Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Xalkori

Descriptions


Crizotinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) that is caused by a defect in either a gene called anaplastic lymphoma kinase (ALK) or a gene called ROS1. Your doctor will test for the presence of this gene.

Crizotinib is also used to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) systemic anaplastic large cell lymphoma (ALCL) with a defect in a gene called anaplastic lymphoma kinase (ALK).

Crizotinib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of crizotinib in children younger than 1 year of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of crizotinib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Bepridil
  • Cisapride
  • Cobicistat
  • Dronedarone
  • Eliglustat
  • Fluconazole
  • Ketoconazole
  • Levoketoconazole
  • Lopinavir
  • Mesoridazine
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Acalabrutinib
  • Acebutolol
  • Alfentanil
  • Alfuzosin
  • Alprazolam
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amprenavir
  • Anagrelide
  • Apalutamide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atenolol
  • Avapritinib
  • Azithromycin
  • Bedaquiline
  • Benzhydrocodone
  • Betaxolol
  • Bisoprolol
  • Boceprevir
  • Bosutinib
  • Brigatinib
  • Buprenorphine
  • Buserelin
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Cilostazol
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clonidine
  • Clothiapine
  • Clozapine
  • Codeine
  • Colchicine
  • Conivaptan
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Daridorexant
  • Dasatinib
  • Deflazacort
  • Degarelix
  • Delamanid
  • Delavirdine
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexmedetomidine
  • Digoxin
  • Dihydrocodeine
  • Dihydroergotamine
  • Diltiazem
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Ebastine
  • Efavirenz
  • Eletriptan
  • Elexacaftor
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Ergotamine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Esmolol
  • Famotidine
  • Fedratinib
  • Felbamate
  • Fentanyl
  • Fexinidazole
  • Finerenone
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluoxetine
  • Formoterol
  • Fosamprenavir
  • Foscarnet
  • Fosnetupitant
  • Fosphenytoin
  • Fostemsavir
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibrutinib
  • Ibutilide
  • Idelalisib
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Indinavir
  • Infigratinib
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Labetalol
  • Lapatinib
  • Lefamulin
  • Lemborexant
  • Lenvatinib
  • Leuprolide
  • Levobunolol
  • Levofloxacin
  • Lofexidine
  • Lumacaftor
  • Lumateperone
  • Lumefantrine
  • Lurasidone
  • Lurbinectedin
  • Macimorelin
  • Mavacamten
  • Mefloquine
  • Meperidine
  • Methadone
  • Methotrimeprazine
  • Metipranolol
  • Metoprolol
  • Metronidazole
  • Mifepristone
  • Mirtazapine
  • Mitapivat
  • Mitotane
  • Mizolastine
  • Mobocertinib
  • Moricizine
  • Moxifloxacin
  • Nadolol
  • Nafarelin
  • Naloxegol
  • Nebivolol
  • Nefazodone
  • Netupitant
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Olaparib
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxprenolol
  • Oxycodone
  • Ozanimod
  • Paclitaxel
  • Pacritinib
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pemigatinib
  • Penbutolol
  • Pentamidine
  • Pentazocine
  • Perhexiline
  • Perphenazine
  • Pexidartinib
  • Phenytoin
  • Pimavanserin
  • Pindolol
  • Pipamperone
  • Pitolisant
  • Ponesimod
  • Practolol
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Propranolol
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Rilpivirine
  • Rimegepant
  • Risperidone
  • Selpercatinib
  • Selumetinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Simeprevir
  • Siponimod
  • Sirolimus
  • Sirolimus Protein-Bound
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sonidegib
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tazemetostat
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Temsirolimus
  • Terodiline
  • Tetrabenazine
  • Tezacaftor
  • Timolol
  • Tolterodine
  • Tolvaptan
  • Toremifene
  • Tramadol
  • Trazodone
  • Triclabendazole
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Troleandomycin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venetoclax
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vorinostat
  • Zanubrutinib
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amlodipine
  • Midazolam
  • Suvorexant

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bradycardia (slow heartbeat) or
  • Congenital long QT syndrome (heart rhythm problem) or
  • Congestive heart failure or
  • Electrolyte or mineral imbalance or
  • QT prolongation (abnormal heart rhythm)—Use with caution. May cause side effects to become worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Swallow the capsule whole. Do not crush, break, chew, or open it. You may take this medicine with or without food.

You may also receive medicines to help prevent or treat diarrhea, nausea, or vomiting. Drink plenty of fluids to help prevent dehydration.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For non-small cell lung cancer:
      • Adults—250 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For systemic anaplastic large cell lymphoma:
      • Adults and children 1 year of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 280 milligrams per square meter (mg/m[2]) of BSA, taken 2 times a day. Your doctor may adjust your dose as needed and tolerated.
        • BSA 1.70 meter squared (m2) or more—500 mg 2 times a day.
        • BSA 1.52 to 1.69 m2—450 mg 2 times a day.
        • BSA 1.17 to 1.51 m2—400 mg 2 times a day.
        • BSA 0.81 to 1.16 m2—250 mg 2 times a day.
        • BSA 0.60 to 0.80 m2—200 mg 2 times a day.
      • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 6 hours until your next regular dose, wait until then to use the medicine and skip the missed dose.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment with this medicine and for at least 45 days after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 90 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause swelling of the lungs (pneumonitis), which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a cough with or without mucous, trouble breathing, or a fever.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.

This medicine may cause serious stomach or bowel problems. Check with your doctor right away if you have black, tarry stools, colicky or burning stomach pain, constipation, diarrhea, loss of appetite, nausea, pain in the back of throat or chest when swallowing, or vomiting blood or material that looks like coffee grounds.

Cancer medicines can cause constipation, diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

This medicine may cause dizziness, tiredness, blurred vision, or other vision problems (eg, flashes of lights, floaters, sensitivity of the eyes to light). If any of these occur, do not drive or do anything else that could be dangerous until you know how this medicine affects you. Check with your doctor if visual changes occur. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause an increased sensitivity of the skin to sunlight (photosensitivity). Check with your doctor right away if you have itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats and avoid sunlamps and tanning beds.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blurred or loss of vision
  4. body aches or pain
  5. chest pain, discomfort, or tightness
  6. chills
  7. colicky or burning stomach pain
  8. constipation
  9. cough
  10. diarrhea
  11. difficult or labored breathing
  12. difficulty in swallowing
  13. disturbed color perception
  14. double vision
  15. ear congestion
  16. fever
  17. halos around lights
  18. headache
  19. hoarseness
  20. increased sensitivity to pain or touch
  21. irregular heartbeat
  22. lightheadedness, dizziness, or fainting
  23. loss of appetite
  24. loss of voice
  25. lower back or side pain
  26. nerve pain
  27. night blindness
  28. overbright appearance of lights
  29. pain in the back of throat or chest when swallowing
  30. pain or burning in the throat
  31. painful or difficult urination
  32. pale skin
  33. rapid weight gain
  34. recurrent fainting
  35. runny or stuffy nose
  36. seeing flashes or sparks of light
  37. slow or irregular heartbeat
  38. sneezing
  39. sore throat
  40. sores, ulcers, or white spots on the lips or tongue or inside the mouth
  41. swelling
  42. trouble breathing
  43. tunnel vision
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. unusual weight gain or loss
  47. vomiting
  48. vomiting blood or material that looks like coffee grounds
  49. weakness in the arms, hands, legs, or feet

Less common

  1. Anxiety
  2. blue lips, fingernails, or skin
  3. clay-colored stools
  4. confusion
  5. dark urine
  6. dry mouth
  7. fast heartbeat
  8. flushed, dry skin
  9. fruit-like breath odor
  10. increased hunger
  11. increased thirst
  12. increased urination
  13. irregular, fast or slow, or shallow breathing
  14. itching, skin rash
  15. loss of consciousness
  16. nausea
  17. stomach pain or tenderness
  18. sweating
  19. swelling of the feet or lower legs
  20. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. change in taste
  6. heartburn
  7. increased weight
  8. indigestion
  9. loss of taste
  10. muscle spasm or weakness
  11. pain in the arms or legs
  12. stomach discomfort or upset
  13. trouble in walking
  14. unsteadiness or awkwardness
  15. weakness in the arms, hands, legs, or feet

Rare

  1. Increased sensitivity of the skin to sunlight
  2. redness or discoloration of the skin
  3. severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.