUPs), there’s a higher risk of developing inhibitors, which can reduce or negate the effect of the drug.

Seek immediate medical attention if symptoms of an allergic reaction (tightness of chest, swelling of lips/tongue, difficulty breathing) occur.

ADVATE 250 IU Contraindications ADVATE 250 IU

ADVATE is contraindicated in patients with specific conditions or known sensitivities. It should be avoided in the following scenarios:

• Hypersensitivity:
  • Known allergy to Octocog alfa or any of the excipients in the formulation
  • History of life-threatening hypersensitivity (e.g., anaphylaxis) to mouse or hamster proteins (used in the manufacturing process)
• Active inhibitors:
  • Patients with high-titer factor VIII inhibitors may not respond adequately to treatment with ADVATE and should be treated with alternative therapies.

Use with caution in patients with known risk factors for thromboembolic events or those undergoing major surgery. Always assess individual risks before initiating therapy.

Storage of ADVATE 250 IU

Proper storage of ADVATE ensures stability, potency, and safety of the product before use.

• Temperature:
  • Store ADVATE in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • May be stored at room temperature (up to 25°C or 77°F) for a single period of up to 6 months; record the start date if removed from the refrigerator.
• Protection:
  • Keep the vials in the original carton to protect from light.
  • Do not freeze. Freezing may damage the product and solvent.
• After reconstitution:
  • Use immediately or within 3 hours if kept at room temperature.
  • Do not refrigerate after reconstitution.

Keep out of reach of children and do not use beyond the expiration date printed on the packaging.