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XALKORI (crizotinib) is an oral receptor tyrosine kinase inhibitor. The molecular formula for crizotinib is C21H22Cl2FN5O. The molecular weight is 450.34 daltons. Crizotinib is described chemically as (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine.
Crizotinib is a white to pale-yellow powder with a pKa of 9.4 (piperidinium cation) and 5.6 (pyridinium cation). The solubility of crizotinib in aqueous media decreases over the range pH 1.6 to pH 8.2 from greater than 10 mg/mL to less than 0.1 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7.4 is 1.65.
XALKORI capsules are supplied as printed hard-shell capsules containing 250 mg or 200 mg of crizotinib together with colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, and hard gelatin capsule shells as inactive ingredients.
The pink opaque capsule shell components contain gelatin, titanium dioxide, and red iron oxide. The white opaque capsule shell components contain gelatin and titanium dioxide. The printing ink contains shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.
ALK-Positive Metastatic NSCLC
XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Clinical Studies].
ROS1-Positive Metastatic NSCLC
XALKORI is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens [see INDICATIONS AND USAGE and Clinical Studies].
Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.
An FDA-approved test for the detection of ROS1 rearrangements in NSCLC is not currently available. Refer to Section 14.2 for information on the tests used in the clinical study to identify patients with ROS1 rearrangements in NSCLC.
The recommended dose of XALKORI is 250 mg orally, twice daily until disease progression or no longer tolerated by the patient.
The recommended dose of XALKORI in patients with severe renal impairment [creatinine clearance (CLcr) < 30 mL/min] not requiring dialysis is 250 mg orally, once daily [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
XALKORI may be taken with or without food. Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time.
Dosage Forms And Strengths
250 mg capsules: hard gelatin capsule, size 0, pink opaque cap and body, with “Pfizer” on the cap and “CRZ 250” on the body.
200 mg capsules: hard gelatin capsule, size 1, white opaque body and pink opaque cap, with “Pfizer” on the cap and “CRZ 200” on the body.
Storage And Handling
250 mg Capsules
Hard gelatin capsule with pink opaque cap and body, printed with black ink “Pfizer” on the cap, “CRZ 250” on the body; available in: Bottles of 60 capsules: NDC 0069-8140-20
200 mg Capsules
Hard gelatin capsule with pink opaque cap and white opaque body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body; available in: Bottles of 60 capsules: NDC 0069-8141-20
Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].