البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PRALSETINIB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L01EX23
HARD CAPSULE
PRALSETINIB 100 MG
PER OS
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
PRALSETINIB
- GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).- GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.- GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
2022-03-20
Gavreto PL version 2 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only GAVRETO 100 MG Hard capsules COMPOSITION: Each capsule contains: pralsetinib 100 mg * For information on inactive ingredients and allergens, see section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Gavreto is intended for the treatment of certain cancers caused by an abnormal gene called RET (rearranged during transfection): In adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). In patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer (MTC), who require systemic therapy. In patients 12 years of age and older with advanced or metastatic RET fusion- positive thyroid cancer, who require systemic therapy and who are radioactive iodine refractory. THERAPEUTIC GROUP Tyrosine kinase inhibitors. 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 lead to uncontrolled cell growth and cancer. Gavreto blocks the action of abnormal RET proteins and may help to stop or slow lung or thyroid cancer from growing. It may also help to shrink the cancer. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient (pralsetinib) or to any of the other ingredients in this medicine (see section 6 – ‘Additional information’). SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE TREATMENT WITH GAVRETO, TELL YOUR DOCTOR IF YOU: have lung or b اقرأ الوثيقة كاملة
Gavreto PI ver 3 Gavreto ® Pralsetinib Hard capsules NAME OF THE MEDICINAL PRODUCT GAVRETO QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pralsetinib. For the full list of excipients, see section 11. PHARMACEUTICAL FORM Hard capsules. 1 INDICATIONS AND USAGE 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). 1.2 RET-Mutant Medullary Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy. 1.3 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Gavreto PI ver 3 2 DOSAGE AND ADMINISTRATION 2.1 Patient Selection Select patients for treatment with GAVRETO based on the presence of a RET gene fusion (NSCLC or thyroid cancer) or RET gene mutation (MTC) [see Clinical Studies (14)]. 2.2 Recommended Dosage The recommended dosage of GAVRETO is 400 mg orally once daily on an empty stomach (the capsules should be swallowed whole with a glass of water, no food intake for at least 2 hours before and at least 1 hour after taking GAVRETO) [see Clinical Pharmacology (12.3)]. Continue treatment until disease progression or until unacceptable toxicity. If a dose of GAVRETO is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for GAVRETO the next day. Do not take an additional dose if vomiting occurs after GAVRETO but continue with the next dose as scheduled. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions and dosage modifications for adverse reactions are provided in Table 1 and Tabl اقرأ الوثيقة كاملة