Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Daratumumab
Janssen-Cilag Ltd
L01XC24
Daratumumab
20mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5012674902899
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION daratumumab 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. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DARZALEX is and what it is used for 2. What you need to know before you are given DARZALEX 3. How DARZALEX is given 4. Possible side effects 5. How to store DARZALEX 6. Contents of the pack and other information 1. WHAT DARZALEX IS AND WHAT IT IS USED FOR WHAT DARZALEX IS DARZALEX is a cancer medicine that contains the active substance daratumumab. It belongs to a group of medicines called “monoclonal antibodies”. Monoclonal antibodies are proteins that have been designed to recognise and attach to specific targets in the body. Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells. WHAT DARZALEX IS USED FOR DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”. This is a cancer of your bone marrow. DARZALEX is used if your cancer has not responded to, or has come back after treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DARZALEX YOU MUST NOT BE GIVEN DARZALEX: - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6). Do not use DARZALEX if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given DARZALEX. WARNINGS AND PRECAUTIONS Talk to your Baca dokumen lengkapnya
OBJECT 1 DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 29-Jun-2018 | Janssen-Cilag Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product DARZALEX 20 mg/mL concentrate for solution for infusion. 2. Qualitative and quantitative composition Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL). Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL). Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. Excipients with known effect Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion. The solution is colourless to yellow. 4. Clinical particulars 4.1 Therapeutic indications DARZALEX is indicated: • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy 4.2 Posology and method of administration DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Posology Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab. See below “Recommended concomitant medications”, “Management of infusion-rela Baca dokumen lengkapnya