Factor VIII Inhibitor Bypassing Activity (FEIBA)
Indications
Registered South African indications:
- Treatment and prophylaxis of haemophilia A patients with FVIII inhibitor
- Treatment and prophylaxis of haemophilia B patients with FIX inhibitor
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Disseminated intravascular coagulation
- Acute thrombosis or embolism (including myocardial infarction)
Cautions
- Transmission of infectious agents
- Increased erythropoiesis
- Immunodeficiency
- Pregnancy
- Children below 6 years of age
- Breastfeeding
- Elderly
- Patients on a low sodium diet
Adult dosage
Forms avail. in SA and covered in this monograph: inj
Haemophilia A patients with FVIII inhibitor
Haemophilia B patients with FIX inhibitor with:
- Joint, muscle and soft tissue haemorrhage - minor to major bleeding
- Mucous membrane bleeding
- Other severe haemorrhage e.g. central nervous system bleed
- Patients undergoing surgery
- Prophylaxis of bleeding
Treatment should be advised by a Comprehensive Haemophilia Treatment Centre found across South Africa. See Care Coord section for contact numbers.
The dosage and duration of the therapy is dependent upon the severity of the disorder, the location and extent of the bleeding and the patient's clinical condition.
Paediatric dosage
Paed. forms avail. in SA and covered in this monograph: inj
Bleeding prophylaxis
Younger than 6 years
- Not established for use
Older than 6 years
- See adult dosage
Special populations
Pregnancy
Breastfeeding
Renal Impairment
Hepatic Impairment
Elderly
Adverse reactions
Central Nervous System Disorders
- Somnolence
- Dizziness
- Dysgeusia
- Headache
Cardiovascular Disorders
- Hypotension
- Chest pain
- Chest discomfort
Respiratory Disorders
- Dyspnea
Gastrointestinal Disorders
- Nausea
Skin and Subcutaneous Tissue Disorders
- Rash
Immune, Blood and Lymphatic System Disorders
- Increase in inhibitor titer
- Hypersensitivity
Others
- Chills
- Pyrexia
Interactions
- Antifibrinolytics
- Recombinant factor VIIa
Monitoring
- Coagulation analysis
Mechanism of action
Factor VIII Inhibitor bypassing activity (FEIBA) is a plasma-derived concentrate containing activated clotting factors.Multiple interactions of the components in FEIBA restore the impaired thrombin generation of hemophilia patients with inhibitors. FEIBA shortens the activated partial thromboplastin time (aPTT) of plasma containing factor VIII inhibitor.
Dosage forms
- Powder for injection
Formulation
Injection (per ml) 500iu
- FEIBA (Adcock) originator
Injection (per ml) 1000iu
- FEIBA (Adcock) originator
References
1. SAMF_12th Edition_Page 113 2. https://www.medicines.org.uk/emc/medicine/30169 (14/01/2016_Baxalta_FEIBA_500 U) 3. https://www.medicines.org.uk/emc/medicine/30168 14/01/2016_Baxalta_FEIBA_1000 U) 4. https://drive.google.com/drive/folders/0B0xnChtF7vdud3hiNG5PeUlQSDQ (13/03/1992_Adcock_FEIBA_500,1000U) 5.https://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm221749.pdf (Revised 11/2013) 6. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2516.2004.00934.x/full 7. http://www.medicines.ie/medicine/16615/SPC/FEIBA+50+U+ml+powder+and+solvent+for+solution+for+infusion/ (Revised 16/11/20160
Brands & products
2 products · cached snapshot- FEIBA
POIPowder for injection· 2 products
from R16046.04| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Feiba 500 U | 500 iu/ml | 20 | Takeda (Pty) Ltd | R16046.04 |
| Feiba 1000 U | 1000 iu/ml | 20 | Takeda (Pty) Ltd | R32054.92 |
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.