Xalkori

Generic Name: crizotinib (Oral route)

kriz-OH-ti-nib

Commonly used brand name(s)

In the U.S.

  • Xalkori

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Xalkori

Crizotinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer that is caused by a defect in a gene called anaplastic lymphoma kinase (ALK). It is an antineoplastic (cancer) agent. Crizotinib interferes with the growth of cancer cells, which are eventually destroyed by the body.

Slideshow: Flashback: FDA Drug Approvals 2013

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

Before Using Xalkori

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 the pediatric population. 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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.

Interactions with Medicines

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.

  • Amifampridine
  • Atazanavir
  • Boceprevir
  • Cisapride
  • Cobicistat
  • Dronedarone
  • Fluconazole
  • Lomitapide
  • 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.

  • Acebutolol
  • Ado-Trastuzumab Emtansine
  • Alfentanil
  • Alfuzosin
  • Alprazolam
  • Amiodarone
  • Amitriptyline
  • Amprenavir
  • Anagrelide
  • Apixaban
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atenolol
  • Atorvastatin
  • Azithromycin
  • Bedaquiline
  • Bepridil
  • Betaxolol
  • Bisoprolol
  • Bosutinib
  • Brentuximab Vedotin
  • Bromocriptine
  • Buprenorphine
  • Cabazitaxel
  • Cabozantinib
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chloroquine
  • Chlorpromazine
  • Cilostazol
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonidine
  • Clozapine
  • Conivaptan
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Delavirdine
  • Desipramine
  • Dexamethasone
  • Digoxin
  • Dihydroergotamine
  • Diltiazem
  • Disopyramide
  • Docetaxel
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Dutasteride
  • Ebastine
  • Elvitegravir
  • Enzalutamide
  • Ergotamine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Esmolol
  • Estradiol
  • Ethinyl Estradiol
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Fosamprenavir
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydrocodone
  • Hydroquinidine
  • Ibrutinib
  • Ibutilide
  • Iloperidone
  • Imatinib
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Labetalol
  • Lapatinib
  • Letrozole
  • Levobunolol
  • Levofloxacin
  • Losartan
  • Lumefantrine
  • Lurasidone
  • Mefloquine
  • Methadone
  • Metipranolol
  • Metoprolol
  • Mifepristone
  • Mitotane
  • Mizolastine
  • Moxifloxacin
  • Nadolol
  • Nateglinide
  • Nebivolol
  • Nefazodone
  • Nifedipine
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Ospemifene
  • Oxprenolol
  • Oxycodone
  • Paclitaxel
  • Paliperidone
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Penbutolol
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perhexiline
  • Perphenazine
  • Phenobarbital
  • Phenytoin
  • Pindolol
  • Pomalidomide
  • Ponatinib
  • Practolol
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Propranolol
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Regorafenib
  • Rifabutin
  • Rifampin
  • Rilpivirine
  • Risperidone
  • Roflumilast
  • Romidepsin
  • Saxagliptin
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Simeprevir
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telavancin
  • Telithromycin
  • Temsirolimus
  • Terodiline
  • Tetrabenazine
  • Ticagrelor
  • Timolol
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Troleandomycin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vilazodone
  • Vincristine
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zaleplon
  • Zileuton
  • Zolpidem

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.

  • Midazolam

Interactions with Food/Tobacco/Alcohol

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 of Xalkori

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 patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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

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 treatment of non-small cell lung cancer:
      • Adults—250 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
      • Children—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, 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 While Using Xalkori

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

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use an effective form of birth control during therapy and for at least 90 days after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may cause swelling of the lungs (pneumonitis). Pneumonitis is a life-threatening condition and requires immediate medical attention. Check with your doctor right away if you have a cough with or without mucous, shortness of breath, troubled 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 such as QT prolongation.

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, use machines, or do anything else that could be dangerous if you are not able to see well. Check with your doctor if visual changes occur. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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.

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.

Xalkori 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
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • cough or hoarseness
  • difficult or labored breathing
  • ear congestion
  • fever or chills
  • headache
  • increased sensitivity to pain or touch
  • lightheadedness, dizziness, or fainting
  • loss of voice
  • lower back or side pain
  • nerve pain
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • slow or irregular heartbeat
  • sneezing
  • sore throat
  • tightness in the chest
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness in the arms, hands, legs, or feet
Rare
  • Bleeding gums
  • blood in the urine or stools
  • pinpoint red spots on the 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
  • Abdominal or stomach discomfort, pain, or tenderness
  • acid or sour stomach
  • back pain
  • belching
  • change in taste
  • decrease or change in vision
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • difficulty with swallowing
  • heartburn
  • increased sensitivity of the eyes to sunlight
  • indigestion
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pain or burning in the throat
  • pain or discomfort in the chest, upper stomach, or throat
  • problems with balance
  • rash
  • redness, swelling, or soreness of the tongue
  • scaling, redness, burning, pain, chapping, swelling, or other signs of inflammation of the lips
  • seeing flashes or sparks of light
  • swelling or inflammation of the mouth
  • trouble sleeping

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.

See also: Side effects (in more detail)

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