IMPORTANT SAFETY INFORMATION FOR VECTIBIX®
Vectibix® can cause skin side effects, which may be
severe. In a clinical study, nearly all patients (90%) taking
Vectibix® experienced skin rash or other skin reactions.
Skin reactions included but were not limited to:
- Acne-like skin rash
- Itching
- Redness
- Skin rash
- Skin peeling
-
Nail infections at the side of the nail beds of the fingers or
toes
- Dry skin
- Openings in the skin
Of these patients, 15% had severe skin reactions that involved, for
some, pain, disfigurement, ulceration, or loss of outer layers of
skin when receiving Vectibix® alone. Some patients who
developed severe skin reactions also developed infections in the
blood, skin, fat, or tissue that sometimes resulted in death.
Your doctor may need to make changes to your dose to address your
side effects or, in the event of severe or life-threatening side
effects, stop Vectibix® treatment. It is important that
you tell your doctor right away if you have any skin reactions or
any signs of infection (such as chills, fever, or increased redness
or swelling of an existing skin reaction).
Patients who have metastatic colorectal cancer with
RAS-mutant tumors should not receive Vectibix®
with FOLFOX or alone. Several clinical trials have been done
evaluating treatments that block part of the pathway that increases
tumor cell growth (anti-epidermal growth factor receptor [EGFR]).
Anti-EGFR treatments include Vectibix® and Erbitux®
(cetuximab). In studies of these medicines, patients with
RAS-mutant tumors experienced serious side effects without
any benefit from the treatment. In one study, patients with
RAS-mutant tumors who received Vectibix® + FOLFOX
did not live as long as patients who received FOLFOX alone.
Some patients who were taking Vectibix® developed low
levels of certain electrolytes, including magnesium, calcium and potassium. Some patients also developed high levels of potassium. Your doctor may check the levels of these electrolytes in your blood
while you are on treatment and for up to 2 months after you finish
treatment. Your doctor may add other oral or intravenous medications
to your Vectibix® treatment.
Vectibix® is given by infusion into a vein. Some patients
may develop an infusion reaction, which can be severe and in rare
cases has resulted in death. In one clinical study, infusion
reactions developed in 4% of patients, and 1% of patients
experienced serious infusion reactions. Infusion reactions included:
- Fever
- Chills
- Shortness of breath
- Throat spasms
- Low blood pressure
Depending on how severe the reaction is, your doctor may decide to
slow the rate of the infusion, stop the infusion, or stop your
Vectibix® treatment completely.
Tell your doctor right away if you experience severe diarrhea or
dehydration. Some patients treated with Vectibix® and
chemotherapy developed kidney failure and other complications
because of severe diarrhea and dehydration.
Lung disease, including fatal lung disease, occurred in 1% or less
of patients who had taken Vectibix®. Tell your doctor if
you have problems breathing, wheezing, or a cough that doesn't go
away or keeps coming back. If you have had lung problems in the
past, be sure to tell your doctor. Your doctor may decide to stop
Vectibix® treatment.
Being in the sun may make skin reactions worse. Wear sunscreen and
protective clothing (such as a hat) and avoid direct sunlight while
you are on treatment with Vectibix®. Tell your doctor if
you have new or worsening skin reactions.
Inflammation of the eye and injury to the cornea have been reported.
Tell your doctor if you have any vision changes or eye problems. If
you experience any of these side effects or they worsen, your doctor
should interrupt or discontinue Vectibix®.
In a study of patients treated for mCRC, the addition of
Vectibix® to the combination of Avastin®
(bevacizumab) and chemotherapy caused patients to experience severe
side effects and to not live as long as patients receiving only
Avastin® and chemotherapy. Do not take Avastin®
with Vectibix®.
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Some moderate to severe side effects happened at a higher rate for
Vectibix® patients, including acne-like rash, diarrhea,
dehydration, painful ulcers and mouth sores, and abnormally low
levels of potassium and magnesium in the blood.
-
Serious or potentially fatal blood clots that traveled to the
lungs occurred more in Vectibix®-treated patients, and
less than 1% of Vectibix®-treated patients died.
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Because of the side effects experienced, patients receiving
Vectibix®, Avastin®, and chemotherapy
received less chemotherapy for the first 24 weeks of the study
compared with those receiving Avastin® and
chemotherapy.
Vectibix® can cause harm to an unborn child. Use
effective birth control to avoid pregnancy while taking Vectibix®
and for at least 2 months after the last dose.
In patients who received Vectibix® alone, the most
commonly reported side effects (experienced by 20% or more of
patients) were different types of skin rash, infections at the side
of the nail beds of the fingers or toes, fatigue (extreme
tiredness), nausea, and diarrhea.
In patients who received Vectibix® + FOLFOX, the most
commonly reported side effects (experienced by 20% or more of
patients) were diarrhea, sore mouth, inflammation of mucous
membranes, weakness, infection of the nail beds, loss of appetite,
low magnesium, low potassium, rash, acne-like skin rash, itching,
and dry skin. The most common serious side effects were diarrhea and dehydration.
Abnormal liver blood tests are common with LUMAKRAS® and
can sometimes be severe. LUMAKRAS® used in combination
with Vectibix® has led to liver failure and death. Your
healthcare provider should do blood tests before starting and during
treatment with LUMAKRAS®
to check your liver function. Tell your healthcare provider right
away if you develop any signs or symptoms of liver problems,
including: your skin or the white part of your eyes turns yellow
(jaundice); dark or “tea-colored” urine; light-colored stools (bowel
movements); tiredness or weakness; nausea or vomiting; bleeding or
bruising; loss of appetite; or pain, aching, or tenderness on the
right side of your stomach-area (abdomen).
The most common side effects of Vectibix® when used in
combination with LUMAKRAS® for CRC include skin rash, dry
skin, diarrhea, mouth sores, tiredness, muscle and bone pain, and
changes in certain blood tests.
These are not all the possible side effects of Vectibix®. Call your
healthcare provider for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please read the
full Prescribing Information
and discuss it with your doctor.
