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

HEMOFIL M product shot

Instructions for Use (Rx Only)

La información proporcionada no pretende ser un sustituto del asesoramiento médico profesional. Un médico certificado debería ser consultado para el diagnóstico y tratamiento de cualquiera y todas las condiciones médicas.

HEMOFIL M is the first monoclonal antibody purified, solvent detergent–treated factor VIII.1 Prepared exclusively with source plasma from Baxter's qualified donor program, HEMOFIL M has over 20 years of post-licensure clinical experience.1,2

Indications 3

HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated for von Willebrand's disease.

Features3

  • Use of pooled human plasma
  • Patented Method M purification process
  • Available in four (4) single vial dosage strengths – 250 IU, 500 IU, 1000 IU, 1700 IU
  • Room temperature storage, not to exceed 30°C (86°F). Not to exceed printed expiration date
  • 10 mL diluent vial

Safety and Efficacy

Efficacious for the control and prevention of bleeding episodes in hemophilia A3

Important Risk Information for HEMOFIL M Therapy

You should not use HEMOFIL M if you are allergic to mouse proteins.

HEMOFIL M is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses such as parvovirus B19 or hepatitis A, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Consult your physician if such symptoms appear.

You could have an allergic reaction to HEMOFIL M. Early signs of hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. You should discontinue use of HEMOFIL M and contact your doctor if these symptoms occur.

Certain components used in the packaging of HEMOFIL M contain natural rubber latex.

Your body may form inhibitors to Factor VIII. Inhibitors are part of your body’s normal defense system. If you form inhibitors, it may stop HEMOFIL M from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Allergic reactions are possible with FVIII products. HEMOFIL M contains Albumin (Human). Reactions to albumin are extremely rare, although nausea, fever, chills, and skin rash have been reported.

References

1. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics - from whole-blood transfusion to recombinant DNA to gene therapy. Biotechnol. Appl. Biochem. 2002; 35:141-148.

2. Data on File. Westlake Village, CA: Baxter Healthcare Corporation.

3. HEMOFIL M Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; September 2007.