Package Insert of Crizonix-250mg(Crizotinib)
Crizonix-250mg(Crizotinib) is a tyrosine kinase receptor inhibitor used to treat anaplastic lymphoma kinase (ALK) or ROS1-positive non-small cell lung cancer (NSCLC) tumors, as well as ALK-positive anaplastic large cell lymphoma (ALCL) and inflammatory myofibroblastic tumor (IMT). It targets the echinoderm microtubule-associated protein-like 4 (EML4)-ALK fusion protein, offering robust effectiveness in treating NSCLC in patients with this type of rearrangement. FDA-approved in 2011, it is accompanied by FDA-approved tests to detect ALK and ROS1 rearrangements. (1)
Indications for Crizonix-250mg(Crizotinib)
Crizonix-250mg(crizotinib) is a kinase inhibitor used to treat metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) or ROS1-positive tumors. It is also used for relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) in pediatric patients and older and young adults. However, safety and efficacy have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. Crizonix is also used for adult and pediatric patients with unresectable, recurrent, or refractory inflammatory myofibroblastic tumors. (2)
Crizonix is indicated for the treatment of the following:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive or ROS1-positive as detected by an FDA-approved test It is also used for the treatment of metastatic NSCLC with a rearrangement in the ALK gene or ROS1 gene. Crizonix has shown efficacy in improving progression-free survival and the overall response rate in these patients, making it an important therapeutic option for this specific population.
- Relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive in pediatric patients 1 year of age and older and young adults.
- Unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older.
Mechanism of Action
Crizonix-250mg(Crizotinib) is a tyrosine kinase receptor inhibitor that targets anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR), ROS1, and Recepteur d’Origine Nantais (RON).
ALK inhibits apoptosis and promotes cell proliferation, leading to the expression of oncogenic fusion proteins. ALK-positive tumors in NSCLC patients are characterized by the fusion of ALK with EML4, resulting in increased kinase activity. Crizonix inhibits ALK by inhibiting its phosphorylation and creating an inactive protein conformation, lowering cell proliferation and tumor survivability. In vitro assays show that Crizonix inhibits ALK, ROS1, and c-Met phosphorylation in a concentration-dependent manner. (3)
Dosage and Administrations
Crizonix-250mg(Crizotinib) is a medication recommended for adults with ALK-positive or ROS1-positive NSCLC, ALCL, or IMT, taken orally twice daily.
- For patients with moderate hepatic impairment, the starting dose is 200 mg twice daily.
- For severe hepatic impairment, the starting dose is 250 mg once daily. Dose reductions may be required based on individual safety and tolerability.
- For patients treated with Crizonix 250 mg orally twice daily, the recommended dose reductions are 200 mg twice daily and 250 mg once daily.
- If you are unable to tolerate Crizotinib 250 mg taken orally once daily, the medication should be permanently discontinued. Crizonix capsules should be swallowed whole. If a dose is missed, make up the missed dose unless the next dose is due within 6 hours. Do not take two doses at the same time to make up for a missed dose. (4)
Crizonix-250mg(Crizotinib) is a medication that can cause various side effects, including nausea, vomiting, diarrhea, constipation, fatigue, vision problems, liver problems, lung issues, swelling, high blood pressure, heart problems, muscle pain, nerve pain, skin problems, taste changes, loss of appetite, hair loss, and rare side effects like severe liver damage, interstitial lung disease, pancreatitis, myocarditis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Met Amplification in NSCLC
MET amplification is a genetic alteration that occurs when there are extra copies of the MET gene in a cell. The MET gene codes for a protein that is involved in cell growth and development. When there are extra copies of the MET gene, the cells produce more MET protein, which can lead to uncontrolled cell growth and cancer.
MET amplification is most common in non-small cell lung cancer (NSCLC), but it can also occur in other types of cancer, such as colorectal cancer, gastric cancer, and head and neck cancer.
MET amplification can be detected using a variety of tests, including:
- Fluorescence in situ hybridization (FISH)
- Chromogenic in situ hybridization (CISH)
- Next-generation sequencing (NGS)
Cost of Crizonix-250mg(Crizotinib)
Xalkori, a multikinase inhibitor drug, is used for anaplastic large cell lymphoma, inflammatory myofibroblastic tumors, and non-small cell lung cancer. The cost for 60 capsules is around $22,289, depending on the pharmacy. These prices are for cash-paying customers and are not valid with insurance plans. Xalkori is available as a brand-name drug, and a generic version is not yet available. For more information, visit the Drugs.com discount card.
The cost of Criztonix is lower than the xalkori. Because Crizonix is a generic version of Crizotinib. To know more about the price of criztotinib contact us.
Crizotinib FDA Approval
Crizotinib (Xalkori, Pfizer Inc.) was authorized on July 14, 2022, by the Food and Drug Administration for use in adult and pediatric patients aged 1 year and older with unresectable, recurrent, or resistant inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).
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Here are Some FAQs about Crizonix-250mg(Crizotinib)
How Does Crizotinib work?
Crizotinib specifically blocks the activity of the anaplastic lymphoma kinase (ALK) and ROS1 kinases. These kinases are overactive in some types of cancer, including non-small cell lung cancer (NSCLC), anaplastic large cell lymphoma (ALCL), and inflammatory myofibroblastic tumor (IMT).
What is Crizotinib used for?
Non-small cell lung cancer (NSCLC) with a specific gene mutation called anaplastic lymphoma kinase (ALK) or ROS1, anaplastic large cell lymphoma (ALCL) that has returned or is unresponsive to other treatments, and inflammatory myofibroblastic tumor (IMT) that cannot be treated with surgery or has not improved after previous treatments in adults and children 1 year and older