To be eligible for this treatment, your lung cancer must be positive for the anaplastic lymphoma kinase (ALK) or ROS-1 mutation, and the lymphoma must be positive for ALK mutation.
Xalkori is a tyrosine kinase inhibitor that suppresses tumor cell growth or survival by blocking the activity of certain receptors, such as ALK and ROS-1. It’s available in capsule form to be taken by mouth.
What Is Xalkori Used For?
Xalkori is a targeted therapy used to treat:
Brand Name(s): Xalkori
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Kinase inhibitor
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Crizotinib
Dosage Form(s): Capsules
Metastatic NSCLC or NSCLC that has spread to other body parts and has either an ALK or ROS-1 mutation Anaplastic large cell lymphoma (ALCL) with an ALK mutation that is relapsed and refractory (meaning the lymphoma has returned following initial treatment) in young adults and children one year and older ALK-positive unresectable, recurrent, or refractory inflammatory myofibroblastic tumor in adults and children 1 and older
Special tests called genomic testing are performed on the cancer cells to find these mutations. Specialized laboratories do this testing.
How to Take Xalkori
Before starting treatment, read the prescription label and patient information leaflet provided to you with your medication. Talk to your healthcare provider or pharmacist if you have any questions.
Xalkori is dispensed in capsule forms meant to be swallowed whole. You can take them with or without food. However, do not consume grapefruit or grapefruit products when taking them, including supplements that contain grapefruit extract. Grapefruit can increase the amount of drug in the body, potentially causing side effects.
Children should only take Xalkori under adult supervision.
Storage
Keep Xalkori at room temperature (between 68 F and 77 F) and in its original packaging. Do not store it in the bathroom. It should also be kept out of reach of children and pets to prevent accidental consumption.
What Are the Side Effects of Xalkori?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider or a pharmacist. You may report side effects to the Food and Drug Administration (FDA) at www.fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Side effects of Xalkori may be slightly different when taken for lung cancer versus being taken for lymphoma. The most common side effects, when taken for NSCLC, include:
Gastrointestinal (GI) upset, including nausea, vomiting, or diarrhea Vision changes Swelling to the face, hands, or feet (peripheral edema) Constipation Changes in liver tests Feeling tired Numbness/tingling to the arms or legs Decreased appetite Dizziness Upper respiratory infection
The most common side effects of Xalkori when it’s taken for lymphoma include the list above but also:
Itching skin Headache Fever Mouth sores Abdominal pain Cough Low blood counts Abdominal pain Abnormal kidney tests Changes in blood sugar levels Muscle or joint pain
If you have nausea when taking crizotinib, taking your dose with food may be helpful. Crizotinib-related diarrhea can be managed with standard measures, such as antidiarrheal medications, dietary changes, and hydration. Your healthcare team can provide more guidance on strategies for managing these side effects.
Although GI effects with crizotinib are common, they tend to improve over time.
Severe Side Effects
Call your healthcare provider immediately if you have serious side effects. Dial 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
Decreased white blood cells, platelets, and hemoglobin Pneumonitis (inflammation of the lungs), which can cause shortness of breath, cough, and wheezing Vision disorders, including blurred vision and vision impairment Bradycardia (low heart rate), which can cause chest pain, shortness of breath, easy fatigue, lightheadedness, or dizziness, and shortness of breath
Long-Term Side Effects
Xalkori has the potential to cause infertility in both men and women. Talk to your healthcare provider if this is a concern for you.
Dosage: How Much Xalkori Should I Take?
Modifications
You may need a dose adjustment if you experience severe side effects or have abnormal blood test results. Typically, your healthcare provider will hold your treatment with Xalkori until any side effects improve before resuming it at a lower dose.
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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 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. 17 to 1. 51 m2—400 mg 2 times a day. BSA 0. 81 to 1. 16 m2—250 mg 2 times a day. BSA 0. 60 to 0. 80 m2—200 mg 2 times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor. 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. 17 to 1. 51 m2—400 mg 2 times a day. BSA 0. 81 to 1. 16 m2—250 mg 2 times a day. BSA 0. 60 to 0. 80 m2—200 mg 2 times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor.
Routine bloodwork monitoring, including tests to evaluate complete blood count (CBC), kidney function, and liver function, is recommended throughout therapy.
If there is any pre-existing liver or kidney dysfunction, your healthcare provider may start you at a lower dose of Xalkori.
Missed Dose
If you miss a dose, take it as soon as you remember unless it’s within six hours of the next dose. In that case, skip the missed dose and resume your regular dosing schedule. Never double up the medication to make up for a missed dose.
Overdose: What Happens If I Take Too Much Xalkori?
Notify your healthcare team immediately if you take more Xalkori than prescribed. Depending on how much was taken, they may want to keep an eye on things such as lab tests and heart rhythm to ensure everything is OK.
Precautions
What Are Reasons I Shouldn’t Take Xalkori?
Do not take Xalkori if you are allergic to it or its ingredients. You should not take Xalkori during pregnancy or if you are breastfeeding.
If someone collapses or isn’t breathing after taking Xalkori, call 911 immediately.
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.
What Other Medications Interact With Xalkori?
Other medications and substances can interact with Xalkori. Before starting treatment, talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC) products, prescription drugs, vitamins, herbs, or plant-based medicines.
Some of the medications that should be avoided when taking Xalkori due to potential interactions include:
Biaxin XL (clarithromycin) Ketoconazole Sporanox (itraconazole) (avoid using Xalkori during and for two weeks after stopping itraconazole) Phenobarbital Dilantin (phenytoin) Rifampin Beta-blockers, such as atenolol, bisoprolol, and Coreg (carvedilol) Digoxin
Other interactions may occur. Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Xalkori.
What Medications Are Similar?
Other targeted medications that treat ALK+ metastatic lung cancer are available. These medications include:
Zykadia (ceritinib)Alecensa (alectinib)Alunbrig (brigatinib)Lobrena (lorlatinib)
These medications should not be taken along with Xalkori.
How Can I Stay Healthy While Taking Xalkori?
Xalkori can be an important medication to help treat your cancer. It’s essential to take Xalkori as prescribed. If you experience any side effects, notify your healthcare provider to discuss how to treat them. Don’t be afraid to report side effects out of fear your medication may be discontinued, especially if it is helping to treat your cancer. Sometimes a dose reduction is needed to manage side effects while you continue treatment.
