Country: Իսրայել
language: անգլերեն
source: Ministry of Health
SOTORASIB
AMGEN EUROPE B.V.
L01XX73
FILM COATED TABLETS
SOTORASIB 120 MG
PER OS
Required
AMGEN EUROPE B.V., NETHERLANDS
SOTORASIB
LUMYKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an approved test, who have received at least one prior systemic therapy.
2022-06-27
Amgen Proprietary - Restricted 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is dispensed according to a doctor’s prescription only LUMYKRAS 120 MG FILM-COATED TABLETS Each film-coated tablet contains 120 mg of sotorasib. For inactive ingredients and allergens in the product - see section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? LUMYKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an approved test, who have received at least one prior systemic therapy. THERAPEUTIC GROUP: LUMYKRAS belongs to a group of medicines known as antineoplastic agents (cancer medicines). LUMYKRAS is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) when it is advanced and has spread to other parts of the body. LUMYKRAS is used when previous treatments were not effective in stopping the growth of the cancer, and when the cancer cells have a genetic change that allows them to produce an abnormal form of protein called KRAS G12C. The abnormal KRAS G12C protein, acts to help make cancer cells grow out of control. LUMYKRAS attaches to the protein and stops it from working, which may slow down or stop the growth of the cancer. Your doctor will test your cancer cells for this change beforehand to make sure that LUMYKRAS is right for you. If you have any questions about how LUMYKRAS works or why this medicine has been prescribed for you, ask your doctor, pharmacist, or nurse. 2. BEFORE USING THE MEDICINE SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Talk to your doctor, pharmaci read_full_document
Amgen Proprietary - Restricted 1 1. NAME OF THE MEDICINAL PRODUCT LUMYKRAS 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of sotorasib. Excipient with known effect Each film-coated tablet contains 108 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow film-coated tablet, oblong-shaped (7 mm × 16 mm), debossed with “AMG” on one side and “120” on the opposite side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LUMYKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an approved test, who have received at least one prior systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with LUMYKRAS must be initiated by a physician experienced in the use of anticancer medicinal products. The presence of a _KRAS G12C_ mutation must be confirmed using a validated test prior to initiation of LUMYKRAS therapy. Posology The recommended dose is 960 mg sotorasib (eight 120 mg tablets) once daily, at the same time each day. _Duration of treatment _ Treatment with LUMYKRAS is recommended until disease progression or unacceptable toxicity. _Missed doses or vomiting _ If less than 6 hours have passed since the scheduled time of dosing, the patient should take the dose as normal. If more than 6 hours have passed since the scheduled time of dosing, the patient must not take the dose. Treatment should be continued as prescribed the next day. If vomiting occurs after taking LUMYKRAS, the patient must not take an additional dose on the same day, and treatment must be continued as prescribed the next day. Amgen Proprietary - Restricted 2 _Dose modifications _ Dosing should be modified based on LUMYKRAS toxicity. The dose reduction rules outlined in section 4.2 are based on clinical data. Pharmacokinetic (PK) data do suggest a similar exposure at lower sotorasib dose read_full_document