Adynovate

Drug overview for ADYNOVATE (antihemophilic factor (fviii) recombinant, full length, peg):

Generic name: ANTIHEMOPHILIC FACTOR (FVIII) RECOMBINANT, FULL LENGTH, PEG (AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents

Antihemophilic factor (recombinant) is a biosynthetic (recombinant DNA origin) preparation of antihemophilic factor (blood coagulation factor VIII). The drug is structurally similar to endogenous human factor VIII and produces the same biologic effects as plasma-derived antihemophilic factor (human).

No enhanced Uses information available for this drug.

DRUG IMAGES

No Image Available

The following indications for ADYNOVATE (antihemophilic factor (fviii) recombinant, full length, peg) have been approved by the FDA:

Indications:
Bleeding episode in hemophilia A
Bleeding prevention in hereditary factor VIII deficiency
Hemophilia A

Professional Synonyms:
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

Moderate List
No disease contraindications

The following adverse reaction information is available for ADYNOVATE (antihemophilic factor (fviii) recombinant, full length, peg):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 20 severe adverse reactions.

More Frequent	Less Frequent
None.	Allergic dermatitis Anaphylaxis Angioedema Dyspnea Erythema Fibrinogen excess Skin rash Thrombotic disorder Urticaria

Rare/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

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Dizziness Fever Headache disorder Injection site sequelae Nausea	Chest discomfort Chills Drowsy Dyspepsia Flushing Insomnia Lethargy Pruritus of skin Upper respiratory infection Vomiting

Rare/Very Rare
Acute abdominal pain Cough Diarrhea Dysgeusia Fatigue Hypotension Paresthesia Sensation of warmth Tachycardia

The following precautions are available for ADYNOVATE (antihemophilic factor (fviii) recombinant, full length, peg):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Animal reproduction studies have not been performed to date with antihemophilic factor (recombinant). It is not known whether antihemophilic factor (recombinant) can cause fetal harm when administered to pregnant women, and the drug should be used during pregnancy only when clearly needed.

It is not known whether antihemophilic factor (recombinant) is distributed into human milk. Because many drugs are distributed into milk, caution should be exercised when antihemophilic factor (recombinant) is used in nursing women. Some manufacturers state that the drug should be used in nursing women only if clinically indicated.

No enhanced Geriatric Use information available for this drug.

Bleeding episode in hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier
Bleeding prevention in hereditary factor VIII deficiency
D66	Hereditary factor VIII deficiency
Hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier