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 A BIOSIMILAR?

KANJINTI® IS A BIOLOGIC MEDICINE CALLED A BIOSIMILAR1

KANJINTI® is a biosimilar to Herceptin® and is carefully made and rigorously tested. The FDA approved KANJINTI® for the same uses as Herceptin®. It was shown to have similar efficacy and safety to Herceptin® in a large study. Some patients in this study started treatment with Herceptin®, then were transitioned to KANJINTI® for the rest of the study to make sure the side effects were similar to those who used KANJINTI® for the whole study.1,2

A BIOSIMILAR IS DIFFERENT FROM A GENERIC3

Biosimilars are made to be almost identical to the original biologic drug. But it is not possible to make exact copies of biologics because they are made from living cells.

Biosimilars go through rigorous testing to demonstrate that they provide results similar to those of the original biologic drug. KANJINTI® is made by Amgen, a world leader in biologic treatments.

AMGEN has a wealth of experience in bringing biologics to patients like you

KANJINTI® is made by Amgen, which has a 40-year track record of developing biologics and bringing treatments to millions of people with cancer.

40 Years of Experience, Manufacturer of 18 Biologic Medicines 40 Years of Experience
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40 Years of Experience 40 Years of Experience
Manufacturer of 18 Biologic Medicines Manufacturer of 18 Biologic Medicines

Amgen is deeply committed to supporting patients through their treatment journey. You can expect Amgen to deliver quality products on time and to provide support every step of the way.

*Current as of September 2022.

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.KANJINTI® (trastuzumab-anns) Prescribing Information, Amgen.

  • 2.von Minckwitz G, Colleoni M, Kolberg HC, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018;19:987-998. 

  • 3.US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed February 28, 2020. 

  • 4.Data on file, Amgen [#1 Prescribed Trastuzumab Biosimilar]; 2022.