Esperoct

Drug overview for ESPEROCT (antihemophilic factor (fviii) rec, b-dom truncated peg-exei):

Generic name: antihemophilic factor (FVIII) rec, B-dom truncated peg-exei (AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents

Antihemophilic factor (recombinant), glycopegylated-exei is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII conjugated with a polyethylene glycol (PEG) molecule.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for ESPEROCT (antihemophilic factor (fviii) rec, b-dom truncated peg-exei) 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 ESPEROCT (antihemophilic factor (fviii) rec, b-dom truncated peg-exei):

Overview
Severe
Less Severe

Adverse reaction overview.

The most commonly reported adverse effects in clinical trials (incidence >=1%) were rash, redness, pruritus, and injection site reactions.

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 ESPEROCT (antihemophilic factor (fviii) rec, b-dom truncated peg-exei):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of antihemophilic factor (recombinant), glycopegylated-exei were evaluated in 93 previously treated pediatric patients <18 years of age, who received at least 1 dose of the drug for routine prophylaxis. No differences in safety were noted between previously treated pediatric patients and adult patients. Pharmacokinetic parameters were evaluated in 27 of the pediatric patients treated with antihemophilic factor (recombinant), glycopegylated-exei.

Compared to adults, pediatric patients <12 years of age had higher clearance, a shorter half-life, and lower incremental recovery of factor VIII, although the pharmacokinetic parameters were similar between young children (1-<6 years) and older children (6-<12 years). Pediatric patients <12 years of age may need a higher dose and more frequent dosing than adults because they have higher clearance (per kg body weight).

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

It is not known whether antihemophilic factor (recombinant), glycopegylated-exei can cause fetal harm when administered to pregnant women or affect fertility. There are no data with use of the drug in pregnant women to determine whether there is a risk.

It is unknown whether antihemophilic factor (recombinant), glycopegylated-exei is distributed into human milk; the effects on the breastfed infant and milk production are also unknown. The known benefits of breast-feeding should be considered along with the mother's clinical need for antihemophilic factor (recombinant), glycopegylated-exei and any potential adverse effects of the drug or underlying maternal condition on the infant.

Clinical studies of antihemophilic factor (recombinant), glycopegylated-exei did not include sufficient numbers of patients 65 years of age and older to determine whether or not geriatric patients respond differently than younger patients. Other reported clinical experience has not found differences in responses between geriatric and younger patients. In general, dosage selection of antihemophilic factor (recombinant), glycopegylated-exei should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, and of concomitant disease and other drug therapy.

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