HER2+ Breast Cancer | Herceptin® (trastuzumab)

Time 2020-12-31 01:04:09

Web Name: HER2+ Breast Cancer | Herceptin® (trastuzumab)

WebSite: http://www.herceptin.com

ID:151422

Keywords:

Breast,Cancer,trastuzumab,

Description:

Adjuvant Breast CancerHerceptin 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 CancerHerceptin 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 cancerHerceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic diseasePatients are selected for therapy based on an FDA-approved test for Herceptin.Gastric CancerHerceptin 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.Adjuvant Breast CancerHERCEPTIN 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 CancerHERCEPTIN 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 cancerHERCEPTIN HYLECTA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic diseasePatients are selected for therapy based on an FDA-approved test for trastuzumab. Possible Serious Side Effects With HERCEPTINNot 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 PROBLEMSThese 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. Be sure to contact your doctor if you:Are a woman who could become pregnant, or may be pregnantHERCEPTIN 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.Your doctor may check for signs of severe lung problems when he or she examines you. Have LOW WHITE BLOOD CELL COUNTSLow 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 HERCEPTINSome patients receiving HERCEPTIN for breast cancer had the following side effects:FeverFeeling sick to your stomach (nausea)Throwing up (vomiting)Infusion reactionsDiarrheaInfectionsIncreased coughHeadacheFeeling tiredShortness of breathLow white and red blood cell countMuscle pain Some patients receiving HERCEPTIN for metastatic stomach cancer had the following side effects:Low white blood cell countsDiarrheaFeeling tiredLow red blood cell countsSwelling of the mouth liningWeight lossUpper respiratory tract infectionsFeverLow platelet countsSwelling of the mucous membranesSwelling of the nose and throatChange in tasteYou 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 HYLECTANot 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 PROBLEMSThese 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 breathScarring of the lungsFluid in or around the lungsWeakening of the valve between the heart and the lungsNot enough oxygen in the bodySwelling of the lungsYour 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 PREGNANTHERCEPTIN 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 COUNTSLow 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 OFTENThe 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. The information contained in this section of the site is intended for U.S. healthcare professionals only. Click OK if you are a healthcare professional. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

TAGS:Breast Cancer trastuzumab 

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