Krazati is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) whose tumor has an abnormal KRAS G12C gene.

Krazati works as a targeted therapy designed to attack the mutated KRAS protein to suppress tumor growth.

Your healthcare provider will perform a test to make sure that Krazati is right for you.

It is not known if this medicine is safe and effective in children.

What is Krazati used to treat?

Krazati is used to treat adults with KRAS G12C-mutated NSCLC that has spread to other parts of the body or cannot be removed by surgery, and who have received at least one prior treatment for their cancer.

KRAS G12C mutations are among the most common mutations that may lead to NSCLC, affecting about 1 in 8 people with NSCLC.

The KRAS gene makes a protein that works like an on/off switch. When it is mutated, it can lead to cancer. Krazati works by inhibiting KRAS G12C to stop the growth of the tumor.

• Take Krazati exactly as your healthcare provider tells you to take it. Do not change your dose or stop treatment unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, or temporarily or permanently stop treatment if you develop certain side effects.
• Take your prescribed dose 2 times each day, at about the same time each day.
• Take Krazati tablets either with food or without food.
• Swallow the tablets whole. Do not chew, crush or split tablets.
• If you vomit after taking a dose, do not take an extra dose. Take your next dose at your next scheduled time.
• If you miss a dose, take the dose as soon as you remember. If it has been more than 4 hours, do not take the dose. Take your next dose at your next scheduled time. Do not take 2 doses at the same time to make up for a missed dose.

Usual Adult Dose for Non-Small Cell Lung Cancer

600 mg orally twice daily

Use: treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including heart failure and congenital long QT syndrome.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if Krazati can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Krazati passes into your breastmilk. Do not breast feed during treatment and for 1 week after your last dose.

Krazati can cause serious side effects, including:

• Stomach and intestinal (gastrointestinal) problems. Stomach and intestinal side effects including nausea, diarrhea, or vomiting, are common with Krazati but can also sometimes be severe. Krazati can also cause serious stomach and intestinal side effects such as bleeding, obstruction, inflammation of the colon (colitis), and narrowing (stenosis).
  • Call your healthcare provider if you develop any of the signs or symptoms of stomach or intestinal problems listed above during treatment.
  • Your healthcare provider may prescribe an antidiarrheal medicine or anti-nausea medicine, or other treatment, as needed.
• Changes in the electrical activity of your heart called QTc prolongation. Certain changes can occur in the electrical activity of your heart during treatment with Krazati, and can be seen on a test called an electrocardiogram (ECG or EKG). QTc prolongation can increase your risk for irregular heartbeats that can be life-threatening, such as torsades de pointes, and can lead to sudden death.
  • You should not take Krazati if you have congenital long QT syndrome or if you currently have QTc prolongation. See Before taking Krazati.
    • Your healthcare provider should monitor the electrical activity of your heart and the levels of body salts in your blood (electrolytes) during treatment if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take a medicine that can prolong the QT interval of your heartbeat.
    • Tell your healthcare provider if you feel dizzy, lightheaded, or faint, or if you get abnormal heartbeats during treatment.
• Liver problems. Abnormal liver blood test results are common with Krazati and can sometimes be severe. Your healthcare provider should do blood tests before starting and during treatment 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)
  • nausea or vomiting
  • dark or "tea-colored" urine
  • bleeding or bruising
  • light-colored stools (bowel movements)
  • loss of appetite
  • tiredness or weakness
  • pain, aching or tenderness on the right side of your stomach area (abdomen)
• Lung or breathing problems. Krazati 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.

The most common Krazati side effects include:

• nausea
• diarrhea
• vomiting
• tiredness
• muscle and bone pain
• kidney problems
• swelling
• breathing trouble
• decreased appetite

Certain abnormal laboratory test results are common with Krazati. Your healthcare provider will monitor you for abnormal laboratory tests, and treat you if needed.

Krazati may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Krazati can affect the way other medicines work, and other medicines can affect how Krazati works.