Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
avelumab, Quantity: 20 mg/mL
Merck Healthcare Pty Ltd
Injection, concentrated
Excipient Ingredients: polysorbate 20; mannitol; glacial acetic acid; sodium hydroxide; water for injections
Intravenous Infusion
1
(S4) Prescription Only Medicine
BAVENCIO is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved based on tumour response rate, duration of response in a single arm study.,BAVENCIO is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy.,BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Visual Identification: Clear, colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-01-03
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 . BAVENCIO ® _avelumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BAVENCIO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of treating you with BAVENCIO against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, TALK TO YOUR DOCTOR, NURSE OR THE HOSPITAL PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT BAVENCIO IS USED FOR BAVENCIO contains the active substance avelumab, a monoclonal antibody, which is a protein designed to recognise and attach to a specific target in the body to help the immune system attack and destroy cancer cells. BAVENCIO is used to treat: • a rare type of skin cancer called metastatic Merkel cell carcinoma (mMCC) where the disease has spread. • a type of cancer in the bladder or urinary tract called urothelial carcinoma, when the disease is advanced or metastatic but has not progressed with platinum- based chemotherapy • a type of kidney cancer called renal cell carcinoma (RCC), when it is advanced, in combination with another medicine, axitinib. It is important that you also read the Consumer Medicine Information for axitinib. If you have any questions about axitinib, ask your doctor. This medicine is available only with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BAVENCIO HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN BAVENCIO _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE BAVENCIO: • if you are allergic (hypersensitive) to avelumab or any of the other ing Les hele dokumentet
Version: a007-0722 1 Supersedes: a006-0122 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 – BAVENCIO ® (AVELUMAB) CONCENTRATED SOLUTION FOR INJECTION (INTRAVENOUS INFUSION) 1. NAME OF THE MEDICINE avelumab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mL vial contains 200 mg of avelumab. Each mL of concentrate contains 20 mg of avelumab. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS BAVENCIO is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved based on tumour response rate, duration of response in a single arm study. BAVENCIO is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in the treatment of cancer. PREMEDICATION Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of BAVENCIO. If the fourth infusion is completed without an infusion-related ▼ Version: a007-0722 2 Supersedes: a006-0122 reaction, premedication for subsequent doses should be administered at the discretion of the physician. DOSAGE Merkel cell carcinoma The recommended dose of BAVENCIO as monotherapy is either 10 mg/kg body weight or 800 mg adm Les hele dokumentet