Land: Israel
Språk: engelsk
Kilde: Ministry of Health
VENETOCLAX
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
L01XX52
FILM COATED TABLETS
VENETOCLAX 50 MG
PER OS
Required
ABBVIE INC., USA
VENETOCLAX
Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaVENCLEXTA in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who have received at least one prior therapy.VENCLEXTA in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).Acute Myeloid LeukemiaVENCLEXTA in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
2020-01-12
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only VENCLEXTA ® 10 MG TABLETS VENCLEXTA ® 50 MG TABLETS VENCLEXTA ® 100 MG TABLETS FILM-COATED TABLETS THE ACTIVE INGREDIENT AND ITS QUANTITY: Each Venclexta 10 mg tablet contains 10 mg venetoclax Each Venclexta 50 mg tablet contains 50 mg venetoclax Each Venclexta 100 mg tablet contains 100 mg venetoclax For the list of inactive ingredients, please see section 6 “Further Information” in this leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for your ailment/ for you. Do not pass it on to others. It may harm them even if it seems to you that their ailment/medical condition is similar. IN ADDITION TO THE LEAFLET, THE MEDICINE VENCLEXTA HAS A ‘QUICK START GUIDE’ FOR CLL/SLL PATIENTS. THIS GUIDE INCLUDES IMPORTANT GUIDELINES REGARDING THE START OF THE TREATMENT, WHICH YOU SHOULD KNOW. READ THE 'QUICK START GUIDE’ THAT COMES WITH THE ‘CLL/SLL STARTING PACK’, BEFORE STARTING TREATMENT WITH THE MEDICINE. KEEP THE GUIDE FOR LATER REFERENCE IF NEEDED. 1. WHAT IS THE MEDICINE INTENDED FOR? Venclexta, as monotherapy or in combination with rituximab, is intended for the treatment of patients with chronic lymphocytic leukemia )CLL) or patients with small lymphocytic lymphoma )SLL), who have received at least one prior treatment. Venclexta, in combination with obinutuzumab, is intended for the treatment of patients with previously untreated chronic lymphocytic leukemia )CLL) or patients with small lymphocytic lymphoma )SLL). Venclexta, in combination with hypomethylating agents or in combination with low-dose cytarabine, is intended for the treatment of patients with newly diagnosed acute myeloid leukemia )AML) who are not eligible for intense chemotherapy. THERAPEUTI Les hele dokumentet
Page 1 of 47 VEN API Jan 22_CL VENCLEXTA ® 10 MG TABLETS VENCLEXTA ® 50 MG TABLETS VENCLEXTA ® 100 MG TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Venclexta 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax. Venclexta 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax. Venclexta 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax. For the full list of inactive ingredients, see section 11 . PATIENT QUICK START GUIDE The 'Patient Quick Start Guide', includes instructions regarding the correct medication schedule and safety information for CLL/SLL Patients. Please explain to the patient the need to review the guide before starting treatment. The 'Patient Quick Start Guide' is included in the 'CLL/SLL Starting Pack'. 1 INDICATIONS AND USAGE 1.1 CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA VENCLEXTA in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who have received at least one prior therapy. VENCLEXTA in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 ACUTE MYELOID LEUKEMIA VENCLEXTA in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 2 DOSAGE AND ADMINISTRATION Page 2 of 47 VEN API Jan 22_CL 2.1 RECOMMENDED DOSAGE Assess patient-specific factors for level of risk of tumor lysis syndrome (TLS) and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of VENCLEXTA to reduce risk of TLS _[see Dosage and Administration (2.2) and Warnings and Precautions _ _(_ 5.1 _)]_ . Instruct patients to take VENCLEXTA tablets with a meal and water at approximately the same time each day. VENCLE Les hele dokumentet