ADYNOVATE 500 IU Lyophilized Powder for solution

What is ADYNOVATE 500 IU

ADYNOVATE 500 IU is a recombinant coagulation factor product specifically designed for the management of Hemophilia A, a genetic bleeding disorder caused by a deficiency or dysfunction of clotting factor VIII (FVIII). This medication provides an exogenous source of factor VIII to help restore normal blood clotting and prevent or control bleeding episodes.

• Formulation: Lyophilized powder for solution, provided in a 5 ml glass vial.
• Contents: Each package includes one vial of lyophilized antihemophilic factor (Recombinant), one vial of solvent (5 ml), and a BAXJECT II Hi-Flow Needleless Transfer Device to facilitate reconstitution.
• Active Ingredient: PEGylated recombinant human factor VIII, engineered to increase the molecule’s half-life in circulation.
• Indications: Used for on-demand treatment of bleeding episodes, routine prophylaxis to reduce bleeding frequency, and perioperative management in patients with hemophilia A.
• PEGylation: This chemical modification enhances stability and prolongs the time factor VIII remains active in the bloodstream, thereby reducing injection frequency compared to non-PEGylated factor VIII products.
• Patient Suitability: Appropriate for both pediatric and adult patients diagnosed with hemophilia A, including those with a history of inhibitor development under close clinical supervision.

Overall, ADYNOVATE 500 IU represents an advanced therapeutic option to improve quality of life and clinical outcomes for individuals living with hemophilia A.

How to use ADYNOVATE 500 IU

Correct preparation and administration of ADYNOVATE 500 IU are critical to achieving optimal therapeutic results while minimizing risks.

• Reconstitution Steps:
  • Use aseptic technique and the included BAXJECT II Hi-Flow Needleless Transfer Device to add the 5 ml sterile solvent to the vial containing the lyophilized powder.
  • Gently swirl the vial to dissolve the powder fully. Do not shake vigorously to avoid protein damage.
  • Inspect the reconstituted solution for clarity and absence of particulate matter before use.
• Administration:
  • Administer intravenously via a suitable vein, using sterile technique and appropriate equipment.
  • Infuse at a controlled rate, generally up to 10 ml per minute, adjusting as tolerated by the patient.
  • Ensure all components are sterile and discard any unused reconstituted product if not used within recommended timeframes (usually 3 hours at room temperature).
• Dosage Scheduling:
  • Dosing intervals and amounts depend on clinical context: prophylactic use, treatment of bleeding episodes, or surgical coverage.
  • Due to PEGylation, dosing frequency can be less than standard factor VIII therapies, typically every 3 to 5 days for prophylaxis.
• Training & Monitoring:
  • Patients or caregivers should receive proper training on preparation and intravenous administration.
  • Monitor clinical response and factor VIII activity levels as advised by healthcare professionals.

Always follow healthcare provider instructions carefully and report any difficulties or adverse reactions promptly.

Mode of Action ADYNOVATE 500 IU

ADYNOVATE 500 IU works by replacing deficient or defective factor VIII in patients with hemophilia A, restoring the normal coagulation cascade to enable effective blood clotting.

• Role of Factor VIII: It acts as a crucial cofactor for activated factor IX (IXa) in the intrinsic coagulation pathway, facilitating the activation of factor X, which leads to thrombin generation and fibrin clot formation.
• Recombinant Protein: ADYNOVATE provides a laboratory-produced factor VIII identical in function to naturally occurring human factor VIII.
• PEGylation Benefits: The addition of polyethylene glycol (PEG) extends the molecule's half-life by protecting it from enzymatic degradation and clearance, thereby maintaining hemostatic activity longer than unmodified factor VIII.
• Hemostatic Effect: The restored factor VIII levels allow the blood clotting cascade to proceed normally, controlling and preventing bleeding episodes associated with hemophilia A.
• Clinical Advantage: This extended half-life formulation reduces treatment burden, improving adherence and overall management of the disease.

In summary, ADYNOVATE 500 IU enhances coagulation by supplementing deficient factor VIII with a more durable therapeutic molecule.

ADYNOVATE 500 IU Interactions ADYNOVATE 500 IU

ADYNOVATE 500 IU has a limited interaction profile but requires careful consideration when administered alongside other medications or therapies.

• Other Factor Concentrates: Concurrent use with other clotting factor products or bypassing agents may increase the risk of thrombotic complications and should be managed by a hematologist.
• Anticoagulant Drugs: Medications such as warfarin, heparin, or direct oral anticoagulants may reduce the effectiveness of ADYNOVATE and increase bleeding risk.
• Immunosuppressants: These may affect the immune response to factor VIII, potentially influencing inhibitor development.
• Vaccines and Immune Therapies: No known direct interactions, but immune status should be monitored due to the risk of antibody formation against factor VIII.
• Hepatic and Renal Agents: Drugs affecting liver or kidney function may impact the metabolism or clearance of factor VIII, necessitating dose adjustments.
• Potential for Inhibitor Formation: Concomitant infections or immune system modulators may alter the development of neutralizing antibodies, reducing treatment efficacy.

Always inform healthcare providers of all medications and supplements to ensure safe use of ADYNOVATE 500 IU.

Dosage of ADYNOVATE 500 IU

The dosage of ADYNOVATE 500 IU must be individualized based on the patient’s weight, severity of factor VIII deficiency, and clinical context such as bleeding episodes or prophylaxis.

• On-Demand Treatment: Typically, 25 to 50 IU per kilogram of body weight per dose, administered as soon as possible after bleeding onset, repeated until bleeding resolves.
• Routine Prophylaxis: Dosage often ranges from 20 to 50 IU per kilogram every 3 to 5 days, leveraging the extended half-life to reduce injection frequency.
• Perioperative Coverage: Higher doses may be required pre-, intra-, and post-operatively to maintain adequate factor VIII activity for hemostasis.
• Monitoring: Regular measurement of factor VIII activity levels is recommended to tailor dosing for optimal efficacy and safety.
• Special Populations: Pediatric dosing and adjustments for comorbidities should be managed by specialized healthcare providers.

Dosing should always be determined by a healthcare professional experienced in hemophilia treatment to ensure proper therapeutic effect and minimize risks.

Possible side effects of ADYNOVATE 500 IU

ADYNOVATE 500 IU is generally well tolerated, but patients should be aware of possible adverse effects that can occur with factor VIII therapy.

• Injection Site Reactions: Pain, swelling, redness, or itching at the infusion site are common but usually mild and transient.
• Allergic or Hypersensitivity Reactions: Symptoms may include rash, hives, itching, or severe anaphylaxis manifesting as difficulty breathing, swelling of the face, lips, tongue, or throat.
• Inhibitor Development: Some patients develop neutralizing antibodies to factor VIII, reducing treatment efficacy and complicating management.
• Systemic Symptoms: Headache, fever, chills, fatigue, or nausea may occur post-infusion.
• Thrombotic Events: Rare but potentially serious blood clots can develop if dosing or patient selection is inappropriate.
• Other Side Effects: Joint pain, dizziness, or swelling have also been reported in some cases.

Any adverse symptoms should be promptly reported to a healthcare provider for assessment and management. Severe allergic reactions require immediate medical attention.

ADYNOVATE 500 IU Contraindications ADYNOVATE 500 IU

ADYNOVATE 500 IU is contraindicated in the following conditions:

• Hypersensitivity: Known allergy or severe reaction to factor VIII, PEGylated proteins, or any excipients in the formulation.
• Anaphylactic History: Patients with previous anaphylaxis to factor VIII products should not use ADYNOVATE unless under strict medical supervision.
• Inhibitor Presence: High-titer factor VIII inhibitors that neutralize the product's activity may contraindicate use or require alternative therapies.
• Off-Label Use: Not suitable for hemophilia B or other coagulation disorders outside factor VIII deficiency.
• Unsupervised Use: Use must be supervised by healthcare professionals experienced in hemophilia management.

Before initiation, full medical evaluation is necessary to identify any contraindications and to ensure safe therapy.

Storage of ADYNOVATE 500 IU

Proper storage is essential to maintain the potency and safety of ADYNOVATE 500 IU.

• Temperature: Store the lyophilized powder and solvent vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Light Protection: Keep vials in their original carton to protect from light exposure.
• After Reconstitution: Use the reconstituted solution immediately or within the time frame recommended by the manufacturer, usually up to 3 hours at room temperature.
• Transport: If refrigeration is unavailable, use insulated containers with cooling packs for short periods.
• Expiration: Do not use beyond the expiration date printed on the vial or packaging.
• Safety: Keep out of reach of children and unauthorized persons.

Always follow the manufacturer's specific instructions and consult healthcare providers if uncertain about storage conditions.