ull; Pre-filled syringe with 4 mL sterile saline diluent[NDC 0169 8008 98]
• Vial adapter1500 IU Gray NDC 0169 8150 01 • ESPEROCT in single-dose vial [NDC 0169 8151 11]
• Pre-filled syringe with 4 mL sterile saline diluent[NDC 0169 8008 98]
• Vial adapter2000 IU Yellow NDC 0169 8200 01 • ESPEROCT in single-dose vial [NDC 0169 8201 11]
• Pre-filled syringe with 4 mL sterile saline diluent[NDC 0169 8008 98]
• Vial adapter3000 IU Black NDC 0169 8300 01 • ESPEROCT in single-dose vial [NDC 0169 8301 11]
• Pre-filled syringe with 4 mL sterile saline diluent[NDC 0169 8008 98]
• Vial adapter
IU = International Units
• The ESPEROCT vials are made of glass, closed with a chlorobutyl rubber stopper (not made with natural rubber latex),and sealed with an aluminum cap.
• The pre-filled diluent syringes are made of glass with a siliconized bromobutyl rubber plunger (not made with rubberlatex).
• The closed vials and pre-filled diluent syringes are equipped with a tamper-evident snap-off cap which is made ofpolypropylene.
Storage and Handling
• Store ESPEROCT in the original package to protect the ESPEROCT vial from light.
• Store ESPEROCT in a powder form under refrigeration at 36°F to 46°F (2°C to 8°C) for up to 30 months from the dateof manufacture until the expiration date stated on the label.
• ESPEROCT may be stored at room temperature [not to exceed 86°F(30°C)] for up to 12 months within the 30-monthtime period. Record the date on the carton when the product was removed from the refrigerator. The total time of storageat room temperature should not exceed 12 months. Do not return the product to the refrigerator after room temperaturestorage.
• Do not use ESPEROCT beyond the expiration date printed on the vial or 12 months after the date it was removed fromrefrigeration (whichever is earlier).
• Do not freeze ESPEROCT.
• Use ESPEROCT within 4 hours after reconstitution when stored at room temperature, or within 24 hours when stored inthe refrigerator. Store the reconstituted product in the vial.
• Reconstituted product must be discarded after 4 hours at room temperature, or 24 hours in the refrigerator.
17 PATIENT COUNSELING INFORMATION
Advise patients:
• To read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• That allergic-type hypersensitivity reactions or anaphylaxis are possible with use of ESPEROCT. Inform patients of theearly signs of hypersensitivity reactions including rash, hives, itching, facial swelling, tightness of the chest, andwheezing. Advise patients to discontinue use of ESPEROCT immediately and contact their healthcare provider and/oseek emergency care promptly if these symptoms occur.
• To contact their healthcare provider or treatment facility for further treatment and/or assessment if they experience a lackof a clinical response to Factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM631602.pdf |
