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DIN (Drug Identification Number)
02384264 XALKORI 250MG CAPSULE
02384256 XALKORI 200MG CAPSULE
How does this medication work? What will it do for me?
Crizotinib belongs to the group of cancer-fighting medications known as antineoplastics and more specifically to a class of medications called tyrosine kinase inhibitors. These medications slow the growth of blood vessels that feed nutrients to cancer cells. By slowing the growth of these blood vessels, crizotinib can help reduce the size of tumours.
Crizotinib is used to treat a certain type of non-small-cell lung cancer caused by a defect in a gene called ALK (anaplastic lymphoma kinase) or ROS1 and that cannot be cured by surgical removal, or has spread to other parts of the body.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
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 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.
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 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.
How should I use this medication?
The usual recommended dose of crizotinib is 250 mg taken by mouth 2 times daily. Your doctor may adjust your dose depending on how you tolerate crizotinib. Swallow the capsules whole – do not crush, dissolve, or open the capsules. Crizotinib can be taken with or without food. Do not take crizotinib with grapefruit, starfruit, pomegranate, Seville oranges, or other similar fruits, since they may interact with 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 this medication 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 this medication 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.
Who should NOT take this medication?
- are allergic to crizotinib or any ingredients of the medication
- have congenital (present at birth) long QT syndrome
Do not use crizotinib if you:
What side effects are possible with this medication?
- back or joint pain
- change of taste
- decreased appetite
- mouth ulcers
- pain in hands, feet, arms, and legs
- shortness of breath
- swelling of the hands and feet
- symptoms of neuropathy (e.g., numbness, prickling or tingling, burning, freezing, throbbing or shooting pain)
- trouble sleeping
- upset stomach
- chest pain
- heart rhythm abnormality (e.g., dizziness, fainting, or chest discomfort)
- low blood pressure
- more frequent infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, sinus pain, sore throat, losing voice, or listlessness)
- slow heart rate
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)
- symptoms of kidney problems (e.g., pain in the back or side, blood in the urine)
- symptoms of lung infection (e.g., fever, chills, shortness of breath, cough)
- symptoms of liver problems (e.g., feeling more tired than usual, decreased appetite, yellowing of the skin or whites of the eyes, stomach pain, dark urine, nausea, vomiting, itching, or bleeding or bruising more easily than normal)
- symptoms of lung infection or inflammation (e.g., difficulty breathing, cough, or fever)
- vision changes (e.g., blurred vision, flashes of light, double vision)
- partial or complete loss of vision in one or both eyes
- signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
- 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
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 this medication.
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with crizotinib. You are more at risk for this type of abnormal heart rhythm and its complications if you:
If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Blood clots: 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Eye problems: You may experience vision disturbances such as flashes of light, blurry vision, "floaters", and double vision. Tell your doctor if you experience any of these symptoms. Do not drive or operate other machinery until you know that this medication does not affect your ability to perform these activities safely. Rarely, patients taking this medication have reported vision loss. If you notice any vision loss in one or both eyes, contact your doctor immediately.
Fatigue and dizziness: Crizotinib can cause fatigue and dizziness. Do not drive or operate machinery until you know that this medication does not affect your ability to perform these activities safely.
Heart problems: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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.
Infection: Crizotinib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Kidney problems: Decreased kidney function may cause this medication to build up in the body, causing side effects. If you have severe kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Decreased liver function or liver disease can cause this medication to build up in the body, causing increased side effects. Crizotinib may also 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 this medication. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication. 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 crizotinib, contact your doctor immediately.
Nerve problems: People taking this medication 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: This medication 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 this medication, contact your doctor immediately.
Male and female fertility may be affected by treatment with crizotinib. Discuss any concerns you have with your doctor.
Breast-feeding: It is not known if crizotinib passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Due to the potential for serious harm to a baby if they are exposed to this medication, breast-feeding mothers are advised not use this medication. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.
What other drugs could interact with this medication?
- alpha-agonists (e.g., clonidine, methyldopa)
- alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
- antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, lidocaine, quinidine, procainamide, propafenone, sotalol)
- anti-cancer medications (e.g., apalutamide, cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
- antimalarials (e.g., quinine, chloroquine, mefloquine, primaquine, praziquantel)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., itraconazole, ketoconazole, posaconazole, voriconazole)
- benzodiazepines (e.g., chlordiazepoxide, clonazepam, diazepam, lorazepam, triazolam)
- beta-2 agonists (e.g., formoterol, indacaterol, salmeterol)
- beta-blockers (e.g., metoprolol, propranolol, atenolol)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- corticosteroids (e.g., budesonide, fluticasone, dexamethasone, hydrocortisone, prednisone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
- other protein kinase inhibitors (e.g., bosutinib, dabrafenib, dasatinib, nilotinib, pazopanib, sunitinib)
- phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, norfloxacin)
- St. John's wort
- seizure medications (e.g., carbamazepine, gabapentin, lacosamide, levetiracetam, phenobarbital, phenytoin, primidone, topiramate)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
- "statin" anticholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- "triptan" migraine medications (e.g., eletriptan, sumatriptan)
- 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.
There may be an interaction between crizotinib and any of the following:
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:
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 this medication. 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.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Xalkori
All material © 1996-2021 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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