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Herceptin® (trastuzumab)
[H3] For Patients & Caregivers

[IMG: Female breast cancer patient]

Early Breast Cancer

Metastatic Breast Cancer

Metastatic Stomach Cancer

Herceptin® (trastuzumab)
[H3] For US Healthcare Professionals

[IMG: Group of doctors]

Adjuvant Breast Cancer

Metastatic Breast Cancer

Metastatic Gastric Cancer

1,4

Herceptin® (trastuzumab) is a prescription medicine designed to treat HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic stomach cancer. It works by binding to the HER2 protein in the body that promotes the growth of cancer cells. By blocking HER2 activity, Herceptin helps slow or stop cancer cell growth.
Herceptin is administered as an intravenous infusion in a clinical setting. It is typically given once every three weeks, although this may vary. Your healthcare provider will determine the right dosing schedule based on your medical condition and response to treatment.
Serious adverse reactions include cardiomyopathy, infusion reactions, pulmonary toxicity, embryo-fetal toxicity, cardiac monitoring, infusion reactions, embryo-fetal toxicity, pulmonary toxicity, and exacerbation of chemotherapy-induced neutropenia. Most common adverse reactions were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, myalgia, upper respiratory tract infections, thrombocytopenia, nasopharyngitis, and dysgeusia.

[H1]
Uses & Important Safety Information for HERCEPTIN and HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk)

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[H3] Herceptin: Indications
[H3] Adjuvant Breast Cancer
Herceptin is approved for the treatment of adults with 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.* Herceptin 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 Herceptin.
*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.
[H3] Metastatic Breast Cancer
Herceptin has 2 approved uses in adults with metastatic breast cancer:
Herceptin 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
Herceptin 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 Herceptin.
[H3] Gastric Cancer
Herceptin 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 Herceptin.
[H3] Herceptin HYLECTA: What it treats
[H3] Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with 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.* HERCEPTIN HYLECTA 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.
[H3] Metastatic Breast Cancer
HERCEPTIN HYLECTA has 2 approved uses in adults with metastatic breast cancer:
HERCEPTIN HYLECTA 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
HERCEPTIN HYLECTA 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.

[H3] Possible Serious Side Effects With HERCEPTIN
Not all people have serious side effects, but side effects with HERCEPTIN 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.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN 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 HERCEPTIN.
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 HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and for 7 months after your last dose of HERCEPTIN. If you are or become pregnant while receiving HERCEPTIN or within 7 months after your last dose of HERCEPTIN, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
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 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 HERCEPTIN 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.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN 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 count
Muscle pain
Some patients receiving HERCEPTIN 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
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

[H3] Possible Serious Side Effects With HERCEPTIN HYLECTA
Not all people have serious side effects, but side effects with HERCEPTIN HYLECTA 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.
HERCEPTIN HYLECTA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
[H3] HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA.
Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.
[H3] SEVERE LUNG PROBLEMS including:
Severe shortness of breath
Scarring of the lungs
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
Your doctor may check for signs of severe lung problems when he or she examines you.
These signs usually happen within 24 hours after receiving HERCEPTIN HYLECTA.
BE SURE TO CONTACT YOUR DOCTOR IF YOU:
[H3] ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT
HERCEPTIN HYLECTA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN HYLECTA and for 7 months after your last dose of HERCEPTIN HYLECTA. If you are or become pregnant while receiving HERCEPTIN HYLECTA or within 7 months after your last dose of HERCEPTIN HYLECTA, you are encouraged to report HERCEPTIN HYLECTA exposure to Genentech at 1–888–835–2555.
[H3] 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 intravenous trastuzumab 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.
Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.
SIDE EFFECTS SEEN MOST OFTEN
The most common side effects seen in treatment of adjuvant breast cancer with HERCEPTIN HYLECTA were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.
The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN HYLECTA.
Please see the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including most serious side effects.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

Herceptin Prescribing Information. Genentech, Inc. June 2024.

Herceptin Prescribing Information. Genentech, Inc. June 2024.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www

[H1] Uses & Important Safety Information

[H3] Quick Links

Herceptin® (trastuzumab): Indications

Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk): Indications

[H3] Herceptin: Indications
Adjuvant Breast Cancer
Herceptin is approved for the treatment of adults with 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.* Herceptin 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 Herceptin.
*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
Herceptin has 2 approved uses in adults with metastatic breast cancer:
Herceptin 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
Herceptin 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 Herceptin.
Gastric Cancer
Herceptin 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 Herceptin.
[H3] Possible Serious Side Effects With HERCEPTIN
Not all people have serious side effects, but side effects with HERCEPTIN 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.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN 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 HERCEPTIN.
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 HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and for 7 months after your last dose of HERCEPTIN. If you are or become pregnant while receiving HERCEPTIN or within 7 months after your last dose of HERCEPTIN, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
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 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 HERCEPTIN 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.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN 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 count
Muscle pain
Some patients receiving HERCEPTIN 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
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

[H3] Herceptin HYLECTA: What it treats
Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with 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.* HERCEPTIN HYLECTA 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
HERCEPTIN HYLECTA has 2 approved uses in adults with metastatic breast cancer:
HERCEPTIN HYLECTA 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
HERCEPTIN HYLECTA 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.
[H3] Possible Serious Side Effects With HERCEPTIN HYLECTA
Not all people have serious side effects, but side effects with HERCEPTIN HYLECTA 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.
HERCEPTIN HYLECTA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA.
Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.
SEVERE LUNG PROBLEMS including:
Severe shortness of breath
Scarring of the lungs
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
Your doctor may check for signs of severe lung problems when he or she examines you.
These signs usually happen within 24 hours after receiving HERCEPTIN HYLECTA.
BE SURE TO CONTACT YOUR DOCTOR IF YOU:
ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT
HERCEPTIN HYLECTA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN HYLECTA and for 7 months after your last dose of HERCEPTIN HYLECTA. If you are or become pregnant while receiving HERCEPTIN HYLECTA or within 7 months after your last dose of HERCEPTIN HYLECTA, you are encouraged to report HERCEPTIN HYLECTA exposure to Genentech at 1‑888‑835‑2555.
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 intravenous trastuzumab 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.
Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.
SIDE EFFECTS SEEN MOST OFTEN
The most common side effects seen in treatment of adjuvant breast cancer with HERCEPTIN HYLECTA were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN HYLECTA.
Please see the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including most serious side effects.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.

Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.

ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.

ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.

ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.

ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.

Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.

Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.

Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-posit

[H1] Supporting you along the Herceptin journey for HER2+ early breast cancer

[H1] Supporting you along the Herceptin journey for HER2+ early breast cancer

[H6] Over 2.4 million people worldwide have taken the Herceptin journey so far across all indications*†

Discover why

[IMG: Herceptin financial support options]

[H2] Out-of-Pocket
Support
up to $25,000
per calendar year

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[IMG: How Herceptin is thought to work]

[H2] How Herceptin is
Thought to Work

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[IMG: Taking Herceptin]

[H2] Taking Herceptin

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*Based upon average weight and vials sold.
†Early Breast Cancer, Metastatic Breast Cancer, and Metastatic Stomach Cancer.
‡Eligibility criteria and annual limits apply. Not valid for patients using federal or state government programs to pay for their medications. Patients must be taking HERCEPTIN for an FDA-approved indication. See full TERMS AND CONDITIONS.

Early breast cancer (EBC) is a condition where cancer cells are found in the breast but have not spread to distant parts of the body. If left untreated, early breast cancer can progress and may significantly impact your health and daily life. Learn more about what early breast cancer is and about treatment options.
HERCEPTIN® is approved to treat early-stage HER2-positive breast cancer. By targeting the HER2 protein, which causes uncontrolled cancer cell growth, HERCEPTIN blocks cellular pathways and enhances the body's immune system to attack these cancer cells. HERCEPTIN is given by intravenous (IV) infusion, on a weekly or once-every-three-weeks schedule. Your healthcare provider will determine a personalized treatment plan for you. Learn the details about preparing for treatment and the treatment schedule.
The most common side effects include fever, chills, headache, and nausea. HERCEPTIN can also cause serious side effects, such as heart problems, infusion reactions, and lung complications. Patients should have regular checks of their heart function during treatment. Explore safety information and understand potential risks. Reach out to your healthcare provider to determine if HERCEPTIN is the right option for you and to discuss available financial assistance options to support your treatment.

[H1]
Uses & Important Safety Information for HERCEPTIN and HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk)

Back to Top

[H3] Herceptin: Indications
[H3] Adjuvant Breast Cancer
Herceptin is approved for the treatment of adults with 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.* Herceptin 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 Herceptin.
*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.
[H3] Metastatic Breast Cancer
Herceptin has 2 approved uses in adults with metastatic breast cancer:
Herceptin 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
Herceptin 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 Herceptin.
[H3] Gastric Cancer
Herceptin 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 Herceptin.
[H3] Herceptin HYLECTA: What it treats
[H3] Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with 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.* HERCEPTIN HYLECTA 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.
[H3] Metastatic Breast Cancer
HERCEPTIN HYLECTA has 2 approved uses in adults with metastatic breast cancer:
HERCEPTIN HYLECTA 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
HERCEPTIN HYLECTA 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.

[H3] Possible Serious Side Effects With HERCEPTIN
Not all people have serious side effects, but side effects with HERCEPTIN 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.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN 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 HERCEPTIN.
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 HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and for 7 months after your last dose of HERCEPTIN. If you are or become pregnant while receiving HERCEPTIN or within 7 months after your last dose of HERCEPTIN, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
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 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 HERCEPTIN 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.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN 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 count
Muscle pain
Some patients receiving HERCEPTIN 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
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

[H3] Possible Serious Side Effects With HERCEPTIN HYLECTA
Not all people have serious side effects, but side effects with HERCEPTIN HYLECTA 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.
HERCEPTIN HYLECTA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
[H3] HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA.
Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.
[H3] SEVERE LUNG PROBLEMS including:
Severe shortness of breath
Scarring of the lungs
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
Your doctor may check for signs of severe lung problems when he or she examines you.
These signs usually happen within 24 hours after receiving HERCEPTIN HYLECTA.
BE SURE TO CONTACT YOUR DOCTOR IF YOU:
[H3] ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT
HERCEPTIN HYLECTA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN HYLECTA and for 7 months after your last dose of HERCEPTIN HYLECTA. If you are or become pregnant while receiving HERCEPTIN HYLECTA or within 7 months after your last dose of HERCEPTIN HYLECTA, you are encouraged to report HERCEPTIN HYLECTA exposure to Genentech at 1–888–835–2555.
[H3] 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 intravenous trastuzumab 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.
Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.
SIDE EFFECTS SEEN MOST OFTEN
The most common side effects seen in treatment of adjuvant breast cancer with HERCEPTIN HYLECTA were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.
The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN HYLECTA.
Please see the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including most serious side effects.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive

[H1] Supporting you along the Herceptin journey for HER2+ metastatic breast cancer

[H1] Supporting you along the Herceptin journey for HER2+ metastatic breast cancer

[H6] Over 2.4 million people worldwide have taken the Herceptin journey so far across all indications*†

Discover why

[IMG: Herceptin financial support options]

[H2] Out-of-Pocket
Support
up to $25,000
per calendar year

Get Started

[IMG: How Herceptin is thought to work]

[H2] How Herceptin is
Thought to Work

Learn More

[IMG: Taking Herceptin]

[H2] Taking Herceptin

Learn More

*Based upon average weight and vials sold.
†Early Breast Cancer, Metastatic Breast Cancer, and Metastatic Stomach Cancer.
‡Eligibility criteria and annual limits apply. Not valid for patients using federal or state government programs to pay for their medications. Patients must be taking HERCEPTIN for an FDA-approved indication. See full TERMS AND CONDITIONS.

HER2-positive metastatic breast cancer is an advanced form of breast cancer that has spread beyond the breast to other parts of the body. It can significantly affect daily life and requires careful management to control the disease and improve quality of life. Learn more about what metastatic breast cancer is and treatment options.
HERCEPTIN® (trastuzumab) is an FDA-approved treatment specifically for HER2-positive metastatic breast cancer. HERCEPTIN targets HER2 proteins, blocking cancer growth signals and helping the immune system destroy HER2-positive cells. HERCEPTIN is administered as an intravenous (IV) infusion on a schedule determined by your doctor based on your individual treatment plan. Learn details about the treatment schedule and tips on preparing for treatment.
Common side effects include nausea, fever, headache, and fatigue. Serious risks can include heart problems, infusion reactions, and lung complications, so regular heart monitoring is important during treatment. Explore more detailed safety information. Speak with your healthcare provider to determine if HERCEPTIN is right for you, and learn more about available financial assistance options for your treatment.

[H1]
Uses & Important Safety Information for HERCEPTIN and HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk)

Back to Top

[H3] Herceptin: Indications
[H3] Adjuvant Breast Cancer
Herceptin is approved for the treatment of adults with 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.* Herceptin 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 Herceptin.
*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.
[H3] Metastatic Breast Cancer
Herceptin has 2 approved uses in adults with metastatic breast cancer:
Herceptin 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
Herceptin 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 Herceptin.
[H3] Gastric Cancer
Herceptin 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 Herceptin.
[H3] Herceptin HYLECTA: What it treats
[H3] Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with 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.* HERCEPTIN HYLECTA 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.
[H3] Metastatic Breast Cancer
HERCEPTIN HYLECTA has 2 approved uses in adults with metastatic breast cancer:
HERCEPTIN HYLECTA 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
HERCEPTIN HYLECTA 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.

[H3] Possible Serious Side Effects With HERCEPTIN
Not all people have serious side effects, but side effects with HERCEPTIN 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.
HERCEPTIN is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN 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 HERCEPTIN.
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 HERCEPTIN.
Be sure to contact your doctor if you:
Are a woman who could become pregnant, or may be pregnant
HERCEPTIN may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN and for 7 months after your last dose of HERCEPTIN. If you are or become pregnant while receiving HERCEPTIN or within 7 months after your last dose of HERCEPTIN, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
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 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 HERCEPTIN 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.
Side Effects Seen Most Often With HERCEPTIN
Some patients receiving HERCEPTIN 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 count
Muscle pain
Some patients receiving HERCEPTIN 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
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

[H3] Possible Serious Side Effects With HERCEPTIN HYLECTA
Not all people have serious side effects, but side effects with HERCEPTIN HYLECTA 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.
HERCEPTIN HYLECTA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
[H3] HEART PROBLEMS
These include heart problems—such as 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 HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA.
Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.
[H3] SEVERE LUNG PROBLEMS including:
Severe shortness of breath
Scarring of the lungs
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
Your doctor may check for signs of severe lung problems when he or she examines you.
These signs usually happen within 24 hours after receiving HERCEPTIN HYLECTA.
BE SURE TO CONTACT YOUR DOCTOR IF YOU:
[H3] ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT
HERCEPTIN HYLECTA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN HYLECTA and for 7 months after your last dose of HERCEPTIN HYLECTA. If you are or become pregnant while receiving HERCEPTIN HYLECTA or within 7 months after your last dose of HERCEPTIN HYLECTA, you are encouraged to report HERCEPTIN HYLECTA exposure to Genentech at 1–888–835–2555.
[H3] 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 intravenous trastuzumab 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.
Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.
SIDE EFFECTS SEEN MOST OFTEN
The most common side effects seen in treatment of adjuvant breast cancer with HERCEPTIN HYLECTA were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.
The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1–800–FDA–1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1–888–835–2555.
Talk to a healthcare professional for more information about the benefits and risks of HERCEPTIN HYLECTA.
Please see the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including most serious side effects.
If you cannot afford your medication, visit genentech-access.com/patient for financial assistance information.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

Herceptin Prescribing Information. Genentech, Inc. February 2021.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.

Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.

Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist