Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
acalabrutinib, Quantity: 100 mg
AstraZeneca Pty Ltd
Capsule, hard
Excipient Ingredients: iron oxide yellow; indigo carmine aluminium lake; pregelatinised starch; sodium starch glycollate type A; Gelatin; Shellac; silicified microcrystalline cellulose; propylene glycol; titanium dioxide; iron oxide black; magnesium stearate
Oral
56 capsules
(S4) Prescription Only Medicine
CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia(CLL)/small lymphocytic lymphoma (SLL).
Visual Identification: Size 1 hard gelatin capsule with a yellow body and blue cap, marked in black ink with ACA 100 mg; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered (with Provisional Indication/s)
2019-11-21
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. You can report side effects to your doctor, or directly at www.tga.gov.au/ reporting-problems . CALQUENCE ® _Acalabrutinib_ THIS MEDICINE HAS PROVISIONAL REGISTRATION IN AUSTRALIA FOR (CALQUENCE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY.). THE DECISION TO PROVISIONALLY REGISTER THIS NEW USE OF THE MEDICINE HAS BEEN MADE ON THE BASIS OF PROMISING RESULTS FROM PRELIMINARY STUDIES. MORE EVIDENCE IS REQUIRED TO BE SUBMITTED WHEN AVAILABLE TO SUBSTANTIATE THE BENEFIT OF THE MEDICINE FOR THIS USE. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CALQUENCE. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CALQUENCE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CALQUENCE IS USED FOR CALQUENCE is an anticancer medicine used in adults to treat: • Mantle Cell Lymphoma (MCL), a type of blood cancer that affects the lymph nodes (lymph glands). It is used in patients who have had at least one other treatment for their cancer. • Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL), a type of blood cancer that affects lymphocytes (a certain type of white blood cell) and the lymph nodes. CALQUENCE contains the active ingredient acalabrutinib which belongs to a group of anti-cancer medicines called Bruton tyrosine kinase (BTK) inhibitors. BTK is a protein in the body that helps cancer cells to grow. CALQUENCE works by blocking BTK which may help to reduce the number of cancer cells and ma Preberite celoten dokument
1 of 23 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION CALQUENCE ® (ACALABRUTINIB) CAPSULES 1 NAME OF THE MEDICINE acalabrutinib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg acalabrutinib. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Capsule, hard. Size 1 hard gelatin capsule with a yellow body and blue cap, marked in black ink with ‘ACA 100 mg’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is approved via the PROVISIONAL APPROVAL pathway, based on overall response rate. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with CALQUENCE should be initiated and supervised by a physician experienced in the use of anticancer therapies. RECOMMENDED DOSAGE (18 YEARS AND ABOVE) _MANTLE CELL LYMPHOMA (MCL) _ The recommended dose of CALQUENCE for the treatment of MCL is 100 mg (1 capsule) twice daily. _CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) _ The recommended dose of CALQUENCE for the treatment of CLL is 100 mg (1 capsule) twice daily, either as monotherapy or in combination with obinutuzumab. Administer CALQUENCE ▼ 2 of 23 prior to obinutuzumab when given on the same day. Refer to the obinutuzumab product information for recommended obinutuzumab dosing information (for details of the combination regimen, see section 5.1 Pharmacodynamic properties). Doses should be separated by approximately 12 hours. Treatment with CALQUENCE should c Preberite celoten dokument