Ontruzant

Ontruzant is a prescription medication used to treat certain types of breast or digestive tract cancers in adults. Herzuma belongs to a group of drugs called HER2/neu receptor antagonists. These work binding to human epithelial growth factor receptor (HER2) and prevents the survival of cancer tumors dependent on HER2.

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

Common side effects of Ontruzant include headache, diarrhea, nausea, fever, chills, infectin, rash, weight loss, or changes in blood cell counts.

Ontruzant is a prescription medication used with other medications to treat adjuvant or metastatic (widespread) breast cancer.

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

Serious side effects have been reported with Ontruzant. See the “Ontruzant Precautions” section.

Common side effects of Ontruzant include the following:

• Fever
• Chills
• Headache
• Diarrhea
• Nausea
• Infection
• Cough
• Rash
• Weight loss
• Changes in blood cell counts

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

Tell your doctor if you have any side effects that bother you or that do 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 medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Anthracycline. Using anthracycline after stopping Ontruzant can increase the risk of heart issues. Anthracyclines should be avoided for up to 7 months after stopping Ontruzant

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

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

• Cardiomyopathy. These are conditions where the heart cannot function properly and can lead to abnormal heart rhythms, elevated blood pressure, a decreased ability of the heart to pump blood, or cardiac death. Tell your healthcare provider right away if you have some or all of the following symptoms:

  • Shortness of breath, particularly with exertion/exercise
  • Heart palpitations
  • High blood pressure
  • Chest pain
  • Sudden swelling in the feet, ankles, and legs

• Infusion reactions. Infusion reactions can occur with this medication. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:

  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • weakness
  • dizziness or feel faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain

• Embryo-fetal toxicity. Fetal harm can occur with this medicaiton if given to a pregnant woman.

• Pulmonary toxicity. Complications with the lungs and airways can occur with this medication. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:

  • breathlessness during exercise
  • fatigue
  • dry cough
  • shortness of breath
  • discomfort or worsening symptoms when lying on your back

• Worsening of low white blood cell count (neutropenia). A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. 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 Ontruzant if you are allergic to Herzuma or to any of this medication’s 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 Ontruzant, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Ontruzant or to any of its ingredients

• have heart or respiratory problems

• see signs of infection like fever, chills, bad sore throat, ear or sinus pain, or wounds that will not heal

• see worsening of heart or respiratory function, including:

  • new or worsening shortness of breath
  • cough
  • swelling of the ankles/legs/face
  • palpitations
  • weight gain of more than 5 pounds in 24 hours
  • dizziness or loss of consciousness 
• are pregnant or plan to become pregnant

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

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ontruzant has not formally been graded for its safety in pregnancy. Post-marketing studies show that products similar to Ontruzant can cause fetal harm when administered to a pregnant woman and lead to serious birth defects or neonatal death. Women who are pregnant or plan to become pregnant should speak to a healthcare professional before starting Ontruzant.

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

It is not known if Ontruzant 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 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 Ontruzant.

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Ontruzant at the same time. A healthcare provide will work with you to make sure that doses are regularly scheduled.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose/dose range of Ontruzant is based on weight and is given with other anti-cancer medications. Your doctor will work with you to establish a proper dose and regimen for the treatment period with this medication.

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

Cardiomyopathy: trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Ontruzant for cardiomyopathy. 

Infusion Reactions, Pulmonary Toxicity: Discontinue Ontruzant for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.