How can side effects be managed? | Rubraca® (rucaparib) tablets
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What are the possible side effects?
How can side effects be managed?

Most side effects can be managed and/or treated by your doctor

When taking Rubraca, discuss how you are feeling with your healthcare team. They may be able to give you tips and/or change your dose to help with side effects you may be experiencing.

Consider these tips to help with the most common side effects of Rubraca

The following tips are from the National Cancer Institute and the American Cancer Society and are not specific to Rubraca. Here are some of the most common side effects (reported by at least 20% of men) associated with Rubraca. They do not include all the side effects. Before you make any changes, be sure to talk with your healthcare team.

If you’re feeling weakness/fatigue, consider:

  • Balancing your daily routine with both rest and physical activity. Try light exercise every day, with plenty of short naps or breaks
  • Joining a support group to help alleviate some of the mental stress that can contribute to feeling tired or weak

If you are experiencing nausea and vomiting, consider:

  • Eating small, frequent meals or all-liquid meals
  • Choosing foods that are easy on the stomach (such as dry toast and crackers)
  • Serving meals at room temperature
  • Asking your healthcare team about antiemetics or antinausea medication that may help with nausea and vomiting

If you have decreased appetite, consider:

  • Eating foods that are high in calories and easy to eat (such as pudding, ice cream, sherbet, or cream-based soups)
  • Eating 5 or 6 small meals or snacks each day instead of 3 big meals
  • Eating with other family members and creating a pleasant ambiance at meals
  • Doing some light exercise an hour before meals
  • Having liquid meals, such as flavored smoothies or milkshakes

If you have diarrhea, consider:

  • Eating more foods that are high in sodium and potassium (including bananas, oranges, boiled or mashed potatoes, and peach or apricot nectar), because you lose these important nutrients when you have diarrhea
  • Drinking 8 to 12 cups of clear liquids each day and avoiding acidic drinks like tomato juice, citrus juices, and soft drinks
  • Talking to your healthcare team before taking any over-the-counter medicines to control your diarrhea
  • Recording the number of loose or runny stools you experience daily. Your healthcare team may prescribe medication to control your diarrhea

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.

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.