Xalkori

The usual recommended dose of Xalkori (Crizotinib) is 250 mg taken by mouth 2 times daily. Your doctor may adjust your dose depending on how you tolerate Xalkori (Crizotinib). Swallow the capsules whole – do not crush, dissolve, or open the capsules. Xalkori (Crizotinib) can be taken with or without food. Do not take Xalkori (Crizotinib) with grapefruit, starfruit, pomegranate, Seville oranges, or other similar fruits, since they may interact with Xalkori (Crizotinib).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Xalkori (Crizotinib) be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as you remember. If it is less than 6 hours until the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Xalkori (Crizotinib) at room temperature (between 15°C and 30°C) and keep it out of the reach of children. Do not touch a crushed or broken capsule.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

200 mg
Each hard gelatin capsule, size 0, white opaque/pink opaque, with "Pfizer" on the cap and "CRZ 200" on the body, contains 200 mg of Xalkori (Crizotinib). Nonmedicinal ingredients: colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, and hard gelatin capsule shells. The pink opaque capsule shell contains gelatin, titanium dioxide, and red iron oxide. The white opaque gelatin shell contains gelatin and titanium dioxide. The printing ink contains shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.

250 mg
Each hard gelatin capsule, size 0, pink opaque/pink opaque, with "Pfizer" on the cap and "CRZ 250" on the body, contains 250 mg of Xalkori (Crizotinib). Nonmedicinal ingredients: colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, and hard gelatin capsule shells. The pink opaque capsule shell contains gelatin, titanium dioxide, and red iron oxide. The printing ink contains shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.

Do not use Xalkori (Crizotinib) if you:

• are allergic to Xalkori (Crizotinib) or any ingredients of the medication
• have congenital (present at birth) long QT syndrome

There may be an interaction between Xalkori (Crizotinib) and any of the following:

• Abiraterone
• alfentanil
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• amantadine
• Amiodarone
• Anagrelide
• antiarrhythmics (e.g., amiodarone, quinidine, procainamide, Propafenone, sotalol)
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antimalarials (e.g., quinine, chloroquine)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., Phenobarbital, secobarbital)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• beta-2 agonists (e.g., formoterol, salmeterol)
• beta-blockers (e.g., Metoprolol, Propranolol, Atenolol)
• Bicalutamide
• boceprevir
• Bosentan
• Bromocriptine
• budesonide
• Buprenorphine
• Bupropion
• Buspirone
• Busulfan
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• chloral hydrate
• cilostazol
• Cimetidine
• Cinacalcet
• Clonidine
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Dantrolene
• Dapsone
• Darifenacin
• Dasatinib
• Deferasirox
• Digoxin
• Dipyridamole
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dofetilide
• Domperidone
• dronabinol
• Dronedarone
• Enzalutamide
• Eplerenone
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Ethosuximide
• Everolimus
• Famotidine
• Fentanyl
• Fingolimod
• Flecainide
• Flutamide
• formoterol
• fusidic acid
• Galantamine
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• Goserelin
• Guanfacine
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• indacterol
• Ivacaftor
• lithium
• Loperamide
• macrolide antibiotics (e.g., clarithromycin, erythromycin,)
• Maprotiline
• maraviroc
• mestranol
• Methadone
• Metoclopramide
• Metronidazole
• mifepristone
• Mirabegron
• Mirtazapine
• Modafinil
• Montelukast
• Nabilone
• narcotic pain relievers (e.g., Codeine, fentanyl, Morphine, Oxycodone)
• Nateglinide
• nefazodone
• Nilotinib
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Octreotide
• other tyrosine kinase inhibitors (e.g., Bosutinib, Sunitinib)
• Pazopanib
• pentamidine
• Perampanel
• Phenytoin
• Pimecrolimus
• pimozide
• praziquantel
• primidone
• Primaquine
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Prucalopride
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, Norfloxacin)
• Ranitidine
• Repaglinide
• rifabutin
• rifampin
• Riociguat
• Rivaroxaban
• Romidepsin
• salmeterol
• Selegiline
• simeprevir
• St. John's wort
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, phenytoin, Topiramate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Sildenafil
• Sirolimus
• "statin" anticholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfamethoxazole
• tacrolimus
• Tamoxifen
• telaprevir
• Temsirolimus
• Tetrabenazine
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Trimethoprim
• "triptan" migraine medications (e.g., Eletriptan, Sumatriptan)
• Ulipristal
• Vardenafil
• Venlafaxine
• vilanterol
• Warfarin
• Zopiclone
• Zolpidem

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xalkori (Crizotinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xalkori (Crizotinib).

Abnormal heart rhythms: Xalkori (Crizotinib) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, , Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Xalkori (Crizotinib). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Xalkori (Crizotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalkori (Crizotinib), and whether any special monitoring is needed.

Blood Clots: Xalkori (Crizotinib) may cause formation of blood clots in the legs (deep vein thrombosis) that can move to the lungs (pulmonary Embolism). Blood clots can also cause a Heart Attack or a stroke. Contact your doctor as soon as possible if you have pain, redness, or swelling in your legs. If you develop chest pain and shortness of breath, seek immediate medical attention. Also seek immediate medical attention if you have sudden headache, dizziness, problems speaking, vision problems, or numbness or weakness, even if they are temporary. If you have had a blood clot in the past, discuss with your doctor how Xalkori (Crizotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalkori (Crizotinib), and whether any special monitoring is needed.

Eye problems: You may experience vision disturbances such as flashes of light, blurry vision, and double vision. Tell your doctor if you experience any of these symptoms. Do not drive or operate other machinery until you know that Xalkori (Crizotinib) does not affect your ability to perform these activities safely. There have been rare repots of vison loss in patients taking Xalkori (Crizotinib). If you notice any vision loss in one or both eyes, contact your doctor immediately.

Fatigue and dizziness: Xalkori (Crizotinib) can cause fatigue and dizziness. Do not drive or operate machinery until you know that Xalkori (Crizotinib) does not affect your ability to perform these activities safely.

Heart problems: Xalkori (Crizotinib) can slow heart rate and decrease blood pressure. It can also decrease heart function, which may lead to heart failure or worsen symptoms of heart disease. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Xalkori (Crizotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalkori (Crizotinib), and whether any special monitoring is needed. If you experience symptoms of heart failure such as unusual tiredness, shortness of breath, or swelling of the feet and ankles, contact your doctor.

Kidney problems: If you have severe kidney problems, discuss with your doctor how Xalkori (Crizotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalkori (Crizotinib), and whether any special monitoring is needed.

Liver function: Xalkori (Crizotinib) may reduce liver function and can cause liver problems that can be severe. Your doctor will monitor your liver function with blood tests while you are taking Xalkori (Crizotinib). If you have liver problems, discuss with your doctor how Xalkori (Crizotinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xalkori (Crizotinib), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Xalkori (Crizotinib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Xalkori (Crizotinib), contact your doctor immediately.

Nerve problems: People taking Xalkori (Crizotinib) may experience symptoms of neuropathy (nerve damage) such as numbness, prickling or tingling, burning, freezing, and throbbing or shooting pain. Tell your doctor if you experience any of these symptoms.

Pregnancy: Xalkori (Crizotinib) should not be used during pregnancy. Both men and women should use effective birth control (e.g., condoms, birth control pill) during treatment and for at least 90 days after treatment is finished. If you or your partner become pregnant while taking Xalkori (Crizotinib), contact your doctor immediately.

Male and female fertility may be affected by treatment with crizotinb. Discuss any concerns you have with your doctor.

Breast-feeding: It is not known if Xalkori (Crizotinib) passes into breast milk. If you are a breast-feeding mother and are taking Xalkori (Crizotinib), it may affect your baby. Due to the potential for serious harm to a baby if they are exposed to Xalkori (Crizotinib), breast-feeding mothers are advised not use Xalkori (Crizotinib). Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Xalkori (Crizotinib) have not been established for children less than 18 years of age.