ADYNOVATE 250 IU Lyophilized Powder for solution

What is ADYNOVATE 250 IU

ADYNOVATE 250 IU is a specialized therapeutic product designed for the treatment and prevention of bleeding episodes in individuals diagnosed with Hemophilia A, a hereditary bleeding disorder characterized by a deficiency or dysfunction of clotting factor VIII (FVIII). This medication contains a recombinant form of factor VIII that has been PEGylated to prolong its circulation time, allowing for less frequent dosing compared to standard FVIII products.

• Form: Lyophilized powder intended for reconstitution with a solvent vial.
• Packaging: Supplied with one vial containing the lyophilized antihemophilic factor, one vial with sterile solvent, and a BAXJECT II Hi-Flow Needleless Transfer Device to facilitate safe and easy reconstitution.
• Active Ingredient: PEGylated recombinant human factor VIII, engineered to replace the deficient factor VIII protein in hemophilia A patients.
• Indications: Used for controlling acute bleeding episodes, prophylactic prevention of bleeding, and perioperative management during surgery in patients with hemophilia A.
• Benefit of PEGylation: Attachment of polyethylene glycol (PEG) extends the half-life of factor VIII in plasma, reducing the number of injections needed and improving patient compliance.
• Patient Population: Suitable for children and adults with confirmed factor VIII deficiency.

ADYNOVATE 250 IU plays an essential role in comprehensive hemophilia management by restoring normal clotting function and preventing severe bleeding complications.

How to use ADYNOVATE 250 IU

Administration of ADYNOVATE 250 IU requires strict adherence to proper preparation and intravenous infusion techniques to ensure safety and therapeutic efficacy.

• Reconstitution:
  • Use the BAXJECT II Hi-Flow Needleless Transfer Device to transfer the solvent into the vial containing the lyophilized powder.
  • Gently swirl the vial until the powder dissolves completely; avoid shaking vigorously to prevent protein denaturation.
  • Inspect the solution visually—it should be clear and free from particulate matter before use.
• Administration:
  • Inject the reconstituted solution intravenously using aseptic technique.
  • Infusion rates typically range up to 10 mL per minute but may be adjusted based on patient tolerance and clinical judgment.
  • Ensure use of sterile needles and syringes for each administration to prevent infection.
• Dosing Schedule:
  • Frequency and dose depend on whether the treatment is for prophylaxis, on-demand bleeding control, or surgery.
  • For prophylaxis, dosing intervals generally range every 3-5 days due to the extended half-life of PEGylated factor VIII.
  • On-demand treatment should begin promptly at bleeding onset.
• Training and Monitoring:
  • Patients and caregivers should be trained by healthcare professionals in reconstitution and intravenous administration.
  • Clinical monitoring of treatment response and possible adverse reactions is essential.

Always follow the dosing regimen and administration instructions prescribed by your healthcare provider or hemophilia treatment center.

Mode of Action ADYNOVATE 250 IU

ADYNOVATE 250 IU functions by supplementing deficient or defective factor VIII in patients with hemophilia A, thereby restoring the blood’s natural ability to form stable clots and prevent bleeding.

• Physiological Role of Factor VIII: Factor VIII acts as a cofactor for activated factor IX (factor IXa), which is critical in the intrinsic coagulation pathway.
• Coagulation Cascade: Activation of factor X by the factor IXa-factor VIIIa complex leads to thrombin generation and subsequent fibrin clot formation, stabilizing blood clots at sites of injury.
• Recombinant Factor VIII: ADYNOVATE delivers a PEGylated recombinant factor VIII that mimics the biological function of endogenous factor VIII.
• PEGylation Advantages: The polyethylene glycol moiety attached to factor VIII enhances stability, reduces proteolytic degradation, and prolongs plasma half-life, thereby maintaining hemostatic activity longer.
• Outcome: By restoring sufficient factor VIII levels, ADYNOVATE effectively prevents and controls bleeding episodes, improving overall hemostatic control in hemophilia A patients.

This extended half-life factor VIII product represents an advancement in hemophilia therapy, improving patient convenience and clinical outcomes.

ADYNOVATE 250 IU Interactions ADYNOVATE 250 IU

ADYNOVATE 250 IU, as a recombinant coagulation factor, generally has a limited range of direct drug interactions. However, several important considerations must be noted:

• Concurrent Use with Other Clotting Factors: Combining with other factor concentrates or bypassing agents requires close monitoring to avoid complications such as excessive clotting or diminished efficacy.
• Anticoagulant Medications: Use with anticoagulants like warfarin or heparin may reduce the effectiveness of ADYNOVATE and increase bleeding risk.
• Immunosuppressants and Immune-Modulating Drugs: These may influence the development of factor VIII inhibitors (neutralizing antibodies), which can reduce therapeutic effectiveness.
• Vaccines: No direct interactions are known, but patients with hemophilia should follow standard vaccination protocols.
• Other Drugs Affecting Renal or Hepatic Function: Since metabolism and clearance of coagulation factors may be affected, caution is warranted when used with nephrotoxic or hepatotoxic agents.
• Potential for Inhibitor Development: Co-administration with certain immune therapies or infections may alter the immune response to factor VIII.

It is crucial to inform healthcare providers about all medications and supplements being taken to ensure safe and effective use of ADYNOVATE 250 IU.

Dosage of ADYNOVATE 250 IU

The dosage of ADYNOVATE 250 IU must be individualized based on clinical factors such as the severity of factor VIII deficiency, the type and location of bleeding, and the patient’s body weight. Key dosing considerations include:

• On-Demand Treatment: For acute bleeding episodes, doses typically range from 25 to 50 IU per kilogram of body weight, repeated as necessary until bleeding stops.
• Prophylaxis: Preventive treatment commonly involves 20 to 50 IU per kilogram every 3 to 5 days, taking advantage of the extended half-life of PEGylated factor VIII to reduce injection frequency.
• Perioperative Management: Higher doses may be required before, during, and after surgical procedures to maintain adequate clotting factor levels.
• Monitoring and Adjustment: Factor VIII activity levels should be regularly monitored to tailor dosing for optimal hemostatic control.
• Special Populations: Dosage adjustments may be necessary for pediatric patients or those with comorbid conditions.

All dosing decisions should be made by a hematologist or specialized healthcare provider experienced in hemophilia management.

Possible side effects of ADYNOVATE 250 IU

While ADYNOVATE 250 IU is generally well tolerated, some patients may experience side effects ranging from mild to serious. Awareness of potential adverse effects is important:

• Injection Site Reactions: Pain, redness, swelling, or itching at the infusion site are among the most common complaints.
• Allergic Reactions: These may include rash, itching, hives, or in rare cases, severe anaphylaxis characterized by difficulty breathing, swelling of the face or throat.
• Development of Factor VIII Inhibitors: The immune system may produce antibodies against factor VIII, which can reduce the medication's effectiveness and complicate treatment.
• Headache, Fever, or Fatigue: Occasionally reported post-infusion symptoms.
• Thrombotic Events: Although rare, inappropriate clot formation can occur if dosing is excessive or not properly managed.
• Other Symptoms: Nausea, dizziness, joint pain, or swelling may occur in some patients.

If any signs of hypersensitivity or severe side effects arise, immediate medical attention is required. Always report adverse reactions to your healthcare provider for timely management.

ADYNOVATE 250 IU Contraindications ADYNOVATE 250 IU

ADYNOVATE 250 IU should not be administered in the following situations:

• Known Hypersensitivity: Allergy to factor VIII or any ingredient in the formulation.
• Severe Allergic Reactions: History of anaphylaxis or severe allergic responses to factor VIII concentrates.
• Presence of Factor VIII Inhibitors: Patients with high-titer inhibitors may not respond effectively.
• Use for Other Coagulation Disorders: Not indicated for hemophilia B or other coagulation deficiencies.
• Inappropriate Use Outside Indications: Use only under specialist supervision.

Always disclose your medical history to your healthcare provider to avoid contraindicated use and ensure safe treatment.

Storage of ADYNOVATE 250 IU

Proper storage of ADYNOVATE 250 IU is essential to maintain its stability and effectiveness:

• Temperature: Store the lyophilized powder and solvent vials refrigerated at 2°C to 8°C (36°F to 46°F).
• Avoid Freezing: Freezing may damage the protein structure and compromise safety.
• Protection from Light: Keep vials in the original carton to protect from light exposure.
• After Reconstitution: Use the reconstituted solution immediately, or within the timeframe recommended by the manufacturer (usually up to 3 hours at room temperature).
• Handling During Transport: Use insulated containers with cooling packs if refrigeration is unavailable temporarily.
• Expiry Date: Do not use beyond the expiration date indicated on the packaging.
• Safety: Keep out of reach of children and unauthorized persons.

Always follow storage instructions provided by the manufacturer and consult healthcare professionals if in doubt.