Krazati

Pronunciation: krah zah tee
Generic name: adagrasib
Dosage form: tablet (200 mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jun 25, 2024.

What is Krazati?

Krazati is a targeted therapy for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) with an abnormal KRAS G12C gene. Krazati reduces tumor growth by locking the KRAS protein so it is inactive. Krazati tablets are taken twice daily.

The KRAS gene makes a protein that works like an on/off switch to control cell growth and cell death. An abnormal KRAS G12C gene it may cause cancer cells to grow and spread in the body. Krazati works by inhibiting KRAS G12C to help stop tumor growth.

Krazati FDA approval was received on December 12, 2022, for specific patients with non-small cell lung cancer, and on June 21, 2024, it received FDA approval for colorectal cancer in certain patients.

What is Krazati used to treat?

Krazati FDA approval is 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 has a KRAS G12C mutation determined by an FDA-approved test. Patients must have tried at least one prior systemic therapy. In NSCLC this medicine is used as a single agent.
• metastatic colorectal cancer (CRC) that has spread to other parts of the body or cannot be removed by surgery and has a KRAS G12C mutation determined by an FDA-approved test. Krazati is used in combination with Erbitux (cetuximab). Patients must already tried a prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Krazati side effects

Common Krazati side effects

Common Krazati side effects may include nausea, diarrhea, vomiting, tiredness, muscle and bone pain, liver problems, trouble breathing, loss of appetite, swelling, less urination, and feeling tired or short of breath. These side effects occurred in 25% or more patients when using this medicine for NSCLC. Changes in laboratory blood tests may also occur.

Common Krazati side effects include rash, nausea, diarrhea, vomiting, tiredness, muscle and joint pain, liver problems, headache, dry skin, abdominal pain, lower appetite, swelling, cough, and low iron blood levels. These side effects occurred in 25% or more patients when used for CRC in combination with cetuximab.

Serious Krazati side effects

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Krazati may cause other serious side effects. 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).

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 the FDA at 1-800-FDA-1088.

Before taking Krazati

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.

Pregnancy

This medicine may harm an unborn baby. Tell your doctor or healthcare provider if you are pregnant.

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

Breastfeeding

Tell your doctor or healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breastmilk. Do not breastfeed during treatment or for one week after your last dose.

Warnings

Gastrointestinal side effects. This medicine may cause diarrhea, nausea, and vomiting. Seek medical advice. Depending on how severe your symptoms are, your dose may be reduced or permanently discontinued.

QTc Interval Prolongation: This medicine should not be used with other products with a known potential to prolong the QTc interval. If you are at risk or on medications known to prolong the QT interval, your ECG will be monitored, and electrolytes, particularly potassium and magnesium. Your healthcare provider will correct any electrolyte abnormalities.

Liver problems: Your healthcare provider will monitor liver laboratory tests prior to the start of this medicine, monthly for 3 months after, and as clinically indicated.

Lung problems: Monitor for new or worsening respiratory symptoms.

How should I take Krazati?

Take Krazati 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 this medicine, do not take another dose. Take your next dose as scheduled.

If you miss a dose, take it as soon as you remember. If it has been more than 4 hours, do not take it. 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.

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 this medicine.

You will need medical tests before and during treatment with this medicine.

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

If you develop certain side effects, your healthcare provider may change your dose or temporarily or permanently stop treatment.

Dosing information

Usual Adult Krazati Dose for Non-Small Cell Lung Cancer

Recommended dosage: 600 mg orally twice daily

Usual Adult Krazati Dose for Colorectal Cancer in combination with cetuximab

Recommended dosage for CRC: 600 mg orally twice daily

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 verifying and describing a clinical benefit in a confirmatory trial(s).

Related/similar drugs

Rybrevant, Opdivo, methotrexate, Keytruda, pembrolizumab, fluorouracil, cisplatin, Avastin, Xeloda, Tagrisso

What other drugs will affect 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.

Medicines that can have an interaction with Krazati include

• Strong CYP3A4 Inducers: Avoid concomitant use.
• Strong CYP3A4 Inhibitors: Avoid concomitant use until Krazati concentrations have reached a steady state (after ~8 days).
• Sensitive CYP3A4 Substrates: Avoid concomitant use with sensitive CYP3A4 substrates.
• Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions.
• Drugs That Prolong QT Interval: Avoid concomitant use with this medicine.

This is not a complete list of side effects, and others may occur. To check for interactions, click the link below.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C ).
• The tablets come in a child-resistant container.
• The container has a desiccant (drying agent) to keep the medicine dry. Do not remove the desiccant from the container after opening. Do not eat or swallow the desiccant.

Krazati Package Insert

Review the Krazati Package Insert for more detailed information about this medicine. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ingredients

Active ingredient: adagrasib
Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate (vegetable sourced), mannitol, and microcrystalline cellulose. The tablet film coating contains hypromellose, maltodextrin, medium-chain triglycerides (vegetable sourced), polydextrose, talc, and titanium dioxide.

Company

Manufactured for: Mirati Therapeutics, Inc. 3545 Cray Court San Diego, CA 92121, U.S.A.

Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer