Search The Medical Knowledge Base

Drug Details

Fanhdi 25 I.U./ml, 50 I.U./ml and 100 I.U./ml

• Presentation
  Powder and solvent for solution for injection.
• Description
  Fanhdi® is a high purity, solvent-detergent and heat-treated, human coagulation factor VIII, Ph. Eur.
• Indications
  Fanhdi® is indicated for the prevention and control of bleeding in patients with moderate or severe factor VIII deficiency due to classical haemophilia A. Despite the von Willebrand factor content and functionality of this product there are no data from clinical trials supporting use in von Willebrand disease.
• Adult Dosage
  

  Posology

  The dose and duration of treatment with Fanhdi® must be adjusted according to the needs of the individual patient.

  The required dosage may be estimated using the following formula:

  Number of factor VIII units required (I.U.) = Body weight (kg) x Desired factor VIII rise (%) x 0.5

  This calculation is based on the empirical finding that 1 I.U. of factor VIII per kg body weight raises the plasma factor VIII activity approximately 2% (i.e. 0.5 I.U./kg are required for a 1% increase in the plasma factor VIII level).

  The patient's plasma factor VIII levels should be determined and monitored during treatment with Fanhdi^®. This is particularly important in the case of surgical procedures.

  Haemorrhagic event	Therapeutically necessary plasma level of factor VIII activity	Period during which it is necessary to maintain the therapeutic plasma level of factor VIII activity
  Minor Haemorrhages Haemorrhagic into joints	30-40%	At least 1 day, depending on the severity of the Haemorrhage
  Major haemorrhages -Haemorrhages into muscles -Teeth extraction* -Mild trauma capitis -Minor operations -Haemorrhages to the oral cavity*	40-50%	3- 4 dyas or until adequate wound healing has been achieved
  Life threatening haemorrhages -Major operations -Gastro- intestinal bleeding -Intracranial , intra-abdominal or -Intrathoracic haemorrhages -Fractures	60-100%	For 7 days. Factor VIII therapy should continue for atleast another 7 days until adequate healing has been achieved

  
  * For dental and oral bleeding a single dose of Fanhdi^® should be administered to elevate the plasma factor VIII activity to 40 - 50%. Tranexamic acid may be administered in addition. Further doses of Fanhdi^® should only be given if bleeding persists.

  Under certain circumstances larger amounts than those calculated will be required, especially for the initial dose.

  Patients with inhibitors:
  
  If plasma factor VIII does not reach the expected levels or if the bleeding cannot be controlled after the administration of an adequate dose, the presence of inhibitors should be suspected.

  Haemophiliacs with antibodies against factor VIII (inhibitors) need specific therapy. Patients with low titre inhibitors may continue treatment with factor VIII concentrates provided that their inhibitor levels are monitored. Immunetolerance can be achieved by treatment with human plasma coagulation factor VIII concentrate.

  Prophylaxis:
  
  For long-term prophylaxis against bleeding in patients with severe hemophilia A, Fanhdi^® should be administered at doses of 10 to 50 I.U./kg at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

  Method of administration

  The product should be warmed (not above 30 ºC) before administration.

  Fanhdi^® is intended for intravenous administration only. Fanhdi^® may be administered at a rate of no more than 10 ml/minute.

• Contra Indications
  

  Use of this product in patients known to be hypersensitive to any of the constituents should be avoided.

• Special Precautions
  

  If allergic or anaphylactic reactions occur, administration should be stopped immediately (the current specific guidelines of shock therapy should be followed).

  After repeated treatment with human plasma coagulation factor VIII, the level of inhibitor in plasma should be determined.

  When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. This also applies to pathogens of hitherto unknown nature. The risk of transmission of infective agents is however reduced by:

  • selection of donors by a medical interview and screening of donations for the three major pathogenic viruses HIV, HCV and HBV
  • testing of mini-pools and manufacturing pools for HBsAg, HIV and HCV antibodies and HCV-RNA by PCR
  • removal/inactivation procedures included in the production process that have been validated using model viruses and are considered effective for HIV, HCV and HBV

  The viral removal/inactivation procedures may be of limited value against non-enveloped viruses such as Hepatitis A virus or parvovirus B19 and other transmissible infectious agents.

  The plasma used in the manufacture of this product has been collected from remunerated US donors.

  Vaccination guidelines for patients treated with blood or human plasma derivatives must be taken into consideration in all the patients receiving Fanhdi^®.

  Patients receiving factor VIII concentrates should be vaccinated against Hepatitis A and B.

• Interactions
  

  Non known.

• Adverse Drug Reactions
  

   Allergic or anaphylactic reactions are observed in rare cases.

  • Increase in body temperature is observed in rare cases.
  • Development of antibodies to factor VIII (inhibitors)
  • Although the isoagglutinin content is very low, there is a risk of intravascular haemolysis.
  • The transmission of infectious agents cannot be totally excluded