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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Skin Side Effects

Take care of your skin before and during treatment with Vectibix®

In clinical studies, 90% of patients using Vectibix® experienced some form of skin rash or other skin reactions. Severe or life-threatening skin reactions have been reported.1

See Ways to Protect Your Skin
Hypothetical Vectibix patient wearing a backpack and watching a view with water Hypothetical Vectibix patient wearing a backpack and watching a view with water

Some skin reactions you will likely have while taking Vectibix® include:1

  • Acne-like rash
  • Skin rash
  • Nail infections
  • Dry skin
  • Redness
  • Skin peeling
  • Openings in the skin
  • Itching

In a clinical study of Vectibix®, 15% of patients experienced severe skin reactions involving pain, disfigurement, ulceration, or loss of outer layers of skin.1 Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death.1

You will likely also see changes in your nails while taking Vectibix®, including:1-3

  • Redness and swelling around the sides of your nails
  • Grooves or ridges
  • Discoloration
  • Infections in the skin around the edges of nails
  • Tenderness or pain in the skin around and under nails

These changes can start as early as within 20 days of starting treatment or as late as 6 months after treatment.

Hypothetical male doctor conversing with patient Hypothetical male doctor conversing with patient

Always talk to your doctor about any side effects you experience, including skin rash.

Monitor and treat any skin changes as directed by your doctor. Notify your doctor right away if your condition gets worse.

Depending on the severity of the reaction, your doctor may choose to adjust or delay your dose or stop your Vectibix® treatment.1

Proactive steps may help

Treatment guidelines recommend starting skin care early4,5
4 things you can do ahead of treatment:

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Discuss oral antibiotic options with your doctor.4

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Apply skin moisturizer to your face, hands, feet, neck, back, and chest 2 times a day.4,5

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Apply sunscreen on exposed skin areas before going outdoors. Wear hats and limit sun exposure while being treated with Vectibix®.1,5

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Apply topical steroids (eg, hydrocortisone cream) to face, hands, feet, neck, back, and chest 2 times a day.5

Talk with your doctor if you have questions about topical steroids.

Guidelines recommend that you do these things at least 1 day before you begin treatment with Vectibix® unless they interfere with your health and/or you receive alternative guidance from your healthcare team.4,5

Skin and nail care Do's and Don'ts during treatment with Vectibix®

  • Moisturize your skin multiple times throughout the day with a fragrance and dye-free moisturizer2,6,7
  • Use sun protection with an SPF of 30 or higher; reapply throughout the day or as recommended2
  • Limit sun exposure by wearing long-sleeved shirts and pants; wear a hat when outdoors6
  • Wear rubber gloves or cotton-lined gloves when washing dishes or cleaning7,8
  • Use mild soaps when washing skin7

  • Use skin products with perfumes or alcohol6
  • Apply over-the-counter acne medications, creams, and gels2,6
  • Push back your cuticles or bite your fingernails8
  • Use strong soaps or detergents2
  • Wear tight shoes, which may irritate feet or toenails2,8
  • Expose yourself to sun or ultraviolet light from suntanning lamps and beds6
  • Use artificial/acrylic nails8
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References: 1. Vectibix® (panitumumab) prescribing information, Amgen. 2. Burtness B, Anadkat M, Basti S, et al. NCCN Task Force Report: Management of dermatologic and other toxicities associated with EGFR inhibition in patients with cancer. J Natl Compr Canc Netw. 2009;7 Suppl 1:S5-S24. 3. Lacouture ME, Anadkat M, Jatoi A, Garawin T, Bohac C, Mitchell E. Dermatologic toxicity occurring during anti-EGFR monoclonal inhibitor therapy in patients with metastatic colorectal cancer: a systematic review. Clin Colorectal Cancer. 2018;17:85-96. 4. Lacouture ME, Anadkat MJ, Bensadoun RJ, et al. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011;19:1079-1095. 5. Kobayashi Y, Komatsu Y, Yuki S, et al. Randomized controlled trial on the skin toxicity of panitumumab in Japanese patients with metastatic colorectal cancer: HGCSG1001 study; J-STEPP. Future Oncol. 2015;11:617-627. 6. Melosky B, Burkes R, Rayson D, Alcindor T, Shear N, Lacouture M. Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations. Curr Oncol. 2009;16:16-26. 7. Monti M, Motta S. Clinical management of cutaneous toxicity of anti-EGFR agents. Int J Biol Markers. 2007;22:53-61. 8. Fleishman B, Fox LP, Garfield DH, Viele CS, Messner C. Tips for managing treatment-related rash and dry skin. Cancer Care Connect. 2009. https://media.cancercare.org/publications/original/8-ccc_rash.pdf. Accessed November 15, 2023

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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