Feiba

Feiba

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Factor VIII inhibitor bypassing activity
Indications/Uses
Treatment & prophylaxis of hemorrhage in hemophilia A, B & non-hemophilic patients w/ inhibitors to factor VIII, IX & XI.
Dosage/Direction for Use
Recommended dose: 50-100 U/kg; not to exceed 100 U/kg as single dose & max: 200 U/kg daily. Minor to moderate joint, muscle & soft tissue hemorrhage 50-75 U/kg at 12-hr intervals. Severe muscle & soft tissue bleeding eg, retroperitoneal hemorrhage 100 U/kg at 12-hr intervals. Mucous membrane hemorrhage 50 U/kg every 6 hr, may be increased to 100 U/kg. Max: Not to exceed 200 U/kg daily. Other severe hemorrhages eg, CNS bleeding 100 U/kg at 12-hr intervals, may be administered at 6-hr intervals. Max: Not to exceed 200 U/kg daily. Pre-op Initially 100 U/kg, then 50-100 U/kg after 6-12 hr. Post-op maintenance dose 50-100 U/kg at 6-12 hr intervals. Max: Not to exceed 200 U/kg daily. Prophylaxis of bleeding in patient w/ high inhibitor titer & frequent hemorrhages after failed immune tolerance induction (ITI) or when ITI is not considered 70-100 U/kg every other day, may be increased to 100 U/kg daily or may be decreased gradually. Prophylaxis of bleeding in patient w/ high inhibitor titer during ITI 50-100 U/kg bd w/ concomitant factor VIII administration.
Contraindications
Hypersensitivity. Disseminated intravascular coagulation (DIC); acute thrombosis or embolism (including MI).
Special Precautions
Discontinue use at 1st sign or symptom of infusion/hypersensitivity reaction, thrombotic or thromboembolic events. History of CHD, DIC, arterial or venous thrombosis, post-op immobilization; acute coronary ischemia, other thrombotic or thromboembolic events symptoms. Cases of thrombotic microangiopathy in emicizumab clinical trial where subjects received Feiba as part of breakthrough bleeding treatment regimen. Transmission of hepatitis B surface Ab & infectious agents. Initial anamnestic rise in inhibitor levels; discordant response to bypassing agents. Patients on low Na diet. High-dose use. Avoid using antifibrinolytics 6-12 hr after administration. Hepatic disease. Pregnancy & lactation. Neonates. Elderly.
Adverse Reactions
Hypersensitivity reactions; headache, dizziness; hypotension; rash; hepatitis B surface Ab +ve.
Drug Interactions
Possible thromboembolic events w/ systemic antifibrinolytics eg, tranexamic acid, aminocaproic acid. May result in thromboembolic events &/or thrombotic microangiopathy w/ emicizumab when used as part of breakthrough bleeding treatment regimen.
MIMS Class
Haemostatics
ATC Classification
B02BD03 - factor VIII inhibitor bypassing activity ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Feiba powd for inj 1,000 U
Packing/Price
1's
Form
Feiba powd for inj 500 U
Packing/Price
1's
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