Crizotinib
Pronunciation: (zal-KOR-ee).
- Generic name
- crizotinib
- Brand names
- Xalkonib, Xalkori, Crizocent, Crizalk
- Drug class
- Tyrosine kinase inhibitor (TKI); Antineoplastic agent
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What crizotinib is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how crizotinib works
Crizotinib is a selective tyrosine kinase inhibitor that targets ALK (anaplastic lymphoma kinase), ROS1, and MET kinases. By inhibiting these kinases, crizotinib blocks downstream signaling pathways involved in cell proliferation and survival, leading to reduced tumor growth in cancers with ALK or ROS1 gene rearrangements. (1)
What crizotinib is used for
Non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
Non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive (1)
Non-small cell lung cancer (NSCLC) that is ROS1-positive
Non-small cell lung cancer (NSCLC) that is ROS1-positive (1)
Anaplastic large cell lymphoma (ALCL) that is ALK-positive
Anaplastic large cell lymphoma (ALCL) that is ALK-positive (1)
Inflammatory myofibroblastic tumor (IMT) that is ALK-positive
Inflammatory myofibroblastic tumor (IMT) that is ALK-positive (1)
Before taking crizotinib
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to crizotinib or its components. (Contraindication) (1)
- Not recommended during pregnancy or breastfeeding. (Contraindication) (1)
Tell your clinician about
(1)How to take crizotinib
- General Instructions: Take Xalkori exactly as prescribed by your doctor. Do not change your dose or stop taking it without consulting your healthcare provider.. Adult Dosing: The usual adult dose is 250 mg by mouth twice daily, with or without food.. Pediatric Dosing: For pediatric patients (with ALCL), dosing is based on body surface area (BSA) and should be determined by a pediatric oncologist.. Administration: Swallow the capsules whole with water. Do not crush, chew, or open the capsules.. When To Stop: Stop taking Xalkori only if instructed by your doctor, especially if you experience severe side effects or laboratory abnormalities.. Storage: Store at room temperature (20–25°C/68–77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, take it as soon as you remember. If it is less than 6 hours before your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or contact a poison control center immediately. Symptoms may include severe nausea, vomiting, diarrhea, or heart rhythm changes. Supportive care is the mainstay of treatment. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Vision disorders
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Edema
Incidence: Reported in the clinician-authored database; frequency not established
Hepatotoxicity
Incidence: Reported in the clinician-authored database; frequency not established
Pneumonitis
Incidence: Reported in the clinician-authored database; frequency not established
Bradycardia
Incidence: Reported in the clinician-authored database; frequency not established
QT interval prolongation
Incidence: Reported in the clinician-authored database; frequency not established
New or worsening shortness of breath, cough, or fever (possible lung inflammation/pneumonitis)
(1)Yellowing of the skin or eyes, dark urine, unusual tiredness, or right-upper stomach pain (possible liver injury)
(1)Severe dizziness, fainting, or a very slow or irregular heartbeat (possible heart rhythm change)
(1)New or worsening vision changes, such as flashes of light, blurry vision, or seeing halos
(1)Serious warnings
May cause serious lung problems (interstitial lung disease/pneumonitis) — serious
Symptoms: May cause serious lung problems (interstitial lung disease/pneumonitis). May cause liver injury; monitor liver function regularly. Can cause heart rhythm changes (QT prolongation, bradycardia). May cause vision disorders. Risk of fetal harm; avoid use in pregnancy.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with hypersensitivity to crizotinib or its components. Use with caution in patients with hepatic impairment, severe renal impairment, pre-existing interstitial lung disease, bradycardia, or those at risk for QT prolongation. Not recommended during pregnancy or breastfeeding.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Xalkori interacts with many medications, especially those affecting CYP3A enzymes (such as ketoconazole, rifampin, and certain anti-seizure drugs). It may also interact with drugs that prolong the QT interval or affect heart rhythm. Always inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label states that, based on its mechanism of action, Xalkori (crizotinib) can cause fetal harm when given to a pregnant woman; there are no available human data on Xalkori use in pregnancy, but animal studies at human-comparable exposures showed embryotoxicity and fetotoxicity. Effective contraception should be used during treatment and for at least 45 days after the last dose, and pregnancy should be discussed with the prescriber before starting. (1)
Breastfeeding
The FDA label advises women not to breastfeed during treatment with Xalkori (crizotinib) and for 45 days after the final dose, because there is no information on crizotinib or its metabolites in human milk and there is potential for serious adverse reactions in a breastfed child. (1)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (1)
Renal_impairment
FDA label: no starting-dose adjustment is needed for mild (CLcr 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. Increased crizotinib exposure occurs in pre-existing severe renal impairment (CLcr <30 mL/min) not requiring dialysis, so the Xalkori dose should be reduced in that group. Xalkori has not been formally studied in hepatic impairment; because crizotinib is extensively metabolized by the liver, hepatic impairment is likely to increase plasma concentrations, so the dose should be reduced in moderate or severe hepatic impairment, per the prescriber's individualized plan. (1)
Hepatic_impairment
FDA label: no starting-dose adjustment is needed for mild (CLcr 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. Increased crizotinib exposure occurs in pre-existing severe renal impairment (CLcr <30 mL/min) not requiring dialysis, so the Xalkori dose should be reduced in that group. Xalkori has not been formally studied in hepatic impairment; because crizotinib is extensively metabolized by the liver, hepatic impairment is likely to increase plasma concentrations, so the dose should be reduced in moderate or severe hepatic impairment, per the prescriber's individualized plan. (1)
Monitoring
(1)Storage
Store Xalkori (crizotinib) capsules at room temperature, 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F), out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
Dose summary: 250 mg orally twice daily
Renal context: FDA label: no starting-dose adjustment is needed for mild (CLcr 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. Increased crizotinib exposure occurs with pre-existing severe renal impairment (CLcr <30 mL/min) not requiring dialysis, so the dose should be reduced in that group — the exact reduced dose must be individualized by the prescriber. (1)
Hepatic guidance
FDA label: Xalkori has not been formally studied in patients with hepatic impairment. Because crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma crizotinib concentrations, so the dose should be reduced in moderate or severe hepatic impairment, individualized by the prescriber.
Frequently asked questions
What is Xalkori used for?
Xalkori is used to treat certain types of non-small cell lung cancer (NSCLC) that are ALK-positive or ROS1-positive, and in some cases, relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) in children.
How does Xalkori work?
Xalkori blocks the activity of specific proteins (ALK and ROS1 tyrosine kinases) that help cancer cells grow, thereby slowing or stopping cancer progression.
What are the most common side effects of Xalkori?
Common side effects include vision changes, nausea, vomiting, diarrhea, constipation, swelling, fatigue, and changes in taste.
Can I take Xalkori with other medications?
Xalkori can interact with many medications, especially those affecting liver enzymes or heart rhythm. Always check with your doctor or pharmacist before starting new medicines.
Is Xalkori safe during pregnancy or breastfeeding?
Xalkori can harm an unborn baby and should not be used during pregnancy. Breastfeeding is not recommended while taking Xalkori.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is less than 6 hours before your next dose. Do not double up doses.
How long will I need to take Xalkori?
Treatment duration depends on your response and tolerance to the medication. Your doctor will determine how long you should continue therapy.
What happens if I take too much Xalkori?
Taking too much Xalkori can lead to an exacerbation of side effects, potentially including severe gastrointestinal issues, visual disturbances, or liver toxicity. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Do not attempt to induce vomiting or self-treat. Contact your healthcare provider or emergency services without delay.
Can I drink alcohol while taking Xalkori?
It is generally advisable to limit or avoid alcohol consumption while taking Xalkori. Both Xalkori and alcohol can be metabolized by the liver, and combining them may increase the risk of liver toxicity or worsen certain side effects like nausea or fatigue. Always discuss alcohol intake with your healthcare provider for personalized guidance based on your health status.
Is Xalkori safe during pregnancy?
Xalkori's safety during pregnancy has not been established, and it is generally not recommended due to potential risks to the fetus. It falls under a pregnancy category that advises caution. Women of childbearing potential should use effective contraception during treatment and for a period after. Always consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding to discuss the risks and benefits.
What is the mechanism of action of crizotinib?
Crizotinib is a selective tyrosine kinase inhibitor that targets ALK (anaplastic lymphoma kinase), ROS1, and MET kinases. By inhibiting these kinases, crizotinib blocks downstream signaling pathways involved in cell proliferation and survival, leading to reduced tumor growth in cancers with ALK or ROS1 gene rearrangements. (1)
What is the generic name of Crizotinib?
The generic name is crizotinib. It is sold under brand names including Xalkonib, Xalkori, Crizocent, Crizalk.
What class of drug is crizotinib?
Crizotinib is classed as: Tyrosine kinase inhibitor (TKI); Antineoplastic agent.
References
- nullnull · null · accessed null · source 1
- Crizotinib — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 2
- Xalkori — FDA approval record (Drugs@FDA NDA217581)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 3
- crizotinib — RxNorm normalized drug concept (RXCUI 1148495)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient crizotinib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Xalkori250 mg, 20 mg, 50 mg, 150 mg, 200 mg · pfizer laboratories div pfizer inc
Canada
- XALKORI