Generic name: TRASTUZUMAB 420mg in 50mL;
Dosage form: injection
Medically reviewed by Drugs.com. Last updated on Dec 14, 2018.
Select patients for HERZUMA therapy based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Usage (1) and Clinical Studies (14)]. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
Recommended Doses and Schedules
- Do not administer as an intravenous push or bolus. Do not mix HERZUMA with other drugs.
- Do not substitute HERZUMA (trastuzumab-pkrb) for or with ado-trastuzumab emtansine.
Adjuvant Treatment, Breast Cancer:
Administer according to the following dose and schedule for a total of 52 weeks of HERZUMA therapy:
During and following paclitaxel, docetaxel, or docetaxel and carboplatin:
- Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).
- One week following the last weekly dose of HERZUMA, administer HERZUMA at 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks.
- Extending adjuvant treatment beyond one year is not recommended [see Adverse Reactions (6.1)].
Important Dosing Considerations
If the patient has missed a dose of HERZUMA by one week or less, then the usual maintenance dose (weekly schedule: 2 mg/kg; three-weekly schedule: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent HERZUMA maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
If the patient has missed a dose of HERZUMA by more than one week, a re-loading dose of HERZUMA should be administered over approximately 90 minutes (weekly schedule: 4 mg/kg) as soon as possible. Subsequent HERZUMA maintenance doses (weekly schedule: 2 mg/kg; three-weekly schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
- Decrease the rate of infusion for mild or moderate infusion reactions
- Interrupt the infusion in patients with dyspnea or clinically significant hypotension
- Discontinue HERZUMA for severe or life-threatening infusion reactions.
Assess left ventricular ejection fraction (LVEF) prior to initiation of HERZUMA and at regular intervals during treatment. Withhold HERZUMA dosing for at least 4 weeks for either of the following:
- ≥ 16% absolute decrease in LVEF from pre-treatment values
- LVEF below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values.
HERZUMA may be resumed if, within 4–8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is ≤ 15%.
Permanently discontinue HERZUMA for a persistent (> 8 weeks) LVEF decline or for suspension of HERZUMA dosing on more than 3 occasions for cardiomyopathy.
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 HERZUMA (trastuzumab-pkrb) and not ado-trastuzumab emtansine.
Reconstitute each 420 mg vial of HERZUMA 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-pkrb that delivers 20 mL (420 mg trastuzumab-pkrb). 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 HERZUMA. 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-pkrb.
- 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 HERZUMA in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused HERZUMA after 28 days. If HERZUMA is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze.
- Determine the dose (mg) of HERZUMA [see Dosage and Administration (2.2)]. Calculate the volume of the 21 mg/mL reconstituted HERZUMA 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 HERZUMA 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. Do not freeze.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.