Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
imatinib mesilate
Juno Pharmaceuticals Pty Ltd
imatinib mesilate
Registered
Glivanib 100 mg & 400 mg capsules Page 1 of 10 V2-1016 GLIVANIB _Imatinib (as imatinib mesilate) capsules_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GLIVANIB capsules. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. 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 this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GLIVANIB CAPSULES ARE USED FOR GLIVANIB is used to treat adults who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL). CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. GLIVANIB kills the abnormal cells while leaving normal cells alone. GLIVANIB is also used to treat adults for: • MYELODYSPLASTIC / MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. • AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM). It is a cancer in which certain blood cells, called "mast" cells, grow out of control. • HYPEREOSINOPHILIC SYNDROME (HES) AND OR CHRONIC EOSINOPHILIC LEUKAEMIA (CEL). These are blood diseases in which some blood cells, named "eosinophils", start growing out of control. • DERMATOFIBROSARCOMA PROTUBERANS (DFSP). DFSP is a cancer of the tissue beneath the skin in which some Read the complete document
Glivanib PI Juno Pharmaceuticals Pty Ltd Doc ID: 143.GL.P.1.0 Page 1 of 47 GLIVANIB IMATINIB( AS MESILATE) capsules PRODUCT INFORMATION NAME OF THE MEDICINE AUSTRALIAN-APPROVED-NAME Active ingredient: imatinib as the mesilate salt. (alpha crystals) Chemical name: 4‐[(4‐Methylpiperazin‐1‐yl)methyl]‐N‐[4‐methyl‐3‐[[4‐ (pyridin‐3‐yl) pyrimidin‐2‐yl]amino]phenyl]benzamide methanesulfonate Molecular formula: C 29 H 31 N 7 O . CH 4 SO 3 CAS NUMBER : 152459-95-5 (free base); 220127-57-1 (mesilate) Molecular weight: 493.6 (free base) + 96.1 (mesilate) = 589.7 STRUCTURAL FORMULA : C H 3 N C H 3 H N N N N H N N O . CH 3 SO 3 H DESCRIPTION Imatinib mesilate is a white to slightly yellowish powder. It is freely soluble in water and aqueous buffers ≤ pH 5.5 and less soluble in more neutral/alkaline aqueous buffers. In non- aqueous solvents, the compound is soluble in dimethyl sulfoxide, methanol and ethanol, but is insoluble in n-octanol, acetone and acetonitrile. Each hard gelatin capsule contains 100 MG or 400 MG of imatinib (equivalent to 119.50 or 478mg imatinib mesilate, respectively). Glivanib PI Juno Pharmaceuticals Pty Ltd Doc ID: 143.GL.P.1.0 Page 2 of 47 EXCIPIENTS: Lactose anhydrous, crospovidone, colloidal anhydrous silica and magnesium stearate. Capsule cap and body contains gelatin, water- purified, iron oxide red (CI 77491), iron oxide yellow (CI 77492), titanium dioxide (CI 77891) and sodium lauryl sulfate. Since there is no lower dose (50 mg) of GLIVANIB capsules currently available, if a 50 mg dose of imatinib is required, an alternative product must be used. PHARMACOLOGY ATC CODE Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01XE01 MECHANISM OF ACTION Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the BCR-ABL tyrosine kinase (TK), as well as several receptor TKs: KIT, the receptor for stem cell factor (SCF) coded for by the KIT proto-oncogene, the discoidin domain receptors (DDR1) and DDR2), the c Read the complete document