Trazimera Caution For Usage

Incompatibilities: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under Special Precautions for Disposal and Other Handling as follows.
Do not dilute with dextrose or glucose solutions.
Special Precautions for Disposal and Other Handling: 440 mg presentation: Appropriate aseptic technique should be used. Each 440 mg vial of Trastuzumab (Trazimera) is reconstituted with 20 mL of bacteriostatic water for injection (BWFI), containing 1.1% benzyl alcohol as a preservative (supplied). This yields a multi-dose solution containing 21 mg/mL trastuzumab, at a pH of approximately 6.0.
In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 mL of Sterile Water for Injection (SWFI) without preservative (not supplied) to yield a single use solution.
Trastuzumab (Trazimera) should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Trastuzumab (Trazimera) that can be withdrawn from the vial.
The reconstituted solution should not be frozen.
Instructions for reconstitution: 1) Using a sterile syringe, slowly inject the 20 mL of diluent into the vial containing the lyophilized Trastuzumab (Trazimera).
2) Swirl the vial gently to aid reconstitution. DO NOT SHAKE!
Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes. The reconstituted trastuzumab results in a clear to slightly opalescent and colorless to pale yellow-brown solution and should be essentially free of visible particulates.
Store reconstituted Trastuzumab (Trazimera) at 2°C - 8°C.
If Trastuzumab (Trazimera) is reconstituted with BWFI, discard unused Trastuzumab (Trazimera) after 28 days.
If Trastuzumab (Trazimera) is reconstituted with SWFI without preservative, the reconstituted solution is physicochemically stable for 48 hours at 2°C - 8°C. However, from a microbiological point of view, the product should be used immediately. Any remaining reconstituted solution should be discarded.
Determine the volume of the solution required: based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight: See Equation 1.

Click on icon to see table/diagram/image

based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight: See Equation 2.

Click on icon to see table/diagram/image

The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution. Do not use with dextrose- or glucose-containing solutions (See Incompatibilities as previously mentioned). The bag should be gently inverted to mix the solution in order to avoid foaming.
No incompatibilities between Trastuzumab (Trazimera) and polyvinylchloride, polyethylene, polypropylene, or ethylene vinyl acetate bags or glass IV bottles have been observed.
Solutions for intravenous infusion are physicochemically stable in polyvinylchloride, polyethylene, polypropylene, or ethylene vinyl acetate bags or glass IV bottles containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
From a microbiological point of view, the reconstituted solution (if SWFI is used) and infusion solution should be used immediately. The product is not intended to be stored after dilution unless this has taken place under controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
150 mg presentation: Appropriate aseptic technique should be used. Each 150 mg vial of Trastuzumab (Trazimera) is reconstituted with 7.2 mL of SWFI (not supplied). Use of other reconstitution solvents should be avoided.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overfill of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Trastuzumab (Trazimera) should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Trastuzumab (Trazimera) that can be withdrawn from the vial.
The reconstituted solution should not be frozen.
Instructions for reconstitution: 1) Using a sterile syringe, slowly inject 7.2 mL of SWFI in the vial containing the lyophilized trastuzumab.
2) Swirl the vial gently to aid reconstitution. DO NOT SHAKE!
Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes. The reconstituted trastuzumab results in a clear to slightly opalescent and colorless to pale yellow-brown solution and should be essentially free of visible particulates.
After reconstitution with SWFI, the reconstituted solution is physicochemically stable for 48 hours at 2°C - 8°C, however, from a microbiological point of view, the product should be used immediately. Any remaining reconstituted solution should be discarded.
Determine the volume of the solution required: based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight: See Equation 1.

Click on icon to see table/diagram/image

based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight: See Equation 2.

Click on icon to see table/diagram/image

The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution. Do not use with dextrose- or glucose-containing solutions (See Incompatibilities as previously mentioned). The bag should be gently inverted to mix the solution in order to avoid foaming.
No incompatibilities between Trastuzumab (Trazimera) and polyvinylchloride, polyethylene, polypropylene, or ethylene vinyl acetate bags or glass IV bottles have been observed.
Solutions for intravenous infusion are physicochemically stable in polyvinylchloride, polyethylene, polypropylene, or ethylene vinyl acetate bags or glass IV bottles containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
From a microbiological point of view, the reconstituted solution and infusion solution should be used immediately. The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Trastuzumab (Trazimera) is for single-use only, as the product contains no preservatives. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.