Zejula Niraparib Capsules 100mg

Description

ZEJULA (Niraparib 100mg) is a prescription medicine used for the:maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with: a certain BRCA gene mutation, orgene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.Your healthcare provider will perform a test to make sure that ZEJULA is right for you.It is not known if ZEJULA is safe and effective in children.Important Safety InformationZEJULA may cause serious side effects, including:Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:WeaknessFeeling tiredWeight lossFrequent infectionsFeverShortness of breathBlood in urine or stoolBruising or bleeding more easilyYour doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and from time to time afterward.High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with ZEJULA.Posterior reversible encephalopathy syndrome (PRES) is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure, with or without high blood pressure, please contact your doctor.Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:Have heart problemsHave liver problemsHave high blood pressureAre allergic to FD&C Yellow No. 5 (tartrazine) or aspirin. ZEJULA capsules contain tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirinAre pregnant or plan to become pregnant. ZEJULA may harm an unborn baby and may cause loss of pregnancy (miscarriage)If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULAIf you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with ZEJULAYou should tell your doctor right away if you become pregnantAre breastfeeding or plan to breastfeedZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULATell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.