ADVATE 1000 IU Injection/Powder for

What is ADVATE 1000 IU

ADVATE 1000 IU is a recombinant coagulation factor VIII (generic name: Octocog alfa), used for the prevention and treatment of bleeding episodes in patients with Hemophilia A — a congenital deficiency or absence of clotting factor VIII. This condition impairs the blood's ability to clot properly, leading to spontaneous or trauma-induced bleeding, especially into joints and muscles.

• ADVATE is a purified, full-length recombinant factor VIII produced without the use of human or animal plasma-derived proteins.
• It is indicated for use in both children and adults for:
  • On-demand treatment of bleeding episodes
  • Routine prophylaxis to reduce the frequency of bleeding
  • Surgical bleeding management (perioperative use)
• This product is provided in a lyophilized powder form that must be reconstituted with a provided 5ml sterile solvent before intravenous administration.
• Each kit includes:
  • 1 vial of ADVATE powder (1000 IU)
  • 1 solvent vial (5ml of sterile water for injection)
  • Administration kit (1 syringe, 1 butterfly infusion set, 2 alcohol swabs, 2 dermaplasts)
• It is suitable for home infusion by trained patients or caregivers under medical guidance.

ADVATE helps restore factor VIII levels temporarily to prevent or control bleeding episodes. It is a key treatment in maintaining long-term joint and muscle health in patients with moderate to severe Hemophilia A.

How to use ADVATE 1000 IU

ADVATE 1000 IU is administered intravenously after reconstitution. Usage should be under the supervision of a healthcare professional or a trained patient/caregiver familiar with infusion techniques. Here’s a step-by-step guide on its usage:

1. Preparation

• Ensure the product is at room temperature (15–25°C) before preparation.
• Gather all components: powder vial, solvent vial, syringe, butterfly infusion set, and alcohol swabs.
• Wash hands thoroughly before handling.

2. Reconstitution

• Attach the vial adapter to the powder vial (do not remove the needleless cap yet).
• Connect the prefilled solvent syringe to the adapter.
• Inject the entire 5ml of solvent into the powder vial.
• Gently swirl the vial until the powder is fully dissolved. Do not shake as it may denature the protein.

3. Administration

• Draw the reconstituted solution into the provided syringe.
• Inspect the solution—it should be clear and colorless. Do not use if cloudy or contains particles.
• Attach the butterfly needle set and infuse slowly via intravenous injection over several minutes (usually 1–2 ml/min).

4. Post-Infusion Care

• Dispose of all used materials in a sharps container.
• Document the batch number and dose for tracking and reporting.

Always follow your healthcare provider's instructions for proper dosing and frequency of use based on your individual treatment plan.

Mode of Action ADVATE 1000 IU

ADVATE (Octocog alfa) is a recombinant factor VIII that mimics the naturally occurring clotting factor VIII. Its primary role is to participate in the blood coagulation cascade, which is crucial for the formation of a stable fibrin clot at the site of vascular injury.

• Binding with von Willebrand Factor (vWF): After administration, ADVATE binds to endogenous vWF in circulation, stabilizing it and preventing premature degradation.
• Activation of Factor X: Factor VIII acts as a cofactor for activated factor IX (IXa) in the presence of calcium and phospholipids. This complex accelerates the conversion of factor X to factor Xa.
• Thrombin Generation: Activated factor Xa converts prothrombin to thrombin, which then catalyzes the transformation of fibrinogen into fibrin. This process results in the formation of a stable blood clot.
• Temporary Effect: Since ADVATE does not remain in the system indefinitely, its effects are transient, requiring regular infusions for prophylaxis or on-demand management.

Therapeutic Benefits

• Bleeding Prevention: By maintaining therapeutic levels of factor VIII, ADVATE reduces the frequency and severity of spontaneous bleeds.
• Joint Preservation: Reducing bleeding into joints helps prevent long-term joint damage and arthropathy in hemophilia patients.
• Surgical Support: Provides necessary hemostatic support during and after surgical interventions.

ADVATE is particularly advantageous due to its high purity, viral safety (no plasma origin), and predictable pharmacokinetics, making it a reliable option for both acute and long-term management of Hemophilia A.

ADVATE 1000 IU Interactions ADVATE 1000 IU

ADVATE (Octocog alfa) is a highly specific biologic agent that primarily interacts within the coagulation cascade, and it does not exhibit traditional drug-drug interactions like small molecule medications. However, certain factors may affect its efficacy, safety, or monitoring requirements.

1. Drug Interactions

• No known pharmacokinetic interactions: Since ADVATE is a protein-based biologic, it is not metabolized by the liver enzymes (e.g., CYP450). Therefore, it does not interact with common drugs metabolized through those pathways.
• Immunosuppressants or corticosteroids: May affect the immune response to ADVATE or alter bleeding tendency. Use with caution and under specialist supervision.
• Antifibrinolytics (e.g., tranexamic acid): May be used concomitantly during surgeries to enhance hemostasis but require dose adjustments.

2. Clinical Interactions and Concerns

• Development of inhibitors: Some patients may develop neutralizing antibodies (inhibitors) against factor VIII, rendering ADVATE less effective or ineffective. This is the most significant clinical “interaction” and requires special laboratory monitoring.
• Cross-reactions with other factor VIII products: Some patients who develop inhibitors may react differently to plasma-derived vs. recombinant factor VIII products.
• Vaccination: As with any biologic therapy, schedule live vaccines at appropriate intervals to avoid any theoretical risk of immune system interference.

3. Monitoring Recommendations

• Measure factor VIII activity levels during treatment, especially in surgical or acute bleeding settings.
• Perform regular screening for inhibitor development (especially in children and previously untreated patients).

Always inform healthcare professionals about all treatments you are using, including prescription, OTC medications, and supplements. While drug interactions with ADVATE are rare, close clinical monitoring is essential for safe and effective use.

Dosage of ADVATE 1000 IU

The dosage of ADVATE 1000 IU depends on the severity of factor VIII deficiency, the location and severity of bleeding, patient weight, and individual pharmacokinetics. Dosage is always expressed in International Units (IU), where 1 IU of factor VIII activity corresponds to the quantity in 1 ml of normal human plasma.

1. General Dosing Formula

To calculate the required dose (IU):
Dose (IU) = body weight (kg) × desired factor VIII rise (%) × 0.5

2. Indications & Suggested Doses

• On-demand treatment:
  • Mild bleeding (e.g., early hemarthrosis): 20–40 IU/kg
  • Moderate bleeding (e.g., muscle hematomas): 30–60 IU/kg
  • Severe bleeding (e.g., CNS bleed): 60–100 IU/kg
• Surgical prophylaxis:
  • Minor surgery: 30–60 IU/kg pre-op and every 24h post-op for 1–3 days
  • Major surgery: 80–100 IU/kg pre-op followed by maintenance dose of 40–80 IU/kg daily for 7–14 days
• Routine prophylaxis:
  • Adults & adolescents (≥12 years): 20–40 IU/kg every other day or 3×/week
  • Children (<12 years): 25–50 IU/kg every other day

3. Special Populations

• Pediatrics: May require higher and more frequent dosing due to faster metabolism.
• Renal/Hepatic impairment: No direct dose adjustment required, but careful monitoring is needed.

Doses must be individualized, especially for patients with inhibitors or suboptimal responses. Factor VIII levels should be monitored during therapy to ensure efficacy and safety.

Possible side effects of ADVATE 1000 IU

ADVATE 1000 IU is generally well-tolerated. However, like all protein-based therapies, it may cause certain adverse effects ranging from mild to severe. Awareness and early detection are key to managing these reactions effectively.

1. Common Side Effects (mild to moderate)

• Headache
• Fever (pyrexia)
• Nausea
• Fatigue
• Dizziness
• Injection site reactions (e.g., redness, swelling, pain)

2. Serious Adverse Effects

• Inhibitor development: The formation of neutralizing antibodies against factor VIII is the most serious complication. These inhibitors reduce the efficacy of ADVATE and make bleeding episodes harder to control.
• Allergic reactions: Including rash, pruritus, or urticaria.
• Anaphylaxis: Rare but potentially life-threatening hypersensitivity reaction presenting with difficulty breathing, low blood pressure, or swelling of the face and throat.
• Thromboembolic events: Although rare, high or repeated doses can theoretically increase the risk of clot formation, especially in patients with other risk factors.

3. Monitoring

• Routine screening for inhibitors is essential, especially in the first 50 exposure days.
• Document and report any unexpected bleeding or reduced treatment response.

If any adverse effects occur, particularly allergic reactions or lack of efficacy, seek immediate medical attention. Always discuss the risks and benefits with your healthcare provider before and during treatment.

ADVATE 1000 IU Contraindications ADVATE 1000 IU

ADVATE is generally safe and well-indicated for Hemophilia A treatment, but it has a few important contraindications where it should not be used, or where extreme caution is necessary.

Absolute Contraindications

• Known hypersensitivity: To Octocog alfa, any excipients (e.g., polysorbate 80), or trace hamster proteins used in its manufacturing process.
• History of anaphylactic reaction: Following previous use of ADVATE or any factor VIII product.

Relative Contraindications / Use with Caution

• Patients with active inhibitors: ADVATE may be ineffective in patients who have developed neutralizing antibodies against factor VIII. Specialized bypassing agents may be needed in these cases.
• Pregnancy and lactation: Use only if clearly needed and under specialist supervision. Data in pregnant women is limited.
• Children under 1 year: Limited clinical trial data is available; careful monitoring is required.

Patients should be screened for factor VIII inhibitors before initiating or continuing therapy. Regular evaluations by a hematologist are crucial to ensure appropriate and safe use.

Storage of ADVATE 1000 IU

Proper storage of ADVATE is essential to preserve its stability, sterility, and potency. As a biologic product, it is sensitive to temperature and environmental changes.

Storage Guidelines

• Store ADVATE at 2°C to 8°C (refrigerator temperature).
• Do not freeze. Freezing may damage the lyophilized powder and break the solvent vial.
• ADVATE may be stored at room temperature (up to 25°C) for up to 6 months. Once brought to room temperature, do not return to the refrigerator.
• Record the date when removed from refrigeration if stored at room temperature.

After Reconstitution

• Use the reconstituted solution immediately or within 3 hours if kept at room temperature.
• Do not refrigerate or freeze the solution once reconstituted.
• Discard any unused solution safely according to medical waste guidelines.

Packaging Integrity

• Check that the vial seal is intact and not damaged before use.
• Inspect the solution visually before administration. Do not use if the solution is cloudy or contains particulates.

Always keep ADVATE out of reach of children and follow the storage instructions provided in the packaging and by your healthcare provider.