Factor IX Complex
Indications
Registered South African indications:
- Congenital or acquired Factor IX deficiency
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Known allergy to heparin
- History of heparin-induced thrombocytopenia
Cautions
- Pregnancy
- Breastfeeding
- Hepatic impairment
- Congenital deficiency of vitamin K-dependant clotting factors
- Repeated dosing
- Coronary artery disease
- Peri-operative patients
- Neonates
- Risk factors for thromboembolic events
- Risk factors for disseminated intravascular coagulopathy
- Patients on a controlled sodium diet
Adult dosage
Forms avail. in SA and covered in this monograph: inj
Congenital factor IX deficiency (Haemophilia B) without inhibitors with:
- Minor/major bleeding
Treatment should be advised by a Comprehensive Haemophilia Treatment Centre found across South Africa. See Care Co-ord section for contact numbers
Severe bleeding secondary to warfarin anticoagulation
- Consult specialist for dosage
Paediatric dosage
See adult dosage
Special populations
Pregnancy
- FDA Pregnancy Category C drugs.com
Breastfeeding
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warning
Adverse reactions
Central Nervous System Disorders
- Headache
Cardiovascular Disorders
- Thromboembolism
Hepatobiliary Disorders
- Increased hepatic transaminases
Immune, Blood and Lymphatic System Disorders
- Prothrombin complex antibody formation
- Allergic reactions
- Anaphylactic reactions
- Thrombocytopenia
Others
- Increased body temperature
Interactions
No information available
Monitoring
Factor IX levels
Mechanism of action
Factor IX is a vitamin-K dependent coagulation factor and it is synthesised in the liver. It is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed.
Dosage forms
- Powder for injection
Formulation
Injection (per vial) 500 IU
- Haemosolvex Factor IX (National Bioproducts Institute)
References
1. SAMF_12th Edition_Page 113 2. SmPC: Haemonine 500 / Haemonine 1000 powder and solvent for solution for injection, Biotest (UK) Ltd:Last updated on eMC: 28 Jul 2016; Downloaded online 04 Feb 2019 [https://www.medicines.org.uk/emc/medicine/23196] 3. https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-bio-gen/documents/document/ucm261964.pdf (Revised 8/2010) 4. PI: Haemosolvex Factor IX (powder for injection), National Bioproducts Institue:Date of registration: Jan 1991 [https://drive.google.com/drive/folders/0B4_v8Xoq_6PoVjV2cDBXVG9GR0U] 5. MobiMIMS: HAEMOSOLVEX FACTOR IX, NBI [https://drive.google.com/drive/folders/0B4_v8Xoq_6PoVjV2cDBXVG9GR0U (10/03/2017_Mobimims_Haemosolvex_inj) 6. SmPC: octaplex powder and solvent for solution for infusion, Octapharma Limited:Last updated on eMC: 06 Oct 2017; Downloaded online 04 Feb 2019 [https://www.medicines.org.uk/emc/medicine/21897] 7. U2D: Factor IX, human plasma-derived: Drug information; Uptodate;Downloaded online 04 Feb 2019 [https://www.uptodate.com/contents/factor-ix-human-plasma-derived-drug-information?search=factor%20IX&source=panel_search_result&selectedTitle=1~65&usage_type=panel&display_rank=1] 8. Epocrates: Coagulation factor IX (human): Entire monograph;Downloaded online 04 Feb 2019 [https://online.epocrates.com/drugs/1583/coagulation-factor-IX-human] 9. NAPOS: The Drug Database for Acute Porphyria: Coagulation factor IX, II, VII and X in combination; Accessed online 04 Feb 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=B02BD01&l=gbr] 10. South African Institute for Drug-Free Sport: Haemosolvex Factor IX; Accessed online 04 Feb 2019 [http://www.drugfreesport.org.za/online-medication-check/]
Brands & products
1 product · cached snapshot- Haemosolvex Factor IX
POIPowder for injection· 1 product
from R2626.59| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Haemosolvex Factor IX | 500 iu/vial | 10 | National Bioproducts Institute (NPC) | R2626.59 |
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.