Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Niraparib (tosilate monohydrate)
GlaxoSmithKline (Ireland) Limited
L01XK02
niraparib
Antineoplastic agents
Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy., as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.
Revision: 22
Authorised
2017-11-16
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZEJULA 100 MG HARD CAPSULES niraparib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zejula is and what it is used for 2. What you need to know before you take Zejula 3. How to take Zejula 4. Possible side effects 5. How to store Zejula 6. Contents of the pack and other information 1. WHAT ZEJULA IS AND WHAT IT IS USED FOR WHAT ZEJULA IS AND HOW IT WORKS Zejula contains the active substance niraparib. Niraparib is a type of anti-cancer medicine called a PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. This results in tumour cell death, helping to control the cancer. WHAT ZEJULA IS USED FOR Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen). Zejula is used for cancer that has: • responded to the first treatment with platinum-based chemotherapy, or • come back (recurred) after the cancer has responded to previous treatment with standard platinum-based chemotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEJULA _ _ DO NOT TAKE ZEJULA • if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6). • if you are breast-feeding. WA Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zejula 100 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib. Excipients with known effect Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4). Each hard capsule shell also contains 0.0172 mg of the colouring agent tartrazine (E 102). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zejula is indicated: • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. _ _ • as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology _First-line ovarian cancer maintenance treatment _ The recommended starting dose of Zejula is 200 mg (two 100-mg capsules), taken once daily. However, for those patients who weigh ≥ 77 kg and have baseline platelet count ≥ 150,000/μL, the recommended starting dose of Zejula is 300 mg (three 100-mg capsules), taken once daily (see section 4.4 and 4.8). _Recurrent ovarian cancer maintenance treatment_ The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg. Patients should be encouraged to take their dose at ap Læs hele dokumentet