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

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Indication

HEMOFIL M [Antihemophilic Factor (Human) Method M, Monoclonal Purified], Nanofiltered, is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.

HEMOFIL M is not indicated in von Willebrand’s disease.1

Detailed Important Risk Information for HEMOFIL M

HEMOFIL M is contraindicated in patients with a known hypersensitivity to the active substance, to excipients, or to mouse proteins.

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with HEMOFIL M and have been manifested by, for example, bronchospasm, dyspnea, hypotension, chest pain, facial edema, urticaria, rash, flushing, pruritus, and nausea.  Advise patients to discontinue use of the product and contact a physician if these symptoms occur. 

The development of neutralizing antibodies (inhibitors) to Factor VIII is a known complication of the treatment of patients with hemophilia A.  Inhibitors have predominantly been reported in previously untreated patients.  Patients should be evaluated for the development of Factor VIII inhibitors if the expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose.

Because HEMOFIL M is made from human plasma, a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be totally excluded.  This also applies to unknown or emerging viruses and other pathogens.

Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of HEMOFIL M is initiated.

HEMOFIL M contains trace amounts of mouse protein.  The possibility exists that patients treated with HEMOFIL M may develop hypersensitivity to the mouse proteins.

The pulse rate should be determined before and during administration of HEMOFIL M.  Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.

Certain components used in the packaging of HEMOFIL M contain natural rubber latex which may cause allergic reactions. 

Adverse reactions seen in clinical trials with HEMOFIL M include Factor VIII inhibition, dizziness, headache, dysgeusia, pyrexia and infusion site inflammation.

The following adverse reactions have been reported in the post-marketing experience: anaphylaxis, hypersensitivity reactions, visual impairment, ocular hyperemia, cyanosis, bradycardia, tachycardia, hypotension, flushing, bronchospasm, dyspnea, cough, hyperventilation, diarrhea, vomiting, nausea, abdominal pain, urticaria, rash, pruritus, hyperhidrosis, facial edema, edema, chills, fatigue, chest pain, muscoloskeletal pain, and irritability.

Disposal and Recycling

After using HEMOFIL M, dispose of the empty vial, reconstitution device and syringe in a Sharps container.

References

1. HEMOFIL M Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; April 2012.
Baxter and Hemofil M are trademarks of Baxter International Inc.
BIOH0517

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