removing the syringe, gently swirl the ESPEROCT vial until all of the powder is dissolved. Avoid shaking the
2.3 Administration
For intravenous infusion only.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration,whenever solution and container permit. The solution should be clear and have no particles. Do not use if particulatematter or discoloration is observed.
• Do not administer ESPEROCT in the same tubing or container with other medicinal products.
• Administer the ESPEROCT solution immediately [see Administration (2.3)]. If not used immediately afterreconstitution, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≤ 86°F(30°C) for ≤ 4 hours, or stored in a refrigerator at 36°F to 46°F (2°C to 8°C) for ≤ 24 hours.
1. Invert the ESPEROCT vial and slowly draw the solution into the syringe.
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2. Detach the syringe from the vial adapter by turning the syringe counterclockwise.
3. Attach the syringe to the luer end of an infusion needle set.
4. Infuse the reconstituted ESPEROCT intravenously slowly over approximately 2 minutes.
5. After infusion, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused ESPEROCT,and other waste materials.
Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches and is compatible with
a standard Luer-lock connector.
Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certainconnectors with an internal spike, such as Clave®/MicroClave®, InVision-Plus®, InVision-Plus CS®, Invision-Plus Junior®,Bionector®), and their use can damage the connector and affect administration. To administer ESPEROCT throughincompatible needleless connectors, withdraw the reconstituted product into a standard 10 mL sterile Luer-lock plasticsyringe.
3 DOSAGE FORMS AND STRENGTHS
ESPEROCT is available as a sterile white to off-white lyophilized powder supplied in single-dose vials containing nominally500, 1000, 1500, 2000 or 3000 IU. The actual FVIII activity is printed on each ESPEROCT vial and carton.
After reconstitution with 4 mL of saline diluent, the reconstituted solution contains approximately 125, 250, 375, 500 or 750IU per mL of ESPEROCT, respectively.
4 CONTRAINDICATIONS
ESPEROCT is contraindicated in patients who have known hypersensitivity to ESPEROCT or its components (includinghamster proteins) [see Warnings and Precautions (5.1) and Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with ESPEROCT. The product contains traces ofhamster proteins, which in some patients may cause allergic reactions [see Description (11)]. Early signs of allergic reactions,which can progress to anaphylaxis, may include angioedema, chest tightness, difficulty breathing, wheezing, rash, hives, anditching. Observe patients for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases ofexposure to the product. Discontinue use of ESPEROCT if allergic- or anaphylactic-type reactions occur, and initiateappropriate treatment.
5.2 Neutralizing Antibodies
The formation of neutralizing antibodies (inhib |
