ADYNOVATE®

ADYNOVATE® is a brand-name medication that contains Antihemophilic Factor (Recombinant), PEGylated. It is a treatment option for individuals with hemophilia A. ADYNOVATE® is a recombinant clotting factor that contains polyethylene glycol (PEG) and is designed to replace the missing or deficient Factor VIII in individuals with hemophilia A. It is used for the prevention and control of bleeding episodes in people with this condition.

Indications and Uses

ADYNOVATE® is indicated for the following purposes:

• Treatment of hemophilia A (congenital Factor VIII deficiency) in adults and children.

• Used for on-demand treatment and control of bleeding episodes.

• Can be utilized for prophylaxis to reduce the frequency of bleeding episodes.

Dosage and Administration

The dosage and administration of ADYNOVATE® are typically personalized for each patient based on their specific needs and response to treatment. The medication is administered by intravenous injection. The frequency and dose are determined by a healthcare provider and may vary depending on the severity of hemophilia and the specific circumstances.

Contraindications

ADYNOVATE® should not be used in individuals with known hypersensitivity to any of its components, including PEG.

Adverse Effects and Side Effects

Common side effects of ADYNOVATE® may include:

• Headache.

• Dizziness.

• Fever.

• Nausea.

• Diarrhea.

• Rash or itching.

• Injection site reactions, such as redness or pain.

Serious side effects are rare but may include:

• Development of inhibitors (antibodies) that can neutralize the effects of Factor VIII replacement therapy.

• Allergic reactions, which can manifest as hives, difficulty breathing, and swelling of the face, lips, or tongue.

• It is crucial to report any adverse effects or unusual reactions to your healthcare provider.

Storage and Shelf Life

Store ADYNOVATE® in the original packaging in the refrigerator at 2-8°C (36-46°F). Do not freeze the medication. Do not use ADYNOVATE® after the expiration date.

Packaging and Presentation

ADYNOVATE® is available in vials or prefilled syringes, each containing a specified quantity of the medication.

Regulatory Information

ADYNOVATE® is regulated by health authorities and is subject to quality control standards to ensure its safety and efficacy. It is important to use ADYNOVATE® as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the drug's official prescribing information and product labeling for the most up-to-date and comprehensive information on ADYNOVATE®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.