Why does BRCA status matter? | Rubraca® (rucaparib) tablets
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What is Rubraca?
Why does BRCA status matter?

BRCA gene mutations play an important role in mCRPC

Rubraca is for men with BRCA gene mutations. Everyone has BRCA1 and BRCA2 genes, which play an important role in normal day-to-day functions of cells. Some men, however, may have “broken” BRCA genes, called mutations. BRCA gene mutations increase the likelihood of developing certain cancers, including prostate cancer, and may help your doctor anticipate the aggressiveness of your disease and evaluate treatment options.

About 1 in 8 men (12%) with mCRPC may be BRCA gene mutation-positive (BRCA+) About 1 in 8 men (12%) with mCRPC may be BRCA gene mutation-positive (BRCA+)

There are 2 types of BRCA gene mutations:

  • Inherited (also called germline), meaning the gene mutation is passed down from parent to child. Germline mutations are present in every cell in the body, not just in the tumor cells
  • Acquired (also called somatic), meaning the gene mutation is not passed down from parent to child, but occurs randomly and can develop at any time. Somatic mutations are only present in the tumor cells

If you have a family history of certain types of cancers, including prostate cancer, you may have a greater likelihood of carrying a BRCA gene mutation.

There are several tests to detect BRCA gene mutations that will determine if you are a potential candidate for Rubraca

  • While some tests are designed to look for inherited BRCA gene mutations or for acquired BRCA mutations, other tests can look for both. Your doctor will recommend the test that is right for you
  • Your doctor might see if Rubraca is right for you by doing a blood test, called a blood-based biopsy (or liquid biopsy). This test is less invasive than a tissue biopsy and can identify both inherited and acquired BRCA gene mutations

Talk to your doctor to see if getting tested for a BRCA gene mutation is right for you.

INDICATION

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What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for the treatment of castration-resistant prostate cancer (prostate cancer that no longer responds to medical or surgical treatment that lowers testosterone):

  • that has spread to other parts of the body, and
  • has a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, and you have been treated with certain medicines for your cancer.

Rubraca was approved based on response rate and how long patients’ responses lasted. There are ongoing studies to confirm the clinical benefit of Rubraca. 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.

SELECT IMPORTANT SAFETY INFORMATION

What Warnings should I know about Rubraca?

Rubraca 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, although MDS or AML was not observed in men with prostate cancer during the clinical study. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

You should not use Rubraca if you are a male with a female partner who is pregnant or able to become pregnant. Effective birth control should be used during treatment and for 3 months after the last dose of Rubraca. Do not donate sperm during use and for 3 months after the last dose of Rubraca.

What other important information should I know about Rubraca?

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.

Avoid spending time in sunlight while on Rubraca since your skin may become more sensitive to the sun and may sunburn more easily. 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.

What are the side effects of Rubraca?

The most common side effects for men in Rubraca clinical studies were weakness/fatigue, nausea, decreased red blood cell count, changes in liver function tests, decreased appetite, constipation, rash, decreased platelet count, vomiting, and diarrhea.

What other medications might interact with Rubraca?

Rubraca can increase the amounts of other medications you may be taking which can increase the risk of side effects. Tell your healthcare provider about all of your medical conditions and all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

INDICATION

Read Full ISI

What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for the treatment of castration-resistant prostate cancer (prostate cancer that no longer responds to medical or surgical treatment that lowers testosterone):

  • that has spread to other parts of the body, and
  • has a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, and you have been treated with certain medicines for your cancer.

Rubraca was approved based on response rate and how long patients’ responses lasted. There are ongoing studies to confirm the clinical benefit of Rubraca. 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.

SELECT IMPORTANT SAFETY INFORMATION

What Warnings should I know about Rubraca?

Rubraca 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, although MDS or AML was not observed in men with prostate cancer during the clinical study. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

You should not use Rubraca if you are a male with a female partner who is pregnant or able to become pregnant. Effective birth control should be used during treatment and for 3 months after the last dose of Rubraca. Do not donate sperm during use and for 3 months after the last dose of Rubraca.

What other important information should I know about Rubraca?

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.

Avoid spending time in sunlight while on Rubraca since your skin may become more sensitive to the sun and may sunburn more easily. 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.

What are the side effects of Rubraca?

The most common side effects for men in Rubraca clinical studies were weakness/fatigue, nausea, decreased red blood cell count, changes in liver function tests, decreased appetite, constipation, rash, decreased platelet count, vomiting, and diarrhea.

What other medications might interact with Rubraca?

Rubraca can increase the amounts of other medications you may be taking which can increase the risk of side effects. Tell your healthcare provider about all of your medical conditions and all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.