Prospect: information for the patient

Rozlytrek 100 mg hard capsules

Rozlytrek 200 mg hard capsules

entrectinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects that do not appear in this prospect. See section 4.
• This prospect has been written as if you, the person taking the medicine, are reading it.

If you are giving this medicine to your child, replace "you" with "your child" everywhere

at this time.

What is Rozlytrek

Rozlytrek is a cancer medication that contains the active ingredient entrectinib.

What is Rozlytrek used for

Rozlytrek is used to treat:

• adolescents and adults, and children over 1 month of age with solid tumors (cancer) in various parts of the body, caused by a change in the neurotrophic tyrosine receptor kinase (NTRK) gene
• adults with a type of lung cancer called “non-small cell lung cancer” (NSCLC), caused by a change in the ROS1 gene.

This medication is used for solid tumors when:

• a test has shown that their cancer cells have a change in the genes called “NTRK” (see “How Rozlytrek works” below), and
• their cancer has spread within the affected organ or to other organs in their body or if surgery to remove the cancer would cause severe complications, and
• they have not received prior treatment with “NTRK inhibitors”
• other treatments have not been effective or are not suitable for them.

This medication is used for non-small cell lung cancer (NSCLC):

• is ‘ROS1-positive’: this means that their cancer cells have a change in a gene called ‘ROS1’ (see “How Rozlytrek works” below),
• is advanced–for example, it has spread to other parts of their body (i.e., it is metastatic), and
• they have not received prior treatment with medications called ‘ROS1 inhibitors’.

How Rozlytrek works

Rozlytrekworks by blocking the action of defective proteins. These defective proteins are caused by a change in the genes that produce them, calledNTRKorROS1. These defective proteins stimulate the growth of cancer cells.

Rozlytrek can slow down or stop the growth of cancer. It can also help reduce it.

Do not take Rozlytrek:

• if you are allergic to entrectinib or any of the other components of this medication (listed in section 6).

If you are unsure, consult your doctor, pharmacist, or nurse before taking Rozlytrek.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before taking Rozlytrek if:

• you have recently experienced memory loss, confusion, hallucinations, or changes in mental state.
• you have had bone fractures or conditions that may increase the risk of bone fractures, known as 'osteoporosis' or 'osteopenia'.
• you are taking medication to lower uric acid levels in the blood.
• you have heart failure (when your heart has difficulty pumping blood to supply oxygen to the rest of your body) – symptoms may include coughing, difficulty breathing, and swelling in legs and arms.
• you have ever had heart problems or heart conduction problems called 'prolonged QTc interval' – this is shown on an electrocardiogram (ECG) or by low levels of electrolytes in the blood.
• you suffer from a hereditary condition called 'lactose intolerance', 'congenital lactase deficiency', or 'glucose or galactose malabsorption'.

If you meet any of the above conditions (or are unsure), consult your doctor or pharmacist before taking Rozlytrek.

Other medications and Rozlytrek:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because Rozlytrek may affect how other medications work. Similarly, other medications may affect how Rozlytrek works.

Particularly, consult your doctor or pharmacist if you are taking any of the following medications:

• antifungal medications (such as ketoconazole, itraconazole, voriconazole, posaconazole).
• medications for HIV/AIDS (such as ritonavir or saquinavir).
• antidepressants (such as paroxetine, fluvoxamine, or herbal antidepressants – St. John's Wort).
• medications to stop seizures or attacks (such as phenytoin, carbamazepine, or phenobarbital).
• medications for tuberculosis (such as rifampicin, rifabutin).
• medications for solid tumors and blood cancers (such as topotecan, lapatinib, mitoxantrone, apalutamide, or methotrexate).
• medications for joint inflammation or autoimmune joint diseases (such as rheumatoid arthritis) – methotrexate.
• medications for migraines (such as ergotamine).
• medications for intense pain (such as fentanyl).
• medications for mental health (psychosis) or Tourette's syndrome – pimozide.
• medications for irregular heart rhythm – quinidine.
• medications to prevent blood clotting – warfarin or dabigatran etexilate.
• medications for acid reflux (heartburn) – cisapride or omeprazole.
• medications to lower cholesterol levels in the blood – atorvastatin, pravastatin, or rosuvastatin.
• medications to suppress the immune system or prevent organ rejection after transplantation – sirolimus, tacrolimus, or cyclosporine.
• medications to lower blood sugar levels – repaglinide or tolbutamide.
• medications for high blood pressure – bosentan, felodipine, nifedipine, or verapamil.
• medications for inflammation or nausea – dexamethasone.

If you meet any of the above conditions (or are unsure), consult your doctor or pharmacist before taking Rozlytrek.

Use of Rozlytrek with food or drinks:

Do not drink grapefruit juice or eat grapefruits or bitter oranges during treatment with this medication. This may increase the amount of the medication in the blood to harmful levels.

Pregnancy, breastfeeding, and fertility:

Women and contraceptive measures:

You should avoid becoming pregnant while taking this medication, as it may harm the fetus. If you can become pregnant, you should use a highly effective contraceptive method:

• during treatment, and
• for at least 5 weeks after stopping treatment.

We do not know if Rozlytrek may reduce the effectiveness of birth control medications (oral contraceptives or implanted hormonal contraceptives). You should use another reliable method of birth control, such as a barrier method (such as a condom).

Consult your doctor about suitable contraceptive methods for you and your partner.

Men and contraceptive measures:

Your partner should avoid becoming pregnant while you are taking this medication, as it may harm the fetus. If your partner can become pregnant, you should use a highly effective contraceptive method:

• during treatment, and
• for at least 3 months after stopping treatment.

Consult your doctor about suitable contraceptive methods for you and your partner.

Pregnancy:

• Do not take Rozlytrek if you are pregnant, as it may harm the fetus.
• If you become pregnant while taking this medication or within 5 weeks after your last dose, inform your doctor immediately.

Breastfeeding:

You should not breastfeed while taking this medication. We do not know if Rozlytrek may pass into breast milk and harm your baby.

Driving and operating machinery:

Rozlytrek may affect your ability to drive, ride a bike, or operate machinery. The following side effects may occur while taking Rozlytrek:

• blurred vision.
• feeling tired, dizziness, or fainting.
• changes in mental state, confusion, or seeing things that do not exist (hallucinations).

If this occurs, do not drive, ride a bike, or operate heavy machinery until you feel better. Ask your doctor or pharmacist if you can drive, ride a bike, or operate machinery.

Rozlytrek contains:

• lactose–a type of sugar. If your doctor has told you that you have a lactose intolerance, consult them before taking this medication.
• yellow orange FCF (E-110) only in 200mg hard capsules.This is a coloring agent that may cause allergic reactions.

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

How much to take

Adults

• The recommended dose is 3 capsules of 200 mg once a day (this is equivalent to a total dose of 600 mg).
• If you feel unwell, your doctor may reduce your dose, interrupt your treatment for a short period of time, or discontinue treatment completely.

Adolescents and children over 1 month of age:

Your doctor will calculate the correct dose to be taken based on the child's height and weight.

Your doctor will review the dose and change it as necessary.

Rozlytrek is also available in a film-coated granule form on a spoon for patients who cannot swallow capsules but can take soft foods.

How to take it

Rozlytrek can be taken with or without food.

There are two ways your doctor may instruct you to take Rozlytrek capsules:

• Swallow each capsule whole. Do not crush or chew the capsules.
• Take it prepared as an oral suspension (using a syringe) or, if necessary, through a feeding tube.

Read the ‘Instructions for Use’ at the end of the leaflet.

Read and carefully follow the ‘Instructions for Use’ at the end of the leaflet on how to take and administer Rozlytrek. Detailed information is provided on how to prepare, measure, take, or administer Rozlytrek prepared as an oral suspension:

• by mouth, or
• through a feeding tube (such as a gastric or nasogastric tube).

If you vomit after taking Rozlytrek

Capsules

If you vomit immediately after taking a dose of Rozlytrek, take another dose.

Capsules administered as an oral suspension

If you vomit or experience total or partial regurgitation immediately after taking the dose, consult your doctor or pharmacist about the next steps.

If you take more Rozlytrek than you should

If you take more Rozlytrek than you should, inform your doctor immediately or go to the hospital. Bring the medication packaging and this leaflet with you.

If you forget to take Rozlytrek

• If more than 12 hours have passed until your next dose, take the missed dose as soon as you remember.
• If less than 12 hours have passed until your next dose, do not take the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Rozlytrek

Do not stop taking this medication without consulting your doctor first. It is essential to take this medication every day for the time your doctor has prescribed.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. With this medicine, the following side effects may occur.

Severe side effects

Inform your doctor immediately if you experience any of the following severe side effects.Your doctor may reduce your dose, interrupt your treatment for a short period of time, or discontinue treatment completely if:

• You have cough, difficulty breathing, or swelling of the legs or arms (fluid retention)–these may be signs of heart problems (congestive heart failure)
• You feel confused, changes in mood, memory problems, or see things that do not exist (hallucinations)
• You feel dizzy or disoriented, or feel that your heart is beating irregularly and rapidly–this may be a symptom of abnormal heart rhythm
• You notice any joint pain, bone pain, deformities, or changes in your ability to move, as it may be a sign of fractures
• You have kidney problems or arthritis, –you may have high levels of uric acid in your blood
  

Inform your doctor immediately if you notice any of the above side effects.

Other side effects

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

Very common:may affect more than 1 in 10 people:

• fatigue
• alteration of taste
• sensation of instability or dizziness
• blurred vision
• swelling
• diarrhea or constipation
• feeling or being sick
• difficulty swallowing
• abnormal sensation of touch, numbness, itching, tingling, or burning sensation
• skin rash
• difficulty breathing
• cough or fever
• headache
• weight gain
• vomiting
• muscle pain or weakness
• pain, including back, neck, musculoskeletal, limb pain
• stomach pain
• joint pain
• unpleasant sensation in the arms or legs
• loss of muscle control, instability while walking
• alteration in normal sleep patterns
• pulmonary infection
• urinary tract infection
• inability to completely empty the bladder
• loss of appetite
• low blood pressure
• decrease in the number of a type of white blood cell called neutrophils
• decrease in the number of red blood cells (anemia)
• increase in levels of certain liver enzymes (AST/ALT) in the blood
• increase in levels of creatinine in the blood (a substance that is normally eliminated in the urine through the kidneys)

Common:may affect up to 1 in 10 people:

• mood changes
• dehydration
• fluid in the lungs
• syncope
• sensitivity of the skin to sunlight
  

Uncommon:may affect less than 1 in 100 people:

?changes incertain chemical components in your blood, due to the rapid breakdown of tumor cells,–this may cause damage to organs, including kidneys, heart, and liver.

• inflammation of the heart muscle.

Inform your doctor, pharmacist, or nurse if you experience any of the above side effects.

Reporting of 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 thenational reporting system included in theAppendix V.* 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 packaging and the bottle after EXP. The expiration date is the last day of the month indicated.
• Store the capsules in the original packaging and keep the bottle tightly closed to protect it from moisture.
• After preparing the oral suspension, store at a temperature below 30°C and use within 2hours of preparation.
• Medications should not be disposed of through the drain. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Rozlytrek

The active ingredient is entrectinib.

Rozlytrek 100mg: each capsule contains 100mg of entrectinib.
Rozlytrek 200mg: each capsule contains 200mg of entrectinib.

The other components are:

• Content of the capsule:tartaric acid (E334), lactose (see section 2 “Rozlytrek contains lactose”), hypromellose (E464), crospovidone (E1202), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E470b).
• Capsule coating:hypromellose (E464), titanium dioxide (E-171), yellow iron oxide (E172; for Rozlytrek 100mg capsule), yellow-orange FCF (E-110; for Rozlytrek 200mg capsule. See section 2 “Rozlytrek contains yellow-orange FCF (E110)”).
• Printing ink:shellac, propylene glycol, aluminium lake indigo carmine (E-132).

Appearance of Rozlytrek and contents of the pack

Rozlytrek 100mg hard, opaque yellow capsules withENT100 printed in blue ink on the body.

Rozlytrek 200mg hard, opaque orange capsules with ENT200 printed in blue ink on the body.

The capsules are presented in bottles containing:

• 30hard capsules of Rozlytrek 100 mg, or
• 90hard capsules of Rozlytrek 200 mg.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet

This medicinal product has been authorised under a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu,

<------------------------------------------------------------------------------------------------------------------------------->

7.Instructions for use

Rozlytrek

(entrectinib)

Hard capsules for oral use

(administered as a whole capsule or as an oral suspension)

These instructions for use contain information on how to prepare, take and administer Rozlytrek capsules.

Rozlytrek capsules can be swallowed whole or prepared as an oral suspension and taken or administered orally or through a gastric or nasogastric tube.

Before starting

• Read these instructions for usebefore taking or administering Rozlytrek capsules.

• Ask your doctor to teach you how to use Rozlytrek before starting treatment.
• If you have any doubts about using Rozlytrek, ask your doctor.

Important information you need to know before preparing, taking or administering Rozlytrek

• Your doctor should teach you how to prepare and take or administer Rozlytrek correctly. Follow exactly the administration instructions for Rozlytrek indicated by your doctor.

• Do not take oradminister Rozlytrek to another person until you have been shown how to prepare and take or administer Rozlytrek correctly.
• Wash your hands before and after using Rozlytrek.Do nottouch your eyes, nose or mouth during the preparation of the oral suspension.
• Check the expiry date and the presence of damage on the product before using it.Do notuse it if it has expired or is damaged.
• For whole capsules, if you vomit immediately after taking the dose of Rozlytrek, take another dose.
• For capsules administered as an oral suspension, if you vomit or experience partial or total regurgitation immediately after administering a dose, consult your doctor or pharmacist to know the next steps.
• The oral suspension must be administered within 2hours after its preparation.

Administration of Rozlytrek capsules by oral route

Your doctor will decide on the correct daily dose of Rozlytrek for you or your child.

• Swallow the capsules whole, with or without food, with a little water, as indicated by your doctor.
• Do not crush or chew the capsules.

Administration of Rozlytrek as an oral suspension – by oral route or through a gastric or nasogastric tube

If you or your child cannot swallow the capsules whole, the Rozlytrek capsules can be prepared as an oral suspension (in water or milk) and taken or administered orally or through a gastric or nasogastric tube.

Your doctor will indicate the number of capsules to use, the exact amount of liquid (water or milk) to mix with the content of the necessary capsule(s) to prepare the suspension, and the exact amount (ml) of suspension to extract to achieve the prescribed dose of Rozlytrek to take or administer.

InTable 1, the prescribed dose, the number and concentration of capsules needed, the amount of water or milk to mix with the content of the capsule(s) and prepare the suspension, and the amount of suspension to extract to achieve the prescribed dose to take or administer are shown.

You may need to measure a smaller amount of suspension than the one you prepared to take or administer the correct prescribed dose of Rozlytrek.

To prepare the oral suspension, you will need:

• The number of capsules indicated by your doctor
• A clean empty glass (not included in the pack)
• A glass of water or milk at room temperature (below 30°C
• A oral syringe for use (facilitated by your pharmacist) with graduations of 0.5ml
• A paper towel

Preparation of Rozlytrek oral suspension

Administration by oral route

Administration through a gastric or nasogastric tube

Rozlytrek can be taken or administered through a nasogastric or gastric tube placed by a healthcare professional. Check the manufacturer's instructions for the size and dimensions of the enteral zone. Ensure that the size of the tube is at least8French or higher to avoid tube blockage if the doses (amount of suspension) are 3ml or more. To take or administer Rozlytrek in doses of 3ml or more, divide the dose and give it in at least 2parts. Wash the tube with the same amount of water or milk after administering each part. Neonates and children with fluid restrictions may require minimum washing volumes of 1 to 3ml to administer Rozlytrek. The doses must be adjusted accordingly. To take or administer doses of 30ml of Rozlytrek, divide the dose into at least 3parts of 10ml. Wash the tube with the same amount of water or milk after administering each part. The tube should be washed with water or milk after administering Rozlytrek. If you have any doubts, consult your doctor.
Step B1 Place the tip of the syringe in the nasogastric or gastric tube. Push the plunger slowly to the bottom to administer the complete dose of Rozlytrek (Figure M1 and M2).	Figure M1	Figure M2
Step B2 Check that no medicine remains in the syringe (Figure N).	Figure N
Step B3 Wash the nasogastric or gastric tube with water or milk*immediately after administering the prescribed dose ( Страна регистрации Испания Активное вещество Entrectinib Требуется рецепт Да Производитель Roche Registration Gmbh Состав Lactosa anhidra (130 mg mg), Propilenglicol (q.s. mg mg) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Общайтесь с врачом онлайн Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. 5.01 отзыв Анна Морет Дерматология18 лет опыта Анна Морет — врач-дерматолог и дерматовенеролог с международной сертификацией. Специализируется на дерматологии взрослых и детей, венерологии, эстетическом уходе за кожей и общей медицине. Проводит онлайн-консультации, опираясь на доказательную медицину и индивидуальные потребности каждого пациента. Сфера помощи включает: • кожные заболевания: экзема, акне, розацеа, дерматиты, псориаз • проблемы с волосами и кожей головы: выпадение волос, перхоть, себорейный дерматит • детская дерматология — от новорождённых до подростков • венерология и ЗППП (заболевания, передающиеся половым путём) • эстетические запросы: возрастные изменения кожи, неинвазивные косметологические процедуры • аллергические реакции и повышенная чувствительность кожи • проверка родинок, оценка новообразований, скрининг рака кожи • рекомендации по уходу за кожей и подбор индивидуальной космецевтики Объединяя дерматологию с клиническим опытом в общей медицине, Анна Морет оказывает комплексную помощь, охватывая не только состояние кожи, но и сопутствующие проблемы со здоровьем. 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Обращаться можно по следующим поводам: • респираторные инфекции: простуда, грипп, бронхит, пневмония • глазные заболевания: конъюнктивит (инфекционный и аллергический) • ЛОР-заболевания: синусит, отит, тонзиллит • проблемы с пищеварением: гастрит, кислотный рефлюкс, синдром раздражённого кишечника (СРК) • инфекции мочевыводящих путей и другие распространённые инфекции • хронические заболевания: артериальная гипертензия, диабет, нарушения работы щитовидной железы • головная боль и мигрень Помимо лечения симптомов, Алина Цуркан уделяет особое внимание профилактике и раннему выявлению заболеваний. Проводит плановые осмотры, даёт медицинские рекомендации, проводит повторные консультации и выписывает рецепты — с учётом индивидуальных потребностей каждого пациента. Её подход — комплексный, внимательный и адаптированный к каждому этапу жизни пациента: от острых состояний до долгосрочного контроля здоровья. 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Работает со следующими жалобами: • хроническая боль любого происхождения • мигрени и повторяющиеся головные боли • боли в шее, спине, пояснице и суставах • посттравматическая боль (после травм, растяжений, операций) • невропатическая боль, фибромиалгия, невралгии Помимо работы с болевыми синдромами, Андрей Попов помогает в ведении: • респираторных инфекций (ОРВИ, бронхит, пневмония) • артериальной гипертензии и метаболических нарушений (включая диабет) • профилактических осмотров и общего контроля состояния здоровья Онлайн-консультация длится до 30 минут и включает разбор симптомов, рекомендации по обследованиям, формирование плана лечения и дальнейшее сопровождение при необходимости. Андрей Попов придерживается принципов доказательной медицины и предлагает индивидуальный подход с учётом симптомов, истории болезни и образа жизни каждого пациента. Записаться на онлайн-консультацию Больше времени 5.01 отзыв Евгений Яковенко Общая хирургия11 лет опыта Евгений Яковенко — лицензированный хирург и терапевт в Испании. Специализируется на общей и детской хирургии, внутренней медицине и лечении боли. Проводит онлайн-консультации для взрослых и детей, сочетая хирургическую практику с терапевтическим сопровождением. Сфера медицинской помощи включает: • диагностику и лечение острой и хронической боли • пред- и послеоперационное ведение, оценку рисков, контроль состояния • хирургические заболевания: грыжи, желчнокаменная болезнь, аппендицит • консультации по детской хирургии: врождённые состояния, малые вмешательства • травмы: переломы, повреждения мягких тканей, обработка ран • онкохирургия: консультации, планирование, ведение после лечения • внутренние заболевания: патологии сердечно-сосудистой и дыхательной систем • ортопедические состояния, реабилитация после травм • интерпретация результатов визуализации для хирургического планирования Евгений Яковенко активно занимается научной деятельностью и международным сотрудничеством. Член Ассоциации хирургов Германии (BDC), сотрудничает с Ассоциацией семейных врачей Лас-Пальмаса и Генеральным консульством Германии на Канарских островах. Регулярно участвует в международных медицинских конференциях и публикует научные статьи. Объединяя многопрофильный опыт с принципами доказательной медицины, он оказывает точную и индивидуализированную помощь пациентам с различными медицинскими запросами. Записаться на онлайн-консультацию Больше времени Смотреть всех врачей Следите за новостями и экономьте на услугах Советы врачей, обновления платформы и скидки для подписчиков. Подписаться Следите за нами в соцсетях УслугиВрачиПомощь Поиск