Indications and Limitations of Use
  • LUMAKRAS® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer....READ MORE
  • Vectibix® is a prescription medicine used in adults in combination with a prescription medicine called LUMAKRAS® (sotorasib) to treat colon or rectal cancer (CRC) that has spread to other parts of the body and whose tumor has an abnormal KRAS G12C gene, and who have previously received certain chemotherapy medicines.
  • 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. For information about the use of Vectibix® given with FOLFOX or alone, please see Vectibix® Prescribing Information.

Your healthcare provider will perform a test to make sure that LUMAKRAS® is right for you. It is not known if LUMAKRAS® is safe and effective in children.

LUMAKRAS® (sotorasib) Logo

IMPORTANT SAFETY INFORMATION FOR LUMAKRAS®

What should I tell my healthcare provider before taking LUMAKRAS®?

  • Before taking LUMAKRAS®, tell your healthcare provider about all your medical conditions, including if you:
    • have liver problems
    • have lung or breathing problems other than lung cancer
    • are pregnant or plan to become pregnant. It is not known if LUMAKRAS® will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if LUMAKRAS® passes into your breast milk. Do not breastfeed during treatment with LUMAKRAS® and for 1 week after the last dose.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. LUMAKRAS® can affect the way some other medicines work, and some other medicines can affect the way LUMAKRAS® works.
  • Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H2 blockers during treatment with LUMAKRAS®. Ask your healthcare provider if you are not sure.

LUMAKRAS® may cause serious side effects, including:

  • Liver Problems: LUMAKRAS® may cause abnormal liver blood test results. Your healthcare provider should do blood tests before starting and during treatment with LUMAKRAS® to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including: your skin or the white part of your eyes turns yellow (jaundice), dark or “tea-colored” urine, light-colored stools (bowel movements), tiredness or weakness, nausea or vomiting, bleeding or bruising, loss of appetite, and pain, aching, or tenderness on the right side of your stomach-area (abdomen).
  • Lung or breathing problems: LUMAKRAS® may cause inflammation of the lungs that can lead to death. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough or fever.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LUMAKRAS® if you develop side effects.

The most common side effects

  • The most common side effects of LUMAKRAS® when used alone include diarrhea, muscle or bone pain, nausea, tiredness, liver problems, cough, changes in liver function tests, and changes in certain blood tests.
  • These are not all the possible side effects of LUMAKRAS®. Call your doctor for medical advice about side effects.

Please see LUMAKRAS® Patient Information.

IMPORTANT SAFETY INFORMATION FOR VECTIBIX®

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.

Abnormal liver blood tests are common with LUMAKRAS® and can sometimes be severe. LUMAKRAS® used in combination with Vectibix® has led to liver failure and death. Your healthcare provider should do blood tests before starting and during treatment with LUMAKRAS® to check your liver function. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including: your skin or the white part of your eyes turns yellow (jaundice); dark or “tea-colored” urine; light-colored stools (bowel movements); tiredness or weakness; nausea or vomiting; bleeding or bruising; loss of appetite; or pain, aching, or tenderness on the right side of your stomach-area (abdomen).

The most common side effects of Vectibix® when used in combination with LUMAKRAS® for CRC include skin rash, dry skin, diarrhea, mouth sores, tiredness, muscle and bone pain, and changes in certain blood tests.

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 FOR LUMAKRAS®

What should I tell my healthcare provider before taking LUMAKRAS®?

  • Before taking LUMAKRAS®, tell your healthcare provider about all your medical
    conditions, including if you:

IMPORTANT SAFETY INFORMATION FOR VECTIBIX®

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:

References: 1. LUMAKRAS® (sotorasib) prescribing information, Amgen. 2. Vectibix® (panitumumab) prescribing information, Amgen.