Find Patient Assistance

Answer a few simple questions to find out which patient assistance option might be right for your patient.

  • Is your patient insured?

  • Does the patient's insurance cover his or her Tarceva?

  • Does your patient have commercial insurance?

    What does this mean?
  • Has your patient already been referred to the Genentech BioOncology Co-pay Card and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient 18 years of age or older?

Your Patient Might Qualify for a Referral to the Genentech BioOncology Co-pay Card

If eligible commercially insured patients need assistance with their out-of-pocket costs, Tarceva Access Solutions can refer them to the Genentech BioOncology Co-pay Card.*

 

Learn More

 

*In order to be eligible for the Genentech BioOncology Co-pay Card, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit CopayAssistanceNow.com for the full list of terms and conditions.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, Tarceva Access Solutions offers referrals to independent co-pay assistance foundations.*

 

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*Genentech and Astellas Pharma US do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Tarceva Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s or Astellas Pharma US's endorsement or financial support. There may be other foundations to support the patient's disease state.

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Tarceva to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

 

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*To be eligible for free Tarceva from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the Genentech BioOncology Co-pay Card and support from independent co-pay assistance foundations) and must meet financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

Patient Assistance Options

Referrals to the Genentech BioOncology Co-pay Card

Tarceva Access Solutions can refer eligible patients to the Genentech BioOncology Co-pay Card for help with the out-of-pocket costs associated with Tarceva.*

Learn More

Referrals to Independent Co-pay Assistance Foundations

For eligible patients with commercial or public health insurance, Tarceva Access Solutions offers referrals to independent co-pay assistance foundations.†

Learn More

Referrals to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Tarceva to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.‡

Learn More

*In order to be eligible for the Genentech BioOncology Co-pay Card, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit CopayAssistanceNow.com for the full list of terms and conditions.

†Genentech and Astellas Pharma US do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Tarceva Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s or Astellas Pharma US's endorsement or financial support. There may be other foundations to support the patient's disease state.

‡To be eligible for free Tarceva from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the Genentech BioOncology Co-pay Card and support from independent co-pay assistance foundations) and must meet financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

Important Safety Information & Indication

Indication

Metastatic Non-Small Cell Lung Cancer (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.

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

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 accident (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%).
  • Metastatic NSCLC – Maintenance Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 3.0) rash and diarrhea occurred in 9% and 2%, respectively. Rash and diarrhea resulted in dose reductions or interruption (5% and 3%, respectively) and discontinuation (1% and 0.5%, respectively) of Tarceva-treated patients.
  • Metastatic NSCLC – Second/Third-line Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 2.0) rash and diarrhea occurred in 9% and 6%, respectively. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients.
  • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
    • Fatigue, rash, nausea, anorexia, and diarrhea.
    • Grade 3/4 (NCI-CTC version 2.0) rash and diarrhea were each reported in 5% of patients. Rash and diarrhea each resulted in dose reductions in 2% of patients and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.

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 full Prescribing Information at www.tarceva.com.