ION and FDAapprovedpatient labeling.
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Preparation and Reconstitution
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Neutralizing Antibodies
5.3 Monitoring Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and /or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation FactorVIII 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
Limitation of Use:
ESPEROCT is not indicated for the treatment of von Willebrand disease. (1)
2 DOSAGE AND ADMINISTRATION
For intravenous infusion after reconstitution only.
2.1 Dose
• Dosage and duration of treatment depend on the severity of the Factor VIII deficiency, on the location and extent ofbleeding, and on the patient’sclinicalcondition. Careful monitoring of replacement therapy is necessary in cases ofmajor surgery or life-threatening bleeding episodes.
• Each vial of ESPEROCT contains the labeled amount of recombinant Factor VIII in international units (IU). One IU ofFactor VIII activity corresponds to the quantity of Factor VIII in one milliliter of normal human plasma. The calculationof the required dosage of Factor VIII is based on the empirical finding that one IU of Factor VIII per kg body weightraises the plasma Factor VIII activity by two IU/dL.
On–demand Treatment and Control of Bleeding Episodes
Table 1 can be used to guide dosing of ESPEROCT for treatment of bleeding episodes.
Table 1:Dosing of ESPEROCT to Control Bleeding Episodes
Type of bleeding
Adolescents/Adults
≥12 years
Dose (IU/kg)
Children
<12 years
Dose (IU/kg)
Additional doses
Minor
Early hemarthrosis, mild
muscle bleeding, or oral
bleeding
40 65 One dose should be sufficient
Moderate
More extensive hemarthrosis,
muscle bleeding, or hematoma
40 65 An additional dose may be
administered after 24 hours
Major
Life- or limb-threatening
hemorrhages, gastro- intestinal
bleeding, intracranial, intraabdominal
or intrathoracic
bleeding, fractures
50 65
Additional dose(s) may be
administered approximately every
24 hours
Perioperative Management
The dose level and dosing intervals for surgery depend on the procedure and local practice. A gui |
