Indications

KANJINTI® is a prescription medicine used for the treatment of:

  • Adjuvant Breast Cancer

    • KANJINTI® is used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and that 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.
    • KANJINTI® can be used in 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

    • KANJINTI® has 2 approved uses in metastatic breast cancer:

      • KANJINTI® 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
      • KANJINTI® 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

    • KANJINTI® 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.

FOR PATIENTS

GETTING TO KNOW KANJINTI®

what is kanjinti®
Why Amgen
Biosimilars
Support
About her2+
Cancer

WHAT IS HER2-POSITIVE (HER2+) CANCER?

YOUR DOCTOR HAS SAID THAT YOU HAVE A TYPE OF CANCER THAT IS HER2+
What is HER2-positive Cancer? What is HER2-positive Cancer?

Some cells may have more HER2 than is normal. This causes the cells to divide and grow faster than usual. Some may become cancer cells and spread to other areas of the body.1

YOU MAY HEAR HER2 PROTEINS CALLED “HER2 RECEPTORS”1,2

They are called this because they send and get information from other proteins to do their job.
HER2 Receptors HER2 Receptors

When these receptors talk
with one another, they make
cells divide and grow.3
HER2 Receptors
NORMAL

~ 40,000
HER2 receptors4

HER2 Receptors
OVEREXPRESSED

Up to ~ 1,000,000
HER2 receptors4

HER2 Receptors
EXCESSIVE

Excessive cellular division.
This can lead to cells
growing
more and more4

It is important for PATIENTS who have breast OR GASTRIC cancer to be tested for “HER2 status”1,5

This tells your treatment team as soon as possible to use drugs that target the HER2 protein.

HER2 is usually found by testing a small sample of cells. The tests count the number of HER2 proteins and are done by a lab. If there are a large number of HER2 proteins, the cancer is said to be HER2+.5
HER2+ Treated with HER2-targeted Drugs, HER2-negative Treated with Other Drugs HER2+ Treated with HER2-targeted Drugs, HER2-negative Treated with Other Drugs
HER2+ Treated with HER2-targeted Drugs, HER2-negative Treated with Other Drugs HER2+ Treated with HER2-targeted Drugs, HER2-negative Treated with Other Drugs

HER2 = human epidermal growth factor receptor 2.

Important Safety Information

What are the possible Serious Side Effects with KANJINTI®?

KANJINTI® 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 KANJINTI®, 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 KANJINTI®.

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 KANJINTI®.

Tell your doctor if you:

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

    • KANJINTI® may result in the death of an unborn baby or birth defects.

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

    • Tell your doctor right away if you are exposed to KANJINTI® 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

    • 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 KANJINTI®?

Side Effects Seen Most Often With KANJINTI®

  • Some patients receiving trastuzumab products, like KANJINTI®, 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

  • Some patients receiving trastuzumab products, like KANJINTI®, 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

    • Change in taste

These are not all the possible side effects of KANJINTI®. 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.

Indications

KANJINTI® is a prescription medicine used for the treatment of:

  • Adjuvant Breast Cancer

    • KANJINTI® is used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and that 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.

    • KANJINTI® can be used in 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

    • KANJINTI® has 2 approved uses in metastatic breast cancer:

      • KANJINTI® 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
      • KANJINTI® 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

    • KANJINTI® 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.

Please see full Prescribing Information, including Boxed WARNINGS.

Herceptin® (trastuzumab) is a registered trademark of Genentech USA, Inc.
References:

  • 1.Breastcancer.org. HER2 status. www.breastcancer.org/symptoms/diagnosis/her2. Accessed February 28, 2020.

  • 2.Brand F-X, Ravanel N, Gauchez A-S, et al. Prospect for anti-HER2 receptor therapy in breast cancer. Anticancer Res. 2006;26:463-470.

  • 3.Breastcancer.org. How Herceptin works. www.breastcancer.org/treatment/ targeted_therapies/herceptin/how_works. Accessed February 28, 2020.

  • 4.Onsum M, Geretti G, Paragas V, et al. Single-cell quantitative HER2 measurement identifies heterogeneity and distinct subgroups within traditionally defined HER2-positive patients. Am J Pathol. 2013;183:1446-1460.

  • 5.Kumarasinghe MP, Morey A, Bilous M, et al. HER2 testing in advanced gastric and gastro-oesophageal cancer: analysis of an Australia-wide testing program. Pathology. 2017;49:575-581.

  • 6.American Cancer Society. Breast cancer HER2 status. www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed February 28, 2020.