Sevenfact (coagulation factor VIIa recombinant-jncw)
Factor VII Intravenous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Factor VIIa (recombinant) is a biosynthetic preparation of blood coagulation factor VIIa prepared using recombinant DNA technology.
Factor VIIa (recombinant) is a sterile, lyophilized powder containing biosynthetic blood coagulation factor VIIa prepared using recombinant DNA technology. Factor VIIa (recombinant) is structurally similar to endogenous human factor VIIa and promotes hemostasis through activation of the extrinsic blood coagulation pathway. Factor VIIa is a cofactor in the activation of factor X (Stuart-Prower factor) to factor Xa and factor IX (Christmas factor) to IXa.
Following injury to the vessel wall, tissue factor (TF) is exposed to circulating blood; factor VIIa forms complexes with TF on TF-bearing cells, where these complexes activate factor X to factor Xa and factor IX to factor IXa. Factor Xa, in the presence of activated factor V (labile factor), negatively charged phospholipids, and calcium, converts prothrombin to thrombin and subsequently fibrinogen is converted to fibrin to form a hemostatic plug that provides local hemostasis. This process may also occur on the surface of activated platelets.
Factor VIIa (recombinant) produces hemostasis in the absence of factor VIII or factor IX by binding to activated platelets and directly activating factor X to generate thrombin independently of TF. Administration of factor VIIa (recombinant) increases circulating concentrations of factor VIIa approximately 1000-fold higher than physiologic levels.
Factor VIIa (recombinant) is used for the treatment and prevention of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor (factor VIII) deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively. The drug also is used for the treatment and prevention of hemorrhagic episodes in patients with acquired hemophilia (i.e., those with acquired inhibitors to factor VIII or IX). In addition, factor VIIa (recombinant) is used for the treatment and prevention of hemorrhagic episodes in patients with congenital factor VII deficiency.
Generic name: coagulation factor VIIa recombinant-jncw
Pronunciation: (factor VIIA,ree-KOM-bin-unt)
Drug class: Factor VII
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Sevenfact
Indications
The following indications are listed for Sevenfact:
- Bleeding Episode In Hemophilia A
- Bleeding Episode In Hemophilia B
Also known as: Hemorrhaging In Hemophilia A, Hemorrhaging In Hemophilia B.
Dosing
No dosing information is available for this tab.
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
The manufacturer states that there are no known contraindications to the use of factor VIIa (recombinant).
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Atherosclerotic cardiovascular disease
- Cerebrovascular accident
- Crushing injury
- Sepsis
- Thromboembolic disorder
Adverse reactions
The most common adverse effects reported in clinical trials in patients receiving factor VIIa (recombinant) include fever, hemorrhage, hypertension, hypotension, injection site reaction, arthralgia, headache, nausea, vomiting, pain, edema, and rash.
More Frequent
- Hypertension
Less Frequent
- Hypofibrinogenemia
Rare or Very Rare
- Acute myocardial infarction
- Anaphylaxis
- Arterial thrombosis
- Bradycardia
- Cerebral ischemia
- Cerebrovascular accident
- Deep venous thrombosis
- Disseminated intravascular coagulation
- Edema
- Hypersensitivity drug reaction
- Hypotension
- Intracranial hypertension
- Myocardial ischemia
- Peripheral ischemia
- Pneumonia
- Pruritus of skin
- Pulmonary thromboembolism
- Renal artery thrombosis
- Thrombophlebitis
- Thrombotic disorder
More Frequent
- Fever
- Headache disorder
- Nausea
- Pain
- Skin rash
Rare or Very Rare
- Angina
- Dyspnea
- Injection site sequelae
- Osteoarthritis
- Purpura
- Vomiting
Precautions
No enhanced messaging available.
Factor VIIa (recombinant) (NovoSeven(R) RT) has not been evaluated in patients 16 years of age or younger to determine if there are differences in safety and efficacy among various pediatric age groups. In clinical trials involving pediatric patients, dosing was determined according to body weight and not according to age. The predecessor product (Novoseven(R)) has been used in a limited number of pediatric patients 6 months of age and older with hemophilia and in a limited number of neonates with factor VII deficiency; no substantial differences in safety and efficacy were observed relative to adults.
Category C. (See Users Guide.)
Not known whether factor VIIa (recombinant) is distributed into milk. Discontinue nursing or drug, taking into account the importance of the drug to the woman.
Experience in those 65 years of age or older is insufficient to determine whether they respond differently than younger adults. Because of the potential increased risk of thromboembolism in geriatric patients, factor VIIa (recombinant) should be used with caution in this population. (See Thromboembolic Events under Warnings/Precautions: Warnings, in Cautions.)
ICD codes
| Code | Type | Description |
|---|---|---|
| Bleeding episode in hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
| Bleeding episode in hemophilia B | ||
| D67 | ICD10CM | Hereditary factor IX deficiency |
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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