180-count bottle of KRAZATI® tablets.

About
KRAZATI® (adagrasib)
for Advanced NSCLC

 

 

WHAT IS KRAZATI?

KRAZATI is an oral, targeted therapy you can take at home.

Designed to target your specific mutation, KRAZATI helps block the abnormal KRAS G12C protein, targeting it in a way chemotherapy and immunotherapy do not.

If you have KRAS G12C-positive NSCLC that has spread to other parts of your body or can’t be removed by surgery, talk to your doctor about KRAZATI if your previous treatment is no longer working.

Your healthcare provider will perform a biomarker test for KRAS G12C to make sure KRAZATI is right for you.

Designed with your specific type of cancer in mind. KRAZATI is not chemotherapy; it is a therapy that specifically targets KRAS G12C mutations.

How does KRAZATI target KRAS G12C?

Healthy lungs with a regular KRAS protein cell.

KRAS is a protein found inside many cell types in our bodies. The growth and development of cells can be controlled by KRAS, like an on/off switch.

When the development of a genetic mutation changes the KRAS protein to KRAS G12C, the on/off switch is stuck in an “on” position, setting off a domino effect that can lead to cancer.

Lungs being treated by KRAZATI®, which targets and blocks the KRAS G12C mutation.

KRAZATI is designed to find and block mutated KRAS G12C. 

KRAS=Kirsten rat sarcoma viral oncogene homolog; NSCLC=non-small cell lung cancer.

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KRAZATI targets and helps block the KRAS G12C protein that causes tumor growth. See clinical trial results >

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Summary of Warnings and Precautions

KRAZATI may cause serious side effects, including stomach and intestinal (gastrointestinal) problems, changes in the electrical activity of the heart called QTc prolongation, liver problems, and lung or breathing problems.

Important Facts About KRAZATI® (adagrasib)

This is a summary of important information that you need to know about KRAZATI. Your healthcare team can work with you to help answer any questions you may have. Keep this document in a safe place so you can refer to it before you start taking it and during your treatment.

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What is KRAZATI?

KRAZATI is an oral prescription medicine used to treat:

Non-small cell lung cancer (NSCLC) in adults who have:

cancer that has spread to other parts of the body or cannot be removed by surgery, AND

a tumor that has an abnormal KRAS G12C gene, AND

received at least one prior medicine that works throughout your whole body (a systemic treatment)

Colon or rectal cancer (CRC), when used in combination with a prescription medicine called cetuximab, in adults who have:

cancer that has spread to other parts of the body or cannot be removed by surgery, AND

a tumor that has an abnormal KRAS G12C gene, AND

previously received three different types of chemotherapy medicines that are:
  • fluoropyrimidine-based
  • oxaliplatin-based
  • irinotecan-based

Your healthcare team 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.

Talk to your healthcare team for more information about what it means to have an abnormal KRAS G12C gene.

Before taking KRAZATI, what should I discuss with my healthcare team?

Talk to your healthcare team about all of your medical conditions, including if you have:
  • any heart problems, including heart failure
    or if you were born with long QT syndrome
  • liver problems

You should not take KRAZATI if you were born with long QT syndrome or if you currently have QTc prolongation (which means your heart takes longer than usual to recharge between beats).

Talk to your healthcare team about all the medicines you take, including:
  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Taking KRAZATI with certain other medicines may affect how KRAZATI or your other medicines work. It may also increase your chance of getting side effects from the medicines you take.

Keep a list of the medicines you take and show it to your healthcare team and pharmacist before you start taking KRAZATI or any other new medicine.

Talk to your healthcare team about anything you might be unsure of before starting treatment. There may be other topics that are important to discuss with your healthcare team that aren't in this document.

Before taking KRAZATI, what should I discuss with my healthcare team about pregnancy, breastfeeding, and fertility?

Talk to your healthcare team if:

You are pregnant or plan to become pregnant: It is not known if KRAZATI can harm your unborn baby.

You are breastfeeding or plan to breastfeed: It is not known if KRAZATI passes into your breast milk. Do not breastfeed during your treatment and for 1 week after your last dose of KRAZATI.

KRAZATI may cause fertility problems in all genders and may affect your ability to have children.

Talk to your healthcare team if having fertility problems is a concern for you.

What are the serious side effects of KRAZATI?

KRAZATI can cause serious side effects. A serious side effect is a side effect that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Your healthcare team may lower your dose, pause, or stop treatment with KRAZATI if you get certain side effects. The serious side effects of KRAZATI may include:

Problems in your stomach and intestines (gastrointestinal problems). Problems in your stomach and intestines can be severe when taking KRAZATI. These problems may include:

  • severe nausea, vomiting, or diarrhea
  • bleeding in your stomach or intestines
    (gastrointestinal bleeding)
  • a blockage in your stomach or intestines 

    (bowel obstruction)
  • inflammation in your colon (colitis)
  • certain parts of your stomach or intestines becoming narrower than normal (gastrointestinal stenosis)

Call a healthcare provider right away if you have any of the following signs or symptoms of problems in your stomach and intestines:
  • vomiting six or more times (separated by 5 minutes) in 24 hours
  • vomit with blood in it or vomit that looks like coffee grounds
  • nausea that prevents you from eating and drinking enough
  • pain in your stomach (abdominal) area
  • trouble urinating or dark urine
  • dark-colored stool or stool with blood in it
  • diarrhea where you have at least 7 more stools per day than usual and have trouble holding in your bowel movements (fecal incontinence)
  • feeling dizzy, lightheaded, or weak
  • shortness of breath
  • feeling like your heart is beating faster than normal or fluttering (rapid pulse)

Your healthcare team may prescribe you a medicine (such as an anti-diarrheal or anti-nausea medicine) to help treat possible side effects related to your stomach and intestines.

Changes to the way your heart beats (called QTc prolongation). Taking KRAZATI may cause changes to the way your heart beats, including causing your heart to take longer to recharge between beats (this is called QTc prolongation). QTc prolongation may increase your chance of developing an irregular heartbeat that may be life-threatening and lead to sudden death. For example, it may cause a particular kind of very fast heartbeat called Torsades de Pointes.

Before and during your treatment with KRAZATI, your healthcare team may:

  • give you a test called an electrocardiogram (ECG) to measure the electrical activity of your heart
  • give you blood tests to measure how much of certain kinds of minerals (electrolytes) like potassium and magnesium are in your blood

Your healthcare team is more likely to give you the above tests if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or are taking another medicine that may lead to QTc prolongation.

Call a healthcare provider right away if you have any of the following signs or symptoms:
  • feeling dizzy, lightheaded, or weak
  • an abnormal heartbeat (arrhythmia) such as your heart beating faster than usual, slower than usual, or beating in an irregular pattern

Problems with your liver. It is common to get abnormal results on liver blood tests when you take KRAZATI. These abnormal results may sometimes indicate severe problems with your liver. Your healthcare team will do blood tests before and during your treatment with KRAZATI to check how your liver is working.

Call a healthcare provider if you have any of these signs or symptoms:
  • yellowing of your skin or the white parts 

    of your eyes (jaundice)
  • dark-colored urine
  • light-colored stool
  • feeling tired or weak
  • unexplained nausea or vomiting
  • bleeding or bruising more easily than normal
  • losing your appetite
  • pain, aching, or tenderness on the right side of your stomach (abdominal) area

Problems with your lungs or breathing (lung inflammation or pneumonitis): KRAZATI may cause inflammation in your lungs, which may be severe or serious and can lead to death.

Call a healthcare provider or get emergency medical help right away if you have any of these signs or symptoms:
  • new or worsening shortness of breath
  • new or worsening cough
  • fever

What are the most common side effects of KRAZATI?

The most common side effects of KRAZATI when it is taken on its own for non-small cell lung cancer (NSCLC) include:

  • nausea
  • diarrhea
  • vomiting
  • feeling tired
  • pain in your muscles and bones
  • kidney problems
  • swelling in any part of your body
  • feeling less hungry than usual (decreased appetite)
  • trouble breathing

The most common side effects of KRAZATI when it is taken in combination with cetuximab for colon or rectal cancer (CRC) include:

  • skin rash
  • nausea
  • diarrhea
  • vomiting
  • feeling tired
  • pain in your muscles and bones
  • headache
  • dry skin
  • pain in your stomach
  • feeling less hungry than usual (decreased appetite)
  • swelling in any part of your body
  • a low red blood cell (RBC) count
  • cough
  • feeling dizzy
  • constipation
  • nerve damage in your arms and legs

It is also common to get abnormal results on certain blood tests while you are taking KRAZATI, whether you are taking it on its own or in combination with cetuximab. While you are taking KRAZATI, your healthcare team will give you blood tests to monitor you for abnormal blood test results and will treat you if needed.

The common and serious side effects mentioned in this document are not all the possible side effects of KRAZATI.

Talk to your healthcare team for more information or advice about side effects. You are encouraged to report side effects to the FDA at www.fda.gov/medwatch or calling 1-800-FDA-1088.

What does KRAZATI look like and what are its ingredients?

KRAZATI comes as a white or off-white oval-shaped tablet, each containing a 200mg dose of its active ingredient. Each tablet has the number "200" stamped into the surface on one side, and a stylized "M" stamped into the other side.

200mg
tablet

Note: Image does not represent actual tablet sizes

Ingredients:

  • Active: adagrasib
  • Inactive: colloidal silicon dioxide, crospovidone, magnesium stearate (vegetable sourced), mannitol, microcrystalline cellulose, hypromellose, maltodextrin, medium chain triglycerides (vegetable sourced), polydextrose, talc, and titanium dioxide

How should I take KRAZATI?

Take KRAZATI exactly as your healthcare team tells you. Do not change how much you take or stop taking KRAZATI unless a healthcare provider tells you to.

The recommended dose of KRAZATI is three tablets (a 600mg dose) by mouth twice a day, at about the same time each day. If you are taking KRAZATI for colon or rectal cancer, your healthcare team will also give you a medicine called cetuximab through a vein in your arm (as an intravenous (IV) infusion) every week or every other week. Your healthcare team may need to change how much KRAZATI you take, or pause or stop your treatment with KRAZATI (and cetuximab, if you are taking it), if you have certain side effects.

Do take KRAZATI by mouth (orally) twice a day, around the same time each day

Do take KRAZATI with or without food

Do swallow KRAZATI tablets whole

Do not chew, crush or split tablets

Do not take broken or damaged tablets

What if I vomit or miss a dose of KRAZATI? 

Do not take an extra dose.

  • If you vomit after taking a dose of KRAZATI, do not take an extra dose. Take your next dose at your next scheduled time.
  • If you miss a dose of KRAZATI and it has been:
    • Less than four hours since you were supposed to take it, take the dose.  
    • More than four hours since you were supposed to take your dose, skip that dose. Just take your next dose of KRAZATI at your next scheduled time. Do not take two doses at the same time to make up for a missed dose.

Setting an alarm clock or a calendar notification is a great way to help you remember to take your medication.

What if I take too much KRAZATI?

Call a healthcare provider or Poison Health Line at (1-800-222-1222), or go to the nearest hospital emergency room right away.

How should I store KRAZATI?

Keep your KRAZATI tablets in their original containers. These containers are child-resistant and include a packet of desiccant (drying agent) that keeps tablets dry.

  • Do not remove the packet of desiccant (drying agent) from the container.
  • Do not eat or swallow the desiccant.

Store tablets at room temperature between 68°F to 77°F (20°C to 25°C). 

Keep KRAZATI and all medicines out of reach of children.

What else should I know about KRAZATI?

Do not use KRAZATI for any condition other than what your healthcare team has prescribed it for. Healthcare teams may sometimes prescribe KRAZATI for purposes other than those mentioned in this document.

Do not give KRAZATI to other people, even if they have the same symptoms as you. It may harm them.

Ask your healthcare team for the information about KRAZATI that is written for healthcare providers if you would like.

For more information, please see the accompanying U.S. Full Prescribing Information and Patient Information for KRAZATI. Talk to your healthcare team for more information about this medication. 

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