New FDA-approved use for Rubraca as maintenance therapy

For women whose ovarian cancer has come back and is responding to a platinum-based chemotherapy

DETERMINED TO BE ME

New FDA-Approved use for Rubraca as maintenance therapy for women whose ovarian cancer has come back and is responding to a platinum-based chemotherapy. New FDA-Approved use for Rubraca as maintenance therapy for women whose ovarian cancer has come back and is responding to a platinum-based chemotherapy.

I AM MY OWN PERSON. MY DISEASE DOES NOT DEFINE ME. I WILL NOT LET OVARIAN CANCER HOLD ME BACK.

woman

How may Rubraca help?

Find out how Rubraca helped maintain the response to platinum‑based chemotherapy for some women in a clinical trial

woman

Hear Rita's Story

Watch Rita as she talks about her determination and experience taking part in a Rubraca clinical trial

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Looking for important information about Rubraca?

Learn about Rubraca dosing and possible side effects, or download an informational brochure

Please note: you can click on any word that is orange to view the definition in the glossary below.

Only take Rubraca® (rucaparib) tablets if your oncologist prescribed them to you. Do not give Rubraca to other people, even if they have the same symptoms you have. Rubraca may harm them. You can ask your oncologist or pharmacist for more information about Rubraca. Keep Rubraca and all medicines out of the reach of children.

For more information on how Rubraca may help maintain your response to platinum-based chemotherapy, talk to your oncologist today.


How may Rubraca help maintain the response to platinum‑based chemotherapy?

Rubraca® (rucaparib) tablets maintenance therapy was studied in a clinical trial of 564 women

Rubraca was evaluated in women whose ovarian cancer had come back and were in response to their second or later platinum-based chemotherapy. Of the women enrolled in the trial, 375 women were given 600 mg of Rubraca twice a day, and 189 women were given placebo twice a day. These women were treated with placebo because watchful waiting is a standard practice of oncologists when treatment is not considered to be immediately necessary.

Results reported by the clinical trial oncologists:

Median time to disease progression was twice as long in women taking Rubraca® (rucaparib) tablets versus placebo Median time to disease progression was twice as long in women taking Rubraca® (rucaparib) tablets versus placebo

10.8 months was the median* time to disease progression for women treated with Rubraca

5.4 months was the median time to disease progression for women treated with placebo

The goal of maintenance therapy is to help maintain the response to chemotherapy and delay disease progression.

*Median is the middle point in a range of numbers, half of which are above the middle point and half of which are below it.

Meet Rita Lee—diagnosed with ovarian cancer

Find out what inspires Rita Lee the most and how she remains strong for her husband and three daughters

Learn more about Rubraca

How is Rubraca thought to work?

X

Rubraca is a type of therapy called a PARP inhibitor

Rubraca® (rucaparib) tablets are thought to work by blocking PARP—a protein that helps repair DNA when it becomes damaged. This action may keep cancer cells from repairing their damaged DNA, causing them to die. Rubraca may also impact other cells and tissues.

If you have any questions about how Rubraca may work in the body, talk to your oncology healthcare team.

How do I take Rubraca?

X

Take 2 Rubraca tablets 2 times a day

Take 2 Rubraca tablets 2 times a day Take 2 Rubraca tablets 2 times a day
  • Starting dose is 600 mg (two 300-mg tablets) taken twice daily, about 12 hours apart
  • With or without food

Take Rubraca® (rucaparib) tablets exactly as your oncologist tells you

Your oncology healthcare team is the best source of information about how you're doing on your treatment. Don't forget to speak up and ask your oncologist questions at each visit or to call if you need an answer right away.

  • Do not change your dose or stop taking Rubraca unless your oncologist tells you to
  • If you miss a dose, take your next dose at your usually scheduled time. Do not take an extra dose to make up for a missed dose
  • If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time
  • If you take too much Rubraca, call your oncologist or go to the nearest emergency room right away

What are the possible side effects associated with Rubraca?

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Select Important Safety Information

Rubraca® (rucaparib) tablets 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

The most common side effects of Rubraca include:

  • nausea
  • tiredness or weakness
  • vomiting
  • decrease in hemoglobin (anemia)
  • changes in how food tastes
  • constipation
  • decrease in appetite
  • diarrhea
  • low blood cell counts
  • mouth sores
  • upper respiratory tract infection
  • shortness of breath
  • rash
  • changes in liver or kidney function
    blood tests
  • stomach (abdomen) pain
  • increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information about potential side effects with Rubraca, ask your oncology healthcare team or download the brochure below.

Download an informational brochure about Rubraca as maintenance therapy

This brochure was created to help you get started with Rubraca as a maintenance therapy for your ovarian cancer after it has come back and is in a response to platinum-based chemotherapy.

Download an informational brochure about Rubraca® (rucaparib) as maintenance therapy Download brochure
Download an informational brochure about Rubraca® (rucaparib) as maintenance therapy

If you have more questions about Rubraca, talk to your oncology healthcare team today.

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Glossary

Clinical trial: research that is designed to test new medical approaches, such as new medicines, and find out if they work and are safe for people.

Deoxyribonucleic acid (DNA): molecules that tell your cells how to survive and grow.

Disease progression: cancer that continues to grow or spread.

Median: the middle point in a range of numbers, half of which are above the middle point and half of which are below it. For example, in the following list of numbers—3, 5, 12—the median is 5.

Placebo: a substance that does not contain any active medication.

Platinum-based chemotherapy: chemotherapeutic agents containing the metal platinum, which is an important component of some anticancer drugs.

Poly (ADP-ribose) polymerase (PARP) inhibitor: medication that blocks PARP, a protein that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors may also impact other cells and tissues.

Response: therapeutic effect of treatment.

Watchful waiting: when an oncologist does not provide medicine but closely watches the disease to see if symptoms appear or change. Watchful waiting is often adopted when the risks of treatment outweigh the benefits or when treatment is not considered to be immediately necessary. Tests and exams can be used at this time to monitor the disease.

INDICATION

What is Rubraca?

Rubraca® (rucaparib) tablets are 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.

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

SELECT IMPORTANT SAFETY INFORMATION

warning

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.

talk

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
paper and pen

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed 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.

talk

Before you take Rubraca, tell your healthcare provider about all of your medical conditions, including if you:

women
  • 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 at least 6 months after receiving 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.
women
  • 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.
talk

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

talk

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn 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.

pen and paper

The most common side effects of Rubraca include:

  • nausea
  • tiredness or weakness
  • vomiting
  • decrease in hemoglobin (anemia)
  • changes in how food tastes
  • constipation
  • decrease in appetite
  • diarrhea
  • low blood cell counts
  • mouth sores
  • upper respiratory tract infection
  • shortness of breath
  • rash
  • changes in liver or kidney function
    blood tests
  • stomach (abdomen) pain
  • increased cholesterol levels
pen and paper

These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

iPhone

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.

Back to top

SELECT IMPORTANT
SAFETY INFORMATION Read Full

warning

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.

talk

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
paper and pen

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed 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.

talk

Before you take Rubraca, tell your healthcare provider about all of your medical conditions, including if you:

women women talk

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

talk

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn 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.

pen and paper

The most common side effects of Rubraca include:

  • nausea
  • tiredness or weakness
  • vomiting
  • decrease in hemoglobin (anemia)
  • changes in how food tastes
  • constipation
  • decrease in appetite
  • diarrhea
  • low blood cell counts
  • mouth sores
  • upper respiratory tract infection
  • shortness of breath
  • rash
  • changes in liver or kidney function
    blood tests
  • stomach (abdomen) pain
  • increased cholesterol levels
pen and paper

These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

iPhone

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.