KRAZATI

Generic Name/API: adagrasib

Manufacturer: Mirati Therapeutics, Inc.

Dosage Forms & Strength & Pack Size:
Tablets: 200 mg 180’s

Storage:
Store tablets at room temperature, 20°C to 25°C (68°F to 77°F). Temperature excursions
between 15°C and 30°C (59°F to 86°F) are permitted.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
What is KRAZATI?
KRAZATI 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
Your healthcare provider will perform a test to make sure that KRAZATI is right for you.

It is not known if KRAZATI is safe and effective in children.

IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking KRAZATI?
Before taking KRAZATI, tell your healthcare provider about all 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 of KRAZATI
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.

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 with KRAZATI
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, tell your healthcare provider about all of your medical conditions, including if you:”
Your healthcare provider should monitor the electrical activity of your heart and the levels of body salts in your blood (electrolytes) during treatment with KRAZATI 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 with KRAZATI
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 with KRAZATI 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 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, 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 side effects
The most common side effects are 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.

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