Indication and Limitations of Use

Vectibix® is indicated for treating adult patients with wild-type RAS metastatic colorectal cancer (cancer that has spread outside the colon and rectum). RAS status is determined by an FDA-approved test. Wild-type RAS is 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 chemotherapy.

Vectibix®, when given with FOLFOX or alone, is not to be used to treat patients with tumors that have mutations in the RAS gene (called RAS mutant). Vectibix® is not to be used when the RAS mutation status is unknown. Talk to your doctor about your RAS status.

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Not All Metastatic Colorectal Cancer Is the Same

Some tumor types may respond to certain treatments, while others do not.1-4

What is metastatic colorectal cancer (mCRC)?

Cancers that start in the colon or rectum, which make up the large intestine, are called colorectal cancers.3

When colorectal cancer spreads to other organs, it is called metastatic colorectal cancer, which is abbreviated as mCRC.5

~30-40% of people with colorectal cancer will eventually develop metastases6

Different types of metastatic colorectal cancer

There are two main factors that physicians may use to establish a personalized first treatment plan for mCRC:1-3

  1. Biomarker status, or tumor genetics
  2. Location of the original tumor within the colon/rectum

Both factors can influence treatment choices.1-3

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Knowing your biomarker status is a crucial first step toward targeted treatment

Learning about biomarkers in your cancer cells is important for selecting the treatment that may work best for you. When you find out you have metastatic colorectal cancer, it is important for you to have biomarker testing right away.

Biomarker tests reveal the genetic characteristics of your cancer, which can help your doctor choose the best therapy for you.5,7,8

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4 other biomakers to know when
you have mCRC1,5,8

Microsatellite instability    BRAF gene

HER2 protein    NTRK gene    KRAS G12c gene

Talk to your doctor for more information

Discover how Vectibix® is used in a different type of mCRC

Treatment guidelines for oncologists recommend all patients with metastatic colorectal cancer should have tumor tissue tested for biomarkers.13

Tumor location, or “sidedness,” may also inform treatment2,14,15

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Doctors separate the colon into right and left sides when describing where a tumor is located because each side has distinct features.2,14,15 The left side (shown in orange) includes the following regions of the colon:14

  • Splenic flexure
  • Descending colon
  • Sigmoid colon
  • Rectum

The side of the colon that a tumor is on, or sidedness, may influence how well people respond to certain treatments, and can impact potential treatment choices.2,14,15

Most people with colorectal cancer (up to 70%) have tumors on the left side.2

Talk to your doctor about your biomarker status and tumor sidedness.

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Vectibix® is designed to stop cancer cells from growing and multiplying.12

Learn How Vectibix® Works

References: 1. Ciardiello F, Ciardiello D, Martini G, Napolitano S, Tabernero J, Cervantes A. Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin. 2022;72:372-401. 2. Baran B, Mert Ozupek N, Yerli Tetik N, Acar E, Bekcioglu O, Baskin Y. Difference between left-sided and right-sided colorectal cancer: a focused review of literature. Gastroenterology Res. 2018;11:264-273. 3. American Cancer Society. About colorectal cancer. https://www.cancer.org/content/dam/CRC/PDF/Public/8604.00.pdf. Accessed December 12, 2023. 4. Boeckx N, Koukakis R, Op de Beeck K, et al. Primary tumor sidedness has an impact on prognosis and treatment outcome in metastatic colorectal cancer: results from two randomized first-line panitumumab studies. Ann Oncol. 2017;28:1862-1868. 5. NCCN Guidelines for Patients®. Colon cancer, 2022. https://www.nccn.org/patients/guidelines/content/PDF/colon-patient.pdf. Accessed November 15, 2023. 6. Duineveld LA, van Asselt KM, Bemelman WA, et al. Symptomatic and asymptomatic colon cancer recurrence: a multicenter cohort study. Ann Fam Med. 2016;14:215-220. 7. National Cancer Institute. Biomarker testing for cancer treatment. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment. Updated December 14, 2021. Accessed November 15, 2023. 8. American Cancer Society. Colorectal cancer early detection, diagnosis, and staging. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/how-diagnosed.html. Accessed November 15, 2023. 9. Allegra CJ, Rumble RB, Hamilton SR, et al. Extended RAS gene mutation testing in metastatic colorectal carcinoma to predict response to anti–epidermal growth factor receptor monoclonal antibody therapy: American Society of Clinical Oncology provisional clinical opinion update 2015. J Clin Oncol. 2016;34:179-185. 10. National Cancer Institute. NCI Dictionary of Cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/expand/. Accessed January 29, 2024. 11. Zhao B, Wang L, Qiu H, et al. Mechanisms of resistance to anti-EGFR therapy in colorectal cancer. Oncotarget. 2016;8(3):3980-4000. 12. Vectibix® (panitumumab) prescribing information, Amgen. 13. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer, V.4.2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. November 16, 2023. Accessed December 12, 2023. 14. Stintzing S, Tejpar S, Gibbs P, Thiebach L, Lenz HJ. Understanding the role of primary tumour localisation in colorectal cancer treatment and outcomes. Eur J Cancer. 2017;84:69-80. 15. Bahl A, Talwar V, Sirohi B, et al. Primary tumor location as a prognostic and predictive marker in metastatic colorectal cancer (mCRC). Front Oncol. 2020;10:964.

Important Safety Information:

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®.

  • 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.
  • 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. Serious side effects were diarrhea and dehydration.

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.

Important Safety Information:

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®.

  • 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.
  • 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. Serious side effects were diarrhea and dehydration.

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.

 

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