Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Acalabrutinib
AstraZeneca AB
L01EL02
acalabrutinib
Antineoplastic agents, protein kinase inhibitors,
Leukemia, Lymphocytic, Chronic, B-Cell
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Revision: 7
Authorised
2020-11-05
66 B. PACKAGE LEAFLET 67 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CALQUENCE 100 MG HARD CAPSULES acalabrutinib This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET: 1. What Calquence is and what it is used for 2. What you need to know before you take Calquence 3. How to take Calquence 4. Possible side effects 5. How to store Calquence 6. Contents of the pack and other information 1. WHAT CALQUENCE IS AND WHAT IT IS USED FOR WHAT CALQUENCE IS Calquence is a medicine used to treat cancer. Calquence contains the active substance acalabrutinib. It belongs to a group of medicines called Bruton tyrosine kinase (BTK) inhibitors. WHAT CALQUENCE IS USED FOR Calquence is used to treat adults with chronic lymphocytic leukaemia (CLL). CLL is a cancer of white blood cells called B-lymphocytes (or B-cells). These cells are part of the immune system (the body’s defences). HOW CALQUENCE WORKS Calquence works by blocking BTK, a protein in the body that helps these cancer cells grow and survive. By blocking BTK, Calquence helps to kill and can reduce the number of cancer cells which can slow down the worsening of the disease. If you have any questions about how Calquence works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse. 68 Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Calquence 100 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of acalabrutinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Yellow body, blue cap, size 1 (20 mm) hard capsule, marked with “ACA 100 mg” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended dose is 100 mg acalabrutinib twice daily (equivalent to a total daily dose of 200 mg). Refer to obinutuzumab prescribing information for recommended obinutuzumab dosing information. The dose interval is approximately 12 hours. Treatment with Calquence should be continued until disease progression or unacceptable toxicity. 3 Dose adjustments _Adverse reactions_ Recommended dose modifications of Calquence for Grade ≥ 3 adverse reactions are provided in Table 1. TABLE 1. RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS* ADVERSE REACTION ADVERSE REACTION OCCURRENCE DOSE MODIFICATION (Starting dose = 100mg approximately every 12 hours) Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia Or Grade 4 neutropenia lasting longer than 7 days Grade 3 or greater non- haematological Aqra d-dokument sħiħ