For US Healthcare Professionals

Prescribing Information

What type of stomach cancer
does Herceptin treat?

Stomach cancer (also known as gastric cancer) includes cancer of the gastroesophageal junction (GEJ), where the esophagus meets the stomach.

Herceptin 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 GEJ 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.

In one study, about 1 in 5 people with stomach cancer had tumors that were HER2-positive (or HER2+).

Herceptin for HER2+ cancer in the stomach and gastroesophageal junction (GEJ)

What is HER2+ stomach cancer?

In stomach cancer that is HER2+, the cancer cells have too many HER2 receptors.

  • Too many HER2 receptors on cancer cells make this type of cancer grow faster

What is a HER2 receptor?

It’s a type of protein found in everyone. HER2 receptors are on the surface of both normal cells and cancer cells.

This protein tells cells to grow and divide. Too much HER2 is called “HER2 overexpression” or “HER2+.”

HER2+ cancer cells have too much HER2 and grow and divide faster, causing a tumor to form

Herceptin for HER2+ metastatic stomach cancer

Stomach cancers are often diagnosed at the metastatic stage in the US, which means the cancer has spread to other parts of the body.

Herceptin is the first monoclonal antibody therapy approved for use as the first treatment of HER2+ metastatic stomach or GEJ cancer.

Herceptin is proven to increase the chances of living longer

Herceptin was studied in a clinical trial of 594 people with HER2+ metastatic stomach/GEJ cancer that was not previously treated.

  • About half the people were treated with chemotherapy alone—and the other half were treated with chemotherapy plus Herceptin*
  • The group of people who received Herceptin as part of their cancer treatment lived 23% longer (13.5 months vs 11.0 months),† in general, than the group of people who had chemotherapy without Herceptin
  • In a follow-up analysis 1 year later, the group of people who received Herceptin as part of their cancer treatment lived 12% longer (13.1 months in the chemotherapy + Herceptin group vs 11.7 months in the chemotherapy alone group)
Herceptin was studied in a trial of nearly 600 people with HER2+ stomach/GEJ cancer

*Chemotherapy was cisplatin + either capecitabine or 5-fluorouracil.
†This clinical trial analyzed overall survival by statistically comparing the 2 treatment groups: 298 patients who were treated with chemotherapy + Herceptin and 296 patients who were treated with chemotherapy alone. The study found that “median overall survival” was 13.5 months in the chemotherapy + Herceptin group compared with 11.0 months in the chemotherapy alone group—23% longer in the group that received Herceptin. In other words, after starting treatment, half of the patients in the first group lived less than 13.5 months, and half lived longer than 13.5 months. And, after starting treatment, half of the patients in the second group lived less than 11.0 months, and half lived longer than 11.0 months.

Discover how Herceptin is designed to target specific proteins.

Get more information on the side effects of patients receiving Herceptin for metastatic stomach cancer.

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Herceptin is designed to target specific proteins on cells to fight cancer.

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For 20 years, doctors have prescribed Herceptin for millions of people with breast cancer or stomach cancer.

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Herceptin: Indications

Adjuvant Breast Cancer

Herceptin is approved 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.* 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 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 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.

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 beestrogen 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.

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.

 

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.

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.