.
12K
Pooling
If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. Use a larger plastic syringe (not provided) to combine the content of the vials into the syringe.
2.3 Administration
For intravenous use only.
•Inspect reconstituted KOVALTRY visually for particulate matter and discoloration prior to administration. Do not use if you notice any particulate matter or discoloration and immediately contact Bayer Medical Communications at 1-888-84-BAYER (1-888-842-2937).
•Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.
•Infuse KOVALTRY intravenously over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient.
CLOSE
3 DOSAGE FORMS AND STRENGTHS
KOVALTRY is available as a lyophilized powder in single-use glass vials containing nominally 250, 500, 1000, 2000, or 3000 IU of recombinant Factor VIII per vial.
Each vial of KOVALTRY is labeled with actual Factor VIII potency expressed in IU determined using a chromogenic substrate assay. This potency assignment employs a Factor VIII concentrate standard that is referenced to the current WHO International Standard for Factor VIII concentrate, and is eva luated by appropriate methodology to ensure accuracy of the results.
4 CONTRAINDICATIONS
KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY if symptoms occur and seek immediate emergency treatment.
KOVALTRY may contain trace amounts of mouse and hamster proteins [see Description (11)]. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
5.2 Neutralizing Antibodies
Neutralizing antibody (inhibitor) formation can occur following administration of KOVALTRY. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all Factor VIII products [see Adverse Reactions (6.1)]. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody) [see Warnings and Precautions (5.5)].
5.3 Cardiovascular Risk Factors
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
5.4 Catheter-related Infections
Catheter-related infections may be observed when KOVALTRY is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.
5.5 Monitoring Laboratory Tests
•Monitor plasma Factor VIII activity levels using a validated test to confirm that adequate Factor VIII levels h |
