Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Romiplostim
Amgen Australia Pty Ltd
Medicine Registered
NPLATE ® _Romiplostim (rbe) ro''-mi''p-lo''-sti''m_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nplate. 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 Nplate 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 NPLATE IS USED FOR Nplate is used to treat low blood platelet counts in people with immune (idiopathic) thrombocytopenic purpura (called ITP). ITP is a disease in which your immune system destroys your platelets. Platelets are the cells in your blood that help seal cuts and form blood clots. If you have too few platelets you could bruise more easily than normal. You could also bleed for a long time after being injured. If your platelet count is very low, you may be at risk of serious, life-threatening bleeding. This medicine works by increasing the number of platelets made by your body. Nplate makes your bone marrow produce more platelets. This helps to prevent bruising and bleeding. Your doctor, however, may prescribe Nplate for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE NPLATE IF YOU HAVE AN ALLERGY TO: • any medicine containing romiplostim • any of the ingredients listed at the end of this leaflet • any medicines that are produced using the bacteria E.coli. 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 USE IT AFT Citiți documentul complet
Nplate ® (romiplostim) Product Information Page 1 of 16 NAME OF THE MEDICINE Nplate ® is the Amgen Inc. trademark for romiplostim (rbe). DESCRIPTION Romiplostim, a member of the thrombopoietin (TPO) mimetic class, is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as c-Mpl) to increase platelet production. The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing two thrombopoietin receptor-binding domains. Romiplostim is produced by recombinant DNA technology in _Escherichia coli_ (_E. coli_). Nplate is a sterile, white, preservative-free, lyophilised powder for reconstitution and administration as a subcutaneous (SC) injection. For a full list of excipients see PRESENTATION AND STORAGE CONDITIONS. PHARMACOLOGY PHARMACODYNAMICS Romiplostim increases platelet production through binding and activation of the thrombopoietin receptor, a mechanism analogous to endogenous thrombopoietin (eTPO). The TPO receptor is predominately expressed on cells of the myeloid lineage such as megakaryocyte progenitor cells, megakaryocytes and platelets. Nplate ® (romiplostim) Product Information Page 2 of 16 In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet count. The peak platelet counts in immune (idiopathic) thrombocytopenic purpura (ITP) patients who received a single subcutaneous dose of 1 to 10 µg/kg Nplate were 1.3 to 14.9 times greater than the baseline platelet count over a 2 to 3 week period; the response was variable among patients. The platelet counts of ITP patients wh Citiți documentul complet