Generic drug: Anti-Inhibitor Coagulant Complex

Brand Feiba Vh: Feiba Vh

What is Feiba Vh (Anti-Inhibitor Coagulant Complex), and how does it work?

Feiba is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

Feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

What are the side effects of Feiba Vh?

WARNING

THROMBOEMBOLIC EVENTS

Thromboembolic events have been reported during post-marketing surveillance following infusion of Feiba, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving Feiba for signs and symptoms of thromboembolic events.

The most frequently reported adverse reactions observed in > 5% of subjects in the prophylaxis trial were

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including

QUESTION

Sickle cell disease is named after a farming tool. See Answer

What is the dosage for Feiba Vh?

For intravenous use after reconstitution only.

Dose

A guide for dosing Feiba is provided in Table 1.

Table 1 : Dosing Guidelines

  Dose (unit/kg) Frequency of Doses (hours) Duration of Therapy
Control and Prevention of Bleeding
Joint Hemorrhage 50-100 12 Until pain and acute disabilities are improved.
Mucous Membrane Bleeding 50-100 6 At least 1 day or until bleeding is resolved.
Soft Tissue Hemorrhage (e.g., retroperitoneal bleeding) 100 12 Until resolution of bleed.
Other Severe Hemorrhage (e.g., CNS bleeds) 100 6-12 Until resolution of bleed.
Perioperative Management
Preoperative 50-100 One time dose Immediately prior to surgery.
Postoperative 50-100 6-12 Until resolution of bleed and healing is achieved.
Routine Prophylaxis
  85 Every other day  

  • Dosage and duration of treatment depend on the location and extent of bleeding, and the patient's clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery of life-threatening bleeding episodes.
  • Each vial of Feiba contains the labeled amount of factor VIII inhibitor bypassing activity in units.
  • Base the dose and frequency of Feiba on the individual clinical response. Clinical response to treatment with Feiba may vary by patient, and may not correlate with the patient's inhibitor titer.
  • Record the name of the patient and batch number of the product in order to maintain a link between the patient and the batch of the product.
  • Do not exceed a single dose of 100 units per kg body weight and a daily dose of 200 units per kg body.

What drugs interact with Feiba Vh?

Concomitant Medications

  • Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with Feiba.
  • No adequate and wellcontrolled studies of the combined or sequential use of Feiba and recombinant factor VIIa or antifibrinolytics have been conducted.
  • Use of antifibrinolytics within approximately 6 to 12 hours after the administration of Feiba is not recommended.

Is Feiba Vh safe to use while pregnant or breastfeeding?

  • There are no adequate and well-controlled studies in pregnant women. It is also not known whether Feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
  • Feiba should be administered to pregnant women only if clearly needed.
  • It is not known whether this drug is excreted in human milk.
  • Because many drugs are excreted in human milk, caution should be exercised when Feiba is administered to a nursing woman.

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Summary

Feiba is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for control and prevention of bleeding episodes, perioperative management, or routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

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Medically Reviewed on 2/26/2021
References
All sections courtesy of the U.S. Food and Drug Administration