y [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after receiving the last dose of Rubraca [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].
Photosensitivity: Advise patients to use appropriate sun protection due to the increased susceptibility to sunburn while taking Rubraca [see Adverse Drug Reactions (6.1)].
Lactation: Advise females not to breastfeed during treatment and for 2 weeks after the last dose of Rubraca [see Use in Specific Populations (8.2)].
Dosing Instructions: Instruct patients to take Rubraca orally twice daily with or without food. Doses should be taken approximately 12 hours apart. Advise patients that if a dose of Rubraca is missed or if the patient vomits after taking a dose of Rubraca, patients should not take an extra dose, but take the next dose at the regular time [see Dosage and Administration (2.1)].
Distributed by:
Clovis Oncology, Inc.
Boulder, CO 80301
1-844-258-7662
Rubraca is a trademark of Clovis Oncology, Inc.
PATIENT PACKAGE INSERT
This Patient Information has been approved by the U.S. Food and Drug Administration.
Issued: February 2017
PATIENT INFORMATION
Rubraca™ (roo-brah'-kah)
(rucaparib)
tablets
What is the most important information I should know about Rubraca?
Rubraca 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 or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.
Symptoms of low blood cell counts are common during treatment with Rubraca, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca:
weakness
weight loss
fever
frequent infections
blood in urine or stool
shortness of breath
feeling very tired
bruising or bleeding more easily
Your healthcare provider will do blood tests to check your blood cell counts:
before treatment with Rubraca.
every month during treatment with Rubraca.
weekly if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve.
See "WHAT ARE POSSIBLE SIDE EFFECTS OF RUBRACA?" for more information about side effects.
What is Rubraca?
Rubraca is a prescription medicine used to treat people with advanced ovarian cancer who:
have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and
have received previous treatment with 2 or more prior chemotherapy medicines for their cancer.
Your healthcare provider will perform a test to make sure Rubraca is right for you.
It is not known if Rubraca is safe and effective in children.
What should I tell my healthcare provider before taking Rubraca?
Before you take Rubraca, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with |
