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
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 hemorrhages 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. Patients w/ known history of hypersensitivity to hamster proteins.
Special Precautions
Discontinue use if signs of allergic reactions (including hives, generalized urticaria, chills, flushing, angioedema, chest tightness, laryngospasm, bronchospasm, dyspnea, wheezing, faintness, hypotension, tachycardia, blurred vision & anaphylaxis) occur. 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 the development of factor IX inhibitors. Patients known to have major deletion mutations of the factor IX gene. Patients w/ liver disease, post-op, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Administration by continuous infusion. 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.
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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