Krazati

About Krazati 

• Krazati received approval from the US FDA administration on December 12, 2022.
• Krazati is an antineoplastic,which belongs to the class of KRAS Inhibitors. It works as a targeted therapy designed to attack the mutated KRAS protein to suppress tumor growth.
• Krazati is an RAS GTPase family inhibitor prescribed for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). 
• This is determined through an FDA-approved test, and the patient should have undergone at least one prior systemic therapy.
• KRAS G12C mutations, found in approximately 1 in 8 individuals with non-small cell lung cancer (NSCLC), are among the most prevalent mutations associated with this condition. 
• The KRAS gene, functioning as an on/off switch, produces a protein. When mutated, it becomes a catalyst for cancer development. 
• Krazati acts by inhibiting KRAS G12C, effectively halting tumor growth in NSCLC patients.
• Your healthcare provider will conduct a test to determine the suitability of Krazati for your specific condition. The safety and effectiveness of this medication in children are not known.

Strength

Tablets are delivered in a strength of Krazati 200 mg respectively, for oral consumption.

Recommended Dosage

When using Krazati tablet, swallow them whole and avoid opening, crushing, or chewing for proper administration. Take it at the same time, with or without food. Ensure safety by consuming the capsules with a full glass of water, following your healthcare provider’s instructions diligently, and promptly reporting any unusual side effects or concerns during your treatment.

• The recommended dosage for Krazati is 600 mg orally twice daily until disease progression or unacceptable toxicity. 
• In case of vomiting after a dose, refrain from taking an additional one and resume at the next scheduled time. 
• If a dose is missed by more than 4 hours, skip it and continue with the next scheduled dose.
• If adverse reactions occur, a maximum of two dose reductions are permitted. The first dose reduction involves taking 400 mg twice daily, and in the case of a second dose reduction, the dosage is adjusted to 600 mg once daily. 
• Permanently discontinue Krazati in patients who are unable to tolerate 600 mg once daily.

Important

If you are currently taking any medications, please inform your doctor before starting the new medicine. Encourage patients to communicate all concurrent medications, encompassing prescription drugs, over-the-counter medications, vitamins, and herbal products, to their healthcare providers. 

Warnings & Precautions

• Before starting Krazati, it’s crucial to inform your doctor if you have a history of gastrointestinal issues, as monitoring for diarrhea, nausea, and vomiting will be necessary. 
• In the case of prolonged QTc interval, notify your healthcare provider if you are taking other medications known to affect QT interval or if you have any risk factors. 
• Regular ECG and electrolyte monitoring will be advised. For patients with potential liver concerns, liver laboratory tests should be conducted before initiating Krazati and monitored monthly for three months, with dose adjustments or discontinuation as needed. 
• Respiratory symptoms should be closely observed for interstitial lung disease/pneumonitis, and Krazati may need to be withheld or discontinued based on severity and identification of potential causes. 
• Always discuss your medical history and conditions with your healthcare provider before starting Krazati.

Common Krazati Side Effects:

• Nausea
• Diarrhea
• Vomiting
• Tiredness
• Muscle and bone pain
• Kidney problems
• Swelling
• Breathing trouble
• Decreased appetite
• Decreased lymphocytes
• Decreased hemoglobin
• Increased alanine aminotransferase
• Increased aspartate aminotransferase
• Hypokalemia
• Hyponatremia
• Increased lipase
• Decreased leukocytes
• Decreased neutrophils
• Increased alkaline phosphatase

Use in Specific Population

• While using Krazati during pregnancy lacks sufficient data, it is essential to inform your doctor if you are pregnant, planning pregnancy, or suspect pregnancy before starting treatment. 
• No data on the presence of adagrasib or its metabolites in human milk is available, raising concerns about potential effects on the breastfed child or milk production. 
• Due to the risk of serious adverse reactions, it is advised that women do not breastfeed during Krazati treatment and for one week after the last dose. Consult your healthcare provider for personalized guidance. 
• Animal studies suggest Krazati may impact fertility in females and males, yet its safety and effectiveness in pediatric patients remain unestablished. 
• For more information on fertility geriatric, and pediatric use, consult your healthcare provider.

Storage and Handling

• Store within the temperature range of 20°C to 25°C (68°F to 77°F), allowing for excursions between 15°C and 30°C (59°F to 86°F).
• Protect Krazati from light and moisture.
• Do not freeze.
• Do not store Krazati where it may be exposed to heat or humidity.
• Keep Krazati out of the reach of children and pets.