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Patient Information

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IMPORTANT SAFETY INFORMATION

What are the possible Serious Side Effects with OGIVRI?

OGIVRI is not for everyone. Be sure to contact your doctor if you are experiencing any of the following potentially life-threatening side effects:

HEART PROBLEMS

These include 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 a trastuzumab product, like OGIVRI, 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 OGIVRI.

INFUSION REACTIONS, including:

Fever and chills, feeling sick to your stomach (nausea), throwing up (vomiting), pain (in some cases at tumor sites), headache, dizziness, shortness of breath.

These signs usually happen within 24 hours after receiving OGIVRI.

Tell your doctor if you:

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

OGIVRI may result in the death of an unborn baby or birth defects.

Contraception should be used while receiving OGIVRI and for seven months after your last dose of OGIVRI.

Tell your doctor right away if you are exposed to OGIVRI during pregnancy or within 7 months of becoming pregnant.

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, and scarring of the lungs. Your doctor may check for signs of severe lung problems.

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 trastuzumab plus chemotherapy than in patients receiving chemotherapy alone. Your doctor may test your blood and check for signs of low white blood cell counts.

IMPORTANT SAFETY INFORMATION

What is OGIVRI?

ADJUVANT BREAST CANCER

OGIVRI is a prescription medicine used for the treatment of adjuvant breast cancer. OGIVRI is used 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. 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.

OGIVRI 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.

METASTATIC BREAST CANCER

OGIVRI has 2 approved uses in metastatic breast cancer:

OGIVRI 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
OGIVRI 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.

GASTRIC CANCER

OGIVRI is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2-positive metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

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

IMPORTANT SAFETY INFORMATION

What are the possible Serious Side Effects with OGIVRI?

OGIVRI is not for everyone. Be sure to contact your doctor if you are experiencing any of the following potentially life-threatening side effects:

HEART PROBLEMS

These include 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 a trastuzumab product, like OGIVRI, 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 OGIVRI.

INFUSION REACTIONS, including:

Fever and chills, feeling sick to your stomach (nausea), throwing up (vomiting), pain (in some cases at tumor sites), headache, dizziness, shortness of breath.

These signs usually happen within 24 hours after receiving OGIVRI.

Tell your doctor if you:

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

OGIVRI may result in the death of an unborn baby or birth defects.

Contraception should be used while receiving OGIVRI and for seven months after your last dose of OGIVRI.

Tell your doctor right away if you are exposed to OGIVRI during pregnancy or within 7 months of becoming pregnant.

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, and scarring of the lungs. Your doctor may check for signs of severe lung problems.

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 trastuzumab plus chemotherapy than in patients receiving chemotherapy alone. Your doctor may test your blood and check for signs of low white blood cell counts.

What are the possible more common side effects of OGIVRI?

Side Effects Seen Most Often With OGIVRI

Some patients receiving trastuzumab products, like OGIVRI, 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, and muscle pain.

Some patients receiving trastuzumab products, like OGIVRI, for metastatic stomach cancer had the following side effects:

Low white blood cell counts, diarrhea, feeling tired, low red blood cell counts, swelling of the mouth lining, weight loss, upper respiratory tract infections, fever, low platelet counts, swelling of the mucous membranes, swelling of the nose and throat, and change in taste.

These are not all the possible side effects of OGIVRI. For more information, ask your doctor for medical advice about side effects. 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.

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