Rubraca® (rucaparib) tablets

INDICATIONS

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What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for:

  • the maintenance treatment of 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 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. Your healthcare provider will perform a test to make sure Rubraca is right for you.
  • 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 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.
  • You 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.

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 women in the Rubraca clinical studies were nausea, tiredness/weakness, stomach pain, rash, altered taste, decrease in hemoglobin, changes in liver or kidney function blood tests, constipation, vomiting, diarrhea, decrease in platelets, upper respiratory tract infection, mouth sores, decreased appetite, shortness of breath, and decrease in white blood cell count.

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.

INDICATIONS

Read Full ISI

What is Rubraca used for?

Rubraca® (rucaparib) tablets are a prescription medicine used in adults for:

  • the maintenance treatment of 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 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. Your healthcare provider will perform a test to make sure Rubraca is right for you.
  • 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 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.
  • You 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.

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 women in the Rubraca clinical studies were nausea, tiredness/weakness, stomach pain, rash, altered taste, decrease in hemoglobin, changes in liver or kidney function blood tests, constipation, vomiting, diarrhea, decrease in platelets, upper respiratory tract infection, mouth sores, decreased appetite, shortness of breath, and decrease in white blood cell count.

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.