ONTRUZANT is a prescription medication used to treat:
Early Breast Cancer
ONTRUZANT is approved in adults 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.
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
ONTRUZANT is a prescription medication used to treat:
Early Breast Cancer
ONTRUZANT is approved in adults 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.
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
ONTRUZANT is an FDA-approved biosimilar medication to HERCEPTIN (trastuzumab) used to treat the following conditions:
ONTRUZANT is approved in adults 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.
ONTRUZANT has 2 approved uses in adults 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 a trastuzumab product.
ONTRUZANT is approved in adults, 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 a trastuzumab product.
Support and Coverage
The Organon Access Program for ONTRUZANT
Speak to a representative by calling 844-326-2986
Learn about options for co-pay assistance for eligible patients
Find out about insurance coverage for ONTRUZANT costs, including any out-of-pocket costs
ONTRUZANT at a Glance
ONTRUZANT at a Glance
Find answers to the most important questions you may have about your type of cancer and treatment with ONTRUZANT.
What is ONTRUZANT?
ONTRUZANT is a biosimilar prescription medicine that is used in the treatment of cancer. Biosimilars are approved by the US Food and Drug Administration, or FDA, as being highly similar to an already approved biological medicine. Thus the name "biosimilar." ONTRUZANT is an FDA-approved biosimilar of the drug HERCEPTIN (trastuzumab).
How can ONTRUZANT help me?
ONTRUZANT is thought to target tumor cell growth in tumor cells that overexpress HER2. It may stop the HER2 proteins from signaling cancer cells to grow. ONTRUZANT may also be able to identify tumor cells to be destroyed by the immune system. Normal cells can have HER2, so HER2-targeted therapies can also affect normal cells and can cause side effects, including possible serious side effects.
Are there any side effects with ONTRUZANT?
Side effects with ONTRUZANT therapy are common, but not all people have serious side effects. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. 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.
Please see the Important Safety Information on this website for information on serious side effects and other side effects and talk to your doctor.
Can I have children while on ONTRUZANT?
That's an understandable and important concern. 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.
How long will I be on ONTRUZANT?
Everyone’s cancer is different. How long you get ONTRUZANT depends on the stage of your disease and the way your doctor prescribes treatment.
When was ONTRUZANT approved?
In January 2019, the FDA approved ONTRUZANT to treat HER2+ breast cancer and metastatic gastric cancer.
Biologics vs biosimilars—what’s the difference?
Biologics are complex medicines made from living cells. Biosimilars are FDA-approved biological medicines that are highly similar to an already approved biological medicine. ONTRUZANT is a biosimilar to HERCEPTIN (trastuzumab). Before being approved by the FDA, all biosimilars go through rigorous development and testing. Biosimilars may help more people get access to biological medicines.
What support is available to me from Organon?
Cancer is difficult enough without worrying about paying for medicine. The Organon Access Program (OAP) may be able to answer your questions about insurance coverage, co-pay assistance for eligible patients, eligibility determination, and more.
Call 844-326-2986 to speak to a live representative or visit The Organon Access Program.
Are there patient support groups for me?
Emotional support, education, and information sharing are important throughout your journey. There are a range of support groups for patients with cancer and their families. Ask your doctor for a recommendation on the support group best suited for you.
What Is ONTRUZANT?
What Is ONTRUZANT?
Get to know your medicine and how it may help you fight your type of cancer.
ONTRUZANT is a biosimilar of HERCEPTIN
ONTRUZANT is an FDA-approved biosimilar of HERCEPTIN for the treatment of HER2+ breast cancer and metastatic gastric cancer.
ONTRUZANT and HERCEPTIN both
- Work the same way in the body
- Have the same dosage
- Are given the same way
Similar in effectiveness and safety
This means you can expect similar treatment benefits from ONTRUZANT, and similar potential side effects, as you would from HERCEPTIN.
What is a biosimilar?
A biosimilar is an FDA-approved medication that is highly similar to its originator biological medication. A biosimilar also has no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.
Are biosimilars like generic medicines?
No, they are not. Biosimilars are made from living cells and are more complex than generics, which are made from a simpler chemical process. Therefore, the approval standards for biosimilars and generics are different, but each category has its own set of rigorous standards that it needs to meet.
What makes breast cancer HER2+?
HER2 proteins are receptors found on the surface of cells in the breast. In a healthy breast cell, HER2 proteins send signals telling cells to grow and divide. However, HER2-positive breast cancer cells have a higher-than-normal number of HER2 proteins. Having too many HER2 proteins may make the cancer grow and divide faster.
How Is ONTRUZANT Given?
Here is what you can expect when you first receive ONTRUZANT
How to prepare for your IV infusion
You will be receiving infusions of ONTRUZANT at an infusion center on a regular basis.
- Each infusion can range from 30 to 90 minutes
- You can spend this time doing a number of things:
- Keep busy during treatment with various activities
- Take the time to relax and sleep
- Keep in mind that the treatment room may be cold, so you might want to bring something to keep you warm
Pillow
Blanket
Sleep Mask
Hot/Cold Pack
Slippers
Snacks/Drinks
Clothing With Easy IV Access
Phone/Laptop
Headphones
Books
INDICATIONS AND USAGE
What conditions is ONTRUZANT used to treat?
ONTRUZANT is a prescription medication used to treat:
Early Breast Cancer
ONTRUZANT is approved in adults 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 adults 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 a trastuzumab product.
Metastatic Gastric Cancer
ONTRUZANT is approved in adults, 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 a trastuzumab product.
IMPORTANT SAFETY INFORMATION
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
Trastuzumab products (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.
Trastuzumab products (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
Trastuzumab products (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
Some patients receiving trastuzumab for metastatic stomach cancer had the following side effects:
- Low white 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
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 , or call 1-800-FDA-1088.
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.