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Frequently asked questions about Vectibix®

 

What is Vectibix®?

Vectibix® is a medicine that binds to a structure called the epidermal growth factor receptor (EGFR) found on the surface of some cancer cells as well as on normal cells.1 Vectibix® is a therapy known as a monoclonal antibody, which is a man-made version of an immune system protein.2 Vectibix® is an intravenous (IV) drug, so it is given by infusion into a vein.1

Vectibix® is indicated for use as a single agent for the treatment of patients with colorectal cancer that has spread to other parts of the body after treatment with standard chemotherapy, and whose tumors display the EGFR.1

Vectibix® is intended to extend the time until the disease progresses. In clinical trials, Vectibix® has not been shown to improve how a patient feels or help a patient live longer. Vectibix® should not be used to treat patients with tumors that have an abnormal protein called KRAS or when KRAS status is not known. Vectibix® has been shown to be ineffective in patients with tumors that have abnormal KRAS. Talk to your doctor about your KRAS status.1

If you have questions regarding your treatment or your condition, please ask your doctor.

Vectibix® is not approved for use in combination with chemotherapy. In a study of patients with normal and abnormal KRAS evaluating Vectibix® in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) compared to FOLFOX alone as first-line therapy for their colorectal cancer that had spread to other parts of the body, the patients with abnormal KRAS died sooner than those with normal KRAS.

Patients who received chemotherapy with or without Avastin® (bevacizumab) and Vectibix® became worse, died sooner, and had more serious side effects, such as acne-like rash (dermatitis acneiform), diarrhea, dehydration, and abnormally low blood levels of potassium, calcium, and magnesium. Some patients developed blood clots that can travel to the lungs causing serious and potentially fatal results called pulmonary embolism.1

Do not change or discontinue any medications you may be taking (including over-the-counter drugs or supplements you can buy without a prescription) without first speaking with your healthcare professional.

Avastin® is a registered trademark of Genentech, Inc.

What is the most frequently reported side effect of Vectibix® therapy?

In clinical studies, nearly all patients (89%) taking Vectibix® experienced a skin reaction. Reactions included, but weren't limited to, an acne-like rash, itching, redness, other variations of rash, skin peeling, infections at the sides of the nail beds of the fingers or toes, dry skin, and cracks and openings in the skin.1

What happens if a skin reaction becomes severe?

Some patients who developed severe skin reactions (see the description in What is Vectibix®?) also developed infections. In some cases, these infections have been associated with infection in the blood, infection in the tissue that surrounds muscles and organs, or death. Some patients developed infections called an abscess, which required a procedure to drain the infection from the wound. Your doctor may choose a variety of treatments (such as antibiotics) to address these side effects.1,3

In cases of severe or life-threatening skin or soft tissue reactions, your healthcare professional may give you a smaller dose, delay your next dose, or stop Vectibix® treatment altogether.1

It is important that you immediately report skin changes to your healthcare professional, including changes around the eyes or in vision, and if you develop signs of infection such as chills, fever, or increased redness or swelling of an existing skin reaction. It is important that you always limit your exposure to the sun, such as wearing a hat and using sunscreen if you need to be outside, while on Vectibix® and for two months after the last dose.1

What do I need to know about skin reactions?

Here are some important things to know about skin reactions:

  • Severe skin reactions can become infected, possibly resulting in death or the need for a procedure to drain an infected wound1
  • Discuss with your healthcare professional what to look for regarding skin reactions and when to contact your doctor if you develop a skin reaction
  • Your doctor may decide to reduce your dose of Vectibix®, delay your next dose, or stop Vectibix® treatment if your skin reaction becomes too severe1
  • Most patients who receive Vectibix® develop a skin reaction, including skin reactions around the eye such as conjunctivitis, redness, increased tearing, and eye and eyelid irritation, within the first two weeks of starting treatment; the most severe skin reactions occurred about 15 days after starting treatment with Vectibix®1
  • Dermatitis acneiform may look like an acne-like rash, but it is not acne and should not be treated with acne medications3
  • Skin reactions generally appear on the face, neck, or trunk of the body3
  • Skin reactions usually clear up within three months after treatment has ended. Be sure to limit your exposure to the sun when you start Vectibix® and for two months after your last dose. If you are in the sun, be sure to protect your skin by wearing sunscreen and a hat1
  • Skin reactions are not contagious

Talk to your doctor about questions you have regarding skin reactions.

What are other serious side effects of Vectibix® therapy?

During or shortly after a Vectibix® infusion, some patients may develop an infusion reaction, which can be severe and has resulted in death.1

An infusion reaction is a reaction to the medication you are receiving in your IV. It can cause fever, chills, or breathing problems.1

If you have an infusion reaction to Vectibix®, your healthcare professional will treat the reaction and stop Vectibix® therapy. Your doctor may also slow the amount of medication you are getting for the rest of the infusion or stop the infusion completely. Depending on how severe the reaction is, your doctor may decide to stop Vectibix® treatment.1

Other serious side effects of Vectibix® therapy

  • Reports of lung disease, including deaths, have been observed in patients who have taken Vectibix®. If you experience lung problems, such as difficulty breathing, persistent or recurrent cough, or wheezing, notify your doctor. If you have been told that you have lung problems in the past, be sure to tell your doctor1
  • Severe skin reactions: See What is the most frequently reported side effect of Vectibix® therapy?1
  • Abnormal laboratory tests: Your doctor will periodically check your blood to monitor your levels of electrolytes, including calcium and magnesium, while you are taking Vectibix® and for eight weeks after you complete your therapy. In clinical trials, some patients required oral or IV replacement of calcium and magnesium1
  • Exposure to the sun can make skin reactions worse. Be sure to limit your exposure to the sun by wearing a hat and sunscreen while taking Vectibix® and for two months after you stop Vectibix® therapy1
  • Problems with your eyes: Inflammation of the eye and injury to the cornea have been reported with Vectibix®. Tell your healthcare professional if you experience any vision changes or eye pain1

What other side effects are associated with Vectibix® therapy?

In clinical trials, the most common side effects included skin rash with variable presentations, hypomagnesemia (low blood magnesium), infection around the nail beds of the fingers and toes, fatigue, abdominal pain, nausea, diarrhea (including diarrhea that results in dehydration).1

The most serious side effects of Vectibix® are lung problems (see Other serious side effects of Vectibix® therapy), severe skin reaction (see What is the most frequently reported side effect of Vectibix® therapy?), infusion reactions (see What are other serious side effects of Vectibix® therapy?), abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.1

In clinical trials, side effects that resulted in stopping Vectibix® included infusion reactions, severe skin reactions, infection around the nail beds of the fingers and toes, and pulmonary fibrosis.1

Are there any precautions to take while receiving Vectibix®?

Because sunlight can make skin reactions worse, you should avoid sun exposure while taking Vectibix® and for two months after your last dose of Vectibix®. It is also important to wear sunscreen and a hat when outside. Report new or worsening skin reactions to your healthcare professional immediately.1

Both men and women should use adequate methods of birth control and take measures to avoid pregnancy while on Vectibix® therapy and for six months afterward. Talk to your doctor about the best birth control for you.1

If you are a woman in the childbearing years1:

  • Vectibix® may lessen your chance of becoming pregnant
  • Vectibix® can cause miscarriage or harm to a developing fetus
  • You should stop nursing your baby during Vectibix® therapy and for two months afterward
  • Women who become pregnant during Vectibix® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-772-6436 (1-800-77-AMGEN) to enroll

What is KRAS?

KRAS is a protein found in all human cells. Some colorectal cancers have mutations in the KRAS gene.4 Vectibix® should not be used to treat patients with tumors that have abnormal KRAS or when KRAS status is not known. Vectibix® has been shown to be ineffective in people with tumors that have abnormal KRAS. Talk to your doctor about your KRAS status.1

When do I need to call my healthcare professional?

You should contact your healthcare professional if you have any side effects. Call immediately if you experience worsening skin problems, eye problems, fever, chills, or breathing problems, including persistent or recurrent cough, wheezing or shortness of breath, develop diarrhea or become dehydrated, or become pregnant.

How is Vectibix® given?

Vectibix® is available by prescription only and is given as an IV infusion. The infusion typically takes 60 to 90 minutes. Vectibix® is given every 14 days for the period of therapy your healthcare professional recommends.1

What is a monoclonal antibody?

Antibodies are proteins that recognize and bind to specific biologic and non-biologic molecules. Monoclonal antibodies are specific to one particular molecule and can be manufactured to treat various diseases, including cancer.5

Talk to your healthcare professional if you have any other questions about Vectibix®.


Patient resources


Learn more about past and ongoing clinical trials


Indication

Vectibix® (panitumumab) is a medication given intravenously that is used to treat patients with colorectal cancer that has spread to other parts of the body after treatment with standard chemotherapy and that expresses the EGFR.

Vectibix® is intended to extend the time until the disease progresses. In clinical trials, Vectibix® has not been shown to improve how a patient feels or help a patient live longer.

Vectibix® should not be used to treat patients with tumors that have an abnormal protein called KRAS or when KRAS status is not known. Vectibix® has been shown to be ineffective in patients with tumors that have abnormal KRAS. Talk to your doctor about your KRAS status.

IMPORTANT SAFETY INFORMATION

In clinical studies, nearly all patients taking Vectibix® (panitumumab) experienced skin toxicities. These included, but weren’t limited to, an acne-like rash, itching, redness, other variations of rash, skin peeling, infections at the sides of the nail beds of the fingers or toes, dry skin, and cracks and openings in the skin.

Some patients who developed severe skin reactions also developed infections in the blood, skin, fat or tissue which has sometimes resulted in death. Some patients developed infections called an abscess, which required a procedure to drain the infection from the wound.

In cases of severe or life-threatening skin or soft tissue reactions, your healthcare professional may give you a smaller dose, delay your next dose, or stop Vectibix® treatment altogether. It is important that you immediately report skin changes to your healthcare professional, including changes around the eyes or in vision, and if you develop signs of infection such as chills, fever, or increased redness or swelling of an existing skin reaction.

During or shortly after a Vectibix® infusion, some patients may develop an infusion reaction, which can be severe and has resulted in death. An infusion reaction is a reaction to the medication you are receiving in your IV. It can cause fever, chills, low blood pressure, or breathing problems.

If you have an infusion reaction to Vectibix®, your healthcare professional will treat the reaction and stop Vectibix® therapy. Your doctor may also slow the amount of medication you are getting for the rest of the infusion or stop the infusion completely. Depending on how severe the reaction is, your doctor may decide to stop Vectibix® treatment.

Vectibix® is not approved for use in combination with chemotherapy. In a study of patients with normal and abnormal KRAS evaluating Vectibix® in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) compared to FOLFOX alone as first-line therapy for their colorectal cancer that had spread to other parts of the body, the patients with abnormal KRAS died sooner than those with normal KRAS.

Patients who received chemotherapy with or without Avastin® (bevacizumab) and Vectibix® became worse, died sooner, and had more serious side effects, such as acne-like rash (dermatitis acneiform), diarrhea, dehydration, and abnormally low blood levels of potassium, calcium, and magnesium. Some patients developed blood clots that can travel to the lungs causing serious and potentially fatal results called pulmonary embolism.

Do not change or discontinue any medications you may be taking (including over-the-counter drugs or supplements you can buy without a prescription) without first speaking with your healthcare professional.

Reports of lung disease, including deaths, have been observed in patients who have taken Vectibix®. If you experience lung problems, such as difficulty breathing, persistent or recurrent cough, or wheezing, notify your doctor. If you have been told that you have lung problems in the past, be sure to tell your doctor.

You may experience changes in the calcium and magnesium levels in your blood while you are taking Vectibix® and for 2 months after completing your Vectibix® treatment. Your doctor may need to treat this condition with medications either taken orally or in your vein.

Exposure to the sun can make skin toxicities worse so avoid direct sun exposure while taking Vectibix® and for 2 months after you complete your Vectibix® therapy. If you must go out in the sun wear a hat and sunscreen. Tell your doctor if you have new or worsening skin reactions.

Inflammation of the eye and injury to the cornea have been reported with Vectibix®. Tell your healthcare professional if you experience any vision changes or eye pain.

Both men and women should use adequate methods of birth control and take measures to avoid pregnancy while on Vectibix® therapy and for 6 months afterward.

Women who become pregnant during Vectibix® treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-772-6436 (1-800-77-AMGEN) to enroll.

You should not nurse your baby during Vectibix® therapy and for 2 months after stopping Vectibix®.

In clinical trials, the most common side effects included skin rash with variable presentations, low blood magnesium, infection around the nail beds of the fingers and toes, fatigue, abdominal pain, nausea, and diarrhea (including diarrhea that results in dehydration).

The most serious side effects of Vectibix® are lung problems, severe skin reaction, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.

You should contact your healthcare professional if you have any side effects. Call immediately if you experience worsening skin problems, eye problems, fever, chills, or breathing problems, including persistent or recurrent cough, wheezing or shortness of breath, develop diarrhea or become dehydrated, or become pregnant.

Vectibix® is an intravenous (IV) drug, so it is given by infusion into a vein.

Please read the full Prescribing Information and discuss it with your doctor or healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Avastin® is a registered trademark of Genentech, Inc.

References: 1. Vectibix® (panitumumab) prescribing information, Amgen. 2. American Cancer Society website. http://www.cancer.org/Treatment/TreatmentsandSideEffects/GuidetoCancerDrugs/panitumumab. Accessed January 31, 2014. 3. American Cancer Society website. http://www.cancer.org/acs/groups/cid/documents/webcontent/003024-pdf.pdf. Accessed January 31, 2014. 4. American Cancer Society website. http://www.cancer.org/Cancer/ColonandRectumCancer/DetailedGuide/colorectal-cancer-treating-targeted-therapy. Accessed January 31, 2014. 5. Mayo Clinic website. http://www.mayoclinic.com/health/monoclonal-antibody/CA00082. Accessed January 31, 2014.