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Patient support when it’s needed most
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TARCEVA PATIENT
SUPPORT PROGRAM |
| Offering a free source of information, resources, and ongoing support for your patients throughout treatment. |
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Modify your patient’s dose of
Tarceva without delay
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| UPDATED |
TARCEVA DOSE
EXCHANGE PROGRAM |
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For
patients in need of a dose adjustment,
ensure quicker replacement—free of
charge—of the remaining tablets in their existing prescription
with tablets of the modified dose. |
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For more information, call
(866) 926-2895. |
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Genentech offers assistance programs
that may reduce the cost of Tarceva for
eligible patients
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GENENTECH BIOONCOLOGY®
$25 CO-PAY CARD* |
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Qualified commercially insured patients pay a $25 co-pay per prescription. |
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No income requirements. |
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THE FIRST EGFR TKI TO RECEIVE
PREFERRED FORMULARY STATUS |
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Tarceva has preferred tier formulary status on many regional and national plans.† |
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Tarceva’s preferred tier formulary status may offer patients lower out-of-pocket costs.‡ |
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| Indication |
| Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| Tarceva is indicated for: |
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The
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 receiving
first-line, maintenance, or second or greater line treatment after
progression following at least one prior chemotherapy regimen. |
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| Limitations of Use: |
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Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations. |
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Tarceva is not recommended for use in combination with platinum-based chemotherapy. |
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| Important Safety Information |
| WARNINGS AND PRECAUTIONS |
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Interstitial Lung Disease (ILD): |
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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. |
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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. |
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Renal Failure: |
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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. |
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| Important Safety Information continued below. |
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| Important Safety Information (continued) |
| WARNINGS AND PRECAUTIONS (CONTINUED) |
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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. |
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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. |
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Hepatotoxicity With or Without Hepatic Impairment: |
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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. |
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Hepatic
Toxicity: One Tarceva-treated patient experienced fatal hepatic failure
and four additional patients experienced grade 3-4 liver test
abnormalities. |
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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. |
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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. |
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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. |
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Discontinue
Tarceva in patients whose abnormal liver tests meeting the above
criteria do not improve significantly or resolve within 3 weeks. |
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Gastrointestinal Perforation: |
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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. |
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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. |
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Permanently discontinue Tarceva in patients who develop gastrointestinal perforation. |
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Bullous and Exfoliative Skin Disorders: |
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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. |
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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. |
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Discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions. |
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Cerebrovascular Accident: |
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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. |
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Microangiopathic Hemolytic Anemia With Thrombocytopenia: |
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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. |
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Ocular Disorders: |
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Decreased
tear production, abnormal eyelash growth, keratoconjunctivitis sicca or
keratitis can occur with Tarceva treatment and can lead to corneal
perforation or ulceration. |
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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. |
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Interrupt or discontinue Tarceva therapy if patients present with acute or worsening ocular disorders such as eye pain. |
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Hemorrhage in Patients Taking Warfarin: |
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Severe
and fatal hemorrhage associated with International Normalized Ratio
(INR) elevations can occur when Tarceva and warfarin are administered
concurrently. |
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Regularly
monitor prothrombin time and INR during Tarceva treatment in patients
taking warfarin or other coumarin-derivative anticoagulants. |
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Embryo-Fetal Toxicity: |
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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. |
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Advise
females of reproductive potential to use effective contraception during
therapy and for one month after the last dose of Tarceva. |
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| MOST COMMON ADVERSE REACTIONS |
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Metastatic NSCLC — First-Line Treatment of Patients With EGFR Mutations: |
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Most frequent (≥30%) adverse reactions were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite. |
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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%). |
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Metastatic NSCLC – Maintenance Treatment: |
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Rash and diarrhea. |
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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. |
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Metastatic NSCLC – Second/Third-line Treatment: |
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Rash and diarrhea. |
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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. |
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| 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. |
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