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IV formulation: Reconstitution: Herzuma should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted Herzuma solution may result in problems with the amount of Herzuma solution that can be withdrawn from the vial.
Instructions for reconstitution – 440 mg vial: Reconstitution is to be performed with bacteriostatic water for injection, containing 1.1% benzyl alcohol, as supplied. This yields a solution for multiple use, containing 21 mg/ml trastuzumab, at a pH of approximately 6.0. Use of other reconstitution solvents should be avoided except for sterile water for injection in case of a patient with a known hypersensitivity to benzyl alcohol.
1. Using a sterile syringe, slowly inject 20 ml of Bacteriostatic Water for Injection into the vial containing the lyophilized Herzuma, directing the stream into the lyophilized cake.
2. Swirl vial gently to aid reconstitution. DO NOT SHAKE!
Instructions for reconstitution – 150 mg vial: 1. Using a sterile syringe, slowly inject 7.2 ml of sterile water for injection into the vial containing the lyophilized Herzuma, directing the stream into the lyophilized cake.
2. Swirl 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 Herzuma results in a colourless to pale yellow transparent solution and should be essentially free of visible particles.
Dilution of the reconstituted solution: 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/imageBased 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Click on icon to see table/diagram/imageThe appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 ml of 0.9% sodium chloride. Dextrose (5%) solution should not be used (see Incompatibilities as follows). The bag should be gently inverted to mix the solution in order to avoid foaming. Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. Once the infusion is prepared it should be administered immediately (see Storage).
Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems", if available in your location.
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps: Needles and syringes should never be reused.
Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Dispose of the full container according to local requirements.
Incompatibilities: No incompatibilities between trastuzumab and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Dextrose (5%) solution should not be used since it causes aggregation of the protein.
Trastuzumab should not be mixed or diluted with other drugs.
