Xalkori 50 mg granulado en capsulas para abrir

Label: information for the user

XALKORI 20mg granulated powder in capsules to be opened

XALKORI 50mg granulated powder in capsules to be opened

XALKORI 150mg granulated powder in capsules to be opened

crizotinib

The words “you” and “your” are used to refer to both the patient and the pediatric patient's caregiver.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

1. What is XALKORI and what it is used for

2. What you need to know before starting to take XALKORI

3. How to administer XALKORI granulated powder in capsules to be opened

4. Possible adverse effects

5. Storage of XALKORI

6. Contents of the package and additional information

7. Instructions for use

XALKORI is a cancer medication, which contains crizotinib as the active ingredient, used to treat adults with a type of lung cancer called non-microcitic lung cancer, which has a certain alteration or defect in a gene called anaplastic lymphoma kinase (ALK) or in a gene called ROS1.

XALKORI is used to treat children and adolescents (from ≥ 1 to < 18 years of age) with a type of tumor called anaplastic large cell lymphoma (LACG) or a type of tumor called inflammatory myofibroblastic tumor (TMI) that presents with a specific rearrangement or defect in a gene called anaplastic lymphoma kinase (ALK).

XALKORI may be prescribed to children and adolescents to treat LACG if previous treatment has not helped to stop the disease.

XALKORI may be prescribed to children and adolescents to treat TMI if surgical treatment has not helped to stop the disease.

This medication should only be received under the supervision of a doctor with experience in cancer treatment. If you have any doubts about how XALKORI works or why it has been prescribed to you, consult your doctor.

Do not take XALKORI

• If you are allergic to crizotinib or any of the other components of this medication (listed in section 6, “Composition of XALKORI”).

Warnings and precautions

Consult your doctor before starting to take XALKORI:

• If you have a moderate or severe liver disease.

• If you have ever had any lung problems. Some lung problems may worsen during treatment with XALKORI, as XALKORI may cause lung inflammation during treatment. Consult your doctor immediately if you have a new symptom or if any of your symptoms worsen, including difficulty breathing, shortness of breath, or cough with or without mucus, or fever.

• If, after an electrocardiogram (ECG), you have been informed that you have a heart condition known as QT interval prolongation.

• If you have bradycardia.
• If you have ever had stomach or intestinal problems, such as perforation, or have had diseases that cause inflammation in the abdominal cavity (diverticulitis) or if the cancer has spread to the abdomen (metastasis).
• If you have visual disturbances (seeing flashes of light, blurry vision, or double vision).
• If you have severe kidney disease.
• If you are currently being treated with any other medication listed in the section “Other medications and XALKORI”.

If any of the above situations apply to you, inform your doctor.

Talk to your doctor immediately after taking XALKORI:

• If you experience intense stomach or abdominal pain, fever, chills, shortness of breath, rapid pulse, partial or complete loss of vision (in one or both eyes), or changes in bowel habits.

Children and adolescents

The indication for non-small cell lung cancer does not include children or adolescents. Do not administer this medication to children under 1 year of age with LACG ALK-positive or TMI-ALK-positive.XALKORI should be administered to children and adolescents under the supervision of an adult.

Other medications and XALKORI

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal remedies and over-the-counter medications.

In particular, the following medications may increase the risk of adverse effects with XALKORI:

• Claritromycin, telitromycin, erythromycin, antibiotics used to treat bacterial infections.
• Ketoconazole, itraconazole, posaconazole, voriconazole, used to treat fungal infections.
• Atazanavir, ritonavir, cobicistat, used to treat HIV/AIDS.

The following medications may decrease the effectiveness of XALKORI:

• Phenytoin, carbamazepine, or phenobarbital, antiepileptic medications used to treat seizures or epilepsy.
• Rifabutin, rifampicin, used to treat tuberculosis.
• St. John's Wort (Hypericum perforatum), a medicinal herb used to treat depression.

XALKORI may increase the adverse effects associated with the following medications:

• Alfentanil and other short-acting opioids such as fentanyl (anesthetics used for surgical procedures).
• Quinidine, digoxin, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, verapamil, diltiazem, used to treat heart conditions.
• Beta-blockers, such as atenolol, propranolol, labetalol, used to treat hypertension.
• Pimozide, used to treat mental health conditions.
• Metformin, used to treat diabetes.
• Procainamide, used to treat cardiac arrhythmias.

• Cisapride, used to treat gastrointestinal conditions.
• Ciclosporin, sirolimus, and tacrolimus, used in transplant patients.
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) used to treat migraines.
• Dabigatran, an anticoagulant used to reduce blood clotting.
• Colchicine, used to treat gout.
• Pravastatin, used to reduce cholesterol levels.
• Clonidine, guanfacine, used to treat hypertension.
• Mefloquine, used to prevent malaria.
• Pilocarpine, used to treat glaucoma (a serious eye condition).
• Cholinesterase inhibitors, used to restore muscle function.
• Antipsychotics, used to treat mental health conditions.
• Moxifloxacin, used to treat bacterial infections.
• Methadone, used to treat pain and opioid dependence.
• Bupropion, used to treat depression and smoking cessation.
• Efavirenz, raltegravir, used to treat HIV infection.
• Irinotecan, a chemotherapy medication used to treat colon and rectal cancer.
• Morphine, used to treat acute pain and cancer pain.
• Naloxone, used to treat opioid addiction and withdrawal.

These medicationsshould be avoidedduring treatment with XALKORI.

Oral contraceptives

If you are taking oral contraceptives while taking XALKORI, the oral contraceptives may be ineffective.

Taking XALKORI with food and beverages

XALKORI can be taken after a meal or on an empty stomach.Do not disperse the XALKORI granules in food.Avoid drinking grapefruit juice or eating grapefruit while taking XALKORI, as it may alter the amounts of XALKORI in your body.

Sun protection

Avoid spending too much time in the sun. XALKORI may make your skin more sensitive to the sun (photosensitivity), and you may burn more easily. Wear protective clothing and/or sunscreen that covers your skin to protect yourself from sunburn if you must be exposed to sunlight during treatment with XALKORI.

Pregnancy and breastfeeding

If you are pregnant, may become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medication.

It is recommended that women avoid becoming pregnant and that men not father children during treatment with XALKORI, as this medication may harm the fetus. A suitable contraceptive method should be used during treatment and for at least 90 days after completing treatment, if there is any possibility that the person taking this medication may become pregnant or conceive a child, as oral contraceptives may be ineffective while taking XALKORI.

Do not breastfeed during treatment with XALKORI. XALKORI may harm the breastfeeding infant.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Be extra careful when driving or operating machinery, as patients taking XALKORI may experience visual disturbances, dizziness, and fatigue.

XALKORI contains sucrose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose for children and adolescents with LACG ALK-positive or TMI ALK-positive is 280 mg/m^2 orally twice a day. The recommended dose will be calculated by the child's doctor and will depend on the child's weight and height (body surface area, BSA). The maximum daily dose in children and adolescents should not exceed 1,000 mg. XALKORI should be administered under adult supervision.
• Administer the recommended dose once in the morning and once at night.
• Administer the capsules approximately at the same hours each day.
• The granule should be administered in the mouth and should not be crushed, chewed, or dispersed over food.
• Do not swallow the capsule coating.

• Administration Form

To obtain detailed instructions on the administration of XALKORI granule, see section 7 “Instructions for use” at the end of this prospectus.

• Hold the capsule so that the text “Pfizer” is at the top, and tap the capsule to have all the granule fall to the lower half of the capsule.
• Carefully press the lower part of the capsule.
• Turn the cap of the capsule and remove it.
• Pour the granule directly into the child's mouth, OR pour the granule first into a spoon or measuring cup and then pour it into the child's mouth.
• Tap the opened capsule to ensure that all the granule has been administered.
• If you cannot administer the full dose at once, divide it into portions until you have administered the full dose.

• Immediately after administration, give the child a glass of water to ensure that they have swallowed all the granule.
• Once the child has swallowed the granule, you can give them other liquids or foods, except for grapefruit and grapefruit juice.

If necessary, your doctor may reduce the dose to be taken orally. Your doctor may decide to permanently suspend XALKORI treatment if you cannot tolerate XALKORI.

If you take more XALKORI than you should

If you accidentally take more capsules, consult your doctor or pharmacist immediately. You may require medical attention.

If you forgot to take XALKORI

The procedure to follow if you forgot to take a capsule depends on how much time is left until the next dose:

• If the next dose is within6hours or more, take the missed capsule as soon as possible. Then take the next capsule at the usual time.
• If the next dose is inless than 6hours, do not take the missed capsule. Then take the next capsule at the usual time.

Inform your doctor of the missed dose at your next visit.

Do not take a double dose to compensate for the missed capsule.

If you vomit after taking a dose of XALKORI, do not take an additional dose; take the next dose at the usual time.

If you interrupt XALKORI treatment

It is essential that you take XALKORI every day, for the time your doctor has prescribed. If you are unable to take this medication as your doctor has prescribed, or think you no longer need it, contact your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this leaflet.

Although not all side effects identified in adults with NSCLC have been observed in children and adolescents with LACG or TMI, the same side effects should be considered for adult patients with lung cancer and for children and adolescents with LACG or TMI.

Some side effects can be severe. You must contact your doctor immediately if you experience any of the following severe side effects (see also section 2 “What you need to know before starting to take XALKORI”):

• Liver failure

Consult your doctor immediately if you feel more tired than usual, if your skin and the white parts of your eyes turn yellow, if your urine becomes dark or brown (tea color), if you have nausea, vomiting, or less appetite, if you have pain in the right side of your stomach, or if you have itching or if you bruise more easily than usual. Your doctor may perform blood tests to check your liver function, and if the results of these tests are abnormal, your doctor may reduce the dose of XALKORI or discontinue treatment.

• Pulmonary inflammation

Consult your doctor immediately if you experience difficulty breathing, especially if it is associated with cough or fever.

• Reduction in the number of white blood cells in the blood (including neutrophils)

Consult your doctor immediately if you experience fever or infection. Your doctor may perform blood tests and if the results are abnormal, your doctor may decide to reduce the dose of XALKORI.

• Dizziness, fainting, or chest pain

Consult your doctor immediately if you experience any of these symptoms, as they may be signs of changes in electrical activity (seen on an electrocardiogram) or an abnormal heart rhythm. Your doctor may perform electrocardiograms to check that there are no heart problems during treatment with XALKORI.

• Partial or complete loss of vision in one or both eyes

Consult your doctor immediately if you experience new visual problems, loss of vision, or any change in vision, such as difficulty seeing with one or both eyes. Your doctor may discontinue or permanently interrupt treatment with XALKORI and refer you to an ophthalmologist.

For children and adolescents receiving XALKORI for the treatment of LACG ALK-positive or TMI ALK-positive: your doctor must refer you to an ophthalmologist before starting treatment with XALKORI, and within 1 month of starting treatment with XALKORI to detect visual problems. An ophthalmological examination should be performed every 3 months during treatment with XALKORI and more frequently if new visual problems occur.

• Severe gastrointestinal and intestinal problems (gastrointestinal) in children and adolescents with LACG ALK-positive or TMI ALK-positive

XALKORI may cause severe diarrhea, nausea, or vomiting. Inform your doctor immediately if you experience problems swallowing, vomiting, or diarrhea during treatment with XALKORI. Your doctor may prescribe medications as needed to prevent or treat diarrhea, nausea, and vomiting. Your doctor may recommend that you drink more liquids or prescribe electrolyte supplements or other types of nutritional support if severe symptoms occur.

Other side effects of XALKORI observed in adults with NSCLC may include:

Very common side effects(may affect more than 1 in 10 people)

• Visual effects (seeing flashes of light, blurred vision, light sensitivity, seeing spots or double vision, usually appear soon after starting treatment with XALKORI).
• Gastrointestinal problems, including vomiting, diarrhea, nausea.
• Edema (excess fluid in the body tissue that causes inflammation of the hands and feet).
• Constipation.
• Abnormalities in liver tests in blood tests.
• Loss of appetite.
• Tiredness.
• Dizziness.
• Neuropathy (sensation of numbness or tingling in the joints or extremities).
• Alteration of taste.
• Abdominal pain.
• Reduction in the number of red blood cells in the blood (anemia).
• Rash.
• Reduction in heart rate.

Common side effects(may affect up to 1 in 10 people)

• Indigestion.
• Increased levels of creatinine in the blood (may indicate that the kidneys are not functioning properly).
• Increased levels of the enzyme alkaline phosphatase in the blood (indicator of a dysfunction or injury to an organ, especially the liver, pancreas, bones, thyroid gland, or bile duct).
• Hypophosphatemia (low levels of phosphate in the blood that may cause confusion or muscle weakness).
• Cysts in the kidneys (fluid encapsulated within the kidney).
• Fainting.
• Esophagitis (inflammation of the esophagus).
• Reduction in testosterone levels, a male sex hormone.
• Heart failure.

Rare side effects(may affect up to 1 in 100 people)

• Perforation (hole) in the stomach or intestine.
• Sensitivity to sunlight (photosensitivity).
• High levels in blood tests to check for muscle damage (high levels of creatine phosphokinase).

Other side effects of XALKORI observed in children and adolescents with LACG ALK-positive or TMI ALK-positive may include:

Very common side effects(may affect more than 1 in 10 people)

• Abnormalities in liver tests in blood tests.
• Visual effects (seeing flashes of light, blurred vision, light sensitivity, seeing spots or double vision, usually appear soon after starting treatment with XALKORI).
• Abdominal pain.
• Increased levels of creatinine in the blood (may indicate that the kidneys are not functioning properly).
• Anemia (reduction in the number of red blood cells in the blood).
• Low platelet count in blood tests (may increase the risk of bleeding and bruising).
• Tiredness.
• Loss of appetite.
• Constipation.
• Edema (excess fluid in the body tissue that causes inflammation of the hands and feet).
• Increased levels of the enzyme alkaline phosphatase in the blood (indicator of a dysfunction or injury to an organ, especially the liver, pancreas, bones, thyroid gland, or bile duct).
• Neuropathy (sensation of numbness or tingling in the joints or extremities).
• Dizziness.
• Indigestion.
• Alteration of taste.
• Hypophosphatemia (low levels of phosphate in the blood that may cause confusion or muscle weakness).

Common side effects(may affect up to 1 in 10 people)

• Rash.
• Esophagitis (inflammation of the esophagus).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the bottle and on the box after “EXP”. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use this medication if it is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. The empty capsules of XALKORI (oral granule) may be disposed of in household trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of XALKORI

• The active ingredient of XALKORI is crizotinib.

XALKORI 20mg granulated in capsules for opening: each capsule contains 20mg of crizotinib

XALKORI 50mg granulated in capsules for opening: each capsule contains 50mg of crizotinib

XALKORI 150mg granulated in capsules for opening: each capsule contains 150mg of crizotinib

• The other components are (see also the section2 “XALKORI contains sucrose”):

Content of the granulate: stearic acid alcohol, poloxamer, sucrose, talc (E553b), hypromellose (E464), macrogol (E1521), monoestearate of glycerol (E471), medium-chain triglycerides.

Capsule: gelatin, titanium dioxide (E171), brilliant blue (E133) or iron oxide black (E172).

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172).

Appearance of the product and contents of the package

The granulate of XALKORI is white to off-white and is found in a capsule for opening.

XALKORI 20mg granulated in capsules for opening are capsules with a blue clear lid with the text “Pfizer” printed in black ink and a white body with the text “CRZ20” printed in black ink.

XALKORI 50mg granulated in capsules for opening are capsules with a grey lid with the text “Pfizer” printed in black ink and a light grey body with the text “CRZ50” printed in black ink.

XALKORI 150mg granulated in capsules for opening are capsules with a blue clear lid with the text “Pfizer” printed in black ink and a light blue body with the text “CRZ150” printed in black ink.

It is available in plastic bottles with 60capsules for opening.

Marketing Authorization Holder

Pfizer EuropeMAEEIG

Boulevard de la Plaine17

1050Brussels

Belgium

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10

Zaventem

Vlaams-Brabant 1930

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Phone: +34 91 490 99 00

Last review date of this leaflet:08/2024.

Other sources of information

The detailed information about this medicine and the information in different languages is available by scanning the QR code included below and in the box with a mobile device.

QR code to include

The detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

7. Instructions for use

Read the entire section7 before using XALKORI granulated in capsules for opening.

Articles needed for the administration of XALKORI:

• XALKORI granulated in capsules, under the prescription of your doctor
• Optional, a spoon or a measuring cup provided by the user

Preparation of the XALKORI granulate (steps1 to 3):

Administration of the XALKORI granulate (step4):There are2options for administering the granulate orally to the child.

Once step4 is completed, you can give the child other liquids or foods, except for grapefruit and grapefruit juice.

Consult your doctor or pharmacist if you are unsure how to prepare or administer the prescribed dose of XALKORI granulate to the child.