Basic Information
FEIBA 500 U
INJECTION, POWDER, FOR SOLUTION
Regulatory Information
SIN10889P
April 20, 1999
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XB02BD01
Company Information
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Active Ingredients
Strength: 25 u/ml
Detailed Information
Contraindications
**Contraindications** FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available. In the following situations FEIBA should only be used if– for example due to a very high inhibitor titre – no response to treatment with the appropriate coagulation factor concentrate can be expected. **Hypersensitivity to the product** **Disseminated Intravascular Coagulation (DIC):** - Laboratory and/or clinical symptoms, which are clearly indicative of DIC. - Laboratory, histological and/or clinical signs of liver damage; due to the delayed clearance of activated coagulation factors such patients are at an increased risk of developing DIC. **Myocardial Infarction, Acute Thrombosis and/or Embolism:** In patients with a tentative or definite diagnosis of coronary heart disease as well as in patients with acute thrombosis and/or embolism the use of FEIBA is only indicated in life-threatening bleeding episodes.
Indication Information
**Therapeutic Indications** - Treatment and prophylaxis of bleeding in haemophilia A patients with F VIII inhibitor - Treatment and prophylaxis of bleeding in haemophilia B patients with F IX inhibitor - Treatment of bleeding in non-haemophiliacs with acquired inhibitors to factors VIII, XI, XII in cases of severe or life-threatening haemorrhages In one case, FEIBA was successfully used in a patient with an inhibitor, suffering from von Willebrand’s disease. FEIBA was also used in combination with Factor VIII concentrate for a long-term therapy to achieve a complete and permanent elimination of the F VIII inhibitor so as to allow for regular treatment with F VIII concentrate as in patients without inhibitor. For guidelines for treatment of patients with F VIII inhibitors see table 1 in section “Posology and Method of Administration, 3 Prophylactic Treatment”.