Ogivri Caution For Usage

Incompatibilities: Trastuzumab (Ogivri) must not be mixed or diluted with other medicinal products except those mentioned under instructions for reconstitution as follows.
Do not dilute with glucose solutions since these cause aggregation of the protein.
Preparation for Administration: To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is Trastuzumab and not ado-trastuzumab emtansine.
440 mg Multiple-dose vial: Reconstitution: Reconstitute each 440 mg vial of Trastuzumab (Ogivri) with 20 mL of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative to yield a multiple-dose solution containing 21 mg/mL trastuzumab that delivers 20 mL (440 mg trastuzumab). In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 mL of Sterile Water for Injection (SWFI) without preservative to yield a single use solution.
Use appropriate aseptic technique when performing the following reconstitution steps: Using a sterile syringe, slowly inject the 20 mL of diluent into the vial containing the lyophilized cake of Trastuzumab (Ogivri). The stream of diluent should be directed into the lyophilized cake. The reconstituted vial yields a solution for multiple-dose use, containing 21 mg/mL trastuzumab.
Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed for approximately 5 minutes.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect visually for particulates and discoloration. The solution should be free of visible particulates, clear to slightly opalescent and colorless to pale yellow.
Store reconstituted Trastuzumab (Ogivri) in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused Trastuzumab (Ogivri) after 28 days. If Trastuzumab (Ogivri) is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze.
Dilution: Determine the dose (mg) of Trastuzumab (Ogivri) [see Dosage & Administration]. Calculate the volume of the 21 mg/mL reconstituted Trastuzumab (Ogivri) solution needed, withdraw this amount from the vial and add it to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. DO NOT USE DEXTROSE (5%) SOLUTION.
Gently invert the bag to mix the solution.
The solution of Trastuzumab (Ogivri) for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C (36°F to 46°F) for no more than 24 hours prior to use. Discard after 24 hours. This storage time is additional to the time allowed for the reconstituted vials. Do not freeze.
150 mg Single-dose vial: Reconstitution: Reconstitute each 150 mg vial of Trastuzumab (Ogivri) with 7.2 mL of Sterile Water for Injection (SWFI) (not supplied) to yield a single-dose solution containing 21 mg/mL trastuzumab. Use appropriate aseptic technique when performing the following reconstitution steps: Using a sterile syringe, slowly inject 7.2 mL of SWFI (not supplied) into the vial containing the lyophilized 150 mg Trastuzumab (Ogivri), directing the diluent stream into the lyophilized cake. The reconstituted vial yields a solution for single-dose use, containing 21 mg/mL trastuzumab.
Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed for approximately 5 minutes.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect visually for particulates and discoloration. The solution should be free of visible particulates, clear to slightly opalescent and colorless to pale yellow.
Use the Trastuzumab (Ogivri) solution immediately following reconstitution with SWFI, as it contains no preservative and is intended for single-dose only. If not used immediately, store the reconstituted Trastuzumab (Ogivri) solution for up to 90 days at 2°C to 8°C (36°F to 46°F); discard any unused Trastuzumab (Ogivri) after 90 days. Do not freeze.
Dilution: Determine the dose (mg) of Trastuzumab (Ogivri) [see Dosage & Administration].
Calculate the volume of the 21 mg/mL reconstituted Ogivri solution needed.
Withdraw this amount from the vial and add it to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. DO NOT USE DEXTROSE (5%) SOLUTION.
Gently invert the bag to mix the solution.
The solution of Trastuzumab (Ogivri) for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C (36°F to 46°F) for no more than 90 days prior to use. Discard after 90 days. This storage time is additional to the time allowed for the reconstituted vials. Do not freeze.
Special precautions for disposal and other handling: Any unused medicinal product should be disposed of in accordance with the local requirements.