Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
pralsetinib
Roche Registration GmbH
L01XE
pralsetinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Revision: 6
Authorised
2021-11-18
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GAVRETO 100 MG HARD CAPSULES pralsetinib This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gavreto is and what it is used for 2. What you need to know before you take Gavreto 3. How to take Gavreto 4. Possible side effects 5. How to store Gavreto 6. Contents of the pack and other information 1. WHAT GAVRETO IS AND WHAT IT IS USED FOR WHAT GAVRETO IS Gavreto is a cancer medicine that contains the active substance pralsetinib. WHAT GAVRETO IS USED FOR Gavreto is used to treat adults with advanced stages of a form of lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’), that presents with a specific rearrangement in a gene called rearranged during transfection (RET) if you have not been previously treated with another RET inhibitor medicine. HOW GAVRETO WORKS In patients whose cancer is due to an altered RET gene, the change in the gene causes the body to make an abnormal protein called a RET fusion protein, which can lead to uncontrolled cell growth and cancer. Gavreto blocks the action of RET fusion proteins and may help to slow or stop your lung cancer from growing. It may also help to shrink your cancer. If you have any questions about how Gavreto works or why this medicine has been Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT GAVRETO 100 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pralsetinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Light blue, opaque hard capsule, size 0 (22 mm long x 7 mm wide) with “BLU-667” printed on the capsule shell body and “100 mg” on the capsule shell cap in white ink. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the administration of anticancer medicinal products. Patient selection for treatment of RET fusion-positive advanced NSCLC should be based on a validated test method. Posology The recommended dose is 400 mg pralsetinib once daily on an empty stomach (see method of administration). Treatment should be continued until disease progression or unacceptable toxicity. If vomiting occurs after taking a dose of pralsetinib, the patient should not take an additional dose but continue with the next scheduled dose. _Missed doses _ _ _ If a dose of pralsetinib is missed, the patient should make up for the missed dose as soon as possible on the same day. The regular daily dose schedule for pralsetinib should be resumed the next day. 3 _Dose modifications for adverse reactions _ _ _ Interruption of treatment with or without dose reduction may be considered to manage adverse reactions based on severity and clinical presentation. Patients may have their dos Прочитать полный документ