Generic Name: crizotinib (Oral route)
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Tyrosine Kinase Inhibitor
Uses For Xalkori
Crizotinib is used to treat advanced or metastatic (lung cancer that has already spread) non-small cell lung cancer or NSCLC that is caused by a defect in gene called anaplastic lymphoma kinase (ALK).
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of crizotinib in the elderly.
|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.|
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.
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.
- Arsenic Trioxide
- Eslicarbazepine Acetate
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
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.
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:
- Congestive heart failure or
- Heart rhythm problems (e.g., QT prolongation) or
- Mineral imbalance or
- Slow heartbeat—Use with caution. Your doctor may want to monitor you more closely.
- Heart rhythm problems (e.g., congenital long QT syndrome)—Should not be used in patients with this condition.
- 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 break, crush, chew, or open it.
You may take this medicine with or without food.
You may also receive medicines to help prevent nausea and vomiting.
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 advanced or metastatic non-small cell lung cancer:
- Adults—250 milligrams (mg) two times a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of advanced or metastatic non-small cell lung cancer:
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 or forget to use your medicine, use it as soon as you can. If your next regular dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the capsules in the original container.
Precautions While Using Xalkori
It is very important that your doctor check your progress at regular visits to make sure that 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. Use an effective form of birth control to keep from getting pregnant. 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). Pneumonitis is a life-threatening condition and requires immediate medical attention. Stop using this medicine and 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.
This medicine can cause changes in the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
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 (e.g., 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 these visual changes occur. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Do not stop or change your dose without first checking with your doctor.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this 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 (e.g., 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
- increased sensitivity to pain or touch
- lightheadedness, dizziness, or fainting
- loss of voice
- lower back or side pain
- nasal congestion
- nerve pain
- painful or difficult urination
- pale skin
- rapid weight gain
- runny or stuffy nose
- shortness of breath
- slow or irregular heartbeat
- sore throat
- tightness in the chest
- tingling in the hands and feet
- 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
- 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
- blurred vision
- change in color vision
- change in taste
- chapped, red, or swollen lips
- decrease or change in vision
- decreased appetite
- difficulty having a bowel movement (stool)
- difficulty seeing at night
- difficulty with moving
- difficulty with swallowing
- double vision
- increased sensitivity of the eyes to sunlight
- loss of taste
- muscle pain or stiffness
- pain in the joints
- pain or burning in the throat
- pain or discomfort in the chest, upper stomach, or throat
- problems with balance
- redness, swelling, or soreness of the tongue
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- seeing double
- seeing flashes or sparks of light
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- swelling or inflammation of the mouth
- trouble with sleeping
- unable to sleep
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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