Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
LAROTRECTINIB AS SULFATE
BAYER ISRAEL LTD
L01XE53
SOLUTION (ORAL)
LAROTRECTINIB AS SULFATE 20 MG/ML
PER OS
Required
BAYER AG., GERMANY
LAROTRECTINIB
Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,• Who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• Who have no satisfactory treatment options
2020-04-19
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only VITRAKVI 20 MG/ML ORAL SOLUTION ACTIVE INGREDIENT Each ml contains 20 mg larotrectinib (as sulfate) Inactive ingredients and allergens: See section 6 “Additional information” and section 2 “Important information about some of the ingredients of this medicine”. 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? Vitrakvi is a monotherapy intended to treat solid tumours displaying NTRK (neurotrophic tyrosine receptor kinase) gene fusion in adults and children. Vitrakvi is administered when - these tumours are locally advanced or have spread to other parts of the body or if a surgery to remove the tumour is likely to cause severe complications, and IN ADDITION - there are no satisfactory treatment options. Before you receive Vitrakvi, your doctor will perform a test to check if you carry the change in the NTRK gene. THERAPEUTIC GROUP: Anti-neoplastic and immunomodulatory agents, anti-neoplastic agents, protein kinase inhibitors HOW VITRAKVI WORKS In patients whose cancer is due to an altered NTRK gene, the change in the gene causes the body to make an abnormal protein called TRK fusion protein, which can lead to uncontrolled cell growth and cancer. Vitrakvi blocks the activity of TRK fusion proteins and so may slow or stop the growth of the cancerous tumour. It may also help to shrink the cancerous tumour. If you have any questions on how Vitrakvi works or why it has been prescribed for you, ask your doctor, pharmacist or nurse. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitiv Leggi il documento completo
1 1. NAME OF THE MEDICINAL PRODUCT VITRAKVI 20 mg/mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib. Excipients with known effect: Each mL of oral solution contains 2 mg sodium benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Colourless to yellow or orange or red or brownish solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase ( _NTRK_ ) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1). 4.2 Posology and method of administration Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies. The presence of an _NTRK_ gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI. Posology _Adults _ The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs. _ _ _Paediatric population _ Dosing in paediatric patients is based on body surface area (BSA). The recommended dose in paediatric patients is 100 mg/m 2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs. 2 _Missed dose _ If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose. Patients should take the next dose at the next scheduled time. If the patient vomits after taking a dose, the patient should not take an additional dose to make up for vomiting. _ _ _Dose modification _ For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure Leggi il documento completo