Trazimera

Trazimera is a prescription medication used to treat certain types of breast and stomach cancers in men and women. Trazimera may be used alone or in combination with other medications. Trazimera belongs to a group of drugs called monoclonal antibodies, which help stop the growth of cancer cells. 

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Trazimera include fever, headache and diarrhea.

Trazimera is a prescription medicine used to treat metastatic breast cancers, metastatic gastric cancers, or as an add-on for treatment in breast cancers that over-express HER2 gene. Trazimera may be used alone or in combination therapies.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Trazimera. See the "Trazimera Precautions" section for more information.

Common side effects of Trazimera include the following:

• Hypertension
• Dizziness
• Flu-like Symptoms
• Muscle, joint or back pain
• Cough
• Nausea
• Diarrhea
• Headache 
• Rash
• Fever

This is not a complete list of Trazimera side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your doctor about your medications before, during, and after treatment with Trazimera. Especially tell your doctor if you take:

• anthracycline
• daunorubicin
• clozapine
• adalimumab
• etanercept

Tell your doctor if you have recieved a live influenza, polio, rotavirus, smallpox, varicella/zoster, typhoid, yellow fever or MMR vaccine recently.

This is not a complete list of Trazimera drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Trazimera including the following:

• Cardiomyopathy is disease of the heart muscle. Tell your healthcare provider right away if you have some or all of the following symptoms of cardiomyopathy:
  • chest pain
  • shortness of breath
  • lightheaded or dizziness
  • general weakness or fatigue
  • palpitations (feel like your heart is racing or fluttering)
  • fainting
  • high blood pressure
• Infusion Reactions. Infusion reactions can occur with this medication. Tell your healthcare provider or get medical help right away if you have any of these symptoms during or after an infusion with this medication:
  • hives (red itchy welt) or rash
  • itching 
  • swelling of lips, tongue, throat or face
  • sudden cough
  • weakness
  • dizziness or feeling faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain
• Embryo-Fetal Toxicity. Tell your healthcare provider right away if you are pregnant, trying to become pregnant, or become pregnant during or within 7 months of treatment with Trazimera.
• Pulmonary Toxicity is when damage occurs to your lungs. Tell your healthcare provider right away if you have some or all of the following symptoms of pulmonary toxicity.
  • difficulty breathing or catching your breath
  • fatigue
  • dry cough
  • discomfort or worsening of other symptoms when lying flat
• Worsening of chemotherapy-induced neutropenia. A low white blood cell count can cause you to get infections, which may become serious. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
  • fever 
  • shortness of breath
  • pain or burning on urination
  • chills
  • cough

Do not take Trazimera if you are allergic to trastuzumab or any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Trazimera, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Trazimera, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Trazimera or to any of its ingredients
• have a history of heart failure
• have ongoing lung problems
• have an active infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

It has been shown that use of Trazimera in pregnant women caused some babies to be born with problems, and some women to miscarry. However, in some situations, the benefit of using this medication may be greater than the risk of harm to the baby. If you are female and of reproductive age, it is advised that you use effective contraception during treatment and for 7 months following the last dose of Trazimera.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Trazimera crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Trazimera.

This medication should be administered into a vein (IV) by a healthcare professional.

It is usually infused over 90 minutes once per week for 12 weeks, then over 30 to 90 minutes once every three weeks.

Follow your doctor's instructions about your individual dosing schedule.

It is important to keep all of your appointments to receive your Tazimera dose.

The dose you recieve is based on your height and weight, which is used to calculate your body surface area.

Trazimera is administered by a healthcare provider in a medical setting, therefore it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

FDA Warning

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with TRAZIMERA. Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion Reactions; Pulmonary Toxicity

Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt TRAZIMERA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.