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Indications and Dosage
Intravenous
Replacement therapy in haemophilia B
Replacement therapy in haemophilia B
Adult: Dosage and duration is individualised based on preparation used, severity of factor IX deficiency, extent and location of bleeding, and patient’s clinical status. Dose may be titrated as needed based on clinical response. Suggested target factor IX concentrations: Mild to moderate haemorrhage: Increase to 20-40% of normal. More serious haemorrhage or minor surgery: Increase to 30-60% of normal. Severe haemorrhage or major surgery: Increase to 60-100% of normal. Refer to detailed product guideline.
Reconstitution
Refer to individual product labelling for specific details.
Contraindications
Hypersensitivity to factor IX complex, history of heparin-induced thrombocytopaenia, heparin allergy (Bebulin).
Special Precautions
Patient with risk for thromboembolic complications [e.g. fibrinolysis, thrombosis, disseminated intravascular coagulation (DIC), undergoing or underwent surgery], risk of transmitting infectious agents (e.g. risk of variant Creutzfeldt-Jakob disease (vCJD), Creutzfeldt-Jakob disease (CJD) and parvovirus B19 infections). Hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Antibody formation.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Pyrexia, chills, lethargy.
Nervous system disorders: Headache, dizziness, somnolence.
Skin and subcutaneous tissue disorders: Erythema.
Vascular disorders: Flushing.
Potentially Fatal: Serious thromboembolic complications (e.g. venous thrombosis, DIC, stroke, MI, pulmonary embolism), hypersensitivity (e.g. anaphylaxis, urticaria, angioedema, dyspnoea, hypotension, tachycardia).
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Pyrexia, chills, lethargy.
Nervous system disorders: Headache, dizziness, somnolence.
Skin and subcutaneous tissue disorders: Erythema.
Vascular disorders: Flushing.
Potentially Fatal: Serious thromboembolic complications (e.g. venous thrombosis, DIC, stroke, MI, pulmonary embolism), hypersensitivity (e.g. anaphylaxis, urticaria, angioedema, dyspnoea, hypotension, tachycardia).
Pregnancy Category (US FDA)
IV/Parenteral: C
Monitoring Parameters
Monitor factor IX plasma levels, prothrombin time, partial thromboplastin time; signs and symptoms of hypersensitivity, thromboembolic complications, development of inhibitors.
Action
Description: Factor IX complex is a mixture of vitamin K-dependent clotting factors II, IX, X and low, non-therapeutic levels of factor VII. It increases the plasma levels of factor IX in patients with haemophilia B (factor IX deficiency) thereby, temporarily correcting the deficiency and restoring haemostasis.
Synonym: 3-factor prothrombin complex concentrate.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 19-25 hours (factor IX).
Synonym: 3-factor prothrombin complex concentrate.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 19-25 hours (factor IX).
Storage
Bebulin: Store between 2-8°C. Profilnine: Store below 25°C.
MedsGo Class
Haemostatics
Features
Brand
Factor IX Complex
Full Details
Dosage Strength
500 IU / 5 ml%
Drug Ingredients
- Profilnine SD
Drug Packaging
Powder for Injection (I.V.) 5ml x 1's
Generic Name
Profilnine SD
Dosage Form
Powder For Injection (I.V.)
Registration Number
BR-411
Drug Classification
Prescription Drug (RX)