Crizotinib (crizotinib)
Crizotinib is a first-generation alk / ros1 / c-met receptor tyrosine kinase inhibitor from Pfizer, marketed originally as Xalkori. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Crizotinib is a first-generation oral tyrosine kinase inhibitor that blocks ALK, ROS1, c-Met (HGFR) and RON, sold by Pfizer as Xalkori (赛可瑞). It is approved for adults with metastatic non-small cell lung cancer whose tumours are ALK-positive or ROS1-positive, for children and young adults aged one year and older with relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma (ALCL), and for adults and children aged one year and older with unresectable, recurrent or refractory ALK-positive inflammatory myofibroblastic tumour (IMT). Standard adult dosing is 250 mg twice daily. Visual symptoms - photopsia, blurred vision, diplopia - are its signature adverse effect, and liver enzymes, heart rate, BP and QT interval all need watching. Affordability is the deciding factor for most patients in South Asia. Bangladesh registers seven domestic crizotinib brands under the LDC patent exemption, and the spread between them is wide. 21.
How it works
Crizotinib is an oral capsule that blocks the abnormal ALK or ROS1 proteins that make some lung cancers grow. By switching off those signals inside the cancer cell, it slows or shrinks the tumour, and it also acts on the c-Met and RON proteins.
Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, hepatocyte growth factor receptor (HGFR/c-Met), ROS1 (c-ros) and recepteur d'origine nantais (RON); it blocks ALK fusion protein activation and downstream signalling that drives increased proliferation and survival of tumours expressing these proteins.
Approved indications
- Treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive or ROS1-positive as detected by an FDA-approved test
- Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive (limitations of use: safety and efficacy not established in older adults with relapsed or refractory systemic ALK-positive ALCL)
- Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive
Dosage & administration
ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsules must be swallowed whole; if a dose is missed it is taken as soon as remembered unless the next dose is due within 6 hours; do not make up a vomited dose.
Dose adjustment
Moderate hepatic impairment (AST any value and total bilirubin >1. 5x to 3x ULN): 200 mg orally twice daily. Severe hepatic impairment (AST any value and total bilirubin >3x ULN): 250 mg orally once daily. Severe renal impairment (CLcr <30 mL/min, not requiring dialysis): 250 mg orally once daily. Reduce dose with concomitant strong CYP3A inhibitors. Avoid grapefruit and grapefruit juice. Dosage modifications or permanent discontinuation apply for hepatotoxicity, ILD/pneumonitis, QT prolongation, bradycardia, severe visual loss and gastrointestinal toxicity.
Side effects
Vision problems (visual impairment, photopsia, blurred vision, diplopia) · Nausea, diarrhea, vomiting · Peripheral edema / swelling of hands, feet, face or eyes · Constipation · Fatigue · Decreased appetite · Upper respiratory infection · Dizziness · Neuropathy / numbness or tingling in arms and legs · Bradycardia · Photosensitivity / sunburn
- Elevated liver function tests and hepatotoxicity (fatal cases reported)
- QT interval prolongation
- Interstitial lung disease / pneumonitis
- Severe visual loss
Monitoring
- Periodic liver function tests (AST, ALT, bilirubin) for hepatotoxicity; fatal hepatotoxicity has occurred
- Promptly evaluate any new or worsening pulmonary symptoms for ILD/pneumonitis
- ECG and electrolytes in patients at risk of QT interval prolongation
- Heart rate and blood pressure for bradycardia
- Ophthalmologic evaluation for visual changes or severe visual loss
- Complete blood counts, particularly in ALCL and IMT patients
- Serum electrolytes and renal function
Generic and biosimilar landscape
No published bioequivalence study against Xalkori was found for the Bangladeshi or Indian brands; they are nationally approved branded generics, not FDA/EMA-approved generics. Beacon Pharmaceuticals markets Crizonix (also sold domestically in Bangladesh as Alkriz) as the 'global first generic preparation of Crizotinib', manufactured in a dedicated oncology facility to internationally GMP-standard quality, and states it is the datad about 13 times lower than the originator. Differing pack sizes and unit informations between Bangladesh brands (to per capsule) reflect different commercial positioning rather than a documented bioequivalence difference.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Beacon Pharmaceuticals PLC | Bangladesh | Crizonix | 250 mg capsule | Marketed as the global first generic of crizotinib; dedicated oncology facility; pack sizes 28s and 60s; DGDA drug registration number 341-293-10 cited on the product site |
| Beacon Pharmaceuticals PLC | Bangladesh | Alkriz | 250 mg capsule | Domestic Bangladesh listing of Beacon's crizotinib on MedEx at per capsule (7 x 4 pack,) |
| Incepta Pharmaceuticals Ltd. | Bangladesh | Crizocent | 250 mg capsule | Highest pack information among Bangladesh crizotinib brands listed by MedEx at per capsule (3 x 4,) |
| Everest Pharmaceuticals Ltd. | Bangladesh | Alkixen | 250 mg capsule | Lowest pack information among Bangladesh crizotinib brands listed by MedEx at per capsule (1 x 30,) |
| Genvio Pharma Ltd. | Bangladesh | Algrofin | 250 mg capsule | Pack 7 x 4 |
| Drug International Ltd. | Bangladesh | Rizonib | 250 mg capsule | Pack 3 x 10 |
| Jenphar Bangladesh Ltd. | Bangladesh | Crizonil | 250 mg capsule | Pack 1 x 30 |
| Ziska Pharmaceuticals Ltd. | Bangladesh | Crizona | 250 mg capsule | Pack 3 x 10 |
| Hetero Healthcare Limited | India | Crikzo | 250 mg capsule | Indian crizotinib brand listed on 1mg; local the data around |
| Lucius Pharma Private Limited | India / Laos | Lucicriz | 250 mg capsule | Listed on 1mg as an Indian brand; Lucius Pharmaceuticals (Lao) LTD operates an oncology manufacturing campus in Vientiane, Laos |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Indonesia | Approved | XALKORI (crizotinib) 250 mg capsules is registered with BPOM Indonesia; an official BPOM new-drug assessment report and Pfizer Indonesia local product document (approved by BPOM, CDS effective 2 June 2022) are published, with storage instruction 'store below 30 C' |
| Philippines | Approved | Crizotinib has a Philippine product information monograph listed on MIMS Philippines for the treatment of ALK-positive metastatic NSCLC |
| Singapore | Not confirmed | No HSA approval record or public source for crizotinib was located in this search round |
| Malaysia | Not confirmed | No NPRA approval record or public source for crizotinib was located in this search round |
| Thailand | Not confirmed | No Thai FDA approval record or public source for crizotinib was located in this search round |
| Vietnam | Not confirmed | No Vietnamese Drug Administration approval record or public source for crizotinib was located in this search round |
| Laos | Local generic manufacturing | Lucius Pharmaceuticals (Lao) LTD lists crizotinib (250 mg x 60 capsules) in its oncology portfolio from its Vientiane campus, but publishes no the data |
| Bangladesh (regional supply hub) | Available | Beacon's export page lists Bangladesh-origin crizotinib as supplied to Nepal, Sri Lanka, Pakistan, Myanmar and Cambodia; at least seven domestic crizotinib brands are registered |
Frequently asked questions
Crizonix vs Xalkori: what is the difference?
Crizotinib (First-generation ALK / ROS1 / c-Met receptor tyrosine kinase inhibitor, originally Xalkori (赛可瑞) by Pfizer) Crizotinib is an oral capsule that blocks the abnormal ALK or ROS1 proteins that make some lung cancers grow. By switching off those signals inside the cancer cell, it slows or shrinks the tumour, and it also acts on the c-Met and RON proteins. ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsule
What is the correct dose of crizotinib for ALK-positive lung cancer?
Standard dosing for crizotinib: ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsules must be swallowed whole; if a dose is missed it is taken as soon as remembered unless the next dose is due within 6 hours; do not make up a vomited dose. Dose adjustments: Moderate hepatic impairment (AST any value and total bilirubin >1. 5x to 3x ULN): 200 mg orally twice daily. Severe hepatic impairment (AST any value and total bilirubin >3x ULN): 250 mg orally once daily. Severe renal impairment (CLcr <30 mL/min, not requiring dialysis): 250 mg orally once daily. Reduce dose with concomitant strong CYP3A inhibitors. Avoid grapefruit and grapefruit juice. Dosage modifications or permanent discontinuation apply for hepatotoxicity, ILD/pneumonitis, QT prolongation, bradycardia, severe visual loss and gastrointestinal toxicity.
Is crizotinib available in Indonesia or the Philippines?
Crizotinib is made by 9 suppliers tracked in this database, including Beacon Pharmaceuticals PLC, Drug International Ltd. , Everest Pharmaceuticals Ltd. , Genvio Pharma Ltd. , Hetero Healthcare Limited, Incepta Pharmaceuticals Ltd. , Jenphar Bangladesh Ltd. , Lucius Pharma Private Limited. Bangladesh-registered brands: Algrofin, Alkixen, Alkriz, Crizocent, Crizona, Crizonil, Rizonib.
Does crizotinib cause vision problems?
Crizotinib (First-generation ALK / ROS1 / c-Met receptor tyrosine kinase inhibitor, originally Xalkori (赛可瑞) by Pfizer) Crizotinib is an oral capsule that blocks the abnormal ALK or ROS1 proteins that make some lung cancers grow. By switching off those signals inside the cancer cell, it slows or shrinks the tumour, and it also acts on the c-Met and RON proteins. ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsule
What is the half-life of crizotinib and how often is it taken?
Standard dosing for crizotinib: ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsules must be swallowed whole; if a dose is missed it is taken as soon as remembered unless the next dose is due within 6 hours; do not make up a vomited dose. Dose adjustments: Moderate hepatic impairment (AST any value and total bilirubin >1. 5x to 3x ULN): 200 mg orally twice daily. Severe hepatic impairment (AST any value and total bilirubin >3x ULN): 250 mg orally once daily. Severe renal impairment (CLcr <30 mL/min, not requiring dialysis): 250 mg orally once daily. Reduce dose with concomitant strong CYP3A inhibitors. Avoid grapefruit and grapefruit juice. Dosage modifications or permanent discontinuation apply for hepatotoxicity, ILD/pneumonitis, QT prolongation, bradycardia, severe visual loss and gastrointestinal toxicity.
Can crizotinib be taken with food or grapefruit juice?
Crizotinib (First-generation ALK / ROS1 / c-Met receptor tyrosine kinase inhibitor, originally Xalkori (赛可瑞) by Pfizer) Crizotinib is an oral capsule that blocks the abnormal ALK or ROS1 proteins that make some lung cancers grow. By switching off those signals inside the cancer cell, it slows or shrinks the tumour, and it also acts on the c-Met and RON proteins. ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsule
What happens if a crizotinib dose is missed?
Standard dosing for crizotinib: ALK- or ROS1-positive metastatic NSCLC in adults: 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity. Adults with unresectable ALK-positive IMT: 250 mg orally twice daily. Pediatric patients and young adults with ALK-positive ALCL, and pediatric patients with ALK-positive IMT: 280 mg/m2 orally twice daily (BSA-banded 200-500 mg twice daily). Capsules must be swallowed whole; if a dose is missed it is taken as soon as remembered unless the next dose is due within 6 hours; do not make up a vomited dose. Dose adjustments: Moderate hepatic impairment (AST any value and total bilirubin >1. 5x to 3x ULN): 200 mg orally twice daily. Severe hepatic impairment (AST any value and total bilirubin >3x ULN): 250 mg orally once daily. Severe renal impairment (CLcr <30 mL/min, not requiring dialysis): 250 mg orally once daily. Reduce dose with concomitant strong CYP3A inhibitors. Avoid grapefruit and grapefruit juice. Dosage modifications or permanent discontinuation apply for hepatotoxicity, ILD/pneumonitis, QT prolongation, bradycardia, severe visual loss and gastrointestinal toxicity.
Is crizotinib approved for ROS1-positive lung cancer?
Crizotinib is approved for: Treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive or ROS1-positive as detected by an FDA-approved test; Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive (limitations of use: safety and efficacy not established in older adults with relapsed or refractory systemic ALK-positive ALCL); Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. It is a crizotinib (First-generation ALK / ROS1 / c-Met receptor tyrosine kinase inhibitor), originally marketed as Xalkori (赛可瑞) by Pfizer.
Sources
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf
- https://medex.com.bd/generics/1379/crizotinib/brand-names
- https://medeasy.health/medicines/crizonix-250-mg-capsule
- https://global.beaconpharma.com.bd/product/crizonix
- https://www.crizonix.com
- https://beaconmedicare.com.bd/product-detail.php?idname=10-crizonix
- https://www.netmeds.com/product/crizalk-250mg-capsule-60s-lufuti-7524499
- https://www.1mg.com/generics/crizotinib-212892
- https://www.mrmed.in/molecule/crizotinib
- https://labeling.pfizer.com/ShowLabeling.aspx?id=14667
- https://registrasiobat.pom.go.id/files/assesment-reports/obat_baru/xalkori.pdf
- https://www.mims.com/philippines/drug/info/crizotinib/patientmedicine/crizotinib-oral
- https://laoslucius.com/crizotinib/the data
- https://www.unitedpharmacies.md/Crizonix-Crizotinib.html
- https://medspartner.com/products/crizotinib-generic-for-xalkori
- https://www.pfizer.com/news/press-release/press-release-detail/xalkori_crizotinib_approved_by_u_s_fda_for_the_treatment_of_patients_with_ros1_positive_metastatic_non_small_cell_lung_cancer
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