Octanine Dosage & Drug Information

Concise Prescribing Info

Contents

Human coagulation factor IX w/ nanofiltration

Indications/Uses

Treatment & prophylaxis of bleeding in patients w/ haemophilia B (congenital factor IX deficiency).

Dosage/Direction for Use

IV Early haemarthrosis, muscle or oral bleeding 20-40 IU/dL every 24 hr for at least 1 day or until resolved. More extensive haemarthrosis, muscle bleeding or haematoma 30-60 IU/dL every 24 hr for ≥3-4 days or until resolved. Life-threatening haemorrhages eg, head injury, throat or severe abdominal bleeding episodes 60-100 IU/dL every 8-24 hr until resolved. Minor surgery eg, tooth extraction 30-60 IU/dL every 24 hr for at least 1 day. Major surgery (pre- & post-op) 80-100 IU/dL every 8-24 hr. Long-term prophylaxis against bleeding in patient w/ severe haemophilia B 10-25 IU/kg at intervals of 3-4 days.

Contraindications

Hypersensitivity. Known heparin allergy or history of heparin-induced thrombocytopenia type II.

Special Precautions

Discontinue use if early signs of hypersensitivity reactions eg, hives, generalised urticaria, chest tightness, wheezing, hypotension & anaphylaxis occur. Patients w/ signs of fibrinolysis & w/ disseminated intravascular coagulation (DIC); post-op patients, risk of thrombotic events or DIC. Appropriate vaccination against hepatitis A & B for patients in receipt of factor IX products. Monitor for development of factor IX inhibitors. Hepatic disease. Pregnancy & lactation. Childn <6 yr. Newborns.

MIMS Class

Haemostatics

ATC Classification

B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

Regulatory Classification

Presentation/Packing

Form

Octanine soln for infusion 500 IU/5 mL

Packing/Price

1's

Octanine

factor ix

Manufacturer:

Octapharma

Distributor:

Pharmaniaga Manufacturing Berhad