BeneFIX

BeneFIX

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Nonacog α (recombinant coagulation factor IX)
Indications/Uses
Control & prevention of haemorrhagic episodes & for routine prophylaxis in patients w/ hemophilia B (congenital factor IX deficiency or Christmas disease) including control & prevention of bleeding in surgical settings.
Dosage/Direction for Use
Individualized dosage. Early haemarthrosis, muscle/oral bleeding 20-40 IU/dL 24 hrly for at least 1 day. More extensive haemarthrosis, muscle bleeding or haematoma 30-60 IU/dL infusion 24 hrly for ≥3-4 days. Life-threatening haemorrhage 60-100 IU/dL infusion 8-24 hrly. Minor surgery including tooth extraction 30-60 IU/dL 24 hrly for at least 1 day. Major surgery (pre- & post-op) 80-100 IU/dL infusion 8-24 hrly until adequate wound healing, followed by therapy for at least another 7 days to maintain factor IX activity of 30-60 IU/dL. Routine secondary prophylaxis for previously treated patient 40 IU/kg at 3- to 4-day intervals.
Contraindications
Hypersensitivity to nonacog α or hamster proteins.
Special Precautions
Discontinue use if allergic or anaphylactic reactions occur. Increased risk of anaphylaxis in patients w/ factor IX inhibitor. Risk of inhibitor formation; post-op patients; at risk of thromboembolic phenomena or DIC. Monitor for the development of factor IX inhibitors. IV administration. Hepatic disease. Pregnancy & lactation. 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 (vial) 1000 IU
Packing/Price
1's
Form
Benefix powd for inj (vial) 2000 IU
Packing/Price
1's
Form
Benefix powd for inj (vial) 250 IU
Packing/Price
1's
Form
Benefix powd for inj (vial) 500 IU
Packing/Price
1's
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