Trazimera

Generic name: Trastuzumab-qyyp
Dosage form: injection for intravenous infusion
Drug class: HER2 inhibitors

Usage of Trazimera

Trazimera (trastuzumab-qyyp) is a biosimilar to Herceptin that may be used to treat certain types of HER2+ (Human Epidermal Growth Factor Receptor 2-Positive) cancers, following an FDA-approved test for trastuzumab. It is given by IV infusion (a slow infusion into a vein in your arm) over 30 to 90 minutes by a healthcare provider and is approved for :

Early-stage HER2+ breast cancer that has spread to the lymph nodes, OR has not yet spread to the lymph nodes but is estrogen receptor/progesterone receptor (ER/PR)-negative or with one high-risk feature such as tumor size >2 cm, patient age <35 years, or tumor grade 2 or 3. Trazimera can be given:

As part of a treatment course that includes the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel

With the chemotherapy drugs docetaxel and Carboplatin

Alone, after treatment with multiple other therapies, including an anthracycline (doxorubicin) based therapy (a type of chemotherapy).

HER2+ metastatic breast cancer, as first-line treatment in combination with the chemotherapy drug paclitaxel

HER2+ metastatic breast cancer, as the sole treatment for patients who have already received one or more chemotherapy courses for metastatic disease

HER2+ metastatic cancer of the stomach or gastroesophageal junction in combination with chemotherapy (cisplatin and either Capecitabine or 5-fluorouracil), in patients who have not received prior treatment for their metastatic disease.

Trazimera is called a targeted treatment because it targets cancers that have large amounts of receptor proteins called HER2. HER2 is thought to send signals to cells telling them to grow and divide rapidly, causing tumors to form. By targeting and attaching to these receptors, Trazimera is thought to inhibit the growth and cell division of human tumor cells that overexpress HER2 and also tell the body’s immune system to destroy the cell. Normal cells also have HER2, but less of it, so Trazimera can affect normal cells, causing side effects.

Trazimera was approved as a biosimilar to Herceptin on March 11, 2019. A biosimilar means it is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product (in this case, Herceptin), and that there are no clinically meaningful differences.

Trazimera side effects

Get emergency medical help if you have signs of an allergic or administration-related reaction such as dizziness, nausea, chills, fever, vomiting, diarrhea, hives, pain, headache, swelling under the skin, breathing problems, shortness of breath, or chest pain. Some side effects may occur during the injection, or in the days afterward. Tell your healthcare provider right away, even if these symptoms occur a few days later.

Trazimera may cause serious side effects. Call your doctor at once if you have:

new onset or worsening shortness of breath or cough

a light-headed feeling, like you might pass out or loss of consciousness

severe headache, blurred vision, pounding in your neck or ears

blisters or ulcers in your mouth, red or swollen gums, trouble swallowing

heart problems--pounding heartbeats, palpitations, dizziness, swelling in your lower legs, rapid weight gain, feeling short of breath

low blood cell counts--fever, chills, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or

signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

swelling of the ankles/legs or the face, or weight gain of more than 5 pounds in 24 hours.

Common side effects of Trazimera may include:

heart problems

nausea, diarrhea, weight loss

headache

trouble sleeping, feeling tired

low blood cell counts

rash

fever, chills, cough, or other signs of infection

mouth sores

altered sense of taste or

cold symptoms such as stuffy nose, sinus pain, and sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Trazimera

Tell your doctor if you have experienced an infusion reaction or hypersensitivity reaction to trastuzumab, or its biosimilars such as Herceptin, Herzuma, Kanjinti, Ontruzant, or Trazimera, or any of the inactive ingredients in the vial.

Trazimera is only administered to eligible patients identified as having HER2 protein overexpression and HER2 gene amplification using an FDA-approved test specific for breast or gastric cancers by laboratories with demonstrated proficiency.

Before taking Trazimera, tell your doctor if you:

have allergies

have preexisting heart disease, a heart attack, congestive heart failure, or other heart problems

have problems with your lungs or with breathing

have low white blood cell counts

have had chemotherapy treatment before

are pregnant, may become pregnant, or intend to become pregnant

are breastfeeding.

Pregnancy

You may need to have a negative pregnancy test before starting this treatment. Do not use Trazimera if you are pregnant.

Trazimera may result in the death of an unborn baby or birth defects. Females with childbearing potential should use effective contraception while receiving Trazimera and for 7 months after the last dose. If you inadvertently become pregnant while receiving trastuzumab or within 7 months after your last dose, tell your doctor right away.

Breastfeeding

It is unknown if Trazimera passes into human milk. It may not be safe to breastfeed while using this medicine and for up to 7 months after your last dose. Ask your doctor about any risks.

Relate drugs

How to use Trazimera

Trazimera is administered as an intravenous infusion by a healthcare provider.

Trazimera is usually given once every week or every 1 to 3 weeks. Follow your doctor's dosing instructions very carefully.

This medicine must be given slowly, and the infusion can take 30 to 90 minutes depending on the stage of the cycle and type of cancer you have.

Do not administer as an IV push or bolus. Do not mix with other drugs. Trazimera should not be substituted for or with ado-trastuzumab emtansine.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Your heart function may need to be checked before and during treatment with Trazimera. You may also need heart function testing every 6 months for 2 years after your last dose of this medicine.

Trazimera is usually given for 52 weeks, or until your body no longer responds to the medication.

Warnings

Trazimera can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines (such as daunorubicin, doxorubicin, epirubicin, or idarubicin). Your healthcare provider will assess your heart function before treatment and monitor you throughout.

Serious and fatal infusion reactions and pulmonary toxicity have been reported, including bronchospasm, anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Reactions usually occur during or immediately following the infusion. Your healthcare provider will monitor you during the infusion.

Trazimera can cause harm to an unborn baby and result in oligohydramnios (a reduction in the levels of amniotic fluid), and incomplete lung development, which can be fatal. Women of childbearing potential should use effective contraception.

May exacerbate chemotherapy-induced neutropenia (low levels of neutrophils [a type of white blood cell] caused by cancer treatments).

What other drugs will affect Trazimera

Other drugs may affect Trazimera, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Trazimera can have long-lasting effects on your heart, especially if you receive other cancer medicines. For at least 7 months after your last dose of trastuzumab, tell any doctor who treats you that you have used Trazimera.

Disclaimer

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