Corporate websites

Astellas Pharma US, Inc.

Find out more about Astellas Pharma US, Inc.
 http://www.astellas.us/

Resource links

This list includes just some of the organizations that offer support to those who are living with cancer.

Genentech, Inc. and Astellas Pharma US, Inc. do not control or endorse the content of the third-party websites listed here. The information provided by these organizations is meant for informational purposes only and is not meant to replace a physician's medical advice. By selecting any of the links below, you will be leaving Tarceva.com.

Sections

Lung cancer resources

The Bonnie J. Addario Lung Cancer Foundation
The BJALCF works with a diverse group of physicians, organizations, and individuals to identify solutions and make timely and meaningful change through research, early detection, education, prevention, and treatment.
(650) 598-2857
www.lungcancerfoundation.org

Lung Cancer Alliance
The LCA is a national organization that supports research, education, advocacy, and services related to cancer. The LCA hosts an online support community for patients and caregivers. For professionals, it offers cancer reference information, cancer facts and figures, research programs and funding, and news updates.
(800) 298-2436
www.lungcanceralliance.org

Lungcancer.org
A program of CancerCare, Lungcancer.org provides free, professional support services to anyone affected by lung cancer. Services, including counseling, education, financial assistance, and practical help, are provided by trained oncology social workers and are completely free of charge.
(800) 813-4673
www.lungcancer.org

Lung Cancer Research Foundation
The mission of the Lung Cancer Research Foundation is to support national research studies and activities focused on developing innovative strategies for better treatments, screening, and prevention of all cancers of the lung.
(212) 588-1580

www.lungcancerresearchfoundation.org

LUNGevity Foundation
The LUNGevity Foundation is dedicated to funding lung cancer research and providing support to people living with lung cancer. It hosts the Lung Cancer Support Community, an online community for patients and caregivers.
(312) 407-6100
www.lungevity.org

Free to Breathe
This organization brings together lung cancer survivors, advocates, researchers, healthcare professionals, and industry leaders with the goal of helping patients live longer.
www.freetobreathe.org

Associations and societies

American Association for Cancer Research (AACR)
The American Association for Cancer Research is a professional organization of more than 27,000 cancer researchers. The AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research.
(866) 423-3965
www.aacr.org

American Psychosocial Oncology Society (APOS)
The American Psychosocial Oncology Society aims to advance the science and practice of psychosocial care for people with cancer.
(434) 293-5350
www.apos-society.org

American Society of Clinical Oncology (ASCO)
The American Society of Clinical Oncology (ASCO) is a nonprofit organization, founded in 1964, with overarching goals of improving cancer care and prevention and ensuring that all patients with cancer receive care of the highest quality.
(888) 282-2552
www.asco.org

Caregiver Action Network
The Caregiver Action Network is the nation’s leading family caregiver organization working to improve the quality of life for the more than 65 million Americans who care for loved ones with chronic conditions, disabilities, disease, or the frailties of old age.
(202) 454-3970
www.caregiveraction.org

National Hospice and Palliative Care Organization
The NHPCO is an organization dedicated to leading and mobilizing social change for improved care at the end of life.
(703) 837-1500
www.nhpco.org

Oncology Nursing Society (ONS)
The ONS is a professional organization of more than 33,000 registered nurses and other HCPs dedicated to excellence in patient care, education, research, and administration in oncology nursing.

(866) 257-4667
www.ons.org

Medical databases

MEDLINE®/PubMed®
PubMed is a service of the National Library of Medicine that provides access to over 11 million citations from MEDLINE and additional life science journals and includes links to additional sites that provide full-text articles and other related resources.
www.pubmed.gov

National Cancer Institute — Cancer Literature in PubMed
This is a bibliographic database, provided as a service of the National Cancer Institute, that gives citations and abstracts from medical articles pertaining to a variety of health-related topics.
http://www.cancer.gov/publications/pdq

Clinical trials information

You may consider speaking with your doctor about taking part in a clinical trial either before or after you start treatment for your advanced NSCLC or advanced pancreatic cancer. For more information on clinical trials, including locating ongoing clinical trials in your area, visit these websites:

ClinicalTrials.gov
This site provides regularly updated information about federally and privately supported clinical research in human volunteers.
www.clinicaltrials.gov

Coalition of Cancer Cooperative Groups
The Coalition of Cancer Cooperative Groups is a nonprofit organization whose mission is to improve the quality of life and survival of cancer patients by increasing participation in cancer clinical trials. They feature a variety of resources to educate and connect patients to clinical trials.
(215) 789-3600
www.cancertrialshelp.org

National Cancer Institute
The National Cancer Institute website has extensive information on cancer prevention, diagnosis, treatment, statistics, research, clinical trials, and news, as well as links to other NCI websites. Cancer information specialists have access to comprehensive, accurate information on a range of cancer topics, including the most recent advances in cancer treatment.
(800) 422-6237
www.cancer.gov

The NCI also has a list of NCI-designated comprehensive cancer treatment centers, which are actively engaged in transdisciplinary research to reduce cancer incidence, morbidity, and mortality.
http://www.cancer.gov/research/nci-role/cancer-centers

National Institutes of Health
The nation's medical research agency — making important medical discoveries that improve health and save lives. The NIH provides a clinical trials registry of federally and privately supported clinical trials conducted in the United States and around the world.
(301) 496-4000
www.nih.gov

Indication

Metastatic NSCLC

Tarceva is indicated for:

  • The treatment of patients with metastatic non-small cell lung cancer (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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of use:

  • Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Interstitial Lung Disease (ILD): 
    • Cases of serious ILD, including fatal cases, can occur with Tarceva treatment. The overall incidence of ILD in approximately 32,000 Tarceva-treated patients in uncontrolled studies and studies with concurrent chemotherapy was approximately 1.1%. In patients with ILD, the onset of symptoms was between 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy.
    • Withhold Tarceva for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, permanently discontinue Tarceva.
  • Renal Failure: 
    • Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with Tarceva treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration.
    • The pooled incidence of severe renal impairment in the 3 monotherapy lung cancer studies was 0.5% in the Tarceva arms and 0.8% in the control arms. The incidence of renal impairment in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Withhold Tarceva in patients developing severe renal impairment until renal toxicity is resolved. Perform periodic monitoring of renal function and serum electrolytes during Tarceva treatment.
  • Hepatotoxicity With or Without Hepatic Impairment:
    • Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with Tarceva treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment.
      • Hepatic Toxicity: One Tarceva-treated patient experienced fatal hepatic failure and four additional patients experienced grade 3-4 liver test abnormalities. 
    • In clinical studies where patients with moderate to severe hepatic impairment were excluded, the pooled incidence of hepatic failure in the 3 monotherapy lung cancer studies was 0.4% in the Tarceva arms and 0% in the control arms. The incidence of hepatic failure in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Perform periodic liver testing (transaminases, bilirubin, and alkaline phosphatase) during treatment with Tarceva. Increased frequency of monitoring of liver function is required for patients with pre-existing hepatic impairment or biliary obstruction.
    • Withhold Tarceva in patients without pre-existing hepatic impairment for total bilirubin >3 x ULN or transaminases >5 x ULN. Withhold Tarceva in patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline.
    • Discontinue Tarceva in patients whose abnormal liver tests meeting the above criteria do not improve significantly or resolve within 3 weeks.
  • Gastrointestinal Perforation:
    • Gastrointestinal perforation, including fatal cases, can occur with Tarceva treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation.
    • The pooled incidence of gastrointestinal perforation in the 3 monotherapy lung cancer studies was 0.2% in the Tarceva arms and 0.1% in the control arms. The incidence of gastrointestinal perforation in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
  • Bullous and Exfoliative Skin Disorders:
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, can occur with Tarceva treatment.
    • The pooled incidence of bullous and exfoliative skin disorders in the 3 monotherapy lung cancer studies was 1.2% in the Tarceva arms and 0% in the control arms. The incidence of bullous and exfoliative skin disorders in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
  • Cerebrovascular Accident:
    • In the pancreatic carcinoma trial, 7 patients in the Tarceva plus gemcitabine group developed cerebrovascular accidents (incidence: 2.5%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo plus gemcitabine group there were no cerebrovascular accidents. The pooled incidence of cerebrovascular accident in the 3 monotherapy lung cancer studies was 0.6% in the Tarceva arms and not higher than that observed in the control arms.
  • Microangiopathic Hemolytic Anemia With Thrombocytopenia:
    • The pooled incidence of microangiopathic hemolytic anemia with thrombocytopenia in the 3 monotherapy lung cancer studies was 0% in the Tarceva arms and 0.1% in the control arms. The incidence of microangiopathic hemolytic anemia with thrombocytopenia in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
  • Ocular Disorders:
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with Tarceva treatment and can lead to corneal perforation or ulceration.
    • The pooled incidence of ocular disorders in the 3 monotherapy lung cancer studies was 17.8% in the Tarceva arms and 4% in the control arms. The incidence of ocular disorders in the pancreatic cancer study was 12.8% in the Tarceva plus gemcitabine arm and 11.4% in the control arm.
    • Interrupt or discontinue Tarceva therapy if patients present with acute or worsening ocular disorders such as eye pain.
  • Hemorrhage in Patients Taking Warfarin:
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are administered concurrently.
    • Regularly monitor prothrombin time and INR during Tarceva treatment in patients taking warfarin or other coumarin-derivative anticoagulants.
  • Embryo-Fetal Toxicity:
    • Based on animal data and its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.
    • Advise females of reproductive potential to use effective contraception during therapy and for one month after the last dose of Tarceva.

MOST COMMON ADVERSE REACTIONS

  • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
    • Most frequent (≥30%) adverse reactions were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite. 
    • Most frequent Grade 3/4 (NCI-CTC Version 3.0) adverse reactions were rash (14%) and diarrhea (5%). In Tarceva-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%). 

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 Tarceva full Prescribing Information for additional Important Safety Information.