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We focus on access so you can focus on health Welcome to Genentech BioOncology™ Access Solutions.

Genentech BioOncology Access Solutions offers a full range of programs and services to meet the needs of eligible patients and health care professionals. We might be able to help appropriate patients with their access needs, from benefits investigations through patient assistance options for those who are eligible.

 


 

 

Infused Products


Oral Products


Indications and Important Safety Information

 

Avastin

INDICATIONS

Glioblastoma (GBM)
Avastin is indicated for the treatment of glioblastoma as a single agent for adult patients with progressive disease following prior therapy. The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.

Metastatic colorectal cancer (MCRC)
Avastin is indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil–based chemotherapy.

Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.

Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.

Non-squamous non-small cell lung cancer (NSCLC)
Avastin is indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.

Metastatic renal cell carcinoma (mRCC)
Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.

Boxed WARNINGS

  • Gastrointestinal (GI) perforation

    - Serious and sometimes fatal GI perforation occurs at a higher incidence in Avastin-treated patients compared to controls

    - The incidences of GI perforation ranged from 0.3% to 2.4% across clinical studies

    - Discontinue Avastin in patients with GI perforation

  • Surgery and wound healing complications

    - The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients

    - Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. The appropriate interval between termination of Avastin and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined

    - Discontinue Avastin at least 28 days prior to elective surgery and in patients with wound healing complications requiring medical intervention

  • Hemorrhage

    - Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. Across indications, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 1.2% to 4.6%

    - Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis (≥1/2 tsp of red blood)

    - Discontinue Avastin in patients with serious hemorrhage (ie, requiring medical intervention)

Additional serious adverse events

  • Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs control included

    - Non-GI fistula formation (≤0.3%)

    - Arterial thromboembolic events (grade ≥3, 2.6%)

    - Proteinuria (nephrotic syndrome, <1%)

  • Additional serious adverse events with increased incidence in the Avastin-treated arm vs control included

    - Hypertension (grade 3–4, 5%–18%)

    - Reversible posterior leukoencephalopathy syndrome (RPLS) (<0.1%)

  • Infusion reactions with the first dose of Avastin were uncommon (<3%), and severe reactions occurred in 0.2% of patients
  • Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin

Most common adverse events

  • Across indications, the most common adverse reactions observed in Avastin patients at a rate >10% and at least twice the control arm rate were
    - Epistaxis - Proteinuria - Lacrimation disorder
    - Headache - Taste alteration - Back pain
    - Hypertension - Dry skin - Exfoliative dermatitis
    - Rhinitis - Rectal hemorrhage  
  • Across all studies, Avastin was discontinued in 8.4% to 21% of patients because of adverse reactions

Pregnancy warning

  • Avastin may impair fertility
  • Based on animal data, Avastin may cause fetal harm
  • Advise patients of the potential risk to the fetus during and following Avastin and the need to continue adequate contraception for at least 6 months following the last dose of Avastin
  • For nursing mothers, discontinue nursing or Avastin, taking into account the importance of Avastin to the mother

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information, including Boxed WARNINGS, for additional important safety information.

Avastin® and the Access Solutions logo are registered trademarks of Genentech, Inc.

Erivedge

Erivedge Indication and Important Safety Information

INDICATION

ERIVEDGE® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

Boxed Warning and Additional Important Safety Information

Embryo-Fetal Death and Severe Birth Defects

  • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action
  • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen
  • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant
  • Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555

Blood Donation

  • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge

Nursing Mothers

  • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge
  • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the accompanying full Prescribing Information for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.

GAZYVA

Indication

GAZYVA (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

 

Important Safety Information

Boxed WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA

 

Additional Warnings and Precautions

  • Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions. For patients with Grade 4 infusion reactions, including but not limited to anaphylaxis, acute life-threatening respiratory symptoms, or other life-threatening infusion reaction, stop and permanently discontinue GAZYVA therapy. Premedicate patients with acetaminophen, antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Infusion reactions within 24 hours of receiving GAZYVA have occurred. For Grades 1, 2, or 3 infusion reactions, interrupt or discontinue infusion for reactions
  • Tumor Lysis Syndrome (TLS): TLS can occur within 12-24 hours after the first infusion. Patients with high tumor burden and/or high circulating lymphocyte count (>25 x 109/L) are at greater risk for TLS and should receive appropriate tumor lysis prophylaxis with anti-hyperuricemics and hydration beginning 12-24 hours prior to the infusion of GAZYVA
  • Infections: Serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. Do not administer GAZYVA to patients with an active infection
  • Neutropenia: Severe neutropenia can occur. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Neutropenia can also be of late onset and/or prolonged
  • Thrombocytopenia: Severe thrombocytopenia can occur. Monitor patients with Grade 3 or 4 thrombocytopenia for platelet counts and bleeding frequently until resolution. Management of hemorrhage may require blood product support

 

Additional Important Safety Information

  • The most common adverse reactions (incidence ≥10%) were: infusion reactions, neutropenia, thrombocytopenia, anemia, pyrexia, cough, and musculoskeletal disorders

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088.

Please see the full Prescribing Information for additional Important Safety Information, including Boxed WARNINGS.

Herceptin

Herceptin Indication and Important Safety Information

INDICATION

Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

* 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 indication

Herceptin is indicated:

  • In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Herceptin is indicated:

  • In combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Boxed WARNINGS and Additional Important Safety Information

  • Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy.
  • Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of Herceptin. Discontinue Herceptin for cardiomyopathy.
  • Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
  • Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death.
  • Exacerbation of chemotherapy-induced neutropenia has also occurred.
  • Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy.
  • The most common adverse reactions associated with Herceptin in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
  • The most common adverse reactions associated with Herceptin in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.

KADCYLA

KADCYLA Indications and Important Safety Information

INDICATION

KADCYLA® (ado-trastuzumab emtansine), injection for intravenous use, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.

Important Safety Information

Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYOFETAL TOXICITY

  • Do Not Substitute KADCYLA for or with Trastuzumab
  • Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin
  • Cardiac Toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function
  • Embryo-Fetal Toxicity: Exposure to KADCYLA can result in embryo-fetal death or birth defects. Advise patients of these risks and the need for effective contraception

The following additional serious adverse reactions have been reported in clinical trials with KADCYLA:

  • Interstitial Lung Disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatality: KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis
  • Infusion-related reactions (IRR), Hypersensitivity: KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR
  • Thrombocytopenia: Monitor platelet counts prior to initiation of KADCYLA and prior to each dose. Institute dose modifications as appropriate
  • Peripheral neuropathy: KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to = Grade 2
  • Reactions secondary to extravasation: The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration

Additional Important Safety Information:

  • Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA therapy
  • Nursing mothers: Discontinue nursing or discontinue KADCYLA taking into consideration the importance of the drug to the mother
  • The most common adverse drug reactions (frequency > 25%) across clinical trials with KADCYLA were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see accompanying full Prescribing Information for additional important safety information, including Boxed WARNINGS.

PERJETA

PERJETA Indication and Important Safety Information

INDICATION

PERJETA® (pertuzumab) is a HER2/neu receptor antagonist indicated for:

  • Treatment of metastatic breast cancer in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
  • Use in combination with trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival

Limitations of Use:

  • The safety of PERJETA as part of a doxorubicin-containing regimen has not been established
  • The safety of PERJETA administered for greater than 6 cycles for early breast cancer has not been established

Important Safety Information

Boxed WARNINGS: Cardiomyopathy and Embryo-Fetal Toxicity

  • PERJETA administration can result in subclinical and clinical cardiac failure. Evaluate left ventricular function in all patients prior to and during treatment with PERJETA. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
  • Exposure to PERJETA can result in embryo-fetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception

Additional Important Safety Information

  • PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
  • PERJETA has been associated with infusion and hypersensitivity reactions/anaphylaxis
  • Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy
  • In the treatment of MBC, the most common adverse reactions (>30%) seen with PERJETA in combination with Herceptin and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy

Most Common Adverse Reactions in Neoadjuvant Treatment of Breast Cancer:

  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia
  • The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia
  • The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at 1-888-835-2555

Please see PERJETA full Prescribing Information including Boxed WARNINGS for additional Important Safety Information.

PERJETA® and the Access Solutions logo are registered trademarks of Genentech, Inc.

Rituxan NHL and CLL

RITUXAN Indications and Important Safety Information

INDICATION

RITUXAN® (Rituximab) is indicated for the treatment of patients with:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
  • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)

RITUXAN is not recommended for use in patients with severe, active infections.

BOXED WARNINGS

RITUXAN administration can result in serious, including fatal, adverse reactions. These include infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

BOXED WARNINGS

WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
  • Infusion Reactions: RITUXAN administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions
  • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN
  • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN

Warnings and Precautions

  • Tumor Lysis Syndrome: Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12 - 24 hours after the first infusion of RITUXAN in patients with NHL
  • Infections: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy
  • Cardiovascular: Discontinue infusions for serious or life threatening cardiac arrhythmias
  • Renal: Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL
  • Bowel Obstruction and Perforation: Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy

Additional Important Safety Information

  • The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and CLL were infusion reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials
  • The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

RITUXAN® and its logo are trademarks of Biogen Idec, Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.

Tarceva

Tarceva Indications and Important Safety Information

INDICATIONS

Advanced Non-Small Cell Lung Cancer (NSCLC)
Tarceva is indicated for:

  • The first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
  • The maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
  • The treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Limitations of use:

  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.
  • Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.

Advanced Pancreatic Cancer

  • 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

    • CONTRAINDICATIONS: None
    • WARNINGS AND PRECAUTIONS:

- Cases of serious interstitial lung disease (ILD), including fatal cases, have been reported.

- Hepatic failure, hepatorenal syndrome, and severe acute renal failure (all including fatal cases) and renal insufficiency have been reported.

- Gastrointestinal perforation (including fatal cases) has been reported.

- Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, have been reported.

- In the pooled incidences in the 3 monotherapy lung studies and the pancreatic carcinoma trial, serious adverse reactions, including fatal cases, such as myocardial infarction/ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia were reported.

- Corneal perforation or ulceration have been reported.

- Severe and fatal hemorrhage associated with INR elevations can occur when Tarceva and warfarin are used concurrently.

- Embryo-fetal toxicity. Tarceva is pregnancy category D. Women should be advised to avoid pregnancy or breastfeeding.

  • MOST COMMON ADVERSE REACTIONS:

- Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:

- Diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.

- Advanced NSCLC – Maintenance and Second/Third-Line Treatment:

- Rash and diarrhea.

- Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:

- Fatigue, rash, nausea, anorexia, and diarrhea.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional Important Safety Information, please see accompanying full prescribing information.

Tarceva® and its logo are trademarks of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.

XELODA

XELODA Indications and Important Safety Information

INDICATIONS

XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and overall survival (OS), when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.

XELODA is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

XELODA monotherapy is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.

XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

Boxed WARNING and Additional Important Safety Information

Boxed WARNING
Warfarin Interaction — Coagulopathy

  • Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly.
  • A clinically important XELODA-warfarin drug interaction was demonstrated in a clinical pharmacology trial.
  • Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.
  • Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR have been observed in patients who were stabilized on anticoagulants at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA therapy, and infrequently within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases.
  • Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
  • XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, or severe renal impairment. XELODA is also contraindicated in patients with known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil.
  • Additional serious adverse reactions include diarrhea, cardiotoxicity, hand-and-foot syndrome, and hyperbilirubinemia. XELODA can cause fetal harm. Advise women of the potential risk to the fetus. Do not treat patients with neutrophil counts <1.5 x 109/L or thrombocyte counts <100 x 109/L.
  • The most common adverse reactions (≥30%) reported with XELODA were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported.

Monotherapy in Dukes’ C Stage (III) Colon Cancer

In a phase 3 study of XELODA monotherapy in colon cancer in the adjuvant setting, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving either XELODA or 5-FU/LV (%;%) were increase in bilirubin (20;7), hand-foot syndrome (17;<1), decrease in lymphocytes (13;13), diarrhea (12;14), decrease in neutrophils/granulocytes (3;27), decrease in neutrophils (3;27), stomatitis (2;14), and neutropenia (<1;5). The most common adverse events for all grades occurring in ≥30% of patients receiving either XELODA or 5-FU/LV were hand-foot syndrome (60;9), diarrhea (47;65), nausea (34;47), and stomatitis (22;60). A total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 8 (0.8%) patients randomized to XELODA and 10 (1.0%) randomized to 5-FU/LV.

Monotherapy in mCRC

In two phase 3 trials of XELODA monotherapy in metastatic colorectal cancer, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving either XELODA or 5-FU/LV (%;%) were hyperbilirubinemia (23;6), hand-foot syndrome (17;1), diarrhea (15;12), abdominal pain (<10;5), vomiting (<5;<5), ileus (5;3), stomatitis (<3;15), and neutropenia (3;21). The most common adverse events for all grades occurring in ≥30% of patients receiving either XELODA or 5-FU/LV were anemia (80;79), diarrhea (55;61), hand-foot syndrome (54;6), hyperbilirubinemia (48;17), nausea (43;51), fatigue/weakness (42;46), abdominal pain (35;31), vomiting (27;30), appetite decrease (26;31), stomatitis (25;62), and neutropenia (13;46). A total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 50 (8.4%) patients randomized to XELODA and 32 (5.4%) randomized to 5-FU/LV.

Monotherapy in mBC

In a single arm study of XELODA monotherapy in metastatic breast cancer, serious adverse events (grade 3/4) occurring in ≥5% of patients receiving XELODA (%) were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11), fatigue (8), stomatitis (7), and dehydration (5). The most common adverse events for all grades occurring in ≥30% of patients receiving XELODA were lymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), nausea (53), fatigue (41), dermatitis (37), and vomiting (37).

Combination Therapy with Docetaxel in mBC

In a phase 3 study of XELODA combination therapy (XELODA plus docetaxel) in metastatic breast cancer, serious adverse events (grade 3/4) occurring at a ≥2% higher incidence in patients receiving XELODA plus docetaxel vs docetaxel alone (%;%) were lymphocytopenia (89;84), hand-foot syndrome (24;1), stomatitis (<18;5), diarrhea (<15;<6), anemia (10;<6), hyperbilirubinemia (9;4), nausea (7;2), vomiting (5;2), constipation (2;0), and nail disorder (2;0). The most common adverse events for all grades occurring at a ≥5% higher incidence in patients receiving XELODA plus docetaxel vs docetaxel alone were diarrhea (67;48), stomatitis (67;43), hand-foot syndrome (63;8), nausea (45;36), thrombocytopenia (41;23), vomiting (35;24), abdominal pain (30;24), hyperbilirubinemia (20;6), weakness (16;11), dyspepsia (14;8), lacrimation increase (12;7), and appetite decrease (10;5).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see complete XELODA Prescribing Information including Boxed WARNINGS for additional important safety information.

XELODA® is a registered trademark of Hoffmann-La Roche Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.

ZELBORAF

ZELBORAF Indication and Important Safety Information

INDICATION

ZELBORAF® (vemurafenib) tablets are indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

ZELBORAF is not indicated for use in patients with wild-type BRAF melanoma.

Important Safety Information

The following can occur in patients treated with ZELBORAF:

  • New primary malignancies including cutaneous squamous cell carcinoma, non-cutaneous squamous cell carcinoma, new primary melanoma, and other malignancies
  • Tumor promotion in BRAF wild-type melanomas
  • Serious hypersensitivity reactions including anaphylaxis
  • Severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • QT prolongation
  • Hepatotoxicity including liver laboratory abnormalities, and, when concurrently administered with ipilimumab, increases in transaminases and bilirubin
  • Photosensitivity
  • Ophthalmologic reactions

ZELBORAF can cause fetal harm when administered to a pregnant woman based on its mechanism of action.

The most common adverse reactions of any grade (≥30%) reported were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information for additional important safety information.

ZELBORAF® and the Access Solutions logo are registered trademarks of Genentech, Inc.