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What is Trazimera™(trastuzumab-qyyp)?

Trazimera™ (trastuzumab-qyyp) is an engineered biologic immunotherapy medication that was recently approved by the Food and Drug Administration (FDA) to treat certain women with advanced HER2+ breast cancer (human epidermal growth factor receptor-2-positive). Trazimera is classified as “biosimilar” to Herceptin®1. Biosimilar medications are approved based on the similarity of their action to approved medications.

Trazimera is approved as a first-line treatment for people with HER2+ breast cancer that has not spread beyond the lymph nodes or that has a high risk of recurring. It can also be used as “adjuvant therapy,” which means that it is given after surgery to prevent a tumor from coming back. Trazimera is designed to be used after or along with chemotherapy. Trazimera may also be used to treat metastatic breast cancer.
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Breast cancer tumors are characterized as HER2+ or HER2- cancers. HER2 refers to a particular protein that appears on the surface of cancer cells and makes the cells multiply faster. When cancer cells produce too many HER2 molecules, they are referred to as HER2+ tumors. HER2- cancers produce few or no HER2 molecules.3 About 15-30% of breast cancers are HER2+.1

What are the ingredients in Trazimera?

The active ingredient in Trazimera is trastuzumab-qyyp.

How does Trazimera work?

Trazimera is one of several engineered monoclonal antibodies used to treat cancer. Our bodies naturally produce antibodies, which are immune factors that act against foreign organisms that invade and threaten our health. Drugmakers have engineered a variety of antibodies to target the mechanisms that cause certain diseases, including breast cancer.

Trazimera is designed to bind to the HER2 molecule, which appears at high levels on the surface of HER2+ breast cancers. HER2 molecules stimulate tumors to grow especially fast. By blocking HER2, Trazimera tamps down the uncontrolled growth of the tumor cells. Since Trazimera works only with tumors that are HER2+, your doctor will test your tumor for HER2 before prescribing this medication.4

What are the possible side effects of Trazimera?

Common side effects with Trazimera include1:

  • Fever
  • Nausea
  • Vomiting
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain
  • Infusion reactions

In some patients, Trazimera may cause more harmful, sometimes life-threatening side effects. These include1:

  • Serious heart problems, including congestive heart disease
  • Severe lung problems, including swelling and scarring of the lungs
  • Extremely low white blood cell counts, which may lead to serious infections
  • Severe reaction to infusion, which is how the medication is given

Trazimera has been shown to harm fetuses, so it is important not to become pregnant while you are taking it. This is not a complete list of all potential side effects of Trazimera. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.

Things to note about Trazimera

Before taking Trazimera, tell your doctor if you5:

  • Have or have had heart problems
  • Have or have had lung or breathing problems
  • Are being treated for an infection
  • Are pregnant or plan to become pregnant or are breastfeeding

Tell your doctor about any medications or supplements you are taking while on Trazimera. Because Trazimera may cause serious harm to your heart, your doctor will monitor its functioning before and during your treatment.

Dosing information

Trazimera is given either through a vein in your arm via intravenous (IV) infusion. Infusions of Trizimera must be given in a medical office, and they take about 30-90 minutes to complete.4 Your doctor will determine the amount of medicine to give, depending on your weight.

Your first dose will contain a larger dose of medicine and will be given over 90 minutes. Subsequent doses contain less medicine and they are given every 1 to 3 weeks, over the course of 30 minutes for a year for adjuvant treatment.4 For more information about Trazimera, read the complete prescribing information.

Written by: Editorial Team | Last reviewed: October 2019.
  1. R U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA™ (trastuzumab-qyyp), a Biosimilar to Herceptin®1. Pfizer Inc. March 11, 2019. Available at: https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_oncology_biosimilar_trazimera_trastuzumab_qyyp_a_biosimilar_to_herceptin_1 Accessed July 20, 2019.
  2. Jamie DePolo. FDA Approves Herceptin Biosimilar Trazimera to Treat HER2-Positive Breast Cancer. Breastcancer.org. March 19, 2019. Available at: https://www.breastcancer.org/research-news/fda-approves-herceptin-biosimilar-trazimera Accessed July 20, 2019.
  3. Tumor Characteristics: Hormone Receptor Status. Susan G. Komen Breast Cancer Foundation. January 31, 2019. Available at: https://ww5.komen.org/BreastCancer/TumorCharacteristics.html#her2 Accessed July, 12, 2019.
  4. Prescribing Information. Pfizer Labs. March 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf Accessed July 20, 2019.