Crizotinib (Xalkori) 250mg Capsules | Pfizer USA Original ALK/ROS1 Inhibitor for NSCLC | GLT
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Generic Information: Xalkori 250 mg — United States Original Pack
This listing is for the United States presentation of XALKORI (crizotinib), the original Pfizer capsule launched after FDA approval in 2011 — a regulatory first that arrived alongside a companion diagnostic and rewrote expectations for how fast a precision oncology drug could reach patients. The US pack is boxed as 60 capsules of 250 mg, NDC 0069-8140-20, packaged by Pfizer Labs, a division of Pfizer Inc.
What Is the US Xalkori Indicated For?
The American label is the broadest crizotinib label in the world. It covers adults with metastatic NSCLC that is ALK-positive or ROS1-positive; children one year and older plus young adults with relapsed or refractory systemic ALCL that is ALK-positive; and adults and children one year and older with unresectable, recurrent or refractory ALK-positive IMT. Approval milestones followed one another quickly: ROS1-positive NSCLC gained approval in 2016, pediatric ALCL gained approval in 2021, and IMT gained approval in 2022.
How Does the Drug Work in ALK- and ROS1-Positive Tumors?
Crizotinib is an oral inhibitor of ALK, ROS1, hepatocyte growth factor receptor (c-Met) and RON tyrosine kinases. Rearrangements in the ALK or ROS1 genes create fusion proteins with permanently active kinase domains, driving survival signals inside tumor cells. Occupying the kinases' ATP sites interrupts those signals, reducing proliferation and triggering apoptotic cell death in fusion-positive tumors — which is why molecular testing, not histology alone, decides who benefits.
Indications Summary (US Label)
- Metastatic NSCLC, ALK-positive or ROS1-positive, detected by an FDA-approved test
- Relapsed or refractory systemic ALCL, ALK-positive, in patients 1 year and older and young adults
- Unresectable, recurrent or refractory IMT that is ALK-positive (age 1 year and older)
Dosage and How the Capsules Are Taken
For NSCLC and adult IMT the labeled schedule is 250 mg twice daily. Pediatric ALCL and pediatric IMT use a body-surface-area calculation of 280 mg/m² twice daily. Capsules may be taken with or without meals but should not be opened or chewed. Dose reductions step down through the 200 mg strength; severe renal impairment without dialysis calls for once-daily dosing. The US market also carries oral pellets (20 mg, 50 mg, 150 mg) for patients who cannot swallow capsules — ask GLT about availability when you inquire.
Side Effects and Safety Monitoring
Frequently reported reactions include visual brightness or trails, queasiness, loose stools, vomiting, constipation, swelling of the ankles, reduced appetite and fatigue. The label's most serious warnings involve liver injury, interstitial lung disease, QT prolongation, slow heart rhythm and severe visual loss; scheduled liver-function tests and ECGs are part of standard monitoring. Pediatric ALCL and IMT patients face additional gastrointestinal toxicity warnings and should receive antiemetic and antidiarrheal support proactively.
Storage
Store capsules at controlled room temperature, 20°C–25°C, in the original container with the lid tightly closed. Excursions between 15°C and 30°C are permitted. No cold chain is required for transport.
Why Choose the GLT?
Sourcing the genuine US original pack from outside America is difficult: domestic list pricing is among the highest in the world, and many pharmacies will not ship abroad. GLT operates as a Hong Kong licensed wholesaler doing global medicine sourcing — we procure the authentic Pfizer US presentation through verified channels, confirm NDC, batch and expiry before dispatch, and support institutional procurement as comfortably as a single patient's course. Our coordinators stay reachable throughout treatment, not just at checkout.
How to Order from GLT
Contact GLT on WhatsApp +86 15234153837 or by email [email protected], attaching your prescription and genetic test report. We quote the 250 mg US pack, confirm lead time, and organize temperature-aware, trackable international shipping with complete documentation for customs.
FAQ
Q1: Is the US Xalkori pack different from the China version?
The capsule is the same Pfizer molecule; the US pack differs in packaging language, NDC coding and label text. Both originate from Pfizer manufacturing.
Q2: Can GLT supply the oral pellets instead of capsules?
Pellet strengths (20/50/150 mg) are US-specific presentations — tell us the formulation you need and we will confirm current availability.
Q3: Where can I buy the US original Xalkori?
Through GLT's sourcing service: WhatsApp +86 15234153837 or [email protected] with your documents, and we handle procurement and export.
Q4: What doses does the US pack come in?
Capsules of 200 mg and 250 mg; this listing is the 250 mg, 60-capsule pack.
Q5: How should I store it after delivery?
Room temperature, 20°C–25°C, dry place — no refrigeration needed.