Vectibix® (panitumumab) for Metastatic Colorectal Cancer_Health & Fitness

Indication and Limitation of Use Vectibix® (panitumumab) is for treating patients with wild-type RASmetastatic colorectal cancer (cancer that has spread outside of the colon and rectum). RASstatus is determined by an FDA-approved test. Wild-type RAS Readmore is acancer without mutations in the KRAS and NRAS genes. IndicationImportant Safety InformationPrescribingInformationContact UsFor Healthcare Professionals Why Vectibix® How Vectibix® Works Treatment Results Possible Skin Reactions How to Take Vectibix® Resources Financial Assistance Helpful Tools Support Groups ARE YOU A HEALTH CARE PROFESSIONAL?The information provided in this section is intended expressly for health careprofessionals in the United States. Click "Yes, I am" to enter if you are a U.S. health careprofessional.Yes, I am No, I'm Not YOU HAVE WHAT IT TAKES IN THE FIGHT AGAINST mCRC Vectibix® in combination with FOLFOX chemotherapy is designed for patientswith wild-type RAS metastatic colorectal cancer (mCRC), and aRAS test can show what type of mCRC you have.1,2Find out if Vectibix® is right for you A real Vectibix® patient’s perspectiveHear from Maureen about her experience with mCRC and treatment withVectibix® Proven results with Vectibix®Review the benefits of Vectibix® in a largeclinical trial of patients with metastatic colorectal cancer Learn how Vectibix® is takenGet information on how and when your Vectibix® dose will be given by a healthcare professional Get resources to help in your fightExplore resources for your treatment journey, including financialassistance and patient support groups References: 1. Vectibix® (panitumumab) prescribing information,Amgen. 2. Allegra CJ, Rumble RB, Hamilton SR, et al. Extended RAS gene mutationtesting in metastatic colorectal carcinoma to predict response to anti–epidermal growth factorreceptor monoclonal antibody therapy: American Society of Clinical Oncology provisional clinicalopinion update 2015. J Clin Oncol. 2016;34:179-185. Collapse Important Safety InformationIn a clinical study, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Skin reactionsincluded but were not limited to:Acne-like skin rashItchingRednessSkin rashSkin peelingNail infections at the side of the nail beds of the fingers or toesDry skinOpenings in the skinOf 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 alsodeveloped 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 theevent of severe or life-threatening side effects, stop Vectibix®treatment. It is important that you tell your doctor right away if you have any skinreactions or any signs of infection (such as chills, fever, or increased redness or swellingof an existing skin reaction).Patients who have metastatic colorectal cancer with RAS-mutant tumors should notreceive Vectibix®. Several clinical trials have been doneevaluating 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 studiesof these medicines, patients with RAS-mutant tumors experienced serious sideeffects without any benefit from the treatment. In one study, patients withRAS-mutant tumors who received Vectibix® + FOLFOX didnot live as long as patients who received FOLFOX alone.Some patients who were taking Vectibix® developed lowlevels of certain electrolytes, including:MagnesiumCalciumPotassiumYour doctor may check the levels of these electrolytes in your blood while you are ontreatment and for up to 2 months after you finish treatment. Your doctor may add other oralor intravenous medications to your Vectibix® treatment.Vectibix® is given by infusion into a vein. Somepatients may develop an infusion reaction, which can be severe and in rare cases hasresulted in death. In one clinical study, infusion reactions developed in 4% of patients,and 1% of patients experienced serious infusion reactions. Infusion reactions included:FeverChillsShortness of breathThroat spasmsLow blood pressureDepending on how severe the reaction is, your doctor may decide to slow the rate of theinfusion, stop the infusion, or stop your Vectibix® treatmentcompletely.Tell your doctor right away if you experience severe diarrhea or dehydration. Some patientstreated with Vectibix® and chemotherapy developed kidney failureand other complications because of severe diarrhea and dehydration.Lung disease, including fatal lung disease, occurred in 1% or less of patients who had takenVectibix®. 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 lungproblems in the past, be sure to tell your doctor. Your doctor may decide to stopVectibix® treatment.Being in the sun may make skin reactions worse. Wear sunscreen and protective clothing (suchas 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 youhave any vision changes or eye problems. If you experience any of these side effects or theyworsen, 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 notlive as long as patients receiving only Avastin® andchemotherapy. Do not take Avastin® with Vectibix®.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 inthe blood.Serious or potentially fatal blood clots that traveled to the lungs occurred more inVectibix®-treated patients, and less than 1% of Vectibix®-treated patients died.Because of the side effects experienced, patients receiving Vectibix®, Avastin®, and chemotherapyreceived less chemotherapy for the first 24 weeks of the study compared with thosereceiving Avastin® and chemotherapy.Vectibix® can cause harm to an unborn child. Use effective birthcontrol to avoid pregnancy while taking Vectibix® and for atleast 2 months after the last dose.In patients who received Vectibix® alone, the most commonlyreported side effects (experienced by 20% or more of patients) were different types of skinrash, infections at the side of the nail beds of the fingers or toes, fatigue (extremetiredness), nausea, and diarrhea.In patients who received Vectibix® + FOLFOX, the most commonlyreported 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 mostcommon serious side effects were diarrhea and dehydration.Please read the full PrescribingInformation and discuss it with your doctor.INDICATIONVectibix® (panitumumab) is for treating patients with wild-typeRAS metastatic colorectal cancer (cancer that has spread outside of the colon andrectum). RAS status is determined by an FDA-approved test. Wild-type RASis a cancer without mutations in the KRAS and NRAS genes.Vectibix® can be used:As a first-time treatment given with chemotherapy called FOLFOX (folinic acid,fluorouracil, oxaliplatin)Alone, following disease progression with the following chemotherapies:fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapyVectibix® is not to be used to treat patients with tumors thathave mutations in the RAS gene (called RAS mutant), or when theRAS mutation status is unknown. Talk to your doctor about your RAS status.Back to Top Expand Important Safety InformationIn a clinical study, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Skinreactions included but were not limited to:Acne-like skin rashItchingRednessSkin rashSkin peelingNail infections at the side of the nail beds of the fingers or toesDry skinOpenings in the skinOf these patients, 15% had severe skin reactions that involved, for some, pain,disfigurement, ulceration, or loss of outer layers of skin when receivingVectibix® alone. Some patients who developed severe skinreactions also developed infections in the blood, skin, fat, or tissue thatsometimes resulted in death.Your doctor may need to make changes to your dose to address your side effects or, inthe event of severe or life-threatening side effects, stop Vectibix® treatment. It is important that you tell your doctorright 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 shouldnot receive Vectibix®. Several clinical trials have beendone evaluating treatments that block part of the pathway that increases tumor cellgrowth (anti-epidermal growth factor receptor [EGFR]). Anti-EGFR treatments includeVectibix® and Erbitux®(cetuximab). In studies of these medicines, patients with RAS-mutant tumorsexperienced serious side effects without any benefit from the treatment. In onestudy, patients with RAS-mutant tumors who received Vectibix® + FOLFOX did not live as long as patients who receivedFOLFOX alone.Some patients who were taking Vectibix®developed low levels of certain electrolytes, including:MagnesiumCalciumPotassiumYour doctor may check the levels of these electrolytes in your blood while you are ontreatment and for up to 2 months after you finish treatment. Your doctor may addother 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 rarecases has resulted in death. In one clinical study, infusion reactions developed in4% of patients, and 1% of patients experienced serious infusion reactions. Infusionreactions included:FeverChillsShortness of breathThroat spasmsLow blood pressureDepending on how severe the reaction is, your doctor may decide to slow the rate ofthe infusion, stop the infusion, or stop your Vectibix®treatment completely.Tell your doctor right away if you experience severe diarrhea or dehydration. Somepatients treated with Vectibix® and chemotherapydeveloped kidney failure and other complications because of severe diarrhea anddehydration.Lung disease, including fatal lung disease, occurred in 1% or less of patients whohad taken Vectibix®. Tell your doctor if you haveproblems 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 doctormay decide to stop Vectibix® treatment.Being in the sun may make skin reactions worse. Wear sunscreen and protectiveclothing (such as a hat) and avoid direct sunlight while you are on treatment withVectibix®. Tell your doctor if you have new or worseningskin reactions.Inflammation of the eye and injury to the cornea have been reported. Tell your doctorif you have any vision changes or eye problems. If you experience any of these sideeffects 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 toexperience severe side effects and to not live as long as patients receiving onlyAvastin® and chemotherapy. Do not take Avastin® with Vectibix®.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 ofpotassium and magnesium in the blood.Serious or potentially fatal blood clots that traveled to the lungs occurredmore in Vectibix®-treated patients, and less than 1%of Vectibix®-treated patients died.Because of the side effects experienced, patients receiving Vectibix®, Avastin®, andchemotherapy received less chemotherapy for the first 24 weeks of the studycompared with those receiving Avastin® andchemotherapy.Vectibix® can cause harm to an unborn child. Use effectivebirth control to avoid pregnancy while taking Vectibix®and for at least 2 months after the last dose.In patients who received Vectibix® alone, the mostcommonly reported side effects (experienced by 20% or more of patients) weredifferent types of skin rash, infections at the side of the nail beds of the fingersor toes, fatigue (extreme tiredness), nausea, and diarrhea.In patients who received Vectibix® + FOLFOX, the mostcommonly reported side effects (experienced by 20% or more of patients) werediarrhea, sore mouth, inflammation of mucous membranes, weakness, infection of thenail beds, loss of appetite, low magnesium, low potassium, rash, acne-like skinrash, itching, and dry skin. The most common serious side effects were diarrhea anddehydration.Please read the full Prescribing Information and discuss it withyour doctor.INDICATIONVectibix® (panitumumab) is for treating patients withwild-type RAS metastatic colorectal cancer (cancer that has spread outsideof the colon and rectum). RAS status is determined by an FDA-approved test.Wild-type RAS is a cancer without mutations in the KRAS andNRAS genes.Vectibix® can be used:As a first-time treatment given with chemotherapy called FOLFOX (folinic acid,fluorouracil, oxaliplatin)Alone, following disease progression with the following chemotherapies:fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapyVectibix® is not to be used to treat patients with tumorsthat have mutations in the RAS gene (called RAS mutant), or whenthe RAS mutation status is unknown. Talk to your doctor about yourRAS status. Sitemap Privacy Statement Terms of Use Amgen Assist 360™ © 2021 Amgen Inc. 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