ADVATE 500 IU Injection/Powder for

What is ADVATE 500 IU

What is ADVATE 500 IU?

ADVATE 500 IU is a recombinant coagulation factor VIII used for the treatment and prevention of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency). It does not contain human plasma-derived proteins and is produced using recombinant DNA technology in genetically modified Chinese Hamster Ovary (CHO) cells.

• Generic Name: Octocog alfa
• Form: Powder for solution (lyophilized powder) + solvent vial
• Packaging: 1 vial of powder + 1 vial of 5 ml solvent + administration kit (syringe, butterfly infusion set, alcohol swabs, and dermaplasts)
• Therapeutic Class: Antihemorrhagic Agent, Coagulation Factor
• Indication: Prevention and control of bleeding in hemophilia A; perioperative management; routine prophylaxis to reduce bleeding frequency
• Not indicated for: von Willebrand disease or other coagulation disorders

ADVATE is typically administered intravenously and should be used under the supervision of a healthcare professional experienced in hemophilia management.

How to use ADVATE 500 IU

Administration of ADVATE 500 IU should be carried out with strict aseptic technique and typically under medical supervision, especially for the first dose. It may be self-administered after proper training.

• Preparation:
  • Bring both powder and solvent vials to room temperature before reconstitution.
  • Clean the tops of both vials with an alcohol swab.
  • Reconstitute the powder by transferring the solvent using the provided transfer device or syringe.
  • Gently swirl (do not shake) until the powder is fully dissolved.
• Administration:
  • Inspect the solution; it should be clear and colorless. Do not use if particulate matter is visible.
  • Use the provided syringe and butterfly infusion set for intravenous injection.
  • Infuse over several minutes as directed by a healthcare provider (usually 1–2 ml/min).
• Disposal:
  • Safely dispose of used syringes, needles, and vials in a sharps container.

Always follow your doctor’s instructions regarding dosing schedule and frequency. Missed doses should be managed under medical guidance.

Mode of Action ADVATE 500 IU

Octocog alfa in ADVATE is a recombinant form of human coagulation factor VIII. It functions as a key component in the blood clotting cascade.

• Role of Factor VIII:
  • Acts as a cofactor for factor IXa to activate factor X in the intrinsic coagulation pathway.
  • This leads to the conversion of prothrombin to thrombin and subsequently fibrin clot formation.
• Mechanism in Hemophilia A:
  • Individuals with hemophilia A have deficient or defective endogenous factor VIII.
  • Without adequate factor VIII, clotting is delayed, causing prolonged bleeding episodes.
• Therapeutic Effect:
  • Administration of Octocog alfa temporarily replaces the missing clotting factor.
  • Reduces or prevents spontaneous or trauma-induced bleeding.

Recombinant technology ensures viral safety and consistent quality, making ADVATE a preferred option for long-term prophylaxis and on-demand treatment.

ADVATE 500 IU Interactions ADVATE 500 IU

Though ADVATE has a relatively safe interaction profile, there are important considerations for co-administered drugs and biologicals:

• No known pharmacokinetic interactions: ADVATE is a biological product, and interactions like those with small-molecule drugs are uncommon.
• Inhibitor formation:
  • Patients may develop neutralizing antibodies (inhibitors) to factor VIII.
  • This reduces or nullifies the clinical effect of ADVATE and may necessitate the use of bypassing agents.
• Vaccinations:
  • May be administered concurrently but at a separate site and via a different route (i.e., not IV).
• Concurrent anticoagulants or antiplatelets:
  • Generally not recommended as they may increase bleeding risk in hemophilia patients even when using ADVATE.

Always inform your healthcare provider about any medications, supplements, or therapies being used before starting ADVATE treatment.

Dosage of ADVATE 500 IU

ADVATE dosage is individualized based on the severity of factor VIII deficiency, body weight, and clinical situation (e.g., bleeding control vs. prophylaxis).

• Dosing Formula:
  • IU required = Body Weight (kg) × Desired FVIII Rise (%) × 0.5
• On-demand Treatment:
  • Mild bleeding (e.g., oral or superficial muscle bleed): 10–20 IU/kg
  • Moderate bleeding (e.g., muscle or joint bleed): 20–40 IU/kg
  • Severe bleeding (e.g., CNS or GI bleed): 40–60 IU/kg
• Prophylaxis:
  • Typical regimen: 20–40 IU/kg every other day or 3 times per week
  • Children may require more frequent dosing due to higher clearance rates
• Surgical Prophylaxis:
  • Preoperative loading dose: 30–60 IU/kg
  • Postoperative doses adjusted as per clinical response

Plasma FVIII levels should be monitored to guide ongoing therapy, particularly during surgery or major bleeding episodes.

Possible side effects of ADVATE 500 IU

Most patients tolerate ADVATE well, but like all biologics, it carries the risk of certain adverse effects.

• Common Side Effects:
  • Headache
  • Dizziness
  • Nausea
  • Fever (pyrexia)
  • Injection site reactions (pain, swelling, redness)
• Serious Side Effects:
  • Development of inhibitors (neutralizing antibodies)
  • Allergic or anaphylactic reactions (rare)
  • Chest tightness, rash, hypotension (requires emergency care)
• Long-term concerns:
  • Loss of efficacy if inhibitor formation occurs
  • Psychological burden due to frequent IV infusions in pediatric or adolescent patients

Report any unusual or severe reactions to a healthcare provider immediately. Regular monitoring is advised to assess for inhibitor development, particularly in previously untreated patients (PUPs).

ADVATE 500 IU Contraindications ADVATE 500 IU

ADVATE is generally well tolerated but has specific contraindications:

• Known hypersensitivity:
  • To Octocog alfa or any excipient (e.g., mannitol, trehalose, sodium chloride)
  • Includes allergic reactions to mouse or hamster proteins (as it’s derived from CHO cells)
• Patients with inhibitors:
  • Presence of high-titer inhibitors to factor VIII may render ADVATE ineffective
  • These patients may require alternative agents (e.g., bypassing agents)
• Use in other bleeding disorders:
  • Not to be used in patients with von Willebrand disease or acquired factor deficiencies not related to FVIII

Allergy history and previous exposure reactions should be discussed with a healthcare professional before administration.

Storage of ADVATE 500 IU

Proper storage is essential to maintain the stability and effectiveness of ADVATE.

• Unopened Vials:
  • Store in a refrigerator (2°C to 8°C) until the expiration date
  • Can be kept at room temperature (up to 25°C) for a single period of 6 months
  • Record the date the product is removed from refrigeration if stored at room temperature
• Do Not:
  • Freeze the product
  • Expose to direct sunlight
  • Use beyond the expiry date
• Reconstituted Solution:
  • Should be used immediately within 3 hours of preparation
  • Do not refrigerate or store the solution after reconstitution
• Disposal:
  • Dispose of all used components safely in accordance with local regulations

Always follow the manufacturer’s storage guidelines included in the package insert for optimal results.