RECOMBINATE® (Antihemophilic Factor [Recombinant])

RECOMBINATE® is a brand-name medication that contains the active ingredient antihemophilic factor (recombinant). It is primarily used for the treatment and prevention of bleeding in individuals with hemophilia A, a hereditary bleeding disorder caused by a deficiency of clotting factor VIII. RECOMBINATE® is a recombinant form of clotting factor VIII, which is essential for blood clotting. It is used to replace the missing or deficient factor VIII in individuals with hemophilia A, reducing the risk of bleeding episodes and assisting in clot formation.

Indications and Uses

RECOMBINATE® is indicated for the following purposes:

• Treatment and control of bleeding in individuals with hemophilia A.

• Perioperative management of bleeding in individuals with hemophilia A.

• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A.

Dosage and Administration

The dosage of RECOMBINATE® is determined by a healthcare provider based on the patient's specific condition and the severity of the bleeding episode. The medication is administered by intravenous (IV) injection. The dose and frequency are individualized to the patient's needs and the response to treatment.

Contraindications

RECOMBINATE® should not be used in individuals with known hypersensitivity to antihemophilic factor (recombinant) or any of its components. It is essential to discuss any allergies or potential reactions with a healthcare provider.

Adverse Effects and Side Effects

Common side effects of RECOMBINATE® may include:

• Formation of inhibitors to factor VIII.

• Allergic reactions.

• Headache.

• Fever.

• Nausea.

Serious side effects are rare but may include:

• Thrombosis (formation of blood clots).

• Transmission of viral infections (rare due to the manufacturing process).

• Anaphylactic reactions (severe allergic reactions).

It is crucial to report any severe or unusual side effects to your healthcare provider.

Storage and Shelf Life

Store RECOMBINATE® at 2-8°C (36-46°F) in the original carton to protect it from light. Do not use RECOMBINATE® after the expiration date.

Packaging and Presentation

RECOMBINATE® is available as a lyophilized powder in single-use vials for reconstitution.

Regulatory Information

RECOMBINATE® is subject to regulation by health authorities to ensure its safety and efficacy. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on RECOMBINATE®. 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.