Jivi (antihemophilic factor (FVIII) rec, B-domain deleted peg-aucl)
Antihemophilic Products Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Antihemophilic factor (recombinant), PEGylated-aucl is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII consisting of a B-domain-deleted factor VIII linked by site-specific conjugation to polyethylene glycol (PEG).
Antihemophilic factor (recombinant), PEGylated-aucl is a third-generation recombinant DNA-derived, factor VIII concentrate that temporarily replaces the missing coagulation factor VIII needed for effective hemostasis in patients with hemophilia A. The active protein is a B-domain-deleted human coagulation factor VIII conjugated in a site-specific manner to a single (dual-branched) polyethylene glycol (PEG) molecule. The site-specific PEGylation reduces binding to the physiological factor VIII clearance receptors and prolongs the half-life of the drug.
Coagulation factor VIII is essential for blood clotting and maintenance of hemostasis. Administration of antihemophilic factor (recombinant), PEGylated-aucl to patients with hemophilia A results in increased plasma levels of factor VIII and temporarily corrects the coagulation defect in these patients. When antihemophilic factor (recombinant), PEGylated-aucl is used for replacement therapy, administration of 1 unit/kg generally increases plasma factor VIII activity by approximately 2 IU/dL.
Treatment with antihemophilic factor (recombinant), PEGylated-aucl normalizes the activated partial thromboplastin time (aPTT), which is prolonged in patients with hemophilia A.
Antihemophilic factor (recombinant), PEGylated-aucl is produced by recombinant DNA technology in baby hamster kidney (BHK) cells. The BHK cell line used to produce antihemophilic factor (recombinant), PEGylated-aucl into a defined cell culture does not contain any proteins derived from animal or human sources. Compared with plasma-derived antihemophilic factor preparations, recombinant preparations of antihemophilic factor are associated with a substantially reduced risk of transmission of bloodborne human viruses (e.g., human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV)).
USES: This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles).
This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.
Generic name: antihemophilic factor (FVIII) rec, B-domain deleted peg-aucl
Pronunciation: (AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Jivi
Indications
The following indications are listed for Jivi:
- Bleeding Episode In Hemophilia A
- Bleeding Prevention In Hereditary Factor Viii Deficiency
- Hemophilia A
Also known as: Bleeding Prevention In Classic Hemophilia, Bleeding Prevention In Congenital Factor Viii Deficiency, Bleeding Prevention In Hemophilia A, Bleeding Prophylaxis In Hemophilia A, Congenital Factor Viii Deficiency Disease, Hemorrhage Prophylaxis In Hemophilia A, Hemorrhaging In Hemophilia A, Prevention Of Bleeding Episode In Hemophilia A.
Dosing
Dosage and potency of antihemophilic factor (recombinant), PEGylated-aucl are expressed in terms of international units (IU, units) of antihemophilic factor activity; one IU is defined by the current World Health Organization (WHO) international standard for factor VIII concentrate. Calculation of the required dose of factor VIII is based on the empirical finding that 1 IU of factor VIII per kg body weight increases the plasma factor VIII level by 2 IU/dL.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to antihemophilic factor (recombinant) or any ingredient in the formulation, including polyethylene glycol (PEG), or murine or hamster protein.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reactions (incidence >=5%) in clinical trials include headache, fever, cough, and abdominal pain.
Less Frequent
- Allergic dermatitis
- Anaphylaxis
- Angioedema
- Dyspnea
- Erythema
- Fibrinogen excess
- Skin rash
- Thrombotic disorder
- Urticaria
Rare or Very Rare
- Acute myocardial infarction
- Cerebrovascular accident
- Chest tightness
- Disseminated intravascular coagulation
- Hemolytic anemia
- Hypersensitivity drug reaction
- Hypertension
- Injection site infection
- Pulmonary thromboembolism
- Thromboembolic disorder
- Wheezing
More Frequent
- Dizziness
- Fever
- Headache disorder
- Injection site sequelae
- Nausea
Less Frequent
- Chest discomfort
- Chills
- Drowsy
- Dyspepsia
- Flushing
- Insomnia
- Lethargy
- Pruritus of skin
- Upper respiratory infection
- Vomiting
Rare or Very Rare
- Acute abdominal pain
- Cough
- Diarrhea
- Dysgeusia
- Fatigue
- Hypotension
- Paresthesia
- Sensation of warmth
- Tachycardia
Precautions
No enhanced messaging available.
Safety and efficacy of antihemophilic factor (recombinant), PEGylated-aucl have been established in previously treated pediatric patients >=7 years of age. The use of antihemophilic factor (recombinant), PEGylated-aucl in this patient population is supported by evidence from clinical studies including 108 pediatric patients (2 to <12 years of age) and 12 pediatric patients (12 to <17 years of age).
Antihemophilic factor (recombinant), PEGylated-aucl is not indicated for use in pediatric patients <7 years of age; safety and efficacy of antihemophilic factor (recombinant), PEGylated-aucl have not been studied in pediatric patients <2 years of age.
It is not known whether antihemophilic factor (recombinant), PEGylated-aucl can cause fetal harm when administered to pregnant women or affect reproductive capacity. There are no data on use of the drug in pregnant women and no animal developmental and reproductive toxicity studies have been conducted.
It is not known whether antihemophilic factor (recombinant), PEGylated-aucl is distributed into human milk; the effects of the drug on the breastfed infant or on milk production are also unknown. Consider the known benefits of breastfeeding along with the mother's clinical need for antihemophilic factor (recombinant), PEGylated-aucl and any potential adverse effects of the drug or underlying maternal condition on the infant.
Clinical studies of antihemophilic factor (recombinant), PEGylated-aucl in patients >=65 years of age have not been conducted.
ICD codes
| Code | Type | Description |
|---|---|---|
| Bleeding episode in hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
| Bleeding prevention in hereditary factor VIII deficiency | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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