Rubraca® (roo-brah’-kah) (Rucaparib)

Rubraca®
(roo-brah’-kah)
(Rucaparib)

Chemotherapy

Rubraca®
(roo-brah’-kah)
(Rucaparib)

Chemotherapy

What is RUBRACA (Rucaparib)?

Rubraca is a prescription medicine used for:

The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy.
The treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer.

It is not known if Rubraca is safe and effective in children.

What is the most important information I should know about RUBRACA?

RUBRACA can cause serious side effects. These serious side effects include:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have 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:

How should I take RUBRACA?

Take Rubraca exactly as your healthcare provider tells you.
Your healthcare provider may temporarily stop treatment with Rubraca or change your dose of Rubraca if you have side effects. Do not change your dose or stop taking Rubraca unless your healthcare provider tells you to.
Take Rubraca 2 times a day. Each dose should be taken about 12 hours apart.
Take Rubraca with or without food.
If you miss a dose of Rubraca, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose.
If you vomit after taking a dose of Rubraca, do not take an extra dose. Take your next dose at your usual time.
If you take too much Rubraca, call your healthcare provider or go to the nearest emergency room right away.

Important Safety Information

Avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may sunburn more easily during treatment with Rubraca. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight
If you vomit after taking a dose of Rubraca, do not take an extra dose. Take your next dose at your usual time.
If you take too much Rubraca, call your healthcare provider or go to the nearest emergency room right away.
Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca.
It is not known if Rubraca passes into breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca.

Ask your healthcare provider if you do not know.

What should I tell my healthcare provider before taking 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 Rubraca.
If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Rubraca.
Females who are able to become pregnant should use effective birth control during treatment and for 6 months after the last dose of Rubraca. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant.
Are breastfeeding or plan to breastfeed. It is not known if Rubraca passes into breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

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General information about RUBRACA?

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Rubraca for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

What are the ingredients in RUBRACA?

Active ingredient: Rucaparib

Other ingredient: Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. The film coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, and talc. The blue film coating contains brilliant blue aluminum lake and indigo carmine aluminum lake. The yellow film coating contains yellow iron oxide.

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