healthcare provider if blood pressure is elevated [see WARNINGS AND PRECAUTIONS (5.3)].
Dosing Instructions
Inform patients on how to take ZEJULA [see DOSAGE AND ADMINISTRATION (2.1)]. ZEJULA should be taken once daily. Instruct patients that if they miss a dose of ZEJULA, not to take an extra dose to make up for the one that they missed. They should take their next dose at the regularly scheduled time. Each capsule should be swallowed whole. ZEJULA may be taken with or without food. Bedtime administration may be a potential method for managing nausea.
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see WARNINGS AND PRECAUTIONS (5.4) and USE IN SPECIFIC POPULATIONS (8.1)].
Contraception
Advise females of reproductive potential to use effective contraception during treatment with ZEJULA and for at least 6 months after receiving the last dose [see USE IN SPECIFIC POPULATIONS (8.3)].
Lactation
Advise patients not to breastfeed while taking ZEJULA and for 1 month after the last dose [see USE IN SPECIAL POPULATIONS (8.2)].
SPL UNCLASSIFIED SECTION
Manufactured for: TESARO, Inc. 1000 Winter St., #3300, Waltham, MA 02451
ZEJULA is a trademark of TESARO, Inc. All other trademarks referenced herein are the property of their respective owners.
©2017 TESARO, Inc. All rights reserved.
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PATIENT PACKAGE INSERT
PATIENT INFORMATION
ZEJULA™ (zuh-JOO-luh)
(niraparib)
capsules
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: March 2017
What is the most important information I should know about ZEJULA?
ZEJULA may cause serious side effects including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood 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. If you develop MDS or AML, your healthcare provider will stop treatment with ZEJULA.
Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include:
weakness
feeling tired
weight loss
frequent infections
fever
shortness of breath
blood in urine or stool
bruising or bleeding more easily
Your healthcare provider will do blood tests to check your blood cell counts:
before treatment with ZEJULA
weekly for the first month of treatment with ZEJULA
every month for the next 11 months, then as needed during treatment with ZEJULA
High blood pressure. High blood pressure is common during treatment with ZEJULA, and can become serious. Your healthcare provider will check your blood pressure and heart rate monthly for the first year and as needed thereafter during your treatment with ZEJULA.
See "WHAT ARE THE POSSIBLE SIDE EFFECTS OF ZEJULA?" for more information about side effects.
What is ZEJULA?
ZEJULA is a prescription medicine used for the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, w |
