Warning: Skin rash
In clinical studies, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Severe or life-threatening skin reactions have been reported.
Skin reactions included (but were not limited to):
- Dry skin
Openings in the skin
percent of these patients had severe skin reactions, which involved pain, disfigurement, ulceration, or loss of outer layers of skin. Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death.
doctor may decrease your dose, delay your next dose, or stop Vectibix® treatment altogether to manage your side effects. 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).
with RAS-mutant mCRC should not take Vectibix®. Investigations of the clinical studies that used Vectibix® showed that Vectibix® exposed patients with RAS-mutant mCRC to serious side effects without working to treat cancer.
patients who were taking Vectibix® developed low levels of certain electrolytes, including:
doctor may check the levels of these electrolytes in your blood while you are on treatment and for 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. Infusion reactions developed in 4% of patients in one clinical trial, and 1% of patients experienced serious infusion reactions. Infusion reactions included:
Shortness of breath
Low blood pressure
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 or 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 been told that 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 (like 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.
Do not take with Avastin®
Patients treated with Avastin® (bevacizumab) and Vectibix® together did not live as long and had more serious side effects, such as acne-like rash, diarrhea, dehydration, painful ulcers and mouth sores, and low levels of potassium and magnesium in the blood. Some patients developed blood clots that can travel to the lungs, which can be very serious or even fatal. Do not take Avastin® with Vectibix®.
Use effective birth control to avoid pregnancy while taking Vectibix® and for 6 months after the last dose. It is possible for a pregnant patient to transfer Vectibix® to an unborn child, which could be harmful to the unborn child.
Vectibix® could also be transferred to a child through breast milk. Your doctor may tell you that you should not nurse your baby during Vectibix® therapy and for 2 months after your last dose of Vectibix®.
Pregnancy Surveillance Program
Women who become pregnant during Vectibix® treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Women who are nursing during Vectibix® treatment are encouraged to enroll in Amgen’s Lactation Surveillance Program. Call 1 (800) 772-6436 to enroll.
Most common side effects
In clinical studies using Vectibix® alone, the most common side effects were severe skin reactions, nail infections, lack of energy, nausea, and diarrhea. The most common serious side effects were general declining health and blockage of the bowel.
In clinical studies using Vectibix® with FOLFOX, the most commonly reported side effects for wild-type KRAS patients were diarrhea, painful mouth swelling, swelling/redness of the inner lining of the mouth, lack of energy, nail infection, lack of hunger, unusual magnesium and potassium levels in the blood, rash, acne-like rash, severe itching, and dry skin. The most serious side effects reported in Vectibix®-treated wild-type KRAS patients were diarrhea and dehydration.
Talk to your doctor
Tell your doctor right away if you have any side effects such as worsening skin problems, eye problems, fever, chills, breathing problems (such as a cough that doesn’t go away or keeps coming back, wheezing, or shortness of breath), if you develop diarrhea or become dehydrated, or if you become pregnant.
Do not change or stop any medications you may be taking (including over-the-counter drugs or supplements you can buy without a prescription) without first speaking with your doctor.
Please read the full Prescribing Information and discuss it with your doctor.