Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
Axitinib
Pfizer Australia Pty Ltd
Medicine Registered
INLYTA ® _Axitinib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about INLYTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking INLYTA against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT INLYTA IS USED FOR _WHAT INLYTA DOES_ INLYTA is used to treat a certain type of kidney cancer called renal cell carcinoma (RCC). It belongs to a group of medicines called tyrosine kinase inhibitors. _HOW INLYTA WORKS_ INLYTA contains the active substance axitinib. It works by reducing the blood supply to the tumour and slowing down the growth of cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY INLYTA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. INLYTA is only available with a doctor's prescription. It is not addictive. _USE IN CHILDREN_ The safety and efficacy of INLYTA have not been established in children. BEFORE YOU TAKE INLYTA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE INLYTA IF YOU HAVE AN ALLERGY TO: • any medicine containing axitinib • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU START TO TAKE IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PR Đọc toàn bộ tài liệu
Version: pfpinlyt10713 Supersedes: pfpinlyt10712 Page 1 of 17 PRODUCT INFORMATION INLYTA (AXITINIB) NAME OF THE MEDICINE Axitinib has the chemical name _N_-methyl-2-[3-((_E_)-2-pyridin-2-yl-vinyl)-1_H_-indazol- 6-ylsulfanyl]-benzamide. The molecular formula is C 22 H 18 N 4 OS and the molecular weight is 386.47 Daltons. The CAS Registry Number is 319460-85-0. The chemical structure is: O H N CH 3 S N H N N DESCRIPTION Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 g/mL. The partition coefficient (n-octanol/water) is 3.5. INLYTA is supplied as red film-coated tablets containing either 1 mg or 5 mg of axitinib together with cellulose - microcrystalline, lactose, croscarmellose sodium, magnesium stearate, and Opadry II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose, HPMC 2910/Hypromellose 15cP, titanium dioxide, glycerol triacetate, and iron oxide red. PHARMACOLOGY MECHANISM OF ACTION Axitinib is a selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3. These receptors are implicated in pathological angiogenesis, tumour growth, and metastatic progression of cancer. Axitinib has been shown to inhibit VEGF-mediated endothelial cell proliferation and survival. Axitinib inhibited the phosphorylation of VEGFR-2 in xenograft tumour vasculature that expressed the target _in _ _vivo_ and produced tumour growth delay, regression, and inhibition of Đọc toàn bộ tài liệu