Patient Support
The following materials and information are provided to help you support your patients and the people who care for them:
Tarceva Access Solutions provides coverage and reimbursement support, patient assistance and informational resources for both health care providers and their patients.
Find materials you can pass on to your patients including Tarceva patient brochures and lung cancer support materials.
Provide your patients and their caregivers with a list of helpful and informative cancer support websites.
The following links go to online resources that provide support for your patients and the people who care for them:
Together, Facing Lung Cancer is a local event program dedicated to ensuring lung cancer patients and their caregivers receive both the information and the support they need from each other to manage their disease.
The Lung Cancer Connections program will provide your patients and their caregivers with information to help understand more about lung cancer, treatment options, and how to partner with their healthcare team.
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 III 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. In the event of an acute onset of new or progressive, unexplained pulmonary symptoms such as dyspnea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.
Cases of hepatic failure, hepatorenal syndrome, acute renal failure (all including fatalities), and renal insufficiency have been reported during use of Tarceva. Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe. Patients should be closely monitored during therapy with Tarceva.
Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
Corneal perforation and ulceration have been reported during use of Tarceva. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.
When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D.
The most common adverse reactions in patients with NSCLC receiving Tarceva monotherapy 150 mg were mild to moderate rash and diarrhea. Severe rash and diarrhea (9% & 6% NCI-CTC Grades 3-4, respectively) were reported. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients during the single-agent Phase III trial.
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