ADYNOVATE 1000 IU Lyophilized Powder for solution

What is ADYNOVATE 1000 IU

ADYNOVATE 1000 IU is a specialized medication used to treat and prevent bleeding episodes in patients with Hemophilia A, a genetic bleeding disorder caused by deficiency or dysfunction of clotting factor VIII (FVIII). This medicine provides a recombinant (laboratory-produced) form of factor VIII, which is PEGylated to extend its half-life in the bloodstream, allowing for less frequent dosing compared to conventional FVIII products.

• Formulation: Lyophilized powder for reconstitution with a solvent vial.
• Packaging: Supplied as one vial containing lyophilized antihemophilic factor and a separate solvent vial, along with a BAXJECT II Hi-Flow Needleless Transfer Device for easy mixing and administration.
• Active Ingredient: PEGylated recombinant human factor VIII, designed to replace the deficient clotting factor in hemophilia A patients.
• Purpose: Used for on-demand treatment of bleeding, prevention of bleeding episodes (prophylaxis), and control of bleeding during surgery in hemophilia A patients.
• Benefit: PEGylation prolongs factor VIII activity in the circulation, reducing the frequency of injections and improving patient quality of life.
• Patient Population: Approved for use in children and adults diagnosed with hemophilia A, including those with severe factor VIII deficiency.

ADYNOVATE 1000 IU is a critical therapy in hemophilia care, providing effective clotting factor replacement to manage and prevent bleeding complications.

How to use ADYNOVATE 1000 IU

ADYNOVATE 1000 IU must be used carefully under the supervision of a healthcare professional trained in the treatment of hemophilia. Correct preparation and administration are essential for efficacy and safety.

• Preparation:
  • Reconstitute the lyophilized powder by mixing it with the provided sterile solvent vial using the BAXJECT II Hi-Flow Needleless Transfer Device.
  • Follow the instructions exactly to ensure complete dissolution and avoid contamination.
  • Inspect the solution visually before use; it should be clear and free from particles.
• Administration:
  • Administer intravenously through a suitable vein using aseptic technique.
  • Infusion rate should be controlled, typically not exceeding 10 mL/min, but may vary depending on patient tolerance.
  • Use a new sterile needle and syringe for each injection to prevent infection.
• Frequency:
  • Dosage and frequency depend on the severity of factor VIII deficiency, the type of bleeding episode, and the patient’s response.
  • For prophylaxis, infusions may be given every 3-5 days or as prescribed by the physician.
  • On-demand treatment requires administration as soon as possible after bleeding begins.
• Storage during Use: Use the reconstituted solution immediately or within the timeframe recommended in the instructions.
• Training: Patients and caregivers should receive proper training in reconstitution and intravenous injection techniques.

Always consult your hemophilia treatment center or healthcare provider for personalized dosing and administration advice.

Mode of Action ADYNOVATE 1000 IU

ADYNOVATE 1000 IU works by replacing the missing or deficient factor VIII in patients with hemophilia A, thus restoring the blood’s ability to clot effectively.

• Factor VIII Role: Factor VIII is an essential blood coagulation protein that acts as a cofactor for factor IXa, which in turn activates factor X in the clotting cascade.
• Clot Formation: Activation of factor X leads to conversion of prothrombin to thrombin, which converts fibrinogen to fibrin, forming a stable blood clot.
• Recombinant FVIII: ADYNOVATE provides a recombinant, PEGylated form of factor VIII that mimics natural FVIII function, facilitating normal clotting.
• PEGylation Benefits: The polyethylene glycol (PEG) molecule attached to FVIII extends its half-life by protecting it from rapid degradation and clearance, enabling longer circulation time.
• Result: Prolonged factor VIII activity reduces the frequency of injections needed and maintains adequate hemostasis to prevent or control bleeding episodes.

This targeted replacement therapy is crucial for managing hemophilia A, effectively compensating for the defective clotting mechanism and preventing bleeding complications.

ADYNOVATE 1000 IU Interactions ADYNOVATE 1000 IU

While ADYNOVATE 1000 IU is a recombinant clotting factor replacement, several potential interactions and considerations must be kept in mind:

• Other Clotting Factor Concentrates: Use with other factor VIII products or bypassing agents should be carefully monitored by a hemophilia specialist to avoid excessive clotting or inadequate response.
• Anticoagulants: Medications such as warfarin, heparin, or direct oral anticoagulants may counteract the clotting effect of ADYNOVATE, increasing bleeding risk despite factor VIII replacement.
• Aminoglycosides or nephrotoxic drugs: Use cautiously if renal impairment is present as clearance of factor VIII and other medications may be affected.
• Immune Modulators: Immunosuppressants or immune therapies may impact the development of inhibitors (antibodies) against factor VIII, influencing treatment effectiveness.
• Vaccinations: There is no known direct interaction with vaccines, but patients with hemophilia should follow routine vaccination schedules under medical guidance.
• Inhibitor Development: Some patients may develop antibodies against factor VIII, reducing efficacy. This immune response can be influenced by other medications or infections.

Always inform your healthcare provider about all medications and supplements you are taking to ensure safe and effective therapy.

Dosage of ADYNOVATE 1000 IU

Dosage of ADYNOVATE 1000 IU varies widely based on individual patient needs, bleeding severity, and treatment goals. General guidelines include:

• On-demand treatment: Dose depends on the location and severity of bleeding. Typically, 25 to 50 IU per kg body weight is administered, repeated as necessary until bleeding is controlled.
• Prophylaxis: Regular preventive infusions range from 20 to 50 IU per kg every 3 to 5 days to maintain adequate factor VIII levels and prevent spontaneous bleeds.
• Surgical prophylaxis: Higher doses may be required before, during, and after surgery to maintain hemostasis.
• Individualized dosing: Adjustments are based on clinical response, factor VIII activity assays, and patient bleeding history.
• Frequency: Thanks to PEGylation, dosing intervals are longer compared to standard factor VIII products, improving adherence.
• Monitoring: Regular monitoring of factor VIII levels and clinical assessment is essential to optimize therapy.

All dosage regimens must be determined by a hematologist or hemophilia treatment center specialized in managing this disorder.

Possible side effects of ADYNOVATE 1000 IU

Like all medications, ADYNOVATE 1000 IU can cause side effects. Most are mild, but some require prompt medical attention:

• Common side effects: Injection site reactions such as redness, swelling, or pain.
• Allergic reactions: Rash, itching, hives, or more severe hypersensitivity reactions including anaphylaxis (rare but serious).
• Development of inhibitors: The formation of neutralizing antibodies against factor VIII can occur, reducing treatment effectiveness and potentially causing allergic symptoms.
• Headache, fever, or fatigue: Occasionally reported during or after infusion.
• Thromboembolic events: Although rare, excessive clotting can occur if dosing is not properly managed.
• Other rare effects: Nausea, dizziness, or joint pain.

If you experience any signs of allergic reaction such as difficulty breathing, swelling of the face or throat, or severe rash, seek emergency medical help immediately. Inform your healthcare provider of any side effects to ensure proper management.

ADYNOVATE 1000 IU Contraindications ADYNOVATE 1000 IU

ADYNOVATE 1000 IU should not be used in the following situations:

• Known hypersensitivity: Allergy to ADYNOVATE, its ingredients, or any recombinant factor VIII products.
• Inhibitor presence: Patients with high-titer factor VIII inhibitors may not respond effectively to ADYNOVATE.
• Severe allergic reaction history: Prior anaphylactic or severe hypersensitivity to factor VIII therapy warrants caution.
• Use in unapproved conditions: Not intended for other bleeding disorders without factor VIII deficiency.
• Caution during pregnancy and breastfeeding: Safety has not been fully established; consult a physician.

Always disclose your full medical history to your healthcare provider before starting therapy.

Storage of ADYNOVATE 1000 IU

Proper storage of ADYNOVATE 1000 IU is crucial to preserve its potency and safety:

• Temperature: Store lyophilized powder and solvent vials refrigerated between 2°C and 8°C (36°F to 46°F).
• Avoid freezing: Do not freeze the product; freezing can damage the protein structure.
• Light protection: Keep vials in the original packaging to protect from light exposure.
• Stability after reconstitution: Use the reconstituted solution immediately or within the timeframe specified in the instructions, typically within 3 hours at room temperature.
• Transportation: When transporting, use insulated containers with cooling packs if refrigeration is not available.
• Keep out of reach of children: Store safely to prevent accidental misuse.
• Expiry date: Do not use after the expiration date printed on the vial or packaging.

Always follow the manufacturer’s instructions and consult your healthcare provider or pharmacist if you have questions about storage.