Brand: Krazati

What is the most important information I should know about adagrasib?

Call your doctor at once if you have bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What is adagrasib?

Adagrasib is used to treat adults with non-small cell lung cancer:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • has a specific gene marker (an abnormal "KRAS G12C" gene), and
  • who have received at least one treatment for cancer.

Your doctor will perform tests to make sure adagrasib is the right treatment for you.

Adagrasib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking adagrasib?

Tell your doctor if you have ever had:

  • heart problems, including heart failure and congenital long QT syndrome; or
  • liver problems.

Adagrasib may harm an unborn baby. Tell your doctor if you are pregnant.

Adagrasib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I take adagrasib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take adagrasib twice a day with or without food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking adagrasib, do not take another dose. Take your next dose as scheduled.

Your treatment may be changed or permanently discontinued if you have certain side effects.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using adagrasib.

You will need medical tests before and during treatment with adagrasib.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking adagrasib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of adagrasib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • nausea, diarrhea, or vomiting;
  • shortness of breath, cough or fever;
  • fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);
  • stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, diarrhea, vomiting;
  • tiredness;
  • muscle and bone pain;
  • trouble breathing;
  • loss of appetite; or
  • swelling, urinating less, feeling tired or short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect adagrasib?

Adagrasib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect adagrasib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about adagrasib.

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