Ask about your options.
Find out if ERBITUX® is right for you.
Open communication with your healthcare team is important from the moment of diagnosis
and continues beyond completion of treatment.
These questions can help you start a conversation with your doctor about the treatments
that are available to you, what to expect, and if ERBITUX might be an option for you.
What are my treatment options?
INDICATION
• In metastatic colorectal cancer, what is RAS testing? Might it affect my treatment options?
If so, how?
• How do these treatments work? Why are you considering them for me?
• In metastatic colorectal cancer, is genetic testing important? Why or why not?
What is ERBITUX?
• How is ERBITUX given?
Could ERBITUX be right for me?
What kind of support is available for me once I start treatment?
• Who can I speak with about getting help with the cost of ERBITUX?
• Are there resources, support groups, and services to help people with cancer like me?
Metastatic colorectal cancer
ERBITUX® (cetuximab) is
approved for the treatment of
certain patients who have
colorectal cancer that has
spread to other parts of the
body. Only patients whose
tumors are KRAS wild-type
(which means they have a KRAS
mutation-negative gene), and
whose tumors have a protein
called epidermal growth factor
receptor (EGFR), should receive
ERBITUX. FDA-approved tests
are used to determine if tumors
have these particular traits.
Treatment with ERBITUX is given
in combination with FOLFIRI
(irinotecan, 5-fluorouracil,
leucovorin) for patients who are
being treated for this type of
cancer for the first time.
■■ ERBITUX is not approved to treat
colorectal cancer in patients
whose tumors have mutations in
genes called RAS (often called
“RAS mutant”), or in patients for
whom the mutational status of
the genes is not known.
ERBITUX is available by
prescription only.
■■
Notes
IMPORTANT SAFETY INFORMATION FOR ERBITUX
WARNING: ALLERGIC REACTIONS
Allergic Reactions
■■
evere allergic reactions due to ERBITUX® (cetuximab) therapy have occurred in 42 of 1373 patients (3%) receiving ERBITUX during
S
clinical studies, resulting in death in less than 1 in 1000 patients
— Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure,
shock, loss of consciousness, and/or heart attack. Report these signs and symptoms of infusion reactions, as well as fever, chills, or
breathing problems to your doctor or nurse
— Approximately 90% of the severe allergic reactions occurred with the first dose of ERBITUX, although some patients experienced their
first severe allergic reaction during a subsequent dose of ERBITUX
— Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an
allergic reaction
— Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again
Please see Important Safety Information for ERBITUX, including Boxed Warning for allergic reactions
continued on page 2 and the full Prescribing Information.
IMPORTANT SAFETY INFORMATION FOR ERBITUX, continued
Lung Disease
ung disease, which resulted in one death, occurred in 4 of 1570 patients (<0.5%) receiving
L
ERBITUX in several clinical trials in colorectal cancer and head and neck cancer
— N
otify your doctor if you develop shortness of breath while receiving ERBITUX
— E
RBITUX treatment should be stopped if symptoms worsen or lung disease is confirmed
■■
Skin Problems
■■
In several clinical trials in colorectal cancer and head and neck cancer with ERBITUX, skin problems including an acne-like rash, skin drying and
cracking, infections (including infections of the blood, skin, eyes, and lips), and abnormal hair growth were seen
— S
un exposure may worsen these effects
— P
atients taking ERBITUX should wear sunscreen and hats to limit sun exposure while receiving and for 2 months following the last dose of ERBITUX
— Severe reactions with symptoms of rash; blistering of the skin, mouth, eyes, and genitals; and shedding of the skin have been seen in patients
treated with ERBITUX. These reactions may be life-threatening and possibly lead to death. It is not clear if these reactions are related to the way
ERBITUX works or to an immune response, such as Stevens-Johnson syndrome or toxic epidermal necrolysis
— A related nail disorder that causes painful swelling of the skin around the nails—most often of the large toes and thumbs—also was reported
— N
otify your doctor if you develop any of these symptoms while receiving ERBITUX
Electrolyte Depletion
ow levels of magnesium and accompanying low calcium and potassium levels have been reported with ERBITUX when given by itself and in
L
combination with other cancer drugs
— Y
our doctor or nurse should periodically monitor your blood electrolyte levels and administer intravenous replacement as needed
■■
Increased Tumor Growth, Increased Death, or Lack of Benefit in Patients with RAS-Mutation Positive or “Mutant”
Colorectal Cancer
■■
ou should not be treated with ERBITUX if you have colorectal cancer that has mutations in the RAS genes because you will not benefit from ERBITUX
Y
treatment and will experience side effects
Pregnancy and Nursing
■■
■■
otify your doctor if you are pregnant or if you become pregnant while receiving ERBITUX. Contraception must be used, in both males and females,
N
during ERBITUX therapy and for 6 months following the last dose of ERBITUX. ERBITUX may be passed from the mother to the developing fetus, and
may cause harm to the fetus. ERBITUX should only be used during pregnancy if the potential benefit is greater than the potential risk to the fetus
ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, nursing is not
recommended during ERBITUX therapy and for two months following the last dose of ERBITUX
Additional Side Effects
In studies of ERBITUX:
■■ The most serious side effects associated with ERBITUX in colorectal cancer that had spread to other parts of the body are: allergic reactions, skin
problems, infection, kidney failure, lung disease, and blood clots in the lung
■■ The most frequent side effects associated with ERBITUX (reported in at least 25% of patients) are skin problems (including rash, itching, and nail
changes), headache, diarrhea, and infection
In a study of European cetuximab in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) given to 317 patients versus FOLFIRI alone
given to 350 patients with colorectal cancer that had spread to other parts of the body whose tumors were KRAS wild-type and whose tumors had
a protein called Epidermal Growth Factor Receptor (EGFR):
■■ The most frequent side effects were: acne-like rash (86% versus 13%) and diarrhea (66% versus 60%)
■■ Serious side effects reported by at least 10% of patients in either arm were: abnormal decrease in white blood cell count (31% versus 24%), acne-like
rash (18% versus <1%), and diarrhea (16% versus 10%)
■■ ERBITUX yields approximately 22% higher blood levels of cetuximab relative to European cetuximab. In this study, the side effects and severity of
adverse reactions seen with European cetuximab were consistent with other studies of U.S. patients receiving ERBITUX for metastatic colorectal cancer
In a study where ERBITUX and supportive care were given to 118 patients versus supportive care which was given to 124 patients with colorectal
cancer that had spread to other parts of the body whose tumors were KRAS wild-type and whose tumors had a protein called Epidermal Growth
Factor Receptor (EGFR):
■■ The most frequent side effects reported were: rash or shedding of the outer layer of the skin (95% versus 21%), feeling tired (91% versus 79%), nausea
(64% versus 50%), dry skin (57% versus 15%), other pain (59% versus 37%), and constipation (53% versus 38%)
■■ Serious side effects reported by at least 10% of patients included: fatigue (31% versus 29%), other pain (18% versus 10%), rash or shedding of the outer
layer of the skin (16% versus 1%), shortness of breath (16% versus 13%), other intestinal problems (12% versus 5%) and infection without abnormal
decrease in white blood cell count (11% versus 5%)
In studies where ERBITUX and irinotecan were given to 354 patients with colorectal cancer that had spread to other parts of the body whose
tumors had a protein called Epidermal Growth Factor Receptor (EGFR):
■■ The most frequent side effects reported were: acne-like rash (88%), feeling weakness or discomfort (73%), diarrhea (72%), and nausea (55%)
■■ Serious side effects reported by at least 10% of patients included: diarrhea (22%), decrease in white blood cell count (17%), feeling weakness or
discomfort (16%), and acne-like rash (14%)
You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for ERBITUX, including Boxed Warning for allergic reactions.
CE CON ISI_CRC 17JUN2015
PP-CE-US-0265
03/2017 © Lilly USA, LLC 2017. All rights reserved.
2
ERBITUX® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.