Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
ENTRECTINIB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L01XE56
HARD CAPSULE
ENTRECTINIB 200 MG
PER OS
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
ENTRECTINIB
ROZLYTREK is indicated for the treatment of adults with solid tumors that:• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,• are metastatic or where surgical resection is likely to result in severe morbidity, and• have either progressed following treatment or have no satisfactory alternative therapy.ROZLYTREK is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
2020-04-22
Rozlytrek PL version 2 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only ROZLYTREK ROZLYTREK 100 MG 200 MG HARD CAPSULES HARD CAPSULES COMPOSITION: EACH CAPSULE CONTAINS: entrectinib 100 mg EACH CAPSULE CONTAINS: entrectinib 200 mg Inactive ingredients and allergens in the preparation: See section 2 under ‘Important information about some of this medicine’s ingredients’ and see also section 6, ‘Further information’. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, contact the doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Rozlytrek is intended to treat adults with: A. A solid tumor that: was caused by a change in a NTRK-class gene AND has spread to other parts of the body, or in instances when surgery to remove the tumor may cause severe complications AND there is no satisfactory treatment alternative or the tumor grew or spread during the receipt of another treatment. B. Non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has a change in ROS1 gene. THERAPEUTIC GROUP: kinase inhibitor 2. BEFORE USING THIS MEDICINE DO NOT USE THE MEDICINE IF: You are allergic (sensitive) to the active ingredient, entrectinib, or to any of the other ingredients of this medicine referred to in section 6, ‘Further information’. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: Before taking Rozlytrek, tell the doctor about all of your previous medical conditions, including if: you are suffering from liver or kidney problems you have bone fractures you are suffering from any heart problems, including a medical condition called long QT syndrome you Leggi il documento completo
Page 1 of 19 ROZLYTREK PI VER 4 ROZLYTREK ® ENTRECTINIB HARD CAPSULES _______________________________________________________ NAME OF THE MEDICINAL PRODUCT Rozlytrek 100 mg Rozlytrek 200 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Rozlytrek 100 mg hard capsules Each hard capsule contains 100 mg of entrectinib. _Excipient(s) with known effect _ Each hard capsule contains 65 mg lactose. Rozlytrek 200 mg hard capsules Each hard capsule contains 200 mg of entrectinib. _Eexcipient(s) with known effect _ Each hard capsule contains 130 mg lactose, and 0.6 mg of the azo colouring agent sunset yellow FCF (E110). FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 11. 1 INDICATIONS AND USAGE 1.1 Rozlytrek is indicated for the treatment of adults with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy. 1.2 Rozlytrek is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. 2 DOSAGE AND ADMINISTRATION 2.1 PATIENT SELECTION Select patients for the treatment of metastatic NSCLC with ROZLYTREK based on the presence of _ROS1_ rearrangement(s) in tumor specimens _[see Clinical Studies (14.1)]_. Page 2 of 19 Select patients for treatment of locally advanced or metastatic solid tumors with ROZLYTREK based on the presence of a _NTRK_ gene fusion _[see Clinical Studies (14.2)]_. 2.2 RECOMMENDED DOSAGE FOR ROS1 -POSITIVE NON-SMALL CELL LUNG CANCER The recommended dosage of ROZLYTREK is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity. 2.3 RECOMMENDED DOSAGE FOR NTRK GENE FUSION-POSITIVE SOLID TUMORS Adults The recommended dosage of ROZLYTREK in adults is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity. 2.4 DOSAGE Leggi il documento completo