Description
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 also used to treat unresectable (cancer that cannot be removed by surgery), recurrent (cancer that keeps coming back), or refractory (cancer that did not respond to treatment) inflammatory myofibroblastic tumor (IMT) 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:
- Pellet
- 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
- Flibanserin
- Fluconazole
- Ketoconazole
- Levoketoconazole
- 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.
- Abametapir
- Acalabrutinib
- Acebutolol
- Adagrasib
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Asenapine
- Astemizole
- Atenolol
- Avacopan
- Avapritinib
- Axitinib
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Betaxolol
- Bisoprolol
- Boceprevir
- Bosutinib
- Brigatinib
- Buprenorphine
- Buserelin
- Capivasertib
- Carbamazepine
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
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, chew, or split it. You may take this medicine with or without food.
If you are not able to swallow the capsule whole. You may use the oral pellets. Do not chew or crush it, or swallow the shell containing the oral pellets.
To use the oral pellets: Open the shell and empty the contents directly into the mouth. You may also empty the pellets into a medicine cup or dry spoon and then pour them into the mouth. Drink enough water to make sure all oral pellets are swallowed.
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 or pellets):
- 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 1.34 to 1.51 m2—400 mg 2 times a day.
- BSA 1.17 to 1.33 m2—350 mg 2 times a day.
- BSA 0.98 to 1.16 m2—300 mg 2 times a day.
- BSA 0.81 to 0.97 m2—250 mg 2 times a day.
- BSA 0.62 to 0.80 m2—200 mg 2 times a day.
- BSA 0.52 to 0.61 m2—150 mg 2 times a day.
- BSA 0.47 to 0.51 m2—140 mg 2 times a day.
- BSA 0.38 to 0.46 m2—120 mg 2 times a day.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- 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.
- For inflammatory myofibroblastic tumor:
- Adults—250 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- 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 1.34 to 1.51 m2—400 mg 2 times a day.
- BSA 1.17 to 1.33 m2—350 mg 2 times a day.
- BSA 0.98 to 1.16 m2—300 mg 2 times a day.
- BSA 0.81 to 0.97 m2—250 mg 2 times a day.
- BSA 0.62 to 0.80 m2—200 mg 2 times a day.
- BSA 0.52 to 0.61 m2—150 mg 2 times a day.
- BSA 0.47 to 0.51 m2—140 mg 2 times a day.
- BSA 0.38 to 0.46 m2—120 mg 2 times a day.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For non-small cell lung cancer:
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
- Black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred or loss of vision
- body aches or pain
- chest pain, discomfort, or tightness
- chills
- colicky or burning stomach pain
- constipation
- cough
- diarrhea
- difficult or labored breathing
- difficulty in swallowing
- disturbed color perception
- double vision
- ear congestion
- fever
- halos around lights
- headache
- hoarseness
- increased sensitivity to pain or touch
- irregular heartbeat
- lightheadedness, dizziness, or fainting
- loss of appetite
- loss of voice
- lower back or side pain
- nerve pain
- night blindness
- overbright appearance of lights
- pain in the back of throat or chest when swallowing
- pain or burning in the throat
- painful or difficult urination
- pale skin
- rapid weight gain
- recurrent fainting
- runny or stuffy nose
- seeing flashes or sparks of light
- slow or irregular heartbeat
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- swelling
- trouble breathing
- tunnel vision
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- vomiting blood or material that looks like coffee grounds
- weakness in the arms, hands, legs, or feet
Less common
- Anxiety
- blue lips, fingernails, or skin
- clay-colored stools
- confusion
- dark urine
- dry mouth
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- irregular, fast or slow, or shallow breathing
- itching, skin rash
- loss of consciousness
- nausea
- stomach pain or tenderness
- sweating
- swelling of the feet or lower legs
- 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
- Acid or sour stomach
- back pain
- belching
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- heartburn
- increased weight
- indigestion
- loss of taste
- muscle spasm or weakness
- pain in the arms or legs
- stomach discomfort or upset
- trouble in walking
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Rare
- Increased sensitivity of the skin to sunlight
- redness or discoloration of the skin
- 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.
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