Rozlytrek

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking entrectinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

If you are taking the capsules, swallow whole. Do not crush or chew the capsules.

If you have trouble swallowing the capsules, or if you are prescribed a certain dose, your doctor may direct you to open a prescribed number of capsule(s) and mix the contents with room-temperature water or milk to make a suspension. Ask your doctor or pharmacist how much water or milk you should use to mix the capsule(s). Let the suspension sit for 15 minutes, then carefully measure the prescribed dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Take the suspension right away, then drink water to make sure you have swallowed all of the prescribed dose. In some cases, your doctor may direct you to mix more medication than you need for a dose. Always follow your doctor's directions for how to mix your medication, but do not take more of the suspension than your doctor tells you to take. Discard any unused suspension, or any suspension that has not been used within 2 hours after preparation.

The suspension may also be given through a tube into the stomach (nasogastric or gastric tube). If you are giving this medication through a nasogastric or gastric tube, ask your health care professional for detailed instructions on how to give it.

If you are using the pellet form of this medication, open the packet(s) and sprinkle the entire contents of each packet on one or more spoonful(s) of soft food (such as applesauce, yogurt, pudding). Take the mixture right away. To avoid a bitter taste, do not crush or chew the pellets. Drink water after taking to make sure the entire dose is taken. If you are unable to take the pellets sprinkled on soft food within 20 minutes, throw away the mixture and prepare a new dose. Do not use the pellets to make a suspension. Do not give the pellets through a feeding tube.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

The dosage is based on your medical condition, response to treatment, age, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children's dosage is also based on body size.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit right after taking a dose, you may take another dose.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules or pellets.

Nausea, vomiting, tiredness, constipation, dizziness, drowsiness, sleep problems, headache, diarrhea, muscle/joint pain, unusual changes in sense of touch, or changes in how food tastes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, anxiety, depression, trouble paying attention, memory problems), numbness/tingling, vision changes (such as blurred/double vision, decreased vision), eyes being sensitive to light, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual/sudden weight gain), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.

This medication may increase your risk for bone fractures. Fractures may happen with or without a fall or injury. Tell your health care provider right away if you have bone pain or changes in movement.

This medication may cause your blood uric acid levels to increase. Your doctor will check uric acid levels regularly during treatment, and may adjust your dose of entrectinib. You may also be prescribed other medication to treat high uric acid levels.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking entrectinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, eye/vision problems.

This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Entrectinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using entrectinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: heart problems (such as heart failure, previous heart attack, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting.

Entrectinib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using entrectinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules or pellets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using entrectinib. Entrectinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for at least 5 weeks after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 7 days after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of entrectinib from your body, which may affect how entrectinib works. Examples include azole antifungals (such as fluconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as indinavir, nelfinavir), rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, uric acid, kidney/liver/heart function, EKG) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is less than 12 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

See also How to Use section.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.