HEMOFIL M® [Antihemophilic Factor (Human), Method M, Monoclonal Purified]

HEMOFIL M® is a brand-name medication that contains Antihemophilic Factor (Human) purified using the Method M, a monoclonal purification process. It is used to treat individuals with hemophilia A, a genetic bleeding disorder. HEMOFIL M® is a highly purified form of Antihemophilic Factor (Human), which is essential for blood clotting. It is used to replace the missing or deficient factor VIII in individuals with hemophilia A.

Indications and Uses

HEMOFIL M® is indicated for the following purposes:

• Treatment and prevention of bleeding episodes in individuals with hemophilia A.

• It is used to control bleeding during surgical procedures in patients with hemophilia A.

• Routine prophylactic treatment to reduce the frequency of spontaneous bleeding episodes.

Dosage and Administration

The dosage of HEMOFIL M® is determined by a healthcare provider based on the patient's specific condition and weight. The medication is administered through intravenous (IV) injection. The dose and frequency of administration are individualized to the patient's needs.

Contraindications

HEMOFIL M® should not be used in individuals with known hypersensitivity to Antihemophilic Factor (Human) 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 HEMOFIL M® may include:

• Injection site reactions, such as pain, redness, and swelling.

• Headache.

• Dizziness.

• Fever.

• Nausea.

Serious side effects are rare but may include:

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

• The development of inhibitors (antibodies) to factor VIII.

• Blood clots.

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

Storage and Shelf Life

Store HEMOFIL M® in the refrigerator at 2-8°C (36-46°F). Do not freeze. Protect it from light. Do not use HEMOFIL M® after the expiration date.

Packaging and Presentation

HEMOFIL M® is available in vials or bottles as a sterile, white, freeze-dried powder for reconstitution before IV injection.

Regulatory Information

HEMOFIL M® 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 HEMOFIL M®. 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.