Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
acalabrutinib maleate monohydrate, Quantity: 129 mg
AstraZeneca Pty Ltd
Tablet, film coated
Excipient Ingredients: mannitol; microcrystalline cellulose; hyprolose; sodium stearylfumarate; hypromellose; copovidone; titanium dioxide; macrogol 3350; medium chain triglycerides; iron oxide yellow; iron oxide red
Oral
56 tablets
(S4) Prescription Only Medicine
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).
Visual Identification: The CALQUENCE 100 mg film-coated tablet is an orange, 7.5 x 13 mm, oval, biconvex tablet, debossed with 'ACA 100' on one side and plain on the reverse; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered (with Provisional Indication/s)
2022-10-13
CALQUENCE ® TABLETS C A L Q U E N C E ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING CALQUENCE TABLETS? CALQUENCE tablets contains the active ingredient acalabrutinib maleate monohydrate. CALQUENCE tablets is used to treat Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL). For more information, see Section 1. Why am I using CALQUENCE tablets? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CALQUENCE TABLETS? Do not use if you have ever had an allergic reaction to CALQUENCE or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use CALQUENCE tablets? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CALQUENCE tablets and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CALQUENCE TABLETS? • The usual dose is one 100 mg tablet twice a day. Doses should be taken about 12 hours apart. • Swallow the tablet whole with water. Do not chew, crush, dissolve, or divide the tablets. More instructions can be found in Section 4. How do I use CALQUENCE tablets? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CALQUENCE? THINGS YOU SHOULD DO • Remind any doctor, dentist, nurse, surgeon or pharmacist you visit that you are using CALQUENCE tablets. • You should be careful to protect yourself from the sun. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or change the dose without checking with your doctor. • Do not give this medicine to anyone else, even Baca dokumen lengkapnya
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 (AS MALEATE MONOHYDRATE) TABLETS 1 NAME OF THE MEDICINE acalabrutinib maleate monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains acalabrutinib maleate monohydrate equivalent to 100 mg of acalabrutinib . For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The CALQUENCE 100 mg film-coated tablet is an orange, 7.5 x 13 mm, oval, biconvex tablet, debossed with ‘ACA 100’ on one side and plain on the reverse. 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 tablet) twice daily. ▼ 2 of 23 _CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) _ The recommended dose of CALQUENCE for the treatment of CLL is 100 mg (1 tablet) twice daily, either as monotherapy or in combination with obinutuzumab. Administer CALQUENCE 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 Baca dokumen lengkapnya