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Trazimera 150mg Injection
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Indications & Clinical Uses
- Trazimera 150 mg is a biosimilar to the reference product Herceptin, containing trastuzumab-qyyp, a HER2-targeted monoclonal antibody.
- It is FDA-approved (2019) for adults with HER2-overexpressing breast cancer - as adjuvant therapy after surgery in node-positive or high-risk node-negative disease, and for metastatic breast cancer, first-line with paclitaxel or alone after prior chemotherapy - and for HER2-overexpressing metastatic gastric or gastro-oesophageal junction adenocarcinoma, combined with cisplatin and a fluoropyrimidine in patients not previously treated for metastatic disease.
- As a biosimilar, Trazimera has no clinically meaningful differences from Herceptin, but pharmacy-level substitution between different trastuzumab brands should follow local biosimilar-interchangeability rules and prescriber direction, not automatic swapping.
- The 150 mg vial is a lyophilised powder that is reconstituted and then given only by intravenous infusion in a hospital or oncology clinic - never as an IV push or bolus, and never by subcutaneous injection.
Side Effects
- Trazimera carries boxed warnings for cardiomyopathy (reduced heart pumping function or heart failure, more likely with prior or concurrent anthracycline chemotherapy or chest radiotherapy), for serious and fatal infusion reactions and pulmonary toxicity, and for embryo-fetal toxicity.
- Very common effects (over 1 in 10 people) include headache, diarrhoea, nausea, chills, fever, infection, rash, insomnia and cough; in gastric cancer, low neutrophil and red-cell counts, fatigue and mouth sores are also common.
- Serious reactions needing urgent attention include new breathlessness, cough, chest pain, leg swelling or an irregular heartbeat (possible heart problems), fever and chills during or shortly after an infusion (possible infusion reaction), and sudden difficulty breathing (possible lung toxicity).
- Heart function is checked by echocardiogram or MRI before and periodically during treatment.
- Tell your care team immediately about any new breathlessness, swelling or palpitations.
Precautions & Warnings
- Before Trazimera starts, and periodically during treatment, your healthcare team assesses left ventricular heart function, because cardiomyopathy risk rises with cumulative anthracycline exposure and pre-existing heart disease; treatment is usually withheld if heart function declines significantly.
- HER2 status must be confirmed with an FDA-approved test before treatment.
- Trazimera is given only by intravenous infusion, under observation, never as a push or bolus and never diluted with dextrose solutions; the first infusion is monitored closely for infusion reactions.
- It must not be used in pregnancy - exposure can cause oligohydramnios, fetal harm and neonatal death - so a pregnancy test is required beforehand, and effective contraception is needed during treatment and for 7 months after the last dose; do not breastfeed during this period.
- Anthracycline chemotherapy given even after stopping Trazimera may still carry an increased cardiac risk.
Avoid Interactions
- No formal drug-interaction studies have been conducted with Trazimera, since it is a monoclonal antibody not metabolised by liver CYP450 enzymes, so classic drug or food interactions such as grapefruit or enzyme inhibitors are not expected.
- The main concern is with other cancer treatments that affect the heart: combining Trazimera with anthracyclines (such as doxorubicin) substantially raises the risk of cardiomyopathy and heart failure, and this risk can persist even if anthracyclines are given after Trazimera is stopped.
- Live vaccines and other immune-affecting treatments should be discussed with the oncology team first.
- Trazimera must not be mixed with other medicines in the same infusion line or diluted in dextrose (glucose) solutions, which can cause the protein to aggregate.
- Tell your healthcare provider about every prescription medicine, over-the-counter product, herbal remedy and supplement you use, especially other chemotherapy or heart medicines, before each infusion.
References
Frequently Asked Questions
Trazimera (trastuzumab-qyyp) is a biosimilar to Herceptin used to treat HER2-positive breast cancer, both early-stage after surgery and metastatic disease, and HER2-positive metastatic stomach or gastro-oesophageal cancer with chemotherapy. It works by blocking the HER2 protein that drives these cancers to grow.
Trazimera is given as an intravenous infusion by a healthcare professional in a hospital or clinic, usually every 1 to 3 weeks depending on your regimen. It is never given as a quick injection or push, and the first infusion is watched closely for reactions.
Trazimera has boxed warnings for heart failure (cardiomyopathy), serious infusion reactions, lung toxicity and harm to an unborn baby. Common side effects include headache, diarrhoea, nausea, chills and fatigue. Report new breathlessness, swelling, chest pain or irregular heartbeat straight away.
Avoid pregnancy during Trazimera treatment and for 7 months after the last dose, using effective contraception; do not breastfeed. Combining Trazimera with anthracycline chemotherapy raises heart-failure risk. Tell your care team about every other medicine, including other cancer treatments, before each infusion.
Trazimera is an FDA-approved biosimilar to Herceptin (trastuzumab) - highly similar with no clinically meaningful differences in safety or effectiveness. It is a different brand from the same class of HER2-targeted antibodies; ask your care team which trastuzumab product you are receiving.
Yes. Trazimera carries a boxed warning for cardiomyopathy, which can cause heart failure, especially with prior or concurrent anthracycline chemotherapy. Your heart function is checked with an echocardiogram or MRI before treatment starts and at regular intervals throughout.
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