Valsts: Dienvidāfrikas Republika
Valoda: angļu
Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)
Roche Products (Pty) Ltd
100,0 mg
CAPSULES
EACH CAPSULE CONTAINS PRASETINIB 100,0 mg
Registered
GAVRETO ® (560684; Regd) pralsetinib – 100 mg hard capsules eCTD sequence 0005 1 1.3.2 Approved PIL _ SAHPGL-CEM-03_v_ 7 _ _ _17 Oct 2023; CDS 2.0 Page 1 of 10 _ PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 GAVRETO ® 100 mg hard capsules Sugar free READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING GAVRETO Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor, pharmacist, nurse or healthcare provider. Gavreto has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 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 a prescription medicine that is used to treat certain cancers caused by an abnormal gene called rearranged during transfection (RET): adults with advanced stages of a form of a lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’) GAVRETO ® (560684; Regd) pralsetinib – 100 mg hard capsules eCTD sequence 0005 1 1.3.2 Approved PIL _ SAHPGL-CEM-03_v_ 7 _ _ _17 Oct 2023; CDS 2.0 Page 2 of 10 _ adults with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy). adults with thyroid cancer who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working. GAVRETO is used when a test has shown that your cancer cells have a change in the _RET_ gene. 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 RET protein, which can le Izlasiet visu dokumentu
GAVRETO ® (560684; Regd) pralsetinib – 100 mg hard capsules eCTD sequence 0005 1 1.3.1.1 Approved PI _ _ _ SAHPGL-CEM-02_v5 _ _ 17 Oct 2023; CDS 2.0 Page 1 of 28_ PROFESSIONAL INFORMATION SCHEDULING STATUS S4 1 NAME OF THE MEDICINE GAVRETO ® 100 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg pralsetinib. Sugar free For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Size 0, light blue opaque capsule shell with white imprint “BLU-667” on the body and white imprint “100 mg” on the cap, containing a white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _NON-SMALL CELL LUNG CANCER (NSCLC) _ Gavreto is indicated for the treatment of adult patients with rearranged during transfection (_RET_) fusion- positive, locally advanced or metastatic NSCLC. _RET-MUTANT MEDULLARY THYROID CANCER (MTC) _ Gavreto is indicated for the treatment of adult patients with locally advanced or metastatic _RET_-mutant MTC who require systemic therapy. GAVRETO ® (560684; Regd) pralsetinib – 100 mg hard capsules eCTD sequence 0005 1 1.3.1.1 Approved PI _ _ _ SAHPGL-CEM-02_v5 _ _ 17 Oct 2023; CDS 2.0 Page 2 of 28_ _RET-FUSION POSITIVE THYROID CANCER _ Gavreto is indicated for the treatment of adult patients with locally advanced or metastatic _RET_-fusion positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL A validated assay is required for the selection of patients with a _RET_-gene fusion (NSCLC or thyroid cancer) or a _RET_-gene mutation (MTC). POSOLOGY _ADULTS _ The recommended dose of Gavreto for adults is 400 mg given orally, once daily. DURATION OF TREATMENT It is recommended that patients are treated with Gavreto until disease progression or unmanageable toxicity. DELAYED OR MISSED DOSES If a planned dose of Gavreto is missed, patients can make up that dose unless the next dose is due withi Izlasiet visu dokumentu