Sevenfact

Drug overview for SEVENFACT (coagulation factor viia recombinant-jncw):

Generic name: coagulation factor VIIa recombinant-jncw (factor VIIA,ree-KOM-bin-unt)
Drug class: Factor VII
Therapeutic class: Hematological Agents

Factor VIIa (recombinant) is a biosynthetic preparation of blood coagulation factor VIIa prepared using recombinant DNA technology.

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.

DRUG IMAGES

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The following indications for SEVENFACT (coagulation factor viia recombinant-jncw) have been approved by the FDA:

Indications:
Bleeding episode in hemophilia A
Bleeding episode in hemophilia B

Professional Synonyms:
Hemorrhaging in hemophilia A
Hemorrhaging in hemophilia B

Moderate List
Atherosclerotic cardiovascular disease
Cerebrovascular accident
Crushing injury
Sepsis
Thromboembolic disorder

The following adverse reaction information is available for SEVENFACT (coagulation factor viia recombinant-jncw):

Overview
Severe
Less Severe

Adverse reaction overview.

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.

There are 22 severe adverse reactions.

More Frequent	Less Frequent
Hypertension	Hypofibrinogenemia

Rare/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

Rare/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

There are 11 less severe adverse reactions.

More Frequent	Less Frequent
Fever Headache disorder Nausea Pain Skin rash	None.

Rare/Very Rare
Angina Dyspnea Injection site sequelae Osteoarthritis Purpura Vomiting

The following precautions are available for SEVENFACT (coagulation factor viia recombinant-jncw):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.)

Bleeding episode in hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier
Bleeding episode in hemophilia B
D67	Hereditary factor IX deficiency