ONTRUZANT® (trastuzumab-dttb) for Injection, for Intravenous Use 21 mg/mL

IMPORTANT SAFETY INFORMATION

ONTRUZANT treatment can result in heart problems. Serious and sometimes fatal events have occurred. Some patients have had serious and fatal infusion reactions and lung problems. Symptoms usually occur during or within 24 hours of administration. ONTRUZANT can cause harm to an unborn baby, in some cases death of the unborn baby, when taken by a pregnant woman. ONTRUZANT treatment may lead to a worsening of low white blood cell count.

Possible Serious Side Effects With ONTRUZANT

Not all people have serious side effects, but side effects with ONTRUZANT therapy are common.

Although some people may have a life-threatening side effect, most do not.

Your doctor will stop treatment if any serious side effects occur.

ONTRUZANT is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:

HEART PROBLEMS

These may include serious and fatal congestive heart failure or reduced heart function, with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both trastuzumab and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with ONTRUZANT. Your doctor will also evaluate your heart function every 6 months for at least 2 years following completion of ONTRUZANT as a component of adjuvant therapy.

Contact your doctor immediately if you experience any of the following:

  • New or worsening shortness of breath
  • Cough
  • Swelling of the ankles or legs
  • Swelling of the face
  • Heart palpitations
  • Weight gain of more than 5 pounds in 24 hours
  • Dizziness
  • Loss of consciousness

INFUSION REACTIONS

ONTRUZANT can result in serious and fatal infusion reactions and lung problems. Symptoms of infusion reactions include:

  • Fever and chills
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Pain (in some cases at tumor sites)
  • Headache
  • Dizziness
  • Shortness of breath
  • Low blood pressure
  • Rash
  • Physical weakness or lack of energy

These symptoms usually occur during or within 24 hours of administration.

What should I tell my doctor before I take ONTRUZANT?

Be sure to contact your doctor if you:

Are a woman who could become pregnant or may be pregnant.

ONTRUZANT may result in the death of an unborn baby or birth defects. Women who can become pregnant will be checked by their doctor to verify pregnancy status before starting treatment with ONTRUZANT. In pregnant women and women who can become pregnant, exposure to ONTRUZANT during pregnancy or within 7 months prior to conception can result in fetal harm. Contraception should be used while receiving ONTRUZANT and for 7 months after your last dose of ONTRUZANT.

Have any signs of SEVERE LUNG PROBLEMS, including:

  • Severe shortness of breath
  • Fluid in or around the lungs
  • Weakening of the valve between the heart and the lungs
  • Not enough oxygen in the body
  • Swelling of the lungs
  • Scarring of the lungs

ONTRUZANT can result in serious and fatal lung problems. Your doctor may check for signs of severe lung problems when he or she examines you.

Have LOW WHITE BLOOD CELL COUNTS.

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving a trastuzumab product plus chemotherapy than in patients receiving chemotherapy alone.

Your doctor may check for signs of low white blood cell counts when he or she examines you.

What should I watch for and talk to my doctor about before or while taking ONTRUZANT?

Side effects seen most often with ONTRUZANT

Some patients receiving a trastuzumab product for breast cancer had the following side effects:

  • Fever
  • Feeling sick to your stomach (nausea)
  • Throwing up (vomiting)
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Feeling tired
  • Shortness of breath
  • Rash
  • Low white and red blood cell counts
  • Muscle pain

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, you should talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


What conditions is ONTRUZANT used to treat (indications)?

ONTRUZANT is a prescription medicine used to treat:

Adjuvant Breast Cancer

ONTRUZANT is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk* feature. ONTRUZANT can be used in several different ways:

  • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC➝TH”
  • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
  • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy)

Patients are selected for therapy based on an FDA-approved test for trastuzumab.

*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.


Metastatic Breast Cancer

ONTRUZANT has 2 approved uses in metastatic breast cancer:

  • ONTRUZANT in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
  • ONTRUZANT alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Patients are selected for therapy based on an FDA-approved test for trastuzumab.


Please read the accompanying physician Prescribing Information, including the information about heart problems, infusion reactions, lung problems, and harm to an unborn baby, and discuss it with your doctor.


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IMPORTANT SAFETY INFORMATION

ONTRUZANT treatment can result in heart problems. Serious and sometimes fatal events have occurred. Some patients have had serious and fatal infusion reactions and lung problems. Symptoms usually occur during or within 24 hours of administration. ONTRUZANT can cause harm to an unborn baby, in some cases death of the unborn baby, when taken by a pregnant woman. ONTRUZANT treatment may lead to a worsening of low white blood cell count.