200 mg and 250 mg hard capsules
crizotinib
What XALKORI is and what it is used for
XALKORI is a medicine against cancer. It contains the active substance crizotinib, which is used to treat adults with a type of lung cancer called non-small cell lung cancer, which has a specific change or defect in either a gene called anaplastic lymphoma kinase ( ALK ) or a gene called ROS1.
The doctor may prescribe XALKORI as initial treatment if your lung cancer is in an advanced stage of the disease.
The doctor can prescribe XALKORI if your disease is advanced and previous treatment has not been sufficient to control your disease.
XALKORI can delay or stop the growth of lung cancer. It can help reduce tumor size.
XALKORI is used to treat children and adolescents (aged 6 years to less than 18 years) with a type of tumor called anaplastic large cell lymphoma (ALCL) or a type of tumor called an inflammatory myofibroblastic tumor (IMT). In IMT, there is a specific change or defect in a gene called anaplastic lymphoma kinase (ALK).
XALKORI can be prescribed to children and adolescents for the treatment of ALCL if previous treatment has not been sufficient to stop the disease.
XALKORI can be prescribed to children and adolescents for the treatment of IMT if surgery has not been sufficient to stop the disease.
Only a doctor experienced in cancer treatment should give you this medicine and monitor your treatment. If you have any questions about how XALKORI works or why it has been prescribed for you, ask your doctor.
3 What you need to know before you use XALKORI
Do not use XALKORI
- if you are allergic to crizotinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking XALKORI:
- if you have moderate or severe liver disease.
- if you have ever had other lung problems. Some lung problems may get worse during treatment with XALKORI, as XALKORI can cause inflammation of the lungs during treatment. The symptoms can be similar to those of lung cancer. Tell your doctor right away if you develop new or worsening symptoms, including difficulty breathing, shortness of breath, or cough with or without mucus or fever.
- if you have been told that you have an abnormal ECG curve, a so-called prolonged QT interval.
- if you have decreased heart rate.
- if you have ever had gastrointestinal problems such as a hole in the stomach or intestine ( perforation ) or if you have a disease that causes inflammation in the abdomen ( diverticulitis ) or if you have spread of cancer in the abdomen ( metastases er).
- if you have visual disturbances (flashes of light, blurred vision, or double vision).
- if you have severe kidney disease.
- if you are currently being treated with any of the medicines listed in the section “Other medicines and XALKORI”.
Talk to your doctor if any of the above apply to you.
Talk to your doctor immediately after taking XALKORI:
- If you experience severe stomach pains, fever, chills, shortness of breath, high heart rate, or lose sight completely or partially (in one or both eyes).
Most of the available information concerns adult patients with a specific histological type of ALK-positive or ROS1-positive NSCLC ( adenocarcinoma ). Limited information is available on other histologies.
Children and young people
Treatment for non-small cell lung cancer does not include children and adolescents. Do not give this medicine to children under 6 years of age with ALK-positive ALCL or ALK-positive IMT. In the case of children and adolescents, their ability to swallow whole capsules should be assessed before prescribing XALKORI. XALKORI should be given to children and adolescents under the supervision of an adult.
Other medicines and XALKORI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal and non-prescription medicines.
The following medicines in particular may increase the risk of side effects from XALKORI:
- Clarithromycin, telithromycin, and erythromycin, are antibiotics for bacterial infections.
- Ketoconazole , itraconazole, posaconazole and voriconazole, which are used against fungal infections.
- Atazanavir, ritonavir, and cobicistat, are used to treat HIV infections/AIDS.
The following medicines may reduce the effect of XALKORI:
- Phenytoin, carbamazepine, and phenobarbital, are anti-epileptic drugs used to treat seizures.
- Rifabutin and rifampicin, are used against tuberculosis.
- St. John’s wort ( Hypericum perforatum ), is a natural remedy for mild depression and mild anxiety.
XALKORI may increase the side effects associated with the following medicines:
- Alfentanil and other short-acting opiates such as fentanyl (pain reliever used in surgery).
- Quinidine , digoxin , disopyramide , amiodarone , sotalol, dofetilide, ibutilide, verapamil, and diltiazem , used to treat heart problems.
- Medicines for high blood pressure are called beta blockers, eg atenolol, propranolol, labetalol.
- Pimozide, is used to treat mental illnesses.
- Metformin, which is used to treat diabetes.
- Procainamide is used to treat heart arrhythmia.
- Cisapride is used to treat stomach problems.
- Cyclosporine, sirolimus, and tacrolimus, are used in transplants.
- Ergot alkaloids (eg, ergotamine, dihydroergotamine), are used to treat migraines.
- Dabigatran, is a medicine that makes the blood clot more slowly.
- Colchicine is used to treat gout.
- Pravastatin, is used to lower cholesterol levels.
- Clonidine and guanfacine are used to treat high blood pressure.
- Mefloquine is used to prevent malaria.
- Pilocarpine is used to treat glaucoma (a serious eye disease).
- Anticholinesterases, are used to restore muscle function.
- Antipsychotics are used to treat mental illnesses.
- Moxifloxacin is used to treat bacterial infections.
- Methadone, is used as a pain reliever and to treat opioid addiction.
- Bupropion, which is used to treat depression and in smoking cessation.
- Efavirenz, raltegravir, is used to treat HIV infection.
- Irinotecan is, a chemotherapy drug used to treat cancer of the colon and rectum.
- Morphine is used to treat acute pain and pain associated with cancer.
- Naloxone, is used to treat drug addiction and withdrawal problems from opioid therapy.
These medicines should be avoided when you are treated with XALKORI.
Birth control pills
If you take XALKORI while using birth control pills, the birth control pills may become ineffective.
XALKORI with food, drinks, and alcohol
You can take XALKORI with or without food. However, you should avoid drinking grapefruit juice or eating grapefruit while being treated with XALKORI as these may change the amount of XALKORI in your body.
Sun protection
Avoid staying in the sun for a long time. XALKORI can make your skin more sensitive to sunlight (photosensitization) and you can burn more easily. Wear protective clothing and/or use sunscreen that covers the skin to protect against sunburn if you need to stay in the sun during treatment with XALKORI.
Pregnancy, breastfeeding, and fertility
Consult a doctor or pharmacist before taking this medicine if you are pregnant, could become pregnant, or are breastfeeding.
Women taking XALKORI are advised not to become pregnant and men taking the medicine are advised not to make women pregnant as this medicine may cause harm to the baby. If there is any risk that the person taking this medicine could become pregnant or make a woman pregnant, they must use adequate contraception during treatment and for at least 90 days after the end of treatment as birth control pills may be ineffective while taking XALKORI.
Do not breastfeed while being treated with XALKORI. XALKORI can harm a breastfed baby.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
You should be especially careful when driving or using machinery as patients treated with XALKORI may experience visual disturbances, dizziness, or fatigue.
XALKORI contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 200 mg or 250 mg capsule, i.e. it is almost “sodium-free”.
How to use XALKORI
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The recommended dose for adults with NSCLC is one 250 mg capsule to be swallowed twice daily (total dose 500 mg).
- The recommended dose for children and adolescents with ALK-positive ALCL or ALK-positive IMT is 280 mg/m 2. It should be taken by mouth twice daily. The recommended amount is calculated by the child’s doctor and depends on the child’s body surface area. The maximum daily amount for children and adolescents should not exceed 1,000 mg. XALKORI should be given under the supervision of an adult.
- Take the recommended dose once in the morning and once in the evening.
- Take the capsules at about the same time each day.
- You can take the capsules with or without food but always avoid grapefruit.
- Swallow the capsules whole. They must not be crushed, dissolved, or opened.
If necessary, the doctor may decide to lower the dose taken by mouth. The doctor may decide to stop treatment with XALKORI permanently if you cannot tolerate XALKORI.
If you use too much XALKORI
If you accidentally take too many capsules, tell your doctor or pharmacist immediately. You may need medical attention.
If you forget to use XALKORI
What to do if you have forgotten to take a capsule depends on how long it is until the next dose.
- If you are due to take the next dose in 6 hours or longer, take the forgotten capsule as soon as you remember. Then take the next capsule at the usual time.
- If you are due to take the next dose in less than 6 hours, skip the missed capsule. Then take the next capsule at the usual time.
Tell your doctor at your next visit about the missed dose.
Do not take a double dose (two capsules at the same time) to make up for the missed dose.
If you vomit after taking a dose of XALKORI, do not take an extra dose: just take the next dose at the usual time.
If you stop using XALKORI
You must take XALKORI every day for as long as your doctor prescribes it. If you cannot take medicine as prescribed by the doctor or feel that you no longer need it, contact the doctor immediately.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information.
In children and adolescents with ALCL or IMT, not all side effects seen in adults with NSCLC have been seen. However, for children and adolescents with ALCL or IMT, the same side effects must still be taken into account as in adult patients with lung cancer.
Some side effects can be serious. Contact your doctor immediately if you experience any of the following serious side effects (see also section 2 “What you need to know before you take XALKORI”):
- Liver failure
Tell your doctor immediately if you feel more tired than usual, your skin and the whites of your eyes turn yellow, your urine becomes dark or brown (tea-colored), you feel sick, are vomiting or have a decreased appetite, you have pain on the right side of your abdomen, you have itching or bruising more easily than usual. The doctor may take blood tests to check the function of the liver and if the results are not normal, the doctor may decide to lower the XALKORI dose or stop the treatment.
- Pneumonia
Tell the doctor immediately if you experience difficulty breathing, especially if you also develop a cough or fever.
- Decreased number of white blood cells (including neutrophils )
Tell the doctor immediately if you develop a fever or an infection. The doctor may take a blood test and if the results are not normal, the doctor may decide to lower the XALKORI dose.
- Unsteadiness/dizziness, fainting, or chest discomfort
Tell your doctor immediately if you get any of these symptoms. They can be signs of changes in the electrical activity of the heart (can be seen on the EKG ) or abnormal heart rhythm. The doctor may take an EKG to check that there are no problems with the heart while you are being treated with XALKORI.
- Complete or partial loss of vision in one or both eyes
Tell your doctor immediately if you develop new vision problems, lose vision, or experience any other vision changes, such as difficulty seeing in one or both eyes. The doctor interrupts or possibly pauses the treatment with XALKORI and refers you to an ophthalmologist.
For children and adolescents taking XALKORI to treat ALK-positive ALCL or ALK-positive IMT: Your doctor should refer you to an ophthalmologist before you start XALKORI and within 1 month of starting XALKORI to check for any vision problems. During treatment with XALKORI, you should have an eye examination every three months, and more often if you have new vision problems.
- Severe gastrointestinal problems in children and adolescents with ALK-positive ALCL or ALK-positive IMT
XALKORI can cause severe diarrhea, severe nausea, or severe vomiting. Tell your doctor immediately if you have trouble swallowing, vomiting, or diarrhea during treatment with XALKORI. If necessary, the doctor can give you medicine to prevent or treat diarrhea, nausea, and vomiting. The doctor may advise you to drink more fluids or prescribe electrolyte supplements or other types of nutritional support if you experience severe symptoms.
Other side effects of XALKORI in adults with NSCLC may include:
Very common side effects ( may affect more than 1 in 10 users)
- Visual disturbances (you see flashes of light, get blurred vision, become sensitive to light, get spots in the field of vision, or see double, which often occurs soon after starting treatment with XALKORI).
- Constipation such as vomiting, diarrhea, and nausea.
- Edema (accumulation of fluid in the body’s tissue causing swollen hands and feet).
- Constipation.
- Abnormal changes in liver values in blood tests.
- Decreased appetite.
- Fatigue.
- Dizziness.
- Neuropathy (numbness or tingling in joints or arms/legs).
- Changed taste experience.
- Pain in the abdomen
- Decreased number of red blood cells ( anemia ).
- Rash.
- Decreased heart rate.
Common side effects ( may affect up to 1 in 10 users)
- Indigestion.
- Increased levels of creatinine in the blood (may indicate that the kidneys are not working properly).
- Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or damage, especially the liver, pancreas, bones, thyroid, or gallbladder).
- Low levels of phosphate in the blood ( hypophosphatemia ), can cause confusion or muscle weakness.
- Closed, fluid-filled cavities inside the kidneys (complex renal cysts).
- Fainting.
- Inflammation of the esophagus.
- Decreased amount of testosterone, a male sex hormone.
- Heart failure.
Uncommon side effects ( may affect up to 1 in 100 users):
- Hole ( perforation ) in the stomach or intestine.
- Sensitivity to sunlight (photosensitization).
- Elevated blood levels in tests to check for muscle damage (high levels of creatine phosphokinase).
Other side effects of XALKORI in children and adolescents with ALK-positive ALCL or ALK-positive IMT may be:
Very common side effects ( may affect more than 1 in 10 users)
- Abnormal changes in liver values in blood tests.
- Visual disturbances (you see flashes of light, get blurred vision, become sensitive to light, get spots in the field of vision, or see double, which often occurs soon after starting treatment with XALKORI).
- Pain in the abdomen.
- Increased levels of creatinine in the blood (may indicate that the kidneys are not working properly).
- Anemia (reduced number of red blood cells ).
- Low platelet counts in blood tests (may increase the risk of bleeding and bruising).
- Fatigue.
- Decreased appetite.
- Constipation.
- Edema (accumulation of fluid in the body’s tissue causing swollen hands and feet).
- Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or damage, especially the liver, pancreas, bones, thyroid, or gallbladder).
- Neuropathy (numbness or tingling in joints or arms/legs).
- Dizziness.
- Indigestion.
- Changed taste experience.
- Low levels of phosphate in the blood ( hypophosphatemia ), can cause confusion or muscle weakness.
Common side effects ( may affect up to 1 in 10 users)
- Rash.
- Inflammation of the esophagus.
How to store XALKORI
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the can or blister card and carton after “EXP”. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use a package that is damaged or appears to have been tampered with.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in XALKORI is crizotinib.
XALKORI 200 mg: Each hard capsule contains 200 mg of crizotinib
XALKORI 250 mg: Each hard capsule contains 250 mg of crizotinib
- Other ingredients are (see also section 2 “XALKORI contains sodium”):
Capsule contents: colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (type A), and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172).
Printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Appearance and package sizes of the medicine
XALKORI 200 mg is available as hard gelatin capsules with pink cap and white caps, marked with “Pfizer” on cap and “CRZ 200” on the cap in black.
XALKORI 250 mg is available as hard gelatin capsules with a pink cap and body, marked with “Pfizer” on the cap and “CRZ 250” on the body in black.
They are available in blister packs of 60 hard capsules and plastic cans of 60 hard capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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