Brand Name
Xalkori
Generic Name
Crizotinib
View Brand Information FDA approval date: August 26, 2011
Classification: Kinase Inhibitor
Form: Capsule
What is Xalkori (Crizotinib)?
XALKORI is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase or ROS1-positive as detected by an FDA-approved test.
Approved To Treat
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Brand Information
Xalkori (CRIZOTINIB)
1DOSAGE FORMS AND STRENGTHS
Capsules:
- 200 mg: hard gelatin capsule, size 1, white opaque body and pink opaque cap, with "Pfizer" on the cap and "CRZ 200" on the body.
- 250 mg: hard gelatin capsule, size 0, pink opaque cap and body, with "Pfizer" on the cap and "CRZ 250" on the body.
Oral Pellets:
- 20 mg: hard gelatin capsule, size 4, white opaque body and light blue opaque cap, printed with black ink “Pfizer” on the cap and “CRZ 20” on the body.
- 50 mg: hard gelatin capsule, size 3, light gray opaque body and gray opaque cap, printed with black ink “Pfizer” on the cap and “CRZ 50” on the body.
- 150 mg: hard gelatin capsule, size 0, light blue opaque body and cap, printed with black ink “Pfizer” on the cap and “CRZ 150” on the body.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity
- Interstitial Lung Disease/Pneumonitis
- QT Interval Prolongation
- Bradycardia
- Severe Visual Loss
- Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data in the Warnings and Precautions reflect exposure to XALKORI in 1719 patients with NSCLC who received XALKORI 250 mg twice daily enrolled on Studies 1 (including an additional 109 patients who crossed over from the control arm), 2, 3, a single-arm trial (n=1063) of ALK-positive NSCLC, and an additional ALK-positive NSCLC expansion cohort of a dose finding study (n=154). The data also reflect exposure to XALKORI in 121 patients ages 1 to ≤21 years with relapsed or refractory tumors, including 26 patients with systemic ALCL and 14 pediatric patients with IMT, in a single-arm trial (Study ADVL0912). The data are also described for 7 adult patients with IMT treated with XALKORI in a single-arm trial (Study A8081013).
3.2Postmarketing Experience
The following additional adverse reaction has been identified during post-approval use of XALKORI. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Investigations: Increased blood creatine phosphokinase
4DESCRIPTION
Crizotinib is a kinase inhibitor. The molecular formula for crizotinib is C
The chemical structure of crizotinib is shown below:
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.
Capsules:
XALKORI (crizotinib) capsules for oral administration 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.
Oral Pellets:
XALKORI (crizotinib) oral pellets for oral administration are supplied as 20 mg, 50 mg, 150 mg of crizotinib contained in hard gelatin capsules. The inactive ingredients in the uncoated pellets are poloxamer and stearyl alcohol. The film-coating consists of hypromellose, glyceryl monostearate, medium chain triglycerides, polyethylene glycol/macrogol, sucrose, and talc.
5HOW SUPPLIED/STORAGE AND HANDLING
Capsules:
- 200 mg capsules
- 250 mg capsules
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].
Oral Pellets:
- 20 mg oral pellets
- 50 mg oral pellets
- 150 mg oral pellets
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
6PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide; Instructions for Use).
7Instructions for Use
INSTRUCTIONS FOR USE
XALKORI
(crizotinib)
oral pellets
This Instructions for Use contains information on how to give or take XALKORI oral pellets. Read this Instructions for Use each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider or pharmacist about your or your child’s medical condition or treatment.
Important information you need to know before giving or taking XALKORI oral pellets:
- XALKORI oral pellets come in a capsule “shell” that must be opened before giving or taking a dose.
- XALKORI oral pellets come in 3 dosage strengths: 20 mg, 50 mg, and 150 mg. Your healthcare provider may combine different strengths for your prescribed dose. No more than 4 XALKORI oral pellet shells are to be used for a single dose.
- Your healthcare provider will decide the right dose of XALKORI oral pellets for you or your child. Follow your healthcare provider’s instructions for the dose of XALKORI oral pellets to give your child or for you to take.
- Empty XALKORI oral pellets from the shells as described in Steps 1 to 4 below.
- Check the expiration date on the bottle containing XALKORI oral pellets.
- Ask your healthcare provider or pharmacist if you are not sure how to prepare and give or take the prescribed dose of XALKORI oral pellets.
Supplies needed to give or take XALKORI oral pellets:
- XALKORI oral pellet(s), as prescribed by your healthcare provider.
- Spoon or medicine cup (optional). See Step 4
Preparing XALKORI oral pellets (Steps 1 to 3):
Giving or taking XALKORI oral pellets (Step 4): There are 2 options for giving or taking the oral pellets.
Storing XALKORI oral pellets:
- Store XALKORI oral pellets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep XALKORI oral pellets and all medicines out of the reach of children.
Disposing of empty XALKORI oral pellet shells:
- Dispose of (throw away) the empty XALKORI oral pellet shell(s) in the household trash.
- Ask your pharmacist how to throw away medicines you no longer use or are expired.
For more information, go to
LAB-1526-1.0
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 09/2023
8PRINCIPAL DISPLAY PANEL - 250 mg Capsule Bottle Label
ALWAYS DISPENSE ENCLOSED MEDICATION
Pfizer
XALKORI
Swallow capsule whole
60 Capsules
9PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
ALWAYS DISPENSE ENCLOSED MEDICATION
Pfizer
XALKORI
Swallow capsule whole
60 Capsules
10PRINCIPAL DISPLAY PANEL - 20 mg Oral Pellets Label
ALWAYS DISPENSE ENCLOSED MEDICATION
NDC 0069-0251-60
XALKORI
Open capsule shell to administer pellets.
60 Capsules
11PRINCIPAL DISPLAY PANEL - 50 mg Oral Pellets Label
ALWAYS DISPENSE ENCLOSED MEDICATION
NDC 0069-0507-60
XALKORI
Open capsule shell to administer pellets.
60 Capsules
12PRINCIPAL DISPLAY PANEL - 150 mg Oral Pellets Label
ALWAYS DISPENSE ENCLOSED MEDICATION
NDC 0069-1500-60
XALKORI
Open capsule shell to administer pellets.
60 Capsules
