Herceptin/Herceptin SC Caution For Usage

Special Instructions for Use, Handling and Disposal: Appropriate aseptic technique should be used.
Herceptin IV: Reconstitution: Herceptin should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin solution may result in problems with the amount of Herceptin solution that can be withdrawn from the vial.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 uses, 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 Herceptin, 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 Herceptin, 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 Herceptin 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/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.

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The appropriate amount of solution should be withdrawn from the vial using a sterile needle and syringe and added to an infusion bag containing 250 ml of 0.9% sodium chloride.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. Care must be taken to ensure the sterility of prepared solutions. Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed. 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).
Incompatibilities: No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Dextrose (5%) solution should not be used since it causes aggregation of the protein.
Herceptin should not be mixed or diluted with other drugs.
Herceptin SC: The 600 mg/5 ml solution is a ready to use solution for injection which does not need to be diluted.
Herceptin should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Herceptin solution for injection is for single-use only.
Once transferred from the vial to the syringe, the medicine should be used immediately, from a microbiological point of view, since the medicine does not contain any antimicrobial-preservative. If not used immediately, preparation should take place in controlled and validated aseptic conditions. Once transferred from the vial to the syringe, the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (do not store above 30°C) in diffused daylight (see Storage).
After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product. The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 5 ml.
Incompatibilities: No incompatibilities between Herceptin and the following materials have been observed: propylene or polycarbonate syringe, stainless steel transfer, injection needles, polyethylene luer cones stoppers.
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 the 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.
Local requirements should be followed for the disposal process of unused/expired medicines or waste material.