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Genentech BioOncology: Innovation in Oncology
Genentech BioOncology is an industry leader in researching the molecular basis of cancer. Our long-standing commitment to this goal enables us to continue to make significant contributions toward the understanding of cancer.
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Safety Information
None
Indication and Usage
Rituxan® (Rituximab) is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma.
BOXED WARNINGS and Additional Important Safety Information
Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Patients who develop severe infusion reactions should have RITUXAN infusion discontinued and receive medical treatment.
Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) patients with RITUXAN.
Severe Mucocutaneous Reactions: Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with RITUXAN treatment.
Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in patients treated with RITUXAN.
RITUXAN has also been associated with fatal hepatitis B reactivation with related fulminant hepatitis and other serious viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation.
The most common adverse events were infusion-related symptoms, including fever (53%), chills/rigors (33%), nausea (23%), asthenia (26%), and headache (19%). The incidence of infusion reactions was highest during the first infusion and decreased with each subsequent infusion. These reactions generally have resolved with slowing or interruption of the infusion and with supportive care.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage
Herceptin, as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, is indicated for the adjuvant treatment of patients with HER2-overexpressing, node-positive breast cancer.
Herceptin as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.
Boxed WARNINGS and Additional Important Safety Information
Herceptin administration can result in left ventricular dysfunction and congestive heart failure (CHF). The incidence and severity of left ventricular cardiac dysfunction/CHF were highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens. Discontinue Herceptin treatment in patients receiving adjuvant therapy for breast cancer who develop a clinically significant decrease in left ventricular function.
Patients receiving Herceptin should undergo frequent monitoring for deteriorating left ventricular function. More frequent monitoring should be employed in patients with pre-existing cardiac dysfunction receiving Herceptin. Monitoring will not identify all patients who will develop cardiac dysfunction.
Serious infusion reactions and pulmonary toxicity have occurred; rarely, these have been fatal. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Herceptin should be strongly considered for infusion reactions manifesting as anaphylaxis, angioedema, pneumonitis, or acute respiratory distress syndrome.
The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage:
AVASTIN®, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
Boxed WARNINGS and Additional Important Safety Information
Gastrointestinal (GI) perforation: Avastin administration can result in the development of GI perforation, in some cases resulting in fatality. GI perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with Avastin. Permanently discontinue Avastin therapy in patients with GI perforation.
Wound healing complication: Avastin administration can result in the development of wound dehiscence, in some instances resulting in fatality. Permanently discontinue Avastin therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of Avastin and subsequent elective surgery has not been determined.
Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and Avastin. Do not administer Avastin to patients with recent hemoptysis (≥1/2 tsp of red blood). Permanently discontinue Avastin in patients with serious hemorrhage and initiate aggressive medical management.
Additional serious adverse events included non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephrotic syndrome, and congestive heart failure. The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis, and proteinuria.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage
TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
Important Safety Information
- There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.
- When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D.
- The most common side effects in patients with NSCLC receiving Tarceva monotherapy 150 mg were rash and diarrhea.
Please see full prescribing information, including important safety information.
Indication and Usage
TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Important Safety Information
- There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.
- In the pancreatic cancer trial, other serious adverse events associated with Tarceva plus gemcitabine and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia.
- When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D.
- The most common side effects in patients with pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea.
Please see full prescribing information, including important safety information.
Indication and Usage
Rituxan® (Rituximab) is indicated for the first-line treatment of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP chemotherapy.
Rituxan® (Rituximab) is indicated for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Rituxan® (Rituximab) is indicated for the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens.
BOXED WARNINGS and Additional Important Safety Information
Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Patients who develop severe infusion reactions should have RITUXAN infusion discontinued and receive medical treatment.
Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) patients with RITUXAN.
Severe Mucocutaneous Reactions: Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with RITUXAN treatment.
Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in patients treated with RITUXAN.
RITUXAN has also been associated with fatal hepatitis B reactivation with related fulminant hepatitis and other serious viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation.
The most common adverse events were infusion-related symptoms, including fever (53%), chills/rigors (33%), nausea (23%), asthenia (26%), and headache (19%). The incidence of infusion reactions was highest during the first infusion and decreased with each subsequent infusion. These reactions generally have resolved with slowing or interruption of the infusion and with supportive care.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage:
AVASTIN®, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
Boxed WARNINGS and Additional Important Safety Information
Gastrointestinal (GI) perforation: Avastin administration can result in the development of GI perforation, in some cases resulting in fatality. GI perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with Avastin. Permanently discontinue Avastin therapy in patients with GI perforation.
Wound healing complication: Avastin administration can result in the development of wound dehiscence, in some instances resulting in fatality. Permanently discontinue Avastin therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of Avastin and subsequent elective surgery has not been determined.
Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and Avastin. Do not administer Avastin to patients with recent hemoptysis (≥1/2 tsp of red blood). Permanently discontinue Avastin in patients with serious hemorrhage and initiate aggressive medical management.
Additional serious adverse events included non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephrotic syndrome, and congestive heart failure. The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis, and proteinuria.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage
AVASTIN®, in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.
Boxed WARNINGS and Additional Important Safety Information
Gastrointestinal (GI) perforation: Avastin administration can result in the development of GI perforation, in some cases resulting in fatality. GI perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with Avastin. Permanently discontinue Avastin therapy in patients with GI perforation.
Wound healing complication: Avastin administration can result in the development of wound dehiscence, in some instances resulting in fatality. Permanently discontinue Avastin therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of Avastin and subsequent elective surgery has not been determined.
Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and Avastin. Do not administer Avastin to patients with recent hemoptysis (≥1/2 tsp of red blood). Permanently discontinue Avastin in patients with serious hemorrhage and initiate aggressive medical management.
Additional serious adverse events included non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephrotic syndrome, and congestive heart failure. The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis, and proteinuria.
Please see full prescribing information and important safety information, including BOXED WARNINGS.
Indication and Usage
Herceptin, as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, is indicated for the adjuvant treatment of patients with HER2-overexpressing, node-positive breast cancer.
Boxed WARNINGS and Additional Important Safety Information
Herceptin administration can result in left ventricular dysfunction and congestive heart failure (CHF). The incidence and severity of left ventricular cardiac dysfunction/CHF were highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens. Discontinue Herceptin treatment in patients receiving adjuvant therapy for breast cancer who develop a clinically significant decrease in left ventricular function.
Patients receiving Herceptin should undergo frequent monitoring for deteriorating left ventricular function. More frequent monitoring should be employed in patients with pre-existing cardiac dysfunction receiving Herceptin. Monitoring will not identify all patients who will develop cardiac dysfunction.
Serious infusion reactions and pulmonary toxicity have occurred; rarely, these have been fatal. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Herceptin should be strongly considered for infusion reactions manifesting as anaphylaxis, angioedema, pneumonitis, or acute respiratory distress syndrome.
The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see full prescribing information and important safety information, including BOXED WARNINGS.