HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ESPEROCT® safely and effectively. See full prescribing information for
ESPEROCT.
ESPEROCT（antihemophilic factor[recombinant], glycopegylated-exei）lyophilized powder for solution, for intravenous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
ESPEROCT（antihemophilic factor[recombinant], glycopegylated-exei）is acoagulation Factor VIII concentrate indicated for use in adults and children
with hemophilia A for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes。
ESPEROCT is not indicated for the treatment of von Willebrand disease.
DOSAGE AND ADMINISTRATION
For intravenous infusion after reconstitution only
• Each vial label for ESPEROCT states the actual Factor VIII activity ininternational units(IU).
• On-demand treatment/control of bleeding episodes: In adolescents/adults, 40 IU/kg body weight for minor/moderate bleeds and 50 IU/kgbody weight for major bleeds; children (<12 years), 65 IU/kg bodyweight for minor/moderate/major bleeds.
• Perioperative management: For minor/major surgery: In adolescents/adults: pre-operative dose of 50IU/kg body weight; in children(<12years), pre-operative dose of 65 IU/kg body weight. Frequency ofadministration is determined by the treating physician.
• Routine prophylaxis: In adolescents/adults, 50 IU/kg every 4 days; inchildren (<12 years), 65IU/kg twice weekly. A regimen may beindividually adjusted to less or more frequent dosing based on bleedingepisodes.
• ESPEROCT also may be dosed to achieve a specific target Factor VIIIactivity level, depending on the severity of hemophilia, for on-demandtreatment/control of bleeding episodes or perioperative management. Toachieve a specific target Factor VIII activity level, use the followingformula:
Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL
or % normal)×0.5(IU/kg per IU/dL).
DOSAGE FORMS AND STRENGTHS
ESPEROCT is available as a lyophilized powder in single-dose vials ofdosage strengths at 500, 1000, 1500, 2000 and 3000 IU per vial.
CONTRAINDICATIONS
Do not use in patients who have known hypersensitivity to ESPEROCT or itscomponents, including hamster proteins.
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions, including anaphylaxis, may occur. If ahypersensitivity reaction occurs, discontinue ESPEROCT and administerappropriate treatment.
• Development of neutralizing antibodies (inhibitors) has occurred. Ifbleeding is not controlled with the recommended dose of ESPEROCT,or if the expected plasma Factor VIII activity levels are not attained,then perform an assay that measures Factor VIII inhibitor concentration.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1%) were rash, redness,itching and injection site reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Novo NordiskInc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Higher clearance (based on kg body weight), a shorter half-lifeand lower incremental recovery are seen in children. Higher and morefrequent dosing may be needed.
See 17 for PATIENT COUNSELING INFORMAT |
