Adynovate (antihemophilic factor (FVIII) recombinant, full length, peg)
Antihemophilic Products Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Antihemophilic factor (recombinant) pegylated is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII consisting of full-length antihemophilic factor conjugated to polyethylene glycol (PEG).
Antihemophilic factor (recombinant), PEGylated is a third-generation recombinant DNA-derived, factor VIII concentrate that temporarily replaces the missing coagulation factor VIII in patients with hemophilia A. Full-length human coagulation factor VIII is conjugated with one or more molecules of polyethylene glycol (PEG). Pegylation of the parent molecule reduces binding to the physiological factor VIII clearance receptor and prolongs half-life of the drug.
The elimination half-life of antihemophilic factor (recombinant), PEGylated is 14.7 hours compared to an average half-life of 8-12 hours in non-fusion protein plasma-derived or other recombinant factor VIII products.
Coagulation factor VIII is essential for blood clotting and maintenance of hemostasis. Administration of antihemophilic factor (recombinant), PEGylated 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 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 normalizes the activated partial thromboplastin time (aPTT), which is prolonged in patients with hemophilia A.
Antihemophilic factor (recombinant), PEGylated is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell lines. The cell line used to produce the factor product 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)).
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information.
The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
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) recombinant, full length, peg
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 Adynovate
Indications
The following indications are listed for Adynovate:
- 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 are expressed in terms of international units (IU, units) of antihemophilic factor activity; one IU corresponds to the activity of factor VIII contained in one milliliter of normal human plasma. 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
*History of anaphylactic reaction to antihemophilic factor (recombinant), PEGylated, the parent molecule (antihemophilic factor (recombinant)), or any ingredient in the formulation including 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 reported in >=1% of patients in clinical studies were headache, diarrhea, rash, nausea, dizziness, and urticaria.
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 have been evaluated in 91 previously treated pediatric patients 1 year to <18 years of age who received at least one dose of antihemophilic factor (recombinant), PEGylated as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management. Adolescents 12 to <18 years of age were enrolled in the adult and adolescent safety and efficacy trial, and children <12 years of age were enrolled in a pediatric trial. The safety and efficacy of antihemophilic factor (recombinant), PEGylated in routine prophylaxis and the treatment of bleeding episodes were comparable between children and adults.
Pharmacokinetic studies in children (<12 years) have demonstrated higher clearance, shorter half-life, and lower incremental recovery of factor VIII compared to adults. Because clearance (based on body weight per kg) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on body weight may be needed in this population.
There are no data with antihemophilic factor (recombinant), PEGylated use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with the drug. It is not known whether antihemophilic factor (recombinant), PEGylated can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
It is not known whether antihemophilic factor (recombinant), PEGylated distributes into human milk; the effects of the drug on the breastfed infant or on milk production also are not known.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for antihemophilic factor (recombinant), PEGylated and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.
Clinical studies of antihemophilic factor (recombinant), PEGylated did not include patients >=65 years of age.
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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