{"id":91,"date":"2026-07-06T13:13:38","date_gmt":"2026-07-06T13:13:38","guid":{"rendered":"https:\/\/dcenbd.com\/?post_type=product&#038;p=91"},"modified":"2026-07-09T16:36:57","modified_gmt":"2026-07-09T16:36:57","slug":"alkixen-250mg","status":"publish","type":"product","link":"https:\/\/dcenbd.com\/index.php\/product\/alkixen-250mg\/","title":{"rendered":"Alkixen 250mg (Crizotinib)"},"content":{"rendered":"<div id=\"description\">\n<h3 class=\"ac-header\">Description:<\/h3>\n<\/div>\n<div class=\"ac-body\">Alkixen is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive or ROS 1 positive. Alkixen is the first FDA-approved biomarker-driven therapy for both ALK positive and ROS1-positive metastatic NSCLC. It is the only FDA approved drug for ROS 1 positive NSCLC.<\/div>\n<div><\/div>\n<div><strong>Absorption:<\/strong><\/div>\n<div>\n<p>Following oral single-dose administration, crizotinib was absorbed with median time to achieve peak concentration of 4 to 6 hours. Following crizotinib 250 mg twice daily, steady state was reached within 15 days and remained stable, with a median accumulation ratio of 4.8. Steady state systemic exposure (C.min and AUC) appeared to increase in a greater than dose proportional manner over the dose range of 200-300 mg twice daily. The mean absolute bioavailability of crizotinib was 43% (range: 32% to 66%) following the administration of a single 250 mg oral dose. A high-fat meal reduced crizotinib AUCinf and Cmax by approximately 14%.<\/p>\n<p><strong>Distribution<\/strong>:<\/p>\n<\/div>\n<div>\n<p>The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma. Binding of crizotinib to human plasma proteins in vitro is 91% and is independent of drug concentration. In vitro studies suggested that crizotinib is a substrate for P-glycoprotcin (P-gp). The blood-to-plasma concentration ratio is approximately 1.<\/p>\n<\/div>\n<div><strong>Elimination<\/strong>:<\/div>\n<div>Following single doses of crizotinib, the mean apparent plasma terminal half-life of crizotinib was 42 hours in patients. Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in feces and urine, respectively. Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in feces and urine, respectively. The mean apparent clearance (CL\/F) of crizotinib was lower at steady state (60 L\/hr) after 250 mg twice daily than that after a single 250 mg oral dose (100 L\/hr), which was likely due to auto inhibition of CYP3A by crizotinib after multiple dosing.<\/div>\n<div><\/div>\n<div><strong>Metabolism<\/strong>:<\/div>\n<div>In vitro studies demonstrated that crizotinib is predominantly metabolized by CYP3A4\/5. The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O dealkylation, with subsequent Phase 2 conjugation of O-dcalkylatcd metabolites.<\/div>\n<div><\/div>\n<div><\/div>\n<div>\n<div id=\"dosage\">\n<h3 class=\"ac-header\">Dosage:<\/h3>\n<\/div>\n<div class=\"ac-body\">\n<p><strong>Recommended Dose<\/strong>: 250 mg orally, twice daily<\/p>\n<p><strong>Geriatric Use<\/strong>:<\/p>\n<\/div>\n<div class=\"ac-body\">\n<p>No differences in safety or efficacy were observed between older and younger patients. Clinical studies of Crizotinib in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients<\/p>\n<p><strong>Pediatric Dose<\/strong>:<\/p>\n<\/div>\n<div class=\"ac-body\">\n<p>The safety and effectiveness of Crizotinib in pediatric patients have not been established.<\/p>\n<p><strong>Renal impairment<\/strong>:<\/p>\n<\/div>\n<div class=\"ac-body\">\n<p>250 mg orally, once daily in patients with severe renal impairment (creatinine clearance &lt;30 mL\/min) not requiring dialysis.\u00a0No starting dose adjustment is needed for patients with mild (ClCr 60-89 mL\/min) or moderate (ClCr 30-59 mL\/min) renal impairment based on a population pharmacokinetic analysis.<\/p>\n<p><strong>Hepatic<\/strong>:<\/p>\n<\/div>\n<div class=\"ac-body\">Caution should be used in patients with hepatic impairment<\/div>\n<\/div>\n<div><\/div>\n<div>\n<div id=\"pregnancy_cat\">\n<h3 class=\"ac-header\">Pregnancy:<\/h3>\n<\/div>\n<div class=\"ac-body\">Based on its mechanism of action, Crizotinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Crizotinib during pregnancy. Females of reproductive potential should be advised of the potential risk to a fetus and use of effective contraception.<br \/>\nThere is no information regarding the presence of Crizotinib in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for adverse reactions in breastfed infants patients should not breastfeed during treatment with Crizotinib and for 45 days after the final dose.<\/div>\n<\/div>\n<div><\/div>\n<div>\n<div>\n<div class=\"ac-body\"><\/div>\n<\/div>\n<div>\n<div id=\"storage_conditions\">\n<h3 class=\"ac-header\">Storage Condition:<\/h3>\n<\/div>\n<div class=\"ac-body\">Keep below 30\u00b0C temperature, away from light &amp; moisture. Keep out of the reach of children.<\/div>\n<\/div>\n<\/div>\n<div>\n<div id=\"drug_classes\">\n<h3><\/h3>\n<h3 class=\"ac-header\">Therapeutic Class:<\/h3>\n<\/div>\n<div class=\"ac-body\">Targeted Cancer Therapy<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<div id=\"description\">\n<h3 class=\"ac-header\"><span style=\"font-size: 16px;\">Alkixen is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive or ROS 1 positive. Alkixen is the first FDA-approved biomarker-driven therapy for both ALK positive and ROS1-positive metastatic NSCLC. It is the only FDA approved drug for ROS 1 positive NSCLC.<\/span><\/h3>\n<\/div>\n","protected":false},"featured_media":92,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"product_brand":[],"product_cat":[19],"product_tag":[],"class_list":["post-91","product","type-product","status-publish","has-post-thumbnail","product_cat-lung-cancer","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","shipping-taxable","product-type-simple"],"_links":{"self":[{"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/product\/91","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/comments?post=91"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/media\/92"}],"wp:attachment":[{"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/media?parent=91"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/product_brand?post=91"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/product_cat?post=91"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/dcenbd.com\/index.php\/wp-json\/wp\/v2\/product_tag?post=91"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}