Trazimera

Trazimera Dosage/Direction for Use

trastuzumab

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
HER2 testing is mandatory prior to initiation of therapy (see Precautions and Pharmacology: Pharmacodynamics under Actions). TRAZIMERA treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see Precautions), and should be administered by a healthcare professional only.
TRAZIMERA intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is TRAZIMERA (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Posology: Metastatic breast cancer: Three-weekly schedule: The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Weekly schedule: The recommended initial loading dose of TRAZIMERA is 4 mg/kg body weight. The recommended weekly maintenance dose of TRAZIMERA is 2 mg/kg body weight, beginning one week after the loading dose.
Administration in combination with paclitaxel or docetaxel: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Administration in combination with an aromatase inhibitor: In the pivotal trial (BO16216) trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration.
Early breast cancer: Three-weekly and weekly schedule: As a three-weekly regimen the recommended initial loading dose of TRAZIMERA is 8 mg/kg body weight. The recommended maintenance dose of TRAZIMERA at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
See Pharmacology: Pharmacodynamics under Actions for chemotherapy combination dosing.
Advanced gastric cancer: Three-weekly schedule: The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Breast cancer and gastric cancer: Duration of treatment: Patients with MBC or advanced gastric cancer (AGC) should be treated with TRAZIMERA until progression of disease. Patients with EBC should be treated with TRAZIMERA for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see Pharmacology: Pharmacodynamics under Actions).
Dose reduction: No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Refer to the product label for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
If left ventricular ejection fraction (LVEF) percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of TRAZIMERA should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. All such patients should be referred for assessment by a cardiologist and followed up.
Missed doses: If the patient has missed a dose of TRAZIMERA by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent 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 TRAZIMERA by more than one week, a re-loading dose of TRAZIMERA should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. Subsequent TRAZIMERA maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Special populations: Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out. In a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition.
Paediatric population: There is no relevant use of TRAZIMERA in the paediatric population.
Method of administration: TRAZIMERA loading dose should be administered as a 90-minute intravenous infusion. Do not administer as an intravenous push or bolus. TRAZIMERA intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available. Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see Precautions and Adverse Reactions). Interruption or slowing the rate of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
For instructions on reconstitution of TRAZIMERA intravenous formulation before administration, see Cautions for Usage.
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