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BeneFIX

BeneFIX

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Nonacog α (recombinant coagulation factor IX)
Indications/Uses
Treatment & prophylaxis of bleeding in patients w/ hemophilia B (congenital factor IX deficiency).
Dosage/Direction for Use
IV Individualized dosage. Hemorrhage: Early hemarthrosis, muscle or oral bleeding 20-40 IU/dL repeat every 24 hr for at least 1 day until bleeding episode as indicated by pain is resolved or healed. More extensive hemarthrosis, muscle bleeding or hematoma 30-60 IU/dL repeat infusion every 24 hr for ≥3-4 days until pain & acute disability are resolved. Life-threatening hemorrhage 60-100 IU/dL repeat infusion every 8-24 hr until threat is resolved. Surgery: Minor (including tooth extraction) 30-60 IU/dL every 24 hr for at least 1 day until healed. Major (pre- & post-op) 80-100 IU/dL repeat infusion every 8-24 hr until adequate wound healing, then therapy for at least another 7 days to maintain factor IX activity of 30-60% (IU/dL). Routine secondary prophylaxis Previously treated adult 40 IU/kg at 3- to 4-day intervals.
Contraindications
Hypersensitivity. Known history of hypersensitivity to hamster proteins.
Special Precautions
Immediately discontinue use & give appropriate medical management if allergic or anaphylactic reactions occur. Consider alternative hemostatic measures in case of severe allergic reactions. Possible nephrotic syndrome following immune tolerance induction w/ factor IX products in hemophilia B patients w/ factor IX inhibitors & history of allergic reactions to factor IX. Monitor for development of factor IX inhibitors. Patients known to have major deletion mutations of factor IX gene. Patients w/ liver disease, post-op, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Safety & efficacy of administration by continuous infusion has not been established. Should be injected over several min. Pregnancy & lactation. Childn <6 yr & neonates. Elderly ≥65 yr.
Adverse Reactions
Headache; cough; vomiting; pyrexia. Factor IX inhibition; hypersensitivity; dizziness, dysgeusia; phlebitis, hypotension, flushing; nausea; rash, urticaria; chest discomfort, infusion-site reaction & pain.
Drug Interactions
Possible temporary correction of abnormal partial thromboplastin time. Not to be administered in same tubing or container w/ other medicinal products.
MIMS Class
Haemostatics
ATC Classification
B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
BeneFIX powd for inj 500 IU
Packing/Price
1's
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